Inclusion of active substances in Annex I or IA to...

Bifenthrin Product-type 8 24/09/2010

Directive 98/8/EC concerning the placing biocidal products on the market

Inclusion of active substances in Annex I or IA to Directive 98/8/EC

Assessment Report

Bifenthrin Product-type PT8

(Wood preservatives)

24/09/2010

Annex I - FR


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Bifenthrin (PT8)

Assessment report

Finalised in the Standing Committee on Biocidal Products at its meeting on 24/09/2010 in view of its inclusion in Annex I to Directive 98/8/EC

Contents 1 STATEMENT OF SUBJECT MATTER AND PURPOSE..........................................4

1.1 Procedured followed..................................................................................................... 4 1.2 Purpose of the assessment report .................................................................................. 5 1.3 Overall conclusionin the context of Directive 98/8/EC................................................ 5

2 OVERALL SUMMARY AND CONCLUSIONS ..........................................................7 2.1 PresentAtion of the active substance ............................................................................ 7

2.1.1 Identity, Physico-Chemical properties & Methods of Analysis ........................... 7 2.1.1.1 Active substance ............................................................................................... 7 2.1.1.2 Biocidal product................................................................................................ 8

2.1.2 Intended uses and efficacy.................................................................................... 9 2.1.2.1 Field of use / Function / Mode of action........................................................... 9

2.1.2.1.1 Field of use.................................................................................................. 9 2.1.2.1.2 Function .................................................................................................... 10 2.1.2.1.3 Mode of action .......................................................................................... 10

2.1.2.2 Objects to be protected, Target organisms...................................................... 10 2.1.2.3 Resistance ....................................................................................................... 10

2.1.3 Classification and Labelling ............................................................................... 10 2.2 Summary of the risk assessment................................................................................. 13

2.2.1 Human health Risk Assessment.......................................................................... 13 2.2.1.1 Hazard identification....................................................................................... 13 2.2.1.2 Effects assessment .......................................................................................... 13 2.2.1.3 Exposure assessment....................................................................................... 16 2.2.1.4 Risk characterisation....................................................................................... 19

2.2.2 Environment risk assessment.............................................................................. 28 2.2.2.1 Fate and distribution in the environment ........................................................ 28 2.2.2.2 Effects on environemental organisms............................................................. 29

2.2.2.2.1 Effects on aquatic species......................................................................... 29 2.2.2.2.2 Terrestrial compartment............................................................................ 30 2.2.2.2.3 Atmosphere............................................................................................... 30 2.2.2.2.4 Summary of PNEC values ........................................................................ 30

2.2.2.3 Evironmental exposure assessment ................................................................ 31 2.2.2.4 Risk characterisation....................................................................................... 31

2.2.2.4.1 Aquatic compartment (including water, sediment and STP).................... 31 2.2.2.4.2 Sewage treatment plant organisms ........................................................... 32 2.2.2.4.3 Atmosphere............................................................................................... 32 2.2.2.4.4 Terrestrial compartment............................................................................ 32 2.2.2.4.5 Ground water ............................................................................................ 33


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2.2.2.4.6 Secondary poisoning................................................................................. 33 2.2.2.5 PBT assessment .............................................................................................. 33

2.2.3 Risk assessment for physico-chemical properties .............................................. 34 2.2.3.1 Hazard identification for physico-chemical properties (active substance)..... 34 2.2.3.2 Hazard identification for physico-chemical properties (product)................... 34 2.2.3.3 Risk characterisation for the physico-chemical properties ............................. 34

3 DECISION.......................................................................................................................35 3.1 Background to the proposed decision......................................................................... 35 3.2 Decision regarding the inclusion in annex I ............................................................... 36 3.3 Elements to be taken into account by member states when authorising products...... 36 3.4 Requirement for further information .......................................................................... 38 3.5 Updating this evaluation report................................................................................... 38

Appendix I: Listing of endpoints...........................................................................................39 Appendix II: list of intended uses..........................................................................................53 Appendix III: List of studies..................................................................................................54


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1 STATEMENT OF SUBJECT MATTER AND PURPOSE

1.1 PROCEDURED FOLLOWED

This assessment report has been established as a result of the evaluation of bifenthrin as product-type 8 (wood preservatives), carried out in the context of the work programme for the review of existing active substances provided for in Article 16(2) of Directive 98/8/EC concerning the placing of biocidal products on the market1, with a view to the possible inclusion of this substance into Annex I or IA to the Directive. Bifenthrin (CAS no. 82657-04-3) was notified as an existing active substance, by FMC Chemical sprl, hereafter referred to as the applicant, in product-type 8. Commission Regulation (EC) No 2032/2003 of 4 November 20032 lays down the detailed rules for the evaluation of dossiers and for the decision-making process in order to include or not an existing active substance into Annex I or IA to the Directive. In accordance with the provisions of Article 5(2) of that Regulation, France was designated as Rapporteur Member State to carry out the assessment on the basis of the dossier submitted by the applicant. The deadline for submission of a complete dossier for bifenthrin as an active substance in Product Type 8 was 28th of March 2004, in accordance with Annex V of Regulation (EC) No 2032/2003. On 29th of March 2004, the French competent authorities received a dossier from the applicant. The Rapporteur Member State accepted the dossier as complete for the purpose of the evaluation on 27th of September, 2004. On 05th December 2007, the Rapporteur Member State submitted, in accordance with the provisions of Article 10(5) and (7) of Regulation (EC) No 2032/2003, to the Commission and the applicant a copy of the evaluation report, hereafter referred to as the competent authority report. The Commission made the report available to all Member States by electronic means on 17th January 2008. The competent authority report included a recommendation for the inclusion of bifenthrin in Annex I to the Directive for PT 8. In accordance with Article 12 of Regulation (EC) No 2032/2003, the Commission made the competent authority report publicly available by electronic means on 18th February 2008. This report did not include such information that was to be treated as confidential in accordance with Article 19 of Directive 98/8/EC. In order to review the competent authority report and the comments received on it, consultations of technical experts from all Member States (peer review) were organised by the Commission. Revisions agreed upon were presented at technical and competent authority meetings and the competent authority report was amended accordingly.

1 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing biocidal products on the market. OJ L 123, 24.4.98, p.1 2 Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market and amending Regulation (EC) No 1896/2000. OJ L 307, 24.11.2003, p. 1


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On the basis of the final competent authority report, the Commission proposed the inclusion of bifenthrin in Annex I to Directive 98/8/EC and consulted the Standing Committee on Biocidal Product on 24/09/2010. In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the present assessment report contains the conclusions of the Standing Committee on Biocidal Products, as finalised during its meeting held on 24/09/2010.

1.2 PURPOSE OF THE ASSESSMENT REPORT

This assessment report has been developed and finalised in support of the decision to include bifenthrin in Annex I to Directive 98/8/EC for product-type 8. The aim of the assessment report is to facilitate the authorisation in Member States of individual biocidal products in product-type 8 that contain bifenthrin. In their evaluation, Member States shall apply the provisions of Directive 98/8/EC, in particular the provisions of Article 5 as well as the common principles laid down in Annex VI. For the implementation of the common principles of Annex VI, the content and conclusions of this assessment report, which is available at the Commission website3, shall be taken into account. However, where conclusions of this assessment report are based on data protected under the provisions of Directive 98/8/EC, such conclusions may not be used to the benefit of another applicant, unless access to these data has been granted.

1.3 OVERALL CONCLUSION IN THE CONTEXT OF DIRECTIVE 98/8/EC

The overall conclusion from the evaluation is that it may be expected that there are products containing bifenthrin for the product-type 8, which will fulfil the requirements laid down in Article 10(1) and (2) of Directive 98/8/EC. This conclusion is however subject to:

i. compliance with the particular requirements in the following sections of this assessment report,

ii. the implementation of the provisions of Article 5(1) of Directive 98/8/EC, and

iii. the common principles laid down in Annex VI to Directive 98/8/EC.

Furthermore, these conclusions were reached within the framework of the uses that were proposed and supported by the applicant (see Appendix II). Extension of the use pattern beyond those described will require an evaluation at product authorisation level in order to establish whether the proposed extensions of use will satisfy the requirements of Article 5(1) and of the common principles laid down in Annex VI to Directive 98/8/EC. It shall be noted that Bifenthrin was also used as agricultural insecticide on a large variety of crops in Europe, including cereals, vegetable, vine grape and fruits. There was also a use on post harvest treatment on cereals grain (wheat, barley, oat, tritical). A dossier was submitted under directive 91/414/EEC in the first part of the third round of the review program (December 2003). During the evaluation of the PPP uses, a number of concerns have been

3 http://ec.europa.eu/comm/environment/biocides/index htm


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identified. In particular, based on the data lodged by the notifier within the legal deadlines, it was not possible to assess the potential contamination of groundwater by a major soil degradation product (TFP acid). Furthermore, concerns have been raised as regards a possible underestimation of the risk to consumers, due to the limited number of residue data made available and the lack of investigation on the metabolism pattern of the two isomers constituting bifenthrin. As regards ecotoxicology, the risk to aquatic vertebrates has not shown to generate acceptable uses, while there is a remaining uncertainty as regards the effects of the experienced bioaccumulation in fish of the active substance. Furthermore, high risks have been identified for mammals (long-term risk and secondary poisoning), earthworms (long-term risk) and non-target arthropods (in-field), while the risk to non-target plants and non target soil macro-organisms has not been sufficiently addressed. Consequently, it was not possible to conclude, on the basis of the information made available within the legal deadlines, that bifenthrin met the criteria for inclusion in Annex I to Directive 91/414/EEC. A non-inclusion decision of bifenthrin in Annex I to Directive 91/414/EEC was taken on 30 November 2009 (decision 2009/887/EC). A new dossier with additional data has been submitted in February 2010. This dossier is currently under review.


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2 OVERALL SUMMARY AND CONCLUSIONS 2.1 PRESENTATION OF THE ACTIVE SUBSTANCE

2.1.1 Identity, Physico-Chemical properties & Methods of Analysis

2.1.1.1 Active substance

Identification of the substance Bifenthrin is a wood preservative, belonging to the pyrethroid family. Its structure and relevant physical/chemical properties are shown below:

Chemical name of bifenthrin:

IUPAC: 2-methylbiphenyl-3-ylmethyl(1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate

CAS: [1α,3α(Z)]-(±)-3-(2-Chloro-3,3,3-trifluoro-1-propenyl)-2,2-dimethylcyclopropanecarboxylic acid (2-methyl[1,1’-biphenyl]-3-yl)methyl ester

CAS registry number: 82657-04-3 EEC: not allocated CIPAC: 415

Empirical formula C23H22ClF3O2

Molecular weight 422.88 Purity ≥ 911 g/kg

Impurities are by-products of synthesis at maximal levels each comprised between 0.1% and 4.2 % except water (0.1 %) and solvent (1.5 %) arising from incomplete removal of water soluble components and volatile solvents. Physico-chemical properties The purified bifenthrin is a waxy beige solid, melting at 66-69°C, with a fatty odour under normal temperature and pressure conditions. It decomposes before boiling at 285°C. Its relative density is 1.316 g/cm³. Bifenthrin is not volatile and its vapour pressure is low (2.4 x 10-5 Pa at 25°C).


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It is almost insoluble (< 1 µg/L) in water at 20°C at all tested pH’s, however it is soluble in most of the organic solvents (48 g/L in methanol to 743.2 g/L in 1,2 dichloroethane). Its log Pow is >6. Bifenthrin does not hydrolyse, but degrades by photolysis under artificial light with a DT50 of 10 days. The estimated half-life under natural conditions is 24.4 days (40°N, Madrid summer conditions). Under late summer outdoor sunlight irradiation at 41° N (USA) photolysis of bifenthrin was slow with a half-life of about 255 days. Bifenthrin is not flammable, and has a flash point higher than 110°C. It does not present explosive or oxidising properties. It is stable in storage conditions for up to 2 years despite it cannot be considered as thermally stable in the sense of OECD 113. Analytical methods for detection and identification

Adequate methodologies exist for the determination of bifenthrin in the technical substance, soil*, water, sediment* and products of animal origin.

Analytic methods of bifenthrin and impurities in technical material based on high-resolution gas chromatography (HRGC), high-performance liquid chromatography (HPLC) or gel permeation chromatography (GPC) with flame ionization, diode array or UV-absorbance detectors.

The methods in environmental and animal matrices have been adequately validated, with reserve that the specificity was not confirmed for methods in soil and sediment. They are based on either GC or HPLC separation with electron captor (ECD) or mass spectroscopic (MSD) detectors. * GC-ECD methods need to be validated with a confirmatory method for specificity, e.g. by MS identification. When confirmatory methods are not submitted (in this case for soil and sediment), this will be required before product authorisation (see Doc I 3.3)

2.1.1.2 Biocidal product

Identification of the product

Trade name No trade name yet

Manufacturer´s development code number(s)

EQEF 244

Ingredient of preparation Function Content

Bifenthrin Active substance 3 % = 30 g/L (0.03% = 0.3 g/L ready-to-use)

Formulants

Water

Details on the composition of the product are confidential.

Physical state of preparation

1. Liquid in drums

2. Liquid in water-soluble bags

3. Liquid ready-for-use

Nature of preparation Micro-emulsion


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Physico-chemical properties The product EQEF 244 is a homogenous, very clear yellow translucent liquid, free from visible suspended matter and sediment, and with a chemical odour. It has a flashpoint higher than 79°C. Based on the molecular structure of the active substance and the other ingredients, explosive and oxidizing properties are not expected. A 1% dilute emulsion has a pH of 5.21 and an alkalinity of 0.011% w/w as NaOH. The relative density of EQEF 244 is 1.0031 g/cm3 at 20°C ± 0.5°C. The emulsifiability of the product was tested in CIPAC water A and D, and was always higher than 97.7% (0.16%v/v and 1% v/v tested). Furthermore, persistence of foaming was >100 mL after 10 sec and 1 min, 36 mL after 3 min and 20 mL after 12 min. Surface tension of the product was 31.4 mN/m at both 25 and 40°C, dilution of the product resulted in a surface tension of 28.3 mN/m of 0.16% v/v and 28.7 mN/m of 1% v/v, both at 20°C. The viscosity of EQEF 244 was 181.76 mm2/s at 20°C and 69.12 mm2/s at 40°C. The product showed to be stable during accelerated storage test and 2-year storage. Analytical methods for detection and identification A validated method for the determination of bifenthrin in formulated product is available, based on GC/FID.

2.1.2 Intended uses and efficacy

2.1.2.1 Field of use / Function / Mode of action

2.1.2.1.1 Field of use

Main group 2 (MG): preservatives Product type 8 (PT): wood preservative Bifenthrin is intended to be used as a preventive and curative wood preservative for wood and construction timbers in Use Classes 1, 2, and 3 according to ISO draft standard.

- Use Class 1: Situation in which wood or wood-based product is under cover, fully protected from the weather and not exposed to wetting,

- Use Class 2: Situation in which wood or wood-based product is under cover, fully protected from the weather but where high environmental humidity can lead to occasional but not persistent wetting,

- Use Class 3: Situation in which wood or wood-based product is not covered and not in contact with the ground. It is either continually exposed to the weather or is protected from the weather but subject to frequent wetting.

The product is used professionally in industrial setting by dipping (for use classes 1, 2 and 3.1). The vacuum-pressure application, initially submitted by the applicant, was not supported by efficacy data. Further documentation on efficacy will be required in case of a future application for authorisation of products involved in such an application.

The product is also used by professionals for residential treatment of wood (i.e. on attics) by spraying, brushing or injecting. Furthermore, the product is used by the general public, also for residential treatment of wood (i.e. on attics) by spraying, brushing or injecting. Efficacy trials with the bifenthrin wood preservative product show that these products are effective as wood preservative.


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2.1.2.1.2 Function

The active substance Bifenthrin is claimed as a wood preservative against wood destroying insects.

2.1.2.1.3 Mode of action

Bifenthrin is a pyrethroid of type 1. It negatively influences the sodium ion equilibrium along the nerve cell membrane. This disrupts the normal transmission of nerve impulses causing repetitive firing of the insect's nerve resulting in paralysis and ultimately death. Bifenthrin is active by contact, ingestion or inhalation. Because of its low vapour pressure, insects or mites must come into contact with bifenthrin for it to be effective. Bifenthrin, like all pyrethroids, causes knockdown and paralysis of insects and mites. Bifenthrin is not an ovicide but is effective against all other insect life cycle stages.

2.1.2.2 Objects to be protected, Target organisms

The applicant claims an efficacy of bifenthrin as wood preservative against the following wood insects: Scolytus sp., Inoderus minutus, Anobium punctatum, Xestobium rufovillosum, Hylotrupes bajulus, Lyctus bruneus. During the assessment stage, only valid data have been submitted to support the efficiency of Bifenthrin as a wood preservative against Hylotrupes bajulus, Reticulitermes sp. in preventive treatments and only against Hylotrupes bajulus in curative treatments.

2.1.2.3 Resistance

Until the edition of this report, there is no evidence and no suggestion of any pyrethroid resistance in wood boring insects. Given the use and applications of bifenthrin-based wood preservative products, no resistance is expected and reported in wood preservation. The RMS recommends setting up a monitoring as far as protocols and guidelines on how to conduct such a monitoring will be available.

2.1.3 Classification and Labelling

Classification and labelling (active substance) Proposed classification of the substance according to Directive 67/548/EEC: - Hazard symbols: T Toxic

N Dangerous for the environment - Risk phrases: R23 Toxic by inhalation

R25 Toxic if swallowed [R40 Limited evidence of carcinogenic effect. Category 3] R43 May cause sensitisation by skin contact [R48/22 Danger of serious damage to health by prolonged exposure] R50/53 Very toxic to aquatic organisms, may cause long term adverse

effects in the aquatic environment


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The RMS has proposed a multiplying factor of 10 000 on the active substance and therefore the classification N, R50/53 should apply. 4 Under Directive 67/548/EEC, specific concentration limits are proposed for environment:

Specific concentration limits: C ≥ 0.0025 % N, R50/53

0.00025 % ≤ C < 0.0025 % N, R51/53 0.000025 % ≤ C < 0.00025 % R52/53

- Safety phrases: S23 Do not breathe vapour and spray

S36/S37 Wear suitable protective clothing and gloves S38 In case of insufficient ventilation, wear suitable respiratory

equipment. S45 In case of accident or if you feel unwell, seek medical advice

immediately (show the label where possible) S60 This material and its container must be disposed of as hazardous

waste S61 Avoid release to the environment. Refer to special instructions

safety data sheet.

The safety phrase S24 (Avoid contact with skin) usually applied for pyrethroid pesticides causing paresthetic effects is not proposed since the safety phrase S36/37 already apply. Proposed classification of the substance according to GHS: [Carc.2 – H351 Category 2 carcinogen _ Suspected of causing cancer] Acute Tox. 3 – H331 Toxic if inhaled Acute Tox. 2 – H300 Fatal if swallowed Skin Sens. 1 – H317 May cause an allergic skin reaction STOT Rep. 1 – H372 (nervous system) Causes damage to central nervous system through prolonged or

repeated exposure by oral route Aquatic. Acute – H400 Very toxic to aquatic life Aquatic. Chronic – H410 Very toxic to aquatic life with long lasting effects An annex VI dossier according to regulation CE 1272/2006 on classification and labelling has been submitted to ECHA to establish an harmonised classification. Classification, packaging and labelling (product) The concentrated product containing 30 g/L bifenthrin ME is classified as in Directive 67/548/EEC, 99/45/EC as follows: - Hazard symbols: Xn Harmful N Dangerous for the environment - Risk phrases: R20 Harmful by inhalation R22: Harmful if swallowed R36: Irritating to eyes

4 Multiplifying factor according to Directive 2006/8/EC


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[R40 Limited evidence of carcinogenic effect Category 3] R43 May cause sensitisation by skin contact

R50/53: Very toxic to aquatic organisms, may cause long term adverse effects in the aquatic environment

- Safety phrases: S13 Keep away from food, drink and animal feedingstuffs S23 Do not breathe vapour andspray S25 Avoid contact with eyes S36/37 Wear suitable protective clothing and gloves S46 If swallowed, seek medical advice immediately and show this

container or label S57 Use appropriate containment to avoid environmental

contamination S60 This material and its container must be disposed of as

hazardous waste S61 Avoid release to the environment. Refer to special

instructions/safety data sheet The concentrated product containing 30 g/L bifenthrin ME is classified as in GHS as follows: [Carc.2 – H351 Category 2 carcinogen _ Suspected of causing cancer] Acute Tox. 4 – H332 Harmful if inhaled Acute Tox. 4 – H302 Harmful if swallowed Eye irrit. 2 – H319 Causes serious eye irritation Skin Sens. 1 – H317 May cause an allergic skin reaction Aquatic. Acute – H400 Very toxic to aquatic life Aquatic. Chronic – H410 Very toxic to aquatic life with long lasting effects The ready-for-use product containing 0.3 g/L bifenthrin is classified as in Directive 67/548/EEC, 99/45/EC as follows: - Hazard symbols: N Dangerous for the environment - Risk phrases: R50/53: Very toxic to aquatic organisms, may cause long term adverse

effects in the aquatic environment - Safety phrases: S29/56 Do not empty into drains, dispose of this material and its

container at hazardous or special waste collection point S61 Avoid release to the environment. Refer to special

instructions/safety data sheet The ready-for-use product containing 0.3 g/L bifenthrin is classified as in GHS as follows: Aquatic. Acute – H400 Very toxic to aquatic life Aquatic. Chronic – H410 Very toxic to aquatic life with long lasting effects


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2.2 SUMMARY OF THE RISK ASSESSMENT

2.2.1 Human health Risk Assessment

2.2.1.1 Hazard identification

Bifenthrin is a pyrethroid of type 1. It negatively influences the sodium ion equilibrium along the nerve cell membrane. This disrupts the normal transmission of nerve impulses causing tremors, ataxia, clonic convulsions and paraesthetic reactions.

2.2.1.2 Effects assessment

Toxicokinetics Absorption Considering that bile excretion does not necessarily imply that the parent compound or the metabolites are available for the systemic absorption, the oral absorption rate could be estimated in the range of 20-50 %. However, since a definite value should be used for the risk characterisation for the derivation of the systemic NOAEL, the absorption rate of 50% (corresponding to the summation of the urinary and biliary excretion and tissue residues) will be kept as a reasonable percentage value for the derivation of the systemic NOAEL. No animal or human studies were available to estimate an inhalation absorption level of bifenthrin. So, the 100 % default absorption factor for pulmonary fraction is used as a worst case value for bifenthrin penetration by inhalation route. Dermal absorption for the pure active substance was studied in two in vivo rats studies and in one in vitro study with rat and human skins. The value of 11.4 % derived from the human in vitro data will be used for the risk characterisation. Distribution

Blood bio-kinetics showed that blood level of radioactivity slowly increased with time and reached its peak at 4 and 6 hours after oral administration, following low and high dose administration, respectively, and then slowly declined thereafter. In a bioaccumulation study, the highest levels of residues were detected in fat and skin with parent chemical accounting for the majority of the residue. The estimated half-lives were 51 days (fat), 50 days (skin), 19 days (liver), 28 days (kidney), 40 days (ovaries and sciatic nerve). A steady state appeared in plasma concentrations of radioactivity at the 21st day (0.04 to 0.06 µg/ml) and then, decreased rapidly at 78 days and was below <0.01 µg/ml at the remaining sacrifice time. These long biological half-lives were anticipated based on the high log Pow of bifenthrin (log Pow 6.6). In a range-finding developmental neurotoxicity study, exposure of the pups to the test article via the milk was determined based on measurements of the test material in milk on lactation days 5, 11 and 17 following dietary administration of the test article from gestation day 6 through lactation day 22 and comparing internal levels in the dams and pups via the blood. The mean levels of bifenthrin in maternal plasma and in milk samples were clearly increased at the highest tested dose level showing that bifenthrin was excreted in breast milk. The pup plasma bifenthrin level was increased at PND4 when the dams were exposed to the highest dose. It could be then assumed that bifenthrin was able to cross the placenta barrier.


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However, the plasma bifenthrin level was not increased in pups from treated dams at PND22 compared to controls, showing that bifenthrin was not or slightly absorbed from the milk or rate of metabolism was faster in pup rats at PND22. Metabolisation Bifenthrin metabolisation in the rat is similar to other pyrethroids that are also metabolised through typically hydrolysis with formation of the corresponding alcohol, oxidation of the resulting alcohol to the acid followed by a conjugation process. Elimination The majority of radioactivity was eliminated via faeces (66-83%) and at a lesser extent in urine (9-25%) within 48-72 hours. Biliary excretion was the second most significant excretion pathway (20-30%). No remarkable sex differences in elimination or distribution were observed. Acute toxicity Based on the results of the acute toxicity studies, bifenthrin is classified as 'toxic' according to the classification criteria as given in Annex VI to Commission Directive 67/548/EEC with the risk phrase R25 - Toxic if swallowed and R23 - Toxic by inhalation. Bifenthrin showed very low acute dermal toxicity (LD50>2000 mg/kg bw), no additional classification is required. Local toxicity Technical bifenthrin was found to be a skin sensitizer to guinea-pigs in the maximisation test, and therefore has to be classified according to Annex VI to Commission Directive 67/548/EEC as Xi; R43: may cause sensitisation by skin contact. Bifenthrin has no potential for skin or eye irritation and no additional classification is required. Repeated dose toxicity The toxicity of bifenthrin resulting from oral repeated exposure has been evaluated in various animal species (rat, mouse and dog) and for various duration of exposure (28-day, 90-day, 52 -week and 2-year studies). Among these studies, the chronic (52 weeks) toxicity study in dogs is considered to be the pivotal study for bifenthrin. Based on the occurrence of tremors, a NOAEL of 1.5 mg/kg bw/day was determined and used for risk characterisation. The major functional changes (tremors and convulsions) observed from 200 ppm (22 mg/kg bw/day) or 300 ppm respectively, in a 28-day rat study indicated a serious adverse effect. According to the findings of the 90-day rat study, tremors are observed from 100 ppm (approx. 8 mg/kg bw/d). Based on the Directive 67/548/EEC criteria, a classification with Xn; R48/22 is justified when serious damages are observed between 5 and 50 mg/kg/d by oral route in 90-day studies and therefore, Xn; R48/22 might be considered for bifenthrine.

Bifenthrin was found to have a much lower subchronic systemic toxicity by the dermal route with a NOAEL of 50 mg/kg bw/day when administered to rats for 21 days. Bifenthrin induced paresthesia after dermal application.

No study for inhalation exposure was required due to the negligible inhalation exposure during the use of bifenthrin-containing wood preservative products and the weak vapour pressure of bifenthrin. However, it is possible to read-across from the oral study to determine the systemic exposure and calculate an AEL.


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Genotoxicity Assays used to evaluate the genotoxicity of bifenthrin technical were conducted in vitro using bacterial and mammalian cell and in vivo using rats and mice. Some of the in vitro genotoxic assays were positive, namely an unscheduled DNA synthesis (UDS) test and a gene mutation assay on mouse lymphoma L5178Y cells. The unscheduled DNA synthesis (UDS) test was replicated in vitro yielding negative responses. Equivocal results were obtained in other gene mutation tests on CHO and mouse lymphoma L5178Y cells (HGPRT). However, the in vivo available studies, namely a cytogenetic assay, an oral micronucleus test and an Unscheduled DNA Synthesis test did not exhibit any genotoxic potential. Overall, these in vivo test results do not justify a request for classification of bifenthrin as a genotoxic. Chronic toxicity/Carcinogenicity The carcinogenicity studies in rats indicated that bifenthrin technical is not oncogenic. In the oncogenicity study in mice, increased incidences of leiomyosarcoma in the urinary bladder were observed in males (statistically significant at 600 ppm). After re-evaluation of this study by a panel of pathologists, it was concluded that the mouse bladder tumour was not a leiomyosarcoma but rather a pericytoma. Other tumours such as lymphoblastic lymphosarcoma/leukaemia (statistically significant at 600 ppm) and bronchiolar-alveolar adenocarcinoma and adenoma (slight increased incidence, statistically significant at 50, 200 and 600 ppm, without dose-related effect) were observed in females. Dose-related increased incidence of liver adenocarcinoma and adenoma were observed in males from 200 ppm but was not statistically significant. Based on these results, it might be considered that there is a “limited evidence of carcinogenicity effects” which deserves discussion for a R40 classification Category 3. A NOAEL for tumours might be tentatively set at 74 mg/kg bw/d in male mice based upon the increase in urinary bladder tumours at 600 ppm (92 mg/kg bw/day). The NOAEL for systemic toxicity in rat was set at 50 ppm and in mice, at 200 ppm for female (37 mg/kg/day) and 50 ppm for male (7.6 mg/kg/day) based on the occurrence of tremors. No dermal chronic toxicity study has been submitted in the bifenthrin dossier. However, it is possible to read-across from the available oral toxicity studies to determine the systemic exposure and to calculate an AEL. Reproductive toxicity

• Developmental toxicity When bifenthrin was evaluated for embryo/foetotoxicity and teratogenicity by the oral route, there was no evidence of embryotoxicity/foetotoxicity or teratogenicity up to maternally toxic doses in rabbits and rats. An additional study was conducted in rats in which bifenthrin was administered through diet, resulting in a lower toxicity.

• Fertility

In a diet multi-generation reproduction study in rats (two generations), no effect on reproductive performance or fertility was observed at doses which produced maternal toxicity. Neurotoxicity/developmental neurotoxicity Bifenthrin was tested in an acute oral delayed neurotoxicity study and was not considered to be a delayed neurotoxicant when administered to adult hens. The LOAEL was determined to be 5000 mg/kg. In another acute oral neurotoxicity study in Sprague Dawley rats with undiluted bifenthrin, the NOAEL


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was 35 mg/kg bw. It did not cause behavioural neurotoxicity when tested in Wistar rats at 30 mg/kg by oral route in the tilting-plane test. In a sub-chronic neurotoxicity test in Sprague Dawley rats a NOAEL of 50 ppm (2.9 mg/kg bw/d and 3.7 mg/kg bw/d in males and females respectively) was established with clinical signs of neurotoxicity (tremors, twitching, FOB) observed from 100 ppm. Based on the occurrence of tremors at the beginning of the study (week 4), the NOAEL of 3 mg/kg bw/d was used for risk characterisation. In a developmental neurotoxicity test with dietary exposure in rats, a NOAEL of 50 ppm in food was also established. Human data

FMC Corporation Emergency Calls in 2002 included 58 calls involving formulations containing bifenthrin. Most of these calls were pertaining to individuals applying products containing bifenthrin and having experienced accidental exposures. The predominant finding was dermal sensations of burning/tingling, which mostly resolved within 24 hours. The second most common complaint was eye irritation. The third most common complaint was nasal and respiratory irritation.

Medical surveillance data showed that no unexplained/significant changes from the baseline were noted for employees working in the synthetic pyrethroids business unit for 14 years.

A literature search was conducted for reports of signs and symptoms of exposure in the general population. No such reports were found. However, numerous studies reviews of human poisoning with pyrethroids and epidemiological studies have been published. Occupationally, the main adverse effect of dermal exposure of pyrethroids is paresthesia, most commonly affected the face. Management of pyrethroid toxicity is supportive and symptomatic. As paresthesia usually resolve in 12-24 h, specific treatment is not generally required, although topical application of vitamin E may reduce their severity. Based on the occurrence of paresthesia in human exposed to bifenthrin as well as in rodents, the necessity to classify Xn; R48/22 could be discussed at the C&L group.

2.2.1.3 Exposure assessment

The exposure assessment for professional use (industrial and residential), use by the general public, and secondary use are calculated with simple data base models as proposed in the TNG Human exposure to biocidal products – Guidance on exposure estimation, or, when possible, with the computer based models EASE or Riskofderm. The results are summarised in the tables below. Primary exposure Exposure of professionals using bifenthrin as wood preservative

The exposure assessment has been carried out on a water-based in-use formulation containing 0.03% w/w bifenthrin, ready-to-use and using personal protective equipment (PPE).

All the intended uses proposed by the applicant have been assessed. However, in accordance with the conclusion of the efficacy assessment, the application by vacuum pressure was not supported by the RMS because of the lack of efficacy data related to this mode of application. Some of the scenarios are nevertheless based on this application since it is assumed that further efficacy data will be provided at the product authorisation stage. Because vacuum pressure impregnation leads to the highest concentration of the substance in wood, this approach should be thenceforth considered as a worst case for the indirect exposure.


Page 17 of 77

The concentrated product is diluted 100 times and the filling of the basin used for the dilution is done automatically by pumping the product into the basin. Therefore, industrial and professional workers are mainly exposed to the diluted form (0.03%) of the product. The dermal absorption of 11.4%, corresponding to the use concentration (0.03%), has been selected for internal exposure assessment. Summary of direct exposure of professionals using bifenthrin as wood preservative

Inhalation exposure Dermal exposure

Exposure scenario Tier Exposure

duration by inhalation

mg bifenthrin

/m3*

Systemic dose (mg bifenthrin / kg bw / day)**

Use of PPE

mg bifenthrin

/day

Systemic dose (mg bifenthrin / kg bw /day)***

Total systemic exposure

(mg bifenthrin / kg bw /day)

1 40 min

(+30 min) 3.00 x10-4 (5.7 x10-4)

1.01 x10-5 only

gloves 2.93 5.56 x10-3 5.57 x10-3

1. Industrial-dipping (+ post-application) 2

40 min (+30 min)

3.00 x10-4 (5.70 x10-4)

1.01 x10-5 Yes 1.00 1.91 x10-3 1.92 x10-3

1 540 min 5.70 x10-4 1.07 x10-4 No 8.69 1.65 x10-2 1.66 x10-2 2. Industrial- vacuum impregnation 2 540 min 5.70 x10-4 1.07 x10-4 Yes 2.90 5.51 x10-3 5.62 x10-3

1 80 min 2.28 x10-2 6.34 x10-4 No 11.96 2.27 x10-2 2.34 x10-2 3a. Residential spraying 2 80 min 2.28 x10-2 6.34 x10-4 Yes 1.53 2.90 x10-3 3.54 x10-3

1 155 min 9.3 x10-4 5.05 x10-5 No 8.64 1.64 x10-2 1.65 x10-2 3b. Residential brushing 2 155 min 9.3 x10-4 5.05 x10-5 Yes 1.11 2.11 x10-3 2.16 x10-3

1 - - - No 3.95**** - - 3c. Residential injecting 2 - - - Yes 39.47**** - -

* estimated potential exposure per batch is [indicative value exposure from model x 0.03% bifenthrin (dilution of active substance)] see appendix

**exposure duration x inhalation rate (0.021m3/min) x mg bifenthrin/m3 ÷ 60 kg (adult body weight)

*** dermal exposure (mg bifenthrin/day) x dermal absorption (11.4%) ÷ 60 kg (adult body weight)

**** a reverse calculation has been made for this scenario. So exposure data correspond to the lowest potential exposures without and with gloves leading to an unacceptable risk

Exposure of the general public using bifenthrin as wood preservative

Three different application modes are considered: spraying, brushing and injecting. The product is ready-to-use, there is no exposure linked to preparation (mixing and loading). The post-application exposure linked to cleaning of equipment is considered negligible. For each case, inhalation, dermal exposure and oral exposure are determined.


Page 18 of 77

Summary of direct exposure of general public using bifenthrin as wood preservative Table 2.2.1-1: Summary of non-professional exposure data using bifenthrin wood preservative:

Inhalation exposure Dermal exposure

Exposure scenario

exposure duration by inhalation

(min)

mg bifenthrin

/m3*

internal body burden (mg bifenthrin / kg

bw day)**

mg bifenthrin

/day

internal body burden (mg bifenthrin /kg bw

day)***


4a. Residential spraying

80 (+30 post

application) 3.45 x10-2 9.58 x10-4 7.19 1.37 x10-2 1.46 x10-2

4b. Residential brushing

155 9.30 x10-4 5.05 x10-5 8.64 1.64 x10-2 1.64 x10-2

4c. Residential injecting Tier 1

- - - 6.58**** - -

4c. Residential injecting Tier 2 (revised short-term AEL)

18.79****

* Estimated potential exposure per batch is [indicative value exposure from model x 0.03% bifenthrin (dilution of active substance)]

** Duration x inhalation rate (0.021m3/min) x estimated inhalation exposure (mg bifenthrin/m3) ÷ 60 kg (adult body weight)

*** Dermal exposure (mg bifenthrin/day) x dermal absorption (11.4%) ÷ 60 kg (adult body weight)

**** A reverse calculation has been made for this scenario. So exposure data correspond to the lowest potential exposures without PPE leading to an unacceptable risk Secondary exposure Both short- and long-term exposures are considered for indirect (or secondary) exposure.

� Short-term exposure is relevant for:

1. Adults sanding industrial treated wood (inhalation)

2. Adults touching freshly treated wood (dermal exposure)

3. Infants chewing treated wood off-cut (oral exposure)

� Long-term exposure is relevant for:

1. Adults in a moderately ventilated room containing treated wood (inhalation)

2. Children playing on treated wood outdoor playground structure (dermal exposure to surface residues)

3. Infants playing on treated wood outdoor playground structure (dermal and oral exposure to surface residues)


Page 19 of 77

Summary of indirect exposure of general population as a result of the use of bifenthrin as wood preservative

Category of exposure

Exposure scenario

Inhalation (mg bifenthrin

/kg bw/day)

Dermal (mg bifenthrin

/kg bw/day)

Oral (mg bifenthrin/

kg bw/day)


(mg bifenthrin /kg bw/day)

1a. Adult sanding treated timber

1.17 x 10-5 1.44 x 10-4 Not relevant 1.56 x 10-4

2. Adult handling wet treated timber

Not relevant 7.18 x 10-3 Not relevant 1.78 x 10-3 Short-term

3. Infant chewing Not relevant Negligible 3.60 x 10-3 3.6 x 10-3

1b. Adult sanding treated timber

7.03 x 10-5 1.44 x 10-4 Not relevant 2.14 x 10-4

4a. Adult in a room with treated wood

1.29 x 10-3 Negligible Not relevant 1.29 x 10-3

4b. infant in a room with treated wood

1.68 x 10-3 Negligible Negligible 1.68 x 10-3

5. Child playing on playground equipment

Not relevant 2.74 x 10-4 Negligible 2.74 x 10-4

Long-term

6. Infant playing on treated wood and mouthing

Not relevant 4.10 x 10-4 2.25 x 10-3 2.66 x 10-3

2.2.1.4 Risk characterisation

ADI determination Bifenthrin is not intended for use on food or feed, therefore no ADI was determined. The human health risk characterisation is performed using both the AEL and the MOE approaches. AELs determination For each exposure scenario, an appropriate AEL is determined on the basis of the exposure frequency. Accordingly, three types of AELs are classically derived: AELshort-term, AELmedium-term and AELlong-term

corresponding to short-, medium- and long-term exposures respectively. AELs are usually derived by applying the following formula:

factorsAssessment

NOAELAEL =


Page 20 of 77

In the case of bifenthrin, the AELshort-term was derived on the basis of the NOAEL of 3 mg/kg bw/day obtained in the 91-day oral rat neurotoxicity study. This study was actually considered as the most appropriate for deriving a short-term AEL as tremors occurred as soon as the week 4. The AELmedium-term and the AELlong-term were based on the 1-year oral dog study in which the NOAEL was 1.5 mg/kg bw/day. Regarding the assessment factors, a default value of 100 (including an inter-species factor of 10 and an intra-species factor of 10) was applied. This value is used as the reference margin of exposure (MOEref). Taking into account an oral absorption rate of 50%, the following AELs were therefore derived:

• AELshort-term = 3 x 0.5 / 100 = 0.015 mg/kg bw/day

• AELmedium-term = 1.5 x 0.5 / 100 = 0.0075 mg/kg bw/day

• AEL long-term = 1.5 x 0.5 / 100 = 0.0075 mg/kg bw/day In the AEL approach, a risk is considered as acceptable if AEL > exposure. In practice, exposure is expressed as a percentage of the AEL (%AEL). The risk is therefore considered as acceptable if %AEL < 100.

In the MOE approach, a risk is considered as acceptable if MOE > MOEref (where Exposure

NOAELMOE = ).

Risk characterisation for primary exposure scenarios The major occupational routes of exposure to bifenthrin are inhalation and skin contact. Assuming proper hygiene measures are applied, oral exposure would normally not occur at the workplace. The %AELs and the Margins of Exposure (MOE) were calculated for the in-use and post application exposure periods as below:

Bifenthtin Product-type 8 24/09/2010

• Professional users

Table 2.2.1.4-1: Summat-y of systemic. exposure for industrial uses

Total systemic Relevant AEL Exposure

Exposure Scenatio dose NOAEL MOE,., (mg/kg bw/d) (mg/kg bw/d)

(mg/kg bw/d) (%AEL)

J. Industrial- dipping (+ post application)

Tiet· 1 5.57 x10·3 0.75 100 0.0075 74.3

(without PPE)

Tiet· 2 (wit.h PPE *) l.92 x10·3 0.75 100 0.0075 25.6

2. l ndustrial-vac1111m impregnation

Tier 1 l.66 x10·2 0.75 100 0.0075 221.3 (without PPE)

Tiet· 2 (wit.h PPE *) 5.62 x10·3 0.75 100 0.0075 74.9

*(1.e., gloves and cotton coverall)

Conclusion For industrial uses scenarios: "Industrial-dipping" and "Industrial-vacuum impregnation" the % of AEL and the calculated MOE are acceptable for Tier 2 (with PPE: new gloves and cotton coverall) (% AEL ~100 and MOE > MOE1.er). Therefore, for these industrial, the risk is considered as acceptable under the specified conditions.

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MOE

134.6

390.6

45.2

133.5

Bifenth1in Product-type 8 24/09/2010

Table 2.2.1.4-2: Summa1-y of systemic. exposure for residential uses

Total systemic Relevant AEL Exposur e

Exposure Scenario exposm·e NOAEL MOEr.r (mg/kg bw/d) (%AEL) MOE (mg/kg bw/d) (mg/kg bw/d)

1. Residential spraying

Tier 1 2.34 x10·2 0.75 100 0.0075 312 32.1 (without PPE)

Tier 2 (with PPE*) 3.54 x10·3 0.75 100 0.0075 47.2 211.9

2. Residential brushing

Tier 1 1.65 x10·2 0.75 100 0.0075 220 45.5 (without PPE)

Tie1· 2 (with PPE *) 2.16 x10·3 0.75 100 0.0075 28.8 347.2

3. Residential injecting

Tier 1 (without PPE)

See calculations below

Tier 2 (with PPE *)

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Page 23 of 77

Injecting scenario: There is no information available to estimate the exposure during injecting. However, it seems reasonable to assume that both dermal and inhalation exposure during injecting activities is less than for the other two approaches (spraying or brushing). A reverse calculation is proposed to assess injecting exposure:

Tier 1 without gloves

Tier 2 with gloves

Chronic AEL 7.5 x 10-3 Same as tier 1 mg/kg bw

body weight 60 Same as tier 1 kg

dermal absorption 11.40% Same as tier 1

glove penetration 100% 10%

a.s. concentration 0.03% Same as tier 1

density 1.003 Same as tier 1 g/ml

Reverse a.s. actual exposure 3.95 39.47 mg a.s.

reverse product actual exposure 13157.89 131578.95 mg product

reverse product volume actual exposure 13.12 131.19 ml

The reverse calculation show that a potential dermal exposure to 13.12 ml of product without gloves and 131.19 ml with gloves are needed to induce an unacceptable risk. The Emission Scenario Document OCDE for wood preservatives part 2 considers a loss of 5% of injected product by dripping. According to applicant information on injection process, 150 g of product (4.49 g of active substance) are injected per hole. Considering a product density of 1.003 g/cm3, 150 g represent 149.55 ml of product. Based on the ESD 7.48 ml of product will drip from each injection point during the process. Without gloves a contact with the entire product dripping after one injection result to 56.99% of volume needed to achieve an unacceptable risk. With gloves only 5.70% are achieved. So, a potential dermal exposure to 13.12 ml of product does not seem unrealistic. Professional exposure while injecting could be considered acceptable only if gloves are worn and if direct contact with spilling is avoided. Conclusion For professional uses scenarios: “Residential spraying” and “Residential brushing”, the % of AEL and the calculated MOE are acceptable for Tier 2 (with PPE: new gloves and cotton coverall) (% AEL ≤100 and MOE > MOEref). Therefore, the risk is considered as acceptable under the specified conditions. Thus no further adjustment is needed. With regard to the “Residential Injecting” scenario, a reverse calculation was proposed to assess this exposure. The conclusion is that professional exposure while injecting could be considered acceptable only if gloves are worn and if direct contact with spillage is avoided.


• Non-professional users

Table 2.2.1.4-3: Summary of systemic exposure for non-professional uses


Exposm·e Scena1i o dose NOAEL MOEr.r (mg/kg bw/d) (%AEL) MOE (mg/kg bw/d) (mg/kg bw/d)

1. Residential spraying

Tier 1 l.46 x10-2 l.5 100 0.015 97_3

2. Residential brushing

Tier 1 l.64 x10-2 l.5 100 O.Ql5 110

3. Residential injecting

Tier 1 See calculations below

Injecting:

There is no info1mation available to estimate the exposure dming injecting. However, it seems reasonable to assume that both de1mal and inhalation exposure during injecting activities is less than for the other two approaches (spraying or brnshing) .

A reverse calculation is proposed to assess injecting exposure:

Tier 1 without gloves

Short-term AEL 1.5 x 10".l mg/kgbw body weiclit 60 kg dennal absorption 11.40% a.s. concentration 0.03% density 1.003 g/ml reverse a.s. actual exposure 7,89 mga.s. reverse product actual exposure 26315,79 mg product reverse product volume actual exposure 26.24 ml

The reverse calculation shows that a potential dermal exposure to 26.24 ml of product is needed to induce an unacceptable 1isk.

The Emission Scenario Docmnent OCDE for wood preservatives pa1t 2 considers a loss of 5% of injected product by dripping.

Page 24 of77

102.7

91


According to applicant infonnation on injection process, 150 g of product (4.49 g of active substance) are injected per hole. Considering a product density of 1.003 g/cm3

, 150 g represent 149.55 ml of product. Based on the ESD 7.48 ml of product will drip from each injection point dming the process.

A contact with the entire product dripping after one injection result to 28.5% of the volume needed to achieve an miacceptable risk.

It is reasonable to consider that the consumer will not be in contact with all the product chipping after each injection. On this basis, a potential dermal exposure to 26.24 ml of product does not seem realistic. So, consideiing this assessment, non-professional risk while injecting should be considered acceptable.

Conclusion

Based on the risk assessment for general public using bifenthrin wood preservative, it can be concluded that the % of AEL and the MOE are not acceptable for the "Residential brushing" scenario(% AEL >100 and MOE < MOE ref) and are acceptable for the "Residential spraying" scenario (%AEL <100 and MOE > MOE ref). With regard to the "Residential injecting" scenario, a reverse calculation was proposed. The conclusion is that non-professional exposure while injecting is considered as acceptable.

Risk characterisation for secondary exposure scenarios

Scenruios have been considered separately depending on whether they are base on sho1t or long-tenn exposure (see tables below).

Table 2.2.1.4-4: Summa1-y of systemic indirect short-term exposure


Exposure Scenario dose NOAEL MOEr.r (mg/kg bw/d) (mg/kg bw/d)

(mg/kg bw/d) (% AEL) MOE

Adult sanding 1.56 x 104 1.5 100 0.015 1.04 9 615.4

treated timber

Adult handling wet 7.18 x 10-3 1.5 100 0.015 47.9 treated timber

Infant chewing 3.60 x 10-3 1.5 100 0.015 24

Conclusion

Based on this risk assessment for indirect short-term exposure, the % of AEL and the calculated MOE are acceptable (% AEL ~ 100 and MOE > MOErer) for the "Adult sanding treated timber", "Adult handling treated timber" and "Infant chewing" scenarios. Therefore, the risk is considered as acceptable for these scenarios. No further adjustment is needed.

Page 25of 77

208.9

416.7


Table 2.2.1.4-5: Summary of systemic indirect long-term exposure

Total systemic Relevant AEL Exposure Exposm·e Scenario dose NOAEL MOE,.r MOE

(mg/kg bw/d) (mg/kg bw/d) (mg/kg bw/d) (%AEL)

Adult sanding 2.14 x 10-4 0.75 100 0.0075 2.9 3 504.7 treated timber

Adult in a room with 1.29 x 10-3 0.75 100 0.0075 17.2 581.4 treated wood

Infant in a room 1.68 x 10-3 0.75 100 0.0075 22.4 446.4 with treated wood

Child playing on playground 2 .74 x 10-4 0.75 100 0.0075 3.7 2 737.2 equipment

Infant playing on 2 .66 x 10-3 treated wood and 0.75 100 0.0075 35.5 282.0

mouthing

Conclusion

Based on this 1isk assessment for indirect long-term exposure, the % of AEL and the calculated MOE are acceptable (% AEL ~ 100 and MOE > MOErer> for the "Adult sanding treated timber", "Adult in a room with treated room", "Infant in a room with treated wood", "Child playing on playground equipment" and "Infant playing on treated wood and mouthing" scenarios. Therefore, the risk is considered as acceptable for these scenarios. No further adjustment is needed.

Risk characterisation for combined exposure scenarios

Combined exposme can occur for adults (professionals or not), children and infants.

Professionals can experience combined exposure, for instance when a vacuum pressure treatment operator stands in a room with treated wood. Since the industrial vacuum impregnation represents the worst case scena1io for a professional use, other professional uses are therefore considered as covered by this scenario. Such a professional will be directly exposed to 5.62 x 10-3 mg/kg bw/d and indirectly exposed to 1.29 x 10-3 mg/kg bw/d. Consequently, the combined exposure will reach 6.91 x 10-3 mg/kg bw/d, which is still lower than the long-term AEL (7.5 x 10-3 mg/kg bw/d) and only represents 92% of this AEL. Fmthe1more, MOE (0.75 I 6.91 x10-3 = 108) is higher than the MOEref(lOO). This combined exposure is therefore deemed acceptable.

Non-professionals can expetience combined exposure, for instance when someone is spraying and handling treated wood. Such a person will be directly exposed to 1.46 x 10-2 mg/kg bw/d and indirectly exposed to 7.18 x 10-3

mg/kg bw/d. Consequently, the combined exposure will reach 2.18 x 10-2 mg/kg bw/d, which is higher than the sho1t-term AEL (1.5 x 10-2 mg/kg bw/d) and represents 145% of this AEL. Fmthe1more, MOE (1 .5 I 2. 18 x 10-2 = 69) is lower than the MOEref (100).

Page 26of77


Page 27 of 77

This combined exposure is therefore deemed unacceptable. Children can experience combined exposure, when they are playing on treated playground structures and are then standing in a room with treated wood. Such a child will be exposed to 2.74 x 10-4 mg/kg bw/d when playing and to 1.29 x 10-3 mg/kg bw/d when standing in a room with treated wood. Consequently, the combined exposure will reach 1.56 x10-3 mg/kg bw/d, which is still lower than the short-term AEL (1.5 x 10-2 mg/kg bw/d) and only represents 10% of this AEL. Furthermore, MOE (1.5 / 1.56 x 10-3 = 962) is higher than the MOEref (100). This combined exposure is therefore deemed acceptable. Infants can experience combined exposure, when they are chewing treated wood, playing on treated playground structures and are then standing in a room with treated wood. Such a child will be exposed to 3.6 x 10-3 mg/kg bw/d when chewing, to 2.25 x 10-3 when playing and to 1.29 x 10-3 mg/kg bw/d when standing in a room with treated wood. Consequently, the combined exposure will reach 7.14 x10-3 mg/kg bw/d, which is still lower than the short-term AEL (1.5 x 10-2 mg/kg bw/d) and only represents 48% of this AEL. Furthermore, MOE (1.5 / 7.14 x10-3 = 210) is higher than the MOEref (100). This combined exposure is therefore deemed acceptable. Based on the risk assessment for combined exposures, it can be concluded that the % of AEL and the calculated MOE are acceptable (% AEL ≤100 and MOE > MOEref) for professional, child and infant scenarios. However for the non-professional spraying scenario, the % of AEL and the MOE are not acceptable (% AEL >100 and MOE < MOE ref). Overall conclusion of the risk characterisation for human health In conclusion, based on the data provided by the applicant, it is possible to demonstrate that the risk is acceptable for industrial and professional uses claimed. However, the risk is considered as unacceptable for general public using bifenthrin in “Residential brushing” scenario. Furthermore, the spraying by non-professionals becomes at risk when considered as part of a combined exposure.


Page 28 of 77

2.2.2 Environment risk assessment

2.2.2.1 Fate and distribution in the environment

Degradation Bifenthrin is hydrolytically stable in water (pH 5, pH 7 and pH 9 at 25 °C). Under artificial lighting conditions, bifenthrin degrades in water under influence of light with a half-life of ca 10 days, thus indicating that photolysis is a degradation pathway. Metabolites formed are biphenyl alcohol, biphenyl acid, and 4’-OH-bifenthrin. The estimated half-life at 40°N during summer (‘Madrid’ conditions) is 24.4 days. In an older (non GLP) study similar degradation was observed under artificial sunlight, but under late summer outdoor sunlight irradiation at 41° N (USA) photolysis of bifenthrin was slow with a half-life of about 255 days. The RMS did not consider photodegradation as a significant degradation pathway in the risk assessment since under normal water/sediment conditions this photodegradation is not easily observed as it is masked by the movement of bifenthrin to sediment. Photolysis metabolites were not further considered. Bifenthrin (CO2 evolution test) is not readily biodegradable. In view of its relative stability in simulation tests, bifenthrin is considered to be not inherently biodegradable. In water/sediment systems, bifenthrin rapidly dissipates from the water phase (with a DT50 for dissipation from water of less than 3 days) and is transported to the sediment phase. Bifenthrin is slowly degraded in the total system, with DT50 whole system of 176 - 524 d (12°C). No metabolites ≥ 10% were found in the water phase. 4'-OH-bifenthrin was the only metabolite in the sediment ≥ 10% (11.1% on day 99 in one system). The mineralization ranged from 3.5% to 27% after 99 days and the maximum amount of bound residue was 14.2% after 99 days. Based on these water/sediment data, a dissipation half-life from water for bifenthrin of < 3 days was derived. The dissipation half-life combines the degradation of bifenthrin in the aqueous compartment and its adsorption onto sediment as the two mechanisms cannot be distinguished. This value defined for dissipation from water is dependent of the test systems and cannot be used to refine risk assessment in water/sediment system. Bifenthrin is slowly degraded in laboratory soil degradation studies. DT50 values normalized to 20 °C were generally > 125 days and < 366 days. The average DT50 at 20°C and 12°C was 192 and 363 days respectively. The formation of CO2 within approx. 120 days was up to 50%, showing that bifenthrin is mineralized in soil. Bound residues remained below 25% after approx. 120 days and were thus below the threshold value of 70%. No single metabolite exceeded an amount of 10%. Following the review of the EU-Dossier under Directive 91/414/EEC for bifenthrin by the RMS (France), a recalculation of the DT50 values for the available field dissipation studies has been undertaken, according to the procedure outlined in FOCUS (2005). The normalised (20°C and field capacity at 10 kPa (pF2)) geometric mean DT50 was calculated to be 84.6 days, 160.4 days after normalisation at 12°C. This DT50 value at 12°C was used to refine risk assessment for soil. Adsorption/desorption to/from soils Bifenthrin is very strongly adsorbed to soil. Bifenthrin has an average Koc of 236610 L/kg, range 130526 – 301611 L/kg. Bifenthrin is essentially immobile in the soil and no leaching to groundwater is expected.


Page 29 of 77

Measurements of aquatic bioconcentration Based on its log Kow of 6.6, bifenthrin is expected to have a high bioconcentration potential, although this is not confirmed by QSAR calculation (BCFWIN v2.15). In standard bioaccumulation assays, the bioaccumulation factor (BCF) for fish varies from 666 to 6090. The higher value corresponds to an old study with the bluegill sunfish Lepomis macrochirus, which was redone by the applicant in order to met current standard. A BCF of 1414 with Lepomis macrochirus was obtained. The maximum BCF measurement in carp was BCF = 1082. In a Full Life Cycle assay, fish exposed continuously during their complete life to bifenthrin exhibits high BCF, reaching 28000 after 254 days. Conversely, a higher tier study shows that, in natural environment, the strong adsorption of bifenthrin to sediment can significantly lower the bioaccumulation of the substance in organisms. Estimations on aquatic and terrestrial biomagnification For the purpose of the risk assessment, it is proposed to use the highest value obtained in standard test. Highest BCF were obtained with Lepomis macrochirus, and from the two studies available, results from the new one, meeting current standard were used. In view of higher tier study, it was considered that the choice of this BCF is sufficiently realistic for the risk assessment of wood preservative. The risk characterisation of secondary poisoning to either fish-eating or worm-eating predators as calculated according to TGD recommendation indicates an acceptable risk. In November 2007, the Technical Committee for PBT assessment evaluated the bioaccumulation status of this substance and concluded that bifenthrin does not fulfil the B criterion.

2.2.2.2 Effects on environemental organisms

2.2.2.2.1 Effects on aquatic species

Aquatic organisms The toxicity to aquatic organisms is documented by acute and long-term studies. Bifenthrin is highly toxic to fish and invertebrates. The lowest NOEC of 9.5 x 10-4 µg/L in a 21-day daphnia study was taken as the basis for the PNEC derivation in water: PNEC = 9.5E-05 µg/L. Sediment dwelling organisms A chronic study on Chironomus tentans with spiked water is available; nevertheless the 10-day study on Chironomus riparius with spiked sediment showed the most sensitive results. This study is used for the determination of the PNECsed.

Considering that 10 days is a short time duration for the testing of sediment dwelling organisms, the PNECsed is based on the EC50 (growth) of 170 µg/kgwwt with an assessment factor of 1000 and is set to 0.17 µg/kgwwt.


Page 30 of 77

Inhibition of aquatic microbial activity Bifenthrin showed no effect on the respiration of activated sludge micro-organisms up to the solubility limit (tested concentration: 1929 mg/L). Bifenthrin is not expected to have any influence on sewage treatment plants. PNECstp = 192.9 mg/L. This value is much higher than the solubility of the substance, it is then proposed to set the PNEC at the solubility limit of 1 µg/L. PNECstp = 1 µg/L.

2.2.2.2.2 Terrestrial compartment

Acute and long-term studies are available to characterise the toxicity to terrestrial organisms. The terrestrial PNEC is based on the lowest NOEC of 17.5 µg/kgwwt observed in insects (study in field conditions on the soil and ground-active non-target arthropod fauna) using an assessment factor of 10. The PNECsoil is 1.75 µg a.s./kgwwt.

2.2.2.2.3 Atmosphere

Bifenthrin has a low volatility: its saturated vapour pressure is 2.41 x 10-5 Pa. It has a moderate volatility from water because its estimated Henry’s law constant is 101 Pa m3 mol-1 which is equivalent with an air-water partition coefficient of 0.04 L/L. However, emission from surface water to atmosphere is not expected because of the strong adsorption of bifenthrin to sediment. The atmospheric oxidation by hydroxyl radicals and ozone was calculated using the Atmospheric Oxidation Program for Microsoft Windows (AOPWIN v. 4.01, in EPISUITE v 3.11). The calculated overall OH rate constant is 29.6 x 10-12 cm3 mol-1 sec-1. Assuming a 24-h day and an OH concentration of 5.0 x 105 cm-1 this gives a half-life of 0.54 days or 13 hours. For the ozone reaction the overall rate constant is 0.163 x 10-17 cm3 mol-1 sec-1 and the half-life is 7.05 days (at 7 x 1011 mol ozone/cm3). It is also not expected that bifenthrin will have an effect on:

• degrading air quality • tropospheric ozone building • acidification • ozone layer depletion • global warming

2.2.2.2.4 Summary of PNEC values

Table 3.2.4-1: Summary of the selected PNEC values used for the risk characterisation

ENVIRONMENTAL COMPARTMENT PNEC

PNECwater 9.5 x 105 µg a.s./L

PNECsusp sed 0.17 µg a.s./ kgwwt

PNECstp 1 µg a.s./L

PNECsoil 1.75 µg a.s./kgwwt


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2.2.2.3 Evironmental exposure assessment

Information has been provided for the life cycle stages “production” and “formulation of the biocidal product”. No quantitative exposure assessment has been carried out as the active substance is produced outside of the EU. The applicant applied for an intended use of preventive and curative treatment of wood for use classes 1 – 3. No exposure assessment has been performed for the life cycle stages “professional” and “private use of the biocidal product” intended for use classes 1 and 2 (indoor use) assuming negligible emissions to the environment. The environmental exposure assessment is calculated within the definitions of use sectors provided in the OECD Emission Scenario Document for Wood Preservatives, the EU Technical Guidance Document on Risk Assessment, and the EU Leaching Workshop on wood preservatives. The environmental exposure assessment for the “industrial application” was conducted for the treatment of wood by vacuum pressure or dipping (including post-treatment conditioning) and for the industrial storage of the treated wood prior to shipment. As regards in situ treatment, emissions were estimated for application by brushing and spraying. For “wood in service” emissions according to the scenarios “Fence”, “House”, “Noise barrier”, and “Bridge over pond” have been estimated. No specific assessment was carried out for wood in service having received an injection treatment since the corresponding scenario in the OECD ESD for wood preservatives was design for wood used in class 4. As class 4 was not supported by the applicant, the injection will therefore be restricted to indoor applications (classes 1 and 2) with negligible emissions to the environment.

2.2.2.4 Risk characterisation

The risk characterisation was conducted in accordance with the recommendations of the Technical Guidance Document on Risk Assessment (2003).

2.2.2.4.1 Aquatic compartment (including water, sediment and STP)

For the aquatic compartment, estimated risks from industrial applications of bifenthrin (dipping and vacuum impregnation) and due to further leaching from treated wood during storage are unacceptable, even taking into account removal processes (adsorption onto suspended matter). For professional and amateur in situ application of bifenthrin formulations the applicant has applied for application by brushing, spraying or injection, for use classes 1, 2, and 3. As explained in section 2.2.2.3, application by injection will be restricted to indoor uses (classes 1 and 2). Use class 3 has a single aquatic exposure scenario for in situ application, via the bridge scenario. Risk ratios are very high (> 3000) just after the application even when removal is taken into account, indicating a high risk for aquatic organisms. The applicant has therefore proposed that a label restriction be included on bifenthrin products for in situ uses, indicating that use of these products for wood in use class 3 be restricted to wood not over or near water bodies.


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The scenarios for wood in service indicate an acceptable risk for surface water when releases from impregnated wood are directed to the sewage treatment plant (noise barrier scenario) but show unacceptable risk when surface treated wood is located above a water body (bridge scenario) even if removal processes are considered (adsorption onto suspended matter and sediment and time-weighted averaging of concentrations). As above, since there was identified an unacceptable risk where direct loses to water are possible there should be a labelling against applications where direct losses to water are possible, thereby preventing use in these situations. In addition, wood installed over small ponds should therefore normally be protected with a topcoat to avoid leaching into water.

2.2.2.4.2 Sewage treatment plant organisms

No risks are expected either from industrial or in situ application, or from releases from wood in service.

2.2.2.4.3 Atmosphere

No risks are expected due to extremely low volatility of bifenthrin.

2.2.2.4.4 Terrestrial compartment

The values for the size of receiving soil used in risk assessment were for all the scenarios: 50 cm distance from treated wood and 50 cm depth. The dipping and impregnation application scenarios consider the exposure of the soil compartment via the application of sludge to contaminated soil. No risk to terrestrial organisms is expected. However, due to the risk identified for surface water in these scenarios, releases via STP during industrial application should not be allowed. The outdoor storage of treated wood (class 3) following dipping or vacuum pressure industrial treatment on bare soil is expected to pose a risk to soil organisms. Storage on bare soil should not be allowed. The emissions from treated wood to soil should be substantially reduced by covering the storage area with protective roof or covering the soil with impermeable coating e.g. concrete. Leachates should be collected and treated appropriately (e.g. incineration). Industrial treatment for use class 1 and 2 and subsequent covered storage should not cause a risk to the terrestrial organisms. As above, however, due to the risk identified for surface water in these scenarios, releases via STP during industrial application should not be allowed. The risk calculated for in situ application scenarios by brushing or spraying show no acceptable risk just after the application phase for professional and amateur users whatever the type of the treatment (preventive or curative) and whatever the scenario used (fence or house). The PEC/PNEC ratios calculated for impregnated wood in service are below 1 for a preventive treatment indicating an acceptable risk for terrestrial organisms (fence, house and noise barrier scenarios). The risk related to releases from noise barrier to agricultural soil via sludge application is expected to be low. The PEC/PNEC ratios calculated for wood in service treated by industrial dipping are below 1 only for a preventive treatment of house indicating an acceptable risk for terrestrial organisms using this scenario, but lead to unacceptable risk when fence scenario is used. The PEC/PNEC ratios calculated for wood in service treated by brushing or spraying are never below 1, indicating no acceptable risk for terrestrial organisms (fence and house scenarios).


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The inclusion of removal processes in the calculations (degradation with time, DT50 = 160.4 days at 12°C, k = 0.0043, and time-weighted averaging of concentrations) is not sufficient to induce an acceptable risk. The combined risk ratios for application by brushing or spraying and subsequent releases from wood in service are obviously considered as not acceptable. No specific assessment was carried out for wood in service having received an injection treatment since the corresponding scenario in the OECD ESD for wood preservatives was designed for wood used in class 4. As class 4 was not supported by the applicant, the injection will therefore be restricted to indoor applications (classes 1 and 2) with negligible emissions to the environment, unless further data is submitted at the product authorisation stage.

2.2.2.4.5 Ground water

Bifenthrin is strongly adsorbed onto soil. Modelling using PEARL calculation using the maximum soil concentration indicates that bifenthrin as a wood preservative is not expected to pose a risk for groundwater contamination.

2.2.2.4.6 Secondary poisoning

The risk characterisation of secondary poisoning to either fish-eating or worm-eating predators as calculated according to TGD recommendation indicates an acceptable risk.

2.2.2.5 PBT assessment

Persistence criteria (P, vP)

According to the PBT assessment in TGD, criteria for substance to be persistent is fulfilled when : T 1/2 in freshwater > 40 days or , T 1/2 in freshwater sediment > 120 days. DT50 (12°C) in water/sediment studies varies from 176 to 524 days (for the whole system). DT50 (12°C) in soil degradation studies varies from 252 to 695 days (from laboratory and field studies). Considering these results, bifenthrin fulfills the P criterion and is consider as very persistent. Moreover, due to the high persistency criterion of bifenthrin, specific provisions to use in use class 3 should be taken into account and are indicated in chapter 3.2 and 3.

Bioaccumulation criteria (B, vB)

According to the PBT assessment in TGD, a substance is considered to fulfill the B criterion when the bioconcentration factor (BCF) exceeds a value of 2 000 L/kg. To evaluate the B criteria, 3 tests on fish bioaccumulation were made available to the PBT Working group under TCNES on 20th November 2007. In addition, the applicant provided information on the sediment-bound characteristics of bifenthrin and a new study of fish fed with spiked sediment. In the BCF key study done with Lepomis macrochirus according to OECD 305 guideline, the steady-state BCF for uptake of bifenthrin estimated in whole fish was 1414 L/kg. The Working group took notice of this new information but questioned the usefulness of these additional sediment data. The Working group discussed the available data in comparison with previous PBT decisions. While there was no unanimity, a majority of the Working group described bifenthrin as a borderline case for the B criterion.


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Considering this result, bifenthrin is not considered as fulfilling the B criterion.

Toxicity criteria (T)

According to the PBT assessment in TGD, the toxicity criterion is fulfilled when the chronic NOEC for aquatic organism is less than 0.01 mg/L or when the substance is toxic to mammals and classified as Very Toxic or Toxic after oral dosing. Based on ecotoxicity data on Daphnia magna, NOEC (21 d, reproduction) = 9.5 x 10-4 µg/L (flow-through), T criteria is fulfilled .

As the B criterion is not fulfilled, and as there is no indication of long range transport and some indication of metabolisation, the borderline properties translated into the conclusion that bifenthrin does not meet the PBT criteria. This is in line with the decision taken by the PBT Working group under TCNES dated on 20th November 2007.

2.2.3 Risk assessment for physico-chemical properties

2.2.3.1 Hazard identification for physico-chemical properties (active substance)

Bifenthrin is not flammable, and has a flash point higher than 110°C. It does not present explosive or oxidising properties. It is stable in storage conditions for up to 2 years despite it cannot be considered as thermally stable in the sense of OECD 113.

2.2.3.2 Hazard identification for physico-chemical properties (product)

Bifenthrin technical and bifenthrin 30 g/L are thermally stable, non-flammable, non-explosive and non-oxidising, and therefore users are not at risk due to the physico-chemical properties.

2.2.3.3 Risk characterisation for the physico-chemical properties

Bifenthrin technical and bifenthrin 30 g/L are thermally stable, non-flammable, non-explosive and non-oxidising, and therefore users are not at risk due to the physico-chemical properties.


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3 DECISION

3.1 BACKGROUND TO THE PROPOSED DECISION

On the basis of the proposed and supported uses and the evaluation conducted as summarised in the tables appended at the end of this document, it can be concluded that bifenthrin fulfils under the conditions listed in 3.2 the requirements laid down in Article 5(1) (b), (c), and (d) of Directive 98/8/EC. Article 10 of the Biocides Directive 98/8/EC addresses the inclusion of an active substance in the Annexes I, IA or IB. For the decision of inclusion or non-inclusion, it has to be examined if the criteria of article 10 (1) are fulfilled. The physico-chemical properties of bifenthrin are deemed acceptable for the appropriate use, storage and transportation of the biocidal product. With regard to efficacy, sufficient experimental data have showed that bifenthrin is effective as wood preservative, and therefore fulfils this criteria to be included. Based on the assessment, all intended uses are efficient except for the treatment by vacuum pressure for which efficacy has not be supported by sufficient data. Additional efficacy data have to be submitted during the product authorisation stage. The efficacy claimed against the following wood insects: Scolytus sp., Inoderus minutus, Anobium punctatum, Xestobium rufovillosum, Hylotrupes bajulus, Lyctus bruneus has been proved for two species (Hylotrupes bajulus and Reticulitermes sp), for the others species additional efficacy data are awaited during the product authorisation stage. The RMs recommends the applicant to set up a monitoring in order to assess insect resistance emergency. With regard to human health exposure and effects, based on the risk assessments conducted, it is considered that safe uses can be identified for industrial and professional uses and indirect exposure. In contrast, an unacceptable risk was identified for non professional brushing. In addition, the spraying by non-professionals also becomes at risk when considered as part of a combined exposure. With regard to environmental exposure and effects, based on the risk assessments conducted, it is considered that safe use(s) can only be identified if the possibility of surface water exposure is excluded (with the exception of the noise barrier scenario). It is recommended that this should be a condition of Annex I inclusion. The environmental risk assessment indicates that all mode of industrial application result in unacceptable risk for the aquatic compartment (application for class 1, 2 and 3) and in unacceptable risk for the aquatic and terrestrial environment during storage (class 3). The environmental risk assessment for the in-use phase of the treated wood used outdoor (class 3) indicates that the risk to the terrestrial environment is acceptable for all the relevant scenarios only in the case of an industrial preventive application by vacuum pressure impregnation. Wood treated by industrial dipping, in situ spraying or brushing should not be used outdoor (class 3).


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3.2 DECISION REGARDING THE INCLUSION IN ANNEX I

It is proposed that bifenthrin (CAS-No. 82657-04-3) be included in Annex I of Council Directive 98/8/EC as an active substance in wood preservative products (product type 8), subject to the following specific provisions:

1. The active substance bifenthrin, as manufactured, shall have a minimum of purity ≥ 911 g/kg, (cis-Z isomers).

2. In view of the assumptions made during the risk assessment, products authorised for industrial and/or professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial and/or professional users can be reduced to an acceptable level by other means.

3. Products shall not be authorised for non-professional users, unless data have been submitted to demonstrate that risks due to combined exposure and/or due to brushing applications, are reduced to acceptable levels, if necessary by the application of appropriate risk mitigation measures.

4. In view of the risks identified for the aquatic and soil compartments, appropriate risk mitigation measures must be taken to protect those compartments. In particular, labels and/ or safety data sheets of products authorised for industrial use shall indicate that freshly treated timber must be stored after treatment under shelter or on impermeable hard standing to prevent direct losses to soil or water and that any losses must be collected for reuse or disposal.

5. In view of the risks identified for the aquatic and soil compartments, products shall not be authorised for the in situ treatment of wood outdoors or for wood that will be exposed to weathering, unless data have been submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

Specific provision n°2 is necessary due to risks identified for industrial and professional users (see section 2.2.1.4). Specific provision n°3 is necessary due to risks identified for non-professional users, first on combined exposure (see section 2.2.1.4). If combined exposure becomes acceptable, a risk is still identified for non-professional users for brushing application (see section 2.2.1.4). Specific provision n°4 is necessary due to risks identified for the aquatic and soil compartments, in particular for the industrial treatment (see section 2.2.2.4). Specific provision n°5 is necessary due to risks identified for the aquatic and soil compartments, in particular for the treatment in situ by professional or non-professional (during the treatment, and for wood in service; see section 2.2.2.4).

3.3 ELEMENTS TO BE TAKEN INTO ACCOUNT BY MEMBER STATES WHEN AUTHORISING PRODUCTS

1. Product containing bifenthrin may only be used by professionals for industrial dipping and industrial vacuum pressure (if data are provided to show that this mode of application is effective and if data provided show an acceptable risk for the environment concerning the treatment and the storage of treated wood) and for residential brushing, spraying and injecting by professionals.

2. The industrial dipping, the in situ surface treatment and the injection are allowed only for uses in class 1 and 2.

3. Product may only be used as wood preservative (Product type 08) against wood destroying insects for which an efficacy has been proven. The applicant has claimed an efficacy against:


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Scolytus sp., Inoderus minutus, Anobium punctatum, Xestobium rufovillosum, Hylotrupes bajulus, Lyctus bruneus. Efficacy has been proven for two species (Hylotrupes bajulus and Reticulitermes sp) for preventive application by industrial technique dipping in use Class 1 to 3 and for remedial application by professional technician by brushing, spraying and injection. Concerning the treatment by vacuum pressure, sufficient data to prove the effectiveness of bifenthrin against the organism to be controlled have to be submitted.

4. For use class 3, only wood treated by vacuum pressure impregnation for preventive treatment has proven an acceptable risk, and should be used. As indicated above, sufficient data to prove the effectiveness of bifenthrin against the organism to be controlled have to be submitted for this use..

5. Before authorising products, Member States should pay attention to possible occurrence of resistance.

6. No chronic study for inhalation exposure was required during this submission due to the negligible inhalation exposure during the use of bifenthrin-containing wood preservative products and the weak vapour pressure of bifenthrin.

7. In the absence of a clear position regarding the relevance of tumours observed in mice, no specific provision is proposed at this stage. This issue should nevertheless be clarified by the “Classification and Labelling” group, whose conclusions could possibly lead to a review of the risk assessment.

8. Before authorising products, Member States should ensure, that a duly validated method is available to enable the monitoring of the substance in soil and sediment.

9. The assessment of bifenthrin showed that non target arthropods may be sensitive (see section 2.2.2.2.2 "terrestrial compartment"). Member states should consider the need to require additional studies to assess the risk for non target insects where relevant.

10. As a result of the risk assessment, releases to surface water (via STP) during the industrial application of bifenthrin either by dipping or vacuum pressure will cause a risk to aquatic organisms. Effluents should not be allowed and therefore should be treated by an appropriate method (e.g. incineration).

Storage of timber treated with bifenthrin wood preservative formulations on bare soil will pose a risk to soil. Therefore, during on-site storage of industrial pre-treated timber impermeable grounds (e.g. sealed flooring) are demanded as a condition of use.

Since an unacceptable risk was identified where direct losses to water are possible, there should be a labelling to prevent use in these situations. Alternatively, wood installed over small ponds should therefore normally be protected with a topcoat to avoid leaching into water (bridge scenario), provided a sufficient efficacy of the topcoat has been demonstrated.

The risk to terrestrial organisms related to releases from wood in service treated by impregnation (preventive treatment) is acceptable. All the other types of application (industrial dipping and in situ brushing and spraying) present unacceptable risks for the environment. The application of bifenthrin for use in class 3 should be restricted to wood treated by industrial impregnation. Although it has been shown that the risk to the environment may be acceptable for wood treated by industrial impregnation and used in class 3, but considering the persistency of bifenthrin in soil and sediment, exposure of the environment should be avoided. Therefore, the uses of bifenthrin for use class 3 should be limited to cases where it has been demonstrated that the high activity of the substance and persistency are needed. It should be noted that bifenthrin may have the potential to cause endocrine disruption and was listed in the document of the EU Commission on endocrine disrupting chemicals (Communication from the Commission to the council and the European parliament on the implementation of the Community Strategy for Endocrine Disrupters - a range of substances


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suspected of interfering with the hormone systems of humans and wildlife (COM (1999) 706); in Table 4 (Substances with insufficient data)).

3.4 REQUIREMENT FOR FURTHER INFORMATION

The FR CA considers that the evaluation has shown that sufficient data have been provided to verify the outcome and conclusion of the risk assessment and permit the proposal for the inclusion of bifenthrin on to Annex I of the Directive 98/8/CE. The conditions and the restrictions proposed by the FR CA are considered appropriate, and the FR CA does not require further information. However, the future provision of additional efficacy data may allow the authorisation of products for applications by vacuum pressure.

3.5 UPDATING THIS EVALUATION REPORT

This assessment report may need to be updated periodically in order to take into account of scientific developments and results from the examination of any of the information referred to in articles 7, 10.4 and 14 of directive 98/8/CE. Such adaptations will be examined and finalised in connection with any amendment of the conditions for the inclusion of bifenthrin in Annex I to the Directive.

Document I - appendix 1: Listing of end-points Document I - appendix 2: Intended uses Document I - appendix 3: List of standard terms and abbreviations


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APPENDIX I: LISTING OF ENDPOINTS

Listing of end points to be included in the document Overall Summary and Assessment - Doc. I 5

Chapter 1: Identity, Physical and Chemical Properties, Details of Uses, Further Information, and Proposed Classification and Labelling

Active substance (ISO Common Name) Bifenthrin

Function (e.g. fungicide) Insecticide

Rapporteur Member State France

Identity (A2)

Chemical name (IUPAC) 2-methyl-3-phenylbenzyl (1RS)-cis-3-(2-chloro-3,3,3-trifluroprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate

Chemical name (CA) (2-methyl[1,1'-biphenyl]-3-yl)methyl (1R,3R)-rel-3-[(1Z)-2-chloro-3,3,3-trifluoro-1-propenyl]-2,2-dimethylcyclopropanecarboxylate

CAS No 82657-04-3

EC No NA

Other substance No. CIPAC no. 415

Minimum purity of the active substance as manufactured (g/kg or g/L)

≥ 911 g/kg, (cis-Z isomerics)

Identity of relevant impurities and additives (substances of concern) in the active substance as manufactured (g/kg)

list of impurities is confidential. No substance of concern.

Molecular formula C23H22ClF3O2

Molecular mass 422.88

5 Other end points will be relevant in particular cases - decisions as to the additional end points to be included can only be made on a case by case basis.


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Structural formula

Physical and chemical properties (A3)

Melting point (state purity) 66.6-69.0°C (96.1 %)

Boiling point (state purity) Decomposition before boiling (96.1 %)

Temperature of decomposition 285°C

Appearance (state purity) Beige, waxy solid, fatty penetrating smell (purity 94.9%)

Relative density (state purity) 1.316 g cm³ at 24°C (96.1 %)

Surface tension NA (due to very low water solubility)

Vapour pressure (in Pa, state temperature) 2.431 10-5 Pa at 25°C

Henry’s law constant (Pa m3 mol -1) 101 Pa m³/mol

Solubility in water (g/L or mg/L, state temperature)

< 1 µg/L at 20°C, pH 4.05

< 1 µg/L at 20°C, pH 7.18

3.76 µg/L at 20°C, pH 9.02

Solubility in organic solvents (in g/L or mg/L, state temperature) (Annex IIIA, point III.1)

Methanol = 48.0 g/L at 20°C Xylene= 556.3 g/L at 20°C Acetone = 735.7 g/L at 20°C N heptane = 144.5 g/L at 20°C Ethyl acetate = 579.8 g/L at 20°C 1,2 dichloroethane = 743.2 g/L at 20°C

Stability in organic solvents used in biocidal products including relevant breakdown products (IIIA, point III.2)

NA

Partition coefficient (log POW) (state temperature)

Log P = 6.6

Hydrolytic stability (DT50) (state pH and temperature) (point VII.7.6.2.1)

pH 5, 7 and 9, temperature: 25°C: No hydrolysis

Dissociation constant (not stated in Annex IIA or IIIA; additional data requirement from TNsG)

NA (no pKa in range 0-14)


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UV/VIS absorption (max.) (if absorption > 290 nm state ε at wavelength)

Maximum of absorption at 249 nm.

No absorption above 290 nm.

Flammability Not auto flammable, Flash point higher than 110°C

Explosive properties No explosive properties


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Classification and proposed labelling (A9)

Directive 67/548/EEC Regulation 1272/2008

with regard to physical/chemical data

Not classified.

with regard to toxicological data T Toxic R 23 Toxic by inhalation R 25 Toxic if swallowed [R40 Limited evidence of

carcinogenic effect. Category 3]

R 43 May cause sensitisation by skin contact

[R48/22 Danger of serious damage to health by prolonged exposure]

Carc.2 – H351 Category 2 carcinogen _ Suspected of causing cancer

Acute Tox. 3 – H331 Toxic if inhaled Acute Tox. 3 – H301 Toxic if swallowed Skin Sens. 1 – H317 May cause an

allergic skin reaction

STOT Rep. 1 – H372 Causes damage to central nervous system through prolonged or repeated exposure by oral route

with regard to fate and behaviour data

(N, dangerous for environment

R53, May cause long-term adverse effects in the aquatic environment)

with regard to ecotoxicological data

N Dangerous for the environment

R 50/53 Very toxic to aquatic organisms, may cause long term adverse effects in the aquatic environment

(Multiplying factor: 10 000)

Aquatic. Acute – H400 Very toxic to aquatic life

Aquatic. Chronic – H410 Very toxic to aquatic life with

long lasting effects

Chapter 2: Methods of Analysis

Analytical methods for the active substance Technical active substance (principle of method) (A4)

HPLC-UV and GC-FID

Impurities in technical active substance (principle of method) (A4)

HPLC-UV, GC-FID and GPC

Analytical methods for residues Soil (principle of method and LOQ) (A4.2) GC-ECD

LOQ: 0.05 mg/kg soil


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Note: GC-ECD methods need to be validated with a confirmatory method for specificity, e.g. by MS identification. This will be required before product authorisation (see Doc I 3.3)

Air (principle of method and LOQ) (A4.2) GC-ECD and GC-MSD (confirmation)

LOQ: 0.1 µg/filter (equivalent to 0.27 µg/m3)

Water (principle of method and LOQ) (A4.2)

GC-MSD

LOQ: 1 ng/L

Body fluids and tissues (principle of method and LOQ) (A4.2)

GC-ECD and GC-MSD: LOQ in blood 0.01 mg/L

Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes) (A4)

Not applicable: there are no residues on food of plant origin

Food/feed of animal origin (principle of method and LOQ for methods for monitoring purposes) (A4)

GC-ECD and GC-MSD:

LOQ in milk: 0.01 mg/kg LOQ in cow muscle: 0.05 mg/kg

Chapter 3: Impact on Human Health Absorption, distribution, metabolism and excretion in mammals (A6.2)

Rate and extent of oral absorption: 50% absorption via oral route in rat

Rate and extent of dermal absorption: Bifenthrin: 55.5 % after 10 hours

Undiluted 3ME formulation:

in-vivo data: total absorption ranged from 18 % to 55.4 % after 10 hours, and from 24 % to 70.8% after 24 hours. Dilution 1/100:

- in-vitro data: 11.39% (in human) and 52.51% (in rat).

The value of 11.4 % will be used in the risk characterisation

Distribution: Fat and skin mainly (3%-4% of the dose remains in tissues)

Potential for accumulation: No, T ½ = 51 days (fat), 50 days (skin), 19 days (liver), 28 days (kidney), 40 days (ovaries and sciatic nerve)

Rate and extent of excretion: Elimination mainly within 48–72 hours

urine (9-25%) and faeces (66-83%), 3%-4% remained in tissues and organs


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Toxicologically significant metabolite No main metabolites, all less than 10%

Acute toxicity (A6.1)

Rat LD50 oral LD50: 186.1 mg/kg

Rat LD50 dermal LD50: > 2000 mg/kg

Rat LC50 inhalation LC50: 1.01 mg/L

Skin irritation Not irritant

Eye irritation Not irritant

Skin sensitization (test method used and result)

Sensitiser (Magnusson & Kligman)

Repeated dose toxicity (A6.3, 6.4 and 6.5)

Species/ target / critical effect Tremors

Lowest relevant oral NOAEL / LOAEL NOAEL: 2.5 mg/kg/day (dog, 90-day)

Based on tremor from 5.0 mg/kg bw/day

NOAEL: 1.5 mg/kg/day (dog, 1-year)

Based on tremors from 3.0 mg/kg bw/day

Lowest relevant dermal NOAEL / LOAEL NOAEL: 50 mg/kg/day for systemic effects (rat, 21-day)

Based on reduction in tail latency and clinical signs including staggered gait and exaggerated hindlimb flexion from 100 mg/kg bw/day

LOAEL: 25 mg/kg bw/day for local effects (rat, 21-day)

Based on paraesthetic reaction (vocalization, thrashing in the cage and lying on the back) from 25 mg/kg bw/day

Lowest relevant inhalation NOAEL / LOAEL

Not reported

Genotoxicity (A6.6)

Assays employed to evaluate the genotoxicity of bifenthrin technical were conducted in vitro using bacterial and mammalian cell lines and in vivo using albino rats and Drosophila melanogaster. The studies all yielded negative results, except for one mouse lymphoma assay and one unscheduled DNA synthesis (UDS) test. Equivocal results were obtained in another gene mutation assay on CHO cells (non-key study)


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Three in-vivo genotoxicity tests have been performed, a cytogenetic assay in rats, a micronucleus assay in mice, and an unscheduled DNA synthesis assay in rats. Based on these in-vivo studies, there is no convincing evidence that bifenthrin possesses mutagenic/clastogenic potential.

Carcinogenicity (A6.7)

Species/type of tumour Rat: No treatment related tumours observed

Mice: Equivocal response in the urinary bladder of the male mice (increased incidence of pericytoma, initially classified as leiomyosarcoma), which might be considered as limited evidence of carcinogenicity effects.

Chronic toxicity 2-year rat: NOAEL: males: 50 ppm (2.3 mg/kg bw/day) females: 50 ppm (3.0 mg/kg bw/day) Based on the occurrence of tremors

2-year mice: NOAEL: males: 50 ppm (7.6 mg/kg bw/day) females: 200 ppm (37 mg/kg bw/day) Based on the occurrence of tremors

Reproductive toxicity (A6.8)

Species/ Reproduction target / critical effect

Tremor during lactation and marginally lower body weight in the P and F1 generation females during gestation and lactation

Lowest relevant reproductive NOAEL / LOAEL

NOAEL: reproduction≥ 100 ppm (5 mg/kg bw/day)

NOAEL: systemic toxicity: 60 ppm (3.0 mg/kg bw/day)

based on tremor during lactation and marginally lower body weights during gestation and lactation at 100 ppm (5 mg/kg/day) in the P and F1 generation females.

Species/Developmental target / critical effect

No teratogenic effects observed

Lowest relevant developmental NOAEL / LOAEL

Rat (gavage study) based on tremors:

NOAEL (maternal toxic effects): 1 mg/kg bw/day


Page 46 of 77

NOAEL (embryotoxic/teratogenic effects) ≥ 2 mg/kg bw/day

Rabbit (gavage study) based on tremors:

NOAEL (maternal toxic effects) = 2.7 mg/kg bw/day

NOAEL (embryotoxic/teratogenic effects) = 2.7mg/kg bw/day)

Neurotoxicity / Delayed neurotoxicity (A6.9)

Species/ target/critical effect No delayed neurotoxicity effects observed up to 5000 mg/kg bw

Lowest relevant neurotoxicological NOAEL / LOAEL.

LOAEL: 5000 mg/kg bw in domestic hens (neurotoxicity)

91-day neurotoxicity study in rats NOAEL = 50 ppm (corresponding to 3 mg/kg bw/ in males and 3.7 mg/kg bw/d in females)

Developmental neurotoxicity in rats NOAEL = 50 ppm in food (corresponding to 3.6 mg/kg bw/d during gestation and 8.3 mg/kg bw/day during lactation)

Other toxicological studies (A6.11)

Acute Intraperitoneal Toxicity in Rats LD50 = 798.5 (516.1 – 1080.8) mg/kg

Summary

ADI (if residues in food or feed) Not applicable, as not intended for use on food or feed

Short-term AEL 0.015 mg/kg bw /d

Medium AEL 0.0075 mg/kg bw/d

Long-term AEL 0.0075 mg/kg bw/d

Chapter 4: Fate and Behaviour in the Environment

Route and rate of degradation in water (A7.6)

Hydrolysis of active substance and relevant metabolites (DT50) (state pH and temperature)

pH 5, 7 and 9, temperature: 25°C: hydrolytically stable

Photolytic / photo-oxidative degradation of active substance and resulting relevant

Artificial light: DT50 = 10 days

Main metabolites: biphenyl alcohol and


Page 47 of 77

metabolites biphenyl acid Minor metabolites trans-bifenthrin and 4’-OH-bifenthrin. (not considered as ecotoxicologically relevant)

Estimated half life under natural sunlight conditions: DT50 = 24.4 days (40°N, Madrid conditions)

Natural sunlight DT50 = 209 – 300 d (late summer 41°N)

Quantum yield of direct phototransformation in water at λ > 290 nm (point VII.7.6.2.2)

7 • 10-6

Readily biodegradable (yes/no) No

Biodegradation in seawater NA

DT50 values in water/sediment system (days)

DT50 whole system: 93 - 276 at 20°C

176 - 524 at 12°C

Dissipation from water < 3 days

Non-extractable residues Max 14.2% after 99 days

Distribution in water / sediment systems (active substance)

Initial: 45/55 to 75/25

60 & 99 days: 1/98 to 4/96

Distribution in water / sediment systems (metabolites)

4-OH bifenthrin

Whole system & sediment: max 11.1 % at 99 days

Water: max 0.2% at 30 days

Initial: 54/4 max.

99 day: 1/111 max.

Route and rate of degradation in soil (A7)

Mineralization (aerobic) Metabolism study in 1 soil:

Acid label: 39.2% (90 d), 49.7% (126 d)

Alcohol label: 30.5% (90 d), 36.2% (126 d)

Metabolism study in 3 soils:

Alcohol label: 15.6 – 28.8% (120 d)

Acid label: 13.4 – 36.9% (120 d)

Laboratory studies (range or median, with number of measurements, with regression coefficient)

DT50lab (20°C, aerobic):

Bifenthrin:

Soil type DT50 Fit

silty clay loam 200*/133** (best fit)


Page 48 of 77

silt loam 366*/222** (best fit)

sandy loam 138*/158** (best fit)

silt loam 112*/139** (best fit) * Phenyl label, ** Cyclopropyl label

Mean (at 20°C) = 192 days

Mean (at 12°C) = 363 days

DT90lab (20°C, aerobic): not calculated

DT50lab (20°C, anaerobic): Not required

Degradation in the saturated zone: not required

Field studies (state location, range or median with number of measurements)

DT50f (best fit):

46.6 – 266.6 days (at 20°C)

Mean = 84.6 days (cf. FOCUS degradation kinetics)

Mean = 160.4 days at 12°C (value used in risk assessment) (Data submitted in the plant protection product dossier)

Anaerobic degradation Not applicable

Soil photolysis No data

Non-extractable residues Metabolism study in 1 soil:

Acid label: 13.8% (90 d), 14.1% (126 d)

Alcohol label: 18.4% (90 d), 18.6% (126 d)

Metabolism study in 3 soils:

Alcohol label: 13.9% – 24.9% (120 d)

Acid label: 21.6% –23.9% (120 d)

Relevant metabolites - name and/or code, % of applied a.i. (range and maximum)

No major metabolites

(max. 8.2% of 4’OH bifenthrin in alcohol label)

Soil accumulation and plateau concentration

Not reported

Adsorption/desorption (A7)

Ka , Kd (L/kg)

Kaoc , Kdoc (L/kg)

pH dependence (yes / no) (if yes type of dependence)

Active substance: Phenyl ring – 14C bifenthrin Soil type Ka Kaoc Kd Kdoc Sandy loam 4160 239080 11044 634713 Silt loam 5429 301611 11610 645000 Clay Loam 3688 275224 10254 765224 Sand 992 130526 3342 439737


Page 49 of 77

Mean Koc - 236610

No pH dependence

Fate and behaviour in air (A7)

Direct photolysis in air Not reported

Quantum yield of direct photolysis NA

Photo-oxidative degradation in air Half life 0.54 d or 13 hours (OH radical reaction) (assuming a 24hrs-day)

Volatilization Vapor pressure = 2.431 10-5 Pa

Henry's law constant = 101 Pa m³/mol

Monitoring data, if available (A7)

Soil (indicate location and type of study) NA

Surface water (indicate location and type of study)

NA

Ground water (indicate location and type of study)

NA

Air (indicate location and type of study) NA


Page 50 of 77

Chapter 5: Effects on Non-target Species

Toxicity data for aquatic species (most sensitive species of each group) (A7)

Species Time-scale

Endpoint Toxicity

Fish

96 h LC50 0.15 µg/L Rainbow trout

96 h LC50 0.10 µg/L

Rainbow trout with sediment

96 h LC50 6.26 µg/L

96 h LC50 0.35 µg/L Bluegill Sunfish

96 h LC50 0.26 µg/L

Rainbow trout 76d ELS, flow-through

NOEC 0.012 µg/L

Fathead minnow 120d, flow-through

NOEC 0.040 µg/L

Invertebrates

1.6µg/L

0.11µg/L

Daphnia magna 48 h EC50

0.37µg/L*

Daphnia magna with sediment

48 h EC50 2.30 µg/L

Ceriodaphnia dubia 48 h EC50 0.31µg/L*

Thamnocephales platyurus

24 h EC50 5.7µg/L*

Hexagenia sp. 24 h EC50 0.39µg/L*

Caddis fly sp. 48 h EC50 0.12µg/L*

Gammarus pulex 48 h EC50 0.11µg/L*

Daphnia magna 21 d, flow-through

NOEC 0.00095 µg/L (endpoint used in risk assessment for water)

Daphnia magna 21 d NOEC 0.0013 µg/L

Mysidopsis bahia 28 d, flow-through

NOEC 0.0012 µg/L

Algae


Page 51 of 77

Scenedesmus acutus 72 h EC50 > 10 mg/L**

Sediment dwelling organisms Chironomus riparius 10 d, spiked

sediment LC50 EC50

(growth) NOEC

> 544 µg/kgwwt

170 µg/kgwwt (endpoint used in risk assessment for sediment) 18 µg/kgwwt

Chironomus tentans 28 d, spiked water

NOEC 0.32 µg/L

(1647 µg/kgwwt)

Microorganisms Activated sludge 3 h EC50 (resp.

inhib.) 1929 mg/L (Concentrations far exceeding the solubility limit of 1 µg/L)

* static test

** Low reliability (Klimlish index = 3)

Effects on earthworms or other soil non-target organisms

Acute toxicity to earthworm

LC50 = > 18.9 mg/kgdwt soil

NOEC = 5.7 mg/kgdwt soil

Reproductive toxicity to earthworm NOEC = 2.13 mg ai/kgdwt soil

Effects on soil micro-organisms (A7)

Nitrogen mineralization Max 45% effect (rate of nitrate formation - 28 days)

EC50 standard : 0.402 mg/kgdwt soil

Carbon mineralization Max 7.88 % (14 days)

NOEC standard : 0.402 mg/kgdwt soil


Page 52 of 77

Effects on terrestrial vertebrates Acute toxicity to mammals

LD50 = 54.5 mg/kg to 186.1 mg/kg (rat)

LD50 = 42.5 mg/kg (mouse)

Acute toxicity to birds

LD50 = 1800 mg/kg bw (Bobwhite quail)

LD50 > 2150 mg/kg bw (Mallard duck)

Dietary toxicity to birds

LD50 = 4450 mg/kg diet (Bobwhite quail)

LD50 = 1280 mg/kg diet (Mallard duck)

Reproductive toxicity to birds

NOEC > 75 mg/kg diet (Bobwhite quail)

NOEC > 75 mg/kg diet (Mallard duck)

Effects on honeybees (A7)

Acute oral toxicity LD50 = 0.12 – 0.13 µg/bee

Acute contact toxicity LD50 = 0.044 – 0.11 µg/bee

Effects on other beneficial arthropods (A7)

Acute oral toxicity Not required

Acute contact toxicity Not required

Acute toxicity to Not required

Field study Non-target arthropod fauna of a maize crop. Incorporation of the product during drilling of maize. LOEC = 35 µg a.s./kg wwt

NOEC = 17.5 µg a.s./kg wwt

(endpoint used in risk assessment for soil)

Bioconcentration (A7)

Bioconcentration factor (BCF) Lepomis macrochirus: 1414 (steady state BCF) without sediment)

Cyprinus carpio: 1082 (steady state BCF) without sediment

63 in presence of sediment

Depuration time (DT50) / (DT90) Lepomis macrochirus: 22-28 / 73 - 94

Cyprinus carpio: 6/11 days

Level of metabolites (%) in organisms accounting for > 10 % of residues

none

Bioconcentration factor (BCF), earthworm 47774 (calculated from eq. 82d, TGD, 2003)

Chapter 6: Other End Points Effects on Higher Plant seedling emergence (A7)

RMS: France BIFENTHRIN Intended uses

Page 53 of 77

APPENDIX II: LIST OF INTENDED USES6

Object

and/or

situation

Member

State or

Country

Product

name

Organisms

controlled

Formulation

Application

Applied amount per treatment

Remarks:

(a)

(c)

Type

(d-f)

Conc.

of as

(i)

method

kind

(f-h)

number

min

max

(k)

interval

between

applications

(min)

g as/L

min

max

water

L/m2

min max

g as/m2

min max

(m)

Micro emulsion

30 g/L Industrial

a) dipping

b) vacuum impregnation

1 0.3 g/L 1 L/m2

0.3 g / m2

Micro emulsion

Water soluble bags

30 g/L Professional residential

a) spraying

b) brushing

c) injecting

1 0.3 g/L 0.3 L/m2 0.09 g / m2

Wood preservative

EU dossier

EQEF 244

Wood insects:, Hylotrupes bajulus, Reticulitermes sp

Micro emulsion

Ready for use liquid

3 g/L General public residential

spraying

brushing

injecting

1

Not applicable

0.3 g/L 0.3 L/m2 0.09 g / m2

For details see Document II-B

0.3 g / m2 is derived in the environmental risk assessment .

0.3 L/m2 is derived in the human risk assessment

(a) e.g. biting and suckling insects, fungi, molds; (b) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (c) GCPF Codes - GIFAP Technical Monograph No 2, 1989 ISBN 3-8263-3152-4); (d) All abbreviations used must be explained (e) g/kg or g/L;(f) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench; (g) Kind, e.g. overall, broadcast, aerial spraying, row, bait, crack and crevice equipment used must be indicated; (h) Indicate the minimum and maximum number of application possible under practical conditions of use; (i) Remarks may include: Extent of use/economic importance/restrictions 6 adapted from: EU (1998a): European Commission: Guidelines and criteria for the preparation of complete dossiers and of summary dossiers for the inclusion of active substances in Annex I of Directive 91/414/EC (Article 5.3 and 8,2). Document 1663/VI/94 Rev 8, 22 April 1998


Page 54 of 77

APPENDIX III: LIST OF STUDIES

Section no./ Reference no. Author(s) Year

Title Source (where different from company)

Company, Report No. GLP (where relevant) / (Un)Published

Data Protection Claimed

Y/N

Owner

A2.6 (01) Included as confidential information

Lee F-T H. & G.J. Murphy,

1991

Bifenthrin: Product identity and disclosure of ingredients, description of starting materials and Manufacturing Process, Discussion on the formation of the impurities Company: FMC Corporation Report n°: P-2542 GLP/GEP: yes unpublished

Y FMC


Lee F.T.H. 1991

Bifenthrin; analysis and certification of product ingredients Company: FMC Corporation Report n°: P-2543 GLP/GEP: yes unpublished

Y FMC


Hatch C.E.

1987

Bifenthrin impurities Company: FMC Corporation Report n°: 1.2.1/2 GLP/GEP: no unpublished

Y FMC


Hüsgen, K.,

Troubac, F.

2003 Document J 91/414 dossier for plant protection product Company: FMC Corporation

Y FMC

A2.10.1 (01) Included as confidential information

Sheffield, M.

2003 Letter on medical data Company: FMC Corporation

Y FMC

A3.1 (01), A3.7 (02), A3.11 (01), A3.12 (01), A3.13 (01), A3.16 (01)

Spruit W.E.T., et al.

2002

Determination of some physico-chemical properties of bifenthrin Company: TNO - The Netherlands Report n°: PML 2002-C121 GLP: yes Unpublished

Y FMC

A3.1 (02), A3.2 (01), A3.6 (01), A3.7 (01), A3.9 (02), A3.12 (02), A3.15 (01), A3.16 (02)

Lee, F-T.H.,

1991

Bifenthrin: physical and Chemical characteristics Company: FMC Corporation Report n°: P2544 GLP: Yes Unpublished

Y FMC

A3.2 (02) Hu, H.C., 1983

Vapor Pressure of FMC 54800 Company: FMC Corporation Report n°: CGP-83-1 GLP: no

Y FMC

RMS: France BIFENTHRIN listing of endpoints

Page 55 of 77




Data Protection Claimed

Y/N

Owner

Unpublished

A3.2.1 (01) Ferraro, C.F.,

1987

Henry's law constant calculated estimate of water volatility of FMC 54800 (bifenthrin) Company: FMC Corporation Report n°: P-1917 GLP: no unpublished

Y FMC

A3.4 (01) Françon B,

1999

Spectrometric characteristics of bifenthrin (FMC 54800) Company: Batelle - Switzerland Report n°: P-17-99-46 GLP: yes Unpublished

Y FMC

A3.5 (01) Françon B. & D. Zenide,

1999

Water solubility of bifenthrin Company: Batelle - Switzerland Report n°: P-17-99-45 GLP: yes Unpublished

Y FMC

A3.5 (02) Herbst R.M.

1983b

Water solubility of FMC 54800 Company: FMC Agricultural Chemical Group, Princeton Report n°: G182.305 GLP: no Unpublished

Y FMC

A3.5 (03) Herbst R.M.

1986

Water solubility of bifenthrin at pH 2 and pH 11 Company: Batelle - Switzerland Report n°: P-17-99-45 GLP: no Unpublished

Y FMC

A3.9 (01) Herbst R.M.,

1983a

Octanol water partition coefficient of FMC 54800 Company: FMC Corporation Report n°: P-0698 GLP: no unpublished

Y FMC

A3.10 (01) Klein L.C.,

1995

Bifenthrin thermal stability Company: FMC Corporation Report n°: E9729:116 GLP: yes Unpublished

Y FMC

A3.17 (01) Balderstone, M.

2004

Storage stability test: determination of the storage stability of the 3% bifenthrin microemulsion water soluble sachet system. Company: Enviroquest Report n°: no GLP: no Unpublished

Y Enviro-quest


Page 56 of 77

Section no./ Reference

no. Author(s) Year



Data protection Y/N

Owner

A4.1 (01)

Migliacci, J.S.

1988 Analytical support of bifenthrin technical analysis for the United Kingdom Company: FMC Corporation Document No.: 182AF88111 GLP/GEP: yes unpublished

Y FMC

A4.1 (02)

Anonymous 1987 Test Method No. ACG-88. High performance liquid chromatographic analysis of FMC 54800 Company: FMC Corporation Document No.: not stated GLP/GEP: no unpublished

Y FMC

A4.1 (03)

Anonymous (a)

- Test Method No. ACG-89. High performance liquid chromatographic analysis of FMC 54800 Company: FMC Corporation Document No.: not stated GLP/GEP: no unpublished

Y FMC


Anonym, 1984a

Gel permeation chromatographic analysis of technical FMC 54800 tar residues Company: FMC Corporation Report n°: ACG-85 GLP/GEP: no unpublished

Y FMC


Anonym 1984a

High performance liquid chromatographic determination of technical FMC 54800 impurity species Company: FMC Corporation Report n°: ACG-86 GLP/GEP: no unpublished

Y FMC


Anonym 1984c

High performance liquid chromatographic determination of technical FMC 54800 impurity species Company: FMC Corporation Report n°: ACG-87 GLP/GEP: no unpublished

Y FMC


Liu D. & E. Kikta, 1985

High performance liquid chromatographic analysis of FMC 56789 Company: FMC Corporation Report n°: ACG-109

Y FMC


Page 57 of 77


no. Author(s) Year



Data protection Y/N

Owner

GLP/GEP: no unpublished


Herbst 1985

High performance liquid chromatographic determination of technical FMC 54800 impurity species Company: FMC Corporation Report n°: ACG-110 GLP/GEP: yes unpublished

Y FMC


Klein M 1990

High performance liquid chromatography for the determination of impurities (FMC 78161, FMC 78162, FMC 87051) in bifenthrin technical Company: FMC Corporation Report n°: ACG-213 GLP/GEP: yes unpublished

Y FMC

A4.1 (10) Included as confidential information: impurities part

Halfon, M. 2004 Bifenthrin Technical (ZL): Analysis and certification of product ingredients. Company: FMC Corporation Report n°: P-3686 / 182API03P1 GLP/GEP: yes Unpublished

Y FMC

A4.1 (10) Not confidential: bifenthrin technical part

Halfon, M. 2004 Bifenthrin Technical (ZL): Analysis and certification of product ingredients. Company: FMC Corporation Report n°: P-3686 / 182API03P1 GLP/GEP: yes unpublished

Y FMC

A4.2 (01) Becker, J.M. 1991 Analytical method for the determination of bifenthrin and 4’-hydroxy-bifenthrin residue in/on soil Company: FMC Corporation Document No.: P-2491M GLP/GEP: yes unpublished

Y FMC

A4.2 (02) Javick, R.A. 1988 Collection of air borne bifenthrin with determination by GC (ECD) Company: FMC Corporation Document No.: FMC HP5880A GC/ Test method ACG No 163 GLP/GEP: no unpublished

Y FMC

A4.2 (03) Gillis, N.A. 1988 The determination of concentrations of FMC 54800 (bifenthrin) in water, air filters, soil and cotton leaf Company: Huntingdon Research Centre Ltd.

Y FMC


Page 58 of 77


no. Author(s) Year



Data protection Y/N

Owner

Document No.: FCC 130 GLP/GEP: no unpublished

A4.2 (04) Akkari, K.H. 1985 Bifenthrin pond study – analytical methodology, storage stability and pre-test data Company: FMC Corporation Document No.: P-1217 GLP/GEP: no unpublished

Y FMC

A4.2 (05) Akkari, K.H. 1988 Analytical method for the determination of bifenthrin in pond water Company: FMC Corporation Document No.: P-1937M GLP/GEP: yes unpublished

N FMC

A4.2 (06) Ridler, J.E. 1996 Analytical procedure for the determination of FMC 54800 in milk and tissue Company: FMC Corporation Document No.: P-1031 GLP/GEP: no unpublished

Y FMC

A4.2 (07) Leppert, B.C.

1987 Analytical method for determining bifenthrin residues in eggs from a poultry feeding study. Company: FMC Corporation Document No.: RAN-0204M GLP/GEP: yes unpublished

N FMC

A4.2 (08) Wyma-Teitsma, G.R.

2003 Validation of an analytical method for the determination of bifenthrin in surface water and sediment, according to SANCO/825/00 Company: TNO Document no.: V4948 GLP/GEP: yes unpublished

Y FMC

A4.2 (09) Mol, J.G.J. 2003 Validation of a gas chromatographic method for the determination of bifenthrin in soil Company: TNO Document no.: V3648 GLP/GEP: yes unpublished

Y FMC

A4.2 (10) Enriquez, M.A.

2004 Determination of residues of bifenthrin in cow tissue (muscle) samples – Independent laboratory validation (ILV). Company: Battelle Geneva Research Centres Document no.: A-17-04-18 GLP/GEP: yes Unpublished

Y FMC


Page 59 of 77


no. Author(s) Year



Data protection Y/N

Owner

A4.2 (11) Enriquez, M.A.

2004 Determination of residues of bifenthrin in milk samples – Independent laboratory validation (ILV). Company: Battelle Geneva Research Centres Document no.: A-17-04-17 GLP/GEP: yes Unpublished

Y FMC

A4.2 (12) Zenide, D.; Ferreira, J.

2004 Determination of residues of bifenthrin in blood samples – validation of the method (ILV). Company: Battelle Geneva Research Centres Document no.: A-17-04-19 GLP/GEP: yes Unpublished

Y FMC

A4.2 (13) Shaffer, S. 2006 Method validation for the analysis of bifenthrin in air using GC/MS, Company: ABC Laboratories, Inc. Document no.: 50094 GLP/GEP: yes unpublished

Y FMC


Page 60 of 77




Data protect

ion Owner

A6.0(01) FMC 2003 Overview of batch numbers and purity of the tested material in the toxicity studies Company: FMC Corporation Doc No.: not applicable GLP/GEP: not applicable unpublished

Y FMC

A6.1.1 (01) Norvell, M. J.

1982 Acute Oral Toxicity Study in Rats, FMC 54800. Company: FMC Corporation Doc No.: A82-756 GLP/GEP: yes unpublished

Y FMC

A6.1.1 (02) Freeman C. et al.

1983 Acute Oral Toxicity of FMC 54800 in Rat Company: FMC Corporation Document No.: A83-859 GLP/GEP: yes unpublished

Y FMC

A6.1.1 (03) Watt B. A.

1997 FMC54800 technical: Acute Oral Toxicity Study in Rats Company: FMC Corporation Document No.: A97-4681 GLP/GEP: yes unpublished

Y FMC

A6.1.1 (04) Rand, G.M.

1983a Acute Oral Toxicity of FMC 54800 in Mice. Company: FMC Corporation Document No.: A83-837 GLP/GEP: yes unpublished

Y FMC

A6.1.2 (01) Kedderis, L.B.

1985 Acute Dermal Toxicity of FMC 54800 Technical in Rats. Company: FMC Corporation Document No.: A85-1924 GLP/GEP: yes unpublished

Y FMC

A6.1.2 (02) DeProspo, J.R.

1983a Acute Dermal Toxicity of FMC 54800, Technical in Rabbits. Company: FMC Corporation Document No.: A83-1032 GLP/GEP: yes unpublished

Y FMC

A6.1.3 (01) Kiplinger B.S.

2003 Acute nose-only inhalation toxicity study of bifenthrin technical in albino rats Company: WIL Research Laboratories, Inc Document n°: A2003-5589 GLP/GEP: yes unpublished

Y FMC

A6.1.4 (01) DeProspo, 1983b Primary Skin Irritation of FMC 54800 Technical Y FMC


Page 61 of 77




Data protect

ion Owner

J.R. in Rabbits. Company: FMC Corporation Document No.: A83-1033 GLP/GEP: yes unpublished


1983c Primary Eye Irritation of FMC 54800 Technical in Rabbits. Company: FMC Corporation Document No.: A83-1034 GLP/GEP: yes unpublished

Y FMC


1983d Skin Sensitization of FMC 54800, Technical in Guinea Pigs. Company: FMC Corporation Document No.: A83-1035 GLP/GEP: yes unpublished

Y FMC

A6.1.5 (02) Arcelin G. 2003 Bifenthrin Technical: Contact Hypersensitivity in Albino Guinea-Pigs, Maximisation Test Company: RCC Ltd - Switzerland Document No.: A2002-5588 GLP/GEP: yes unpublished

Y FMC

A6.2 (01) Selim, S 1987 Absorption, Distribution and Excretion Studies of FMC 54800 in the Rat. Company: Biological Test Center; 2525 McGaw Avenue; Irvine, CA 92710 Document No.: PC-0047 GLP/GEP: yes unpublished

Y FMC

A6.2 (02) ElNaggar, S.F.

1987 Preliminary Metabolism Study of Alcohol- and Acid- 14C FMC 54800 in the Rat. Excretion and Tissue Distribution. Company: FMC Corporation Document No.: P-1810 GLP/GEP: yes unpublished

Y FMC

A6.2 (03) ElNaggar, S.F.; Wu, J.

1986 Metabolism of FMC 54800 in Rats - Identification of Products in Excreta. Company: FMC Corporation Document No.: P-1439 GLP/GEP: no unpublished

Y FMC

A6.2 (04) Cheng, T. 1988 Metabolism of 14C- bifenthrin (FMC 54800) in Rats. Company: Hazleton Laboratories America Inc.; PO Box 7545, Madison, Wisconsin 53707; USA Document No.: PC-0092

Y FMC


Page 62 of 77




Data protect

ion Owner

GLP/GEP: yes unpublished

A6.2 (05) Wu, T. 1988 Metabolism of 14C- bifenthrin (FMC 54800) in Rats. - Analysis and Quantitation of Metabolites in Excreta. Company: Xenobiotic Laboratories Inc.; P.O. Box 3205, Princeton, New Jersey 08543; USA Document No.: PC-0093 GLP/GEP: yes unpublished

Y FMC

A6.2 (06) Hawkins, D.R.; Elsom, L.F.; Jackson, R.

1986 Bioaccumulation Study of 14C-FMC 54800 in the Rat. Company: Huntington Research Centre Ltd.; Huntingdon; Cambridgeshire, PE18 6ES, England Document No.: PC-0045 GLP/GEP: yes unpublished

Y FMC

A6.2 (07) Selim, S 1986 The Kinetics of FMC 54800 in the Blood of Rats following a Single Oral Dose. Company: Biological Test Center; 2525 McGaw Avenue; Irvine, CA 92710 Document No.: PC-0048 GLP/GEP: yes unpublished

Y FMC

A6.2 (08) Tullman, R.H.

1986 Analysis of FMC 54800 Residues in Plasma from Rats Dosed Orally with 14C- FMC 54800. Company: FMC Corporation Document No.: P-1448 GLP/GEP: no unpublished

Y FMC

A6.2 (09) ElNaggar, S.F.; Tullman, R.H.

1991 (rev Feb 1992)

Metabolism Study: Quantitative Estimates of Urinary, Fecal and Biliary Excretion of Alcohol (phenyl)- 14C bifenthrin in the Laboratory Rat. Company: FMC Corporation Document No.: P-2570 GLP/GEP: yes unpublished

Y FMC

A6.2 (10) Craine, E.M.

1986 A Dermal Absorption Study in Rats with 14C-FMC 54800. Company: WIL Research Laboratories, Inc., Ashland, Ohio Document n°: FMC report n° PC-0059 GLP/GEP: Yes Unpublished

Y FMC

A6.2 (11) Braun, R. 1990 Dermal Absorption of 14C-CAPTURE 2EC (FMC 54800) in the Rat. Company: Biological Test Center, 2525 McGaw

Y FMC


Page 63 of 77




Data protect

ion Owner

Avenue, Irvine, CA 92713 Document n°: FMC report n° A90-3165 GLP/GEP: Yes Unpublished

A6.2 (12) Kennelly, J.C.

1989 An Investigation into Species Differences in Metabolism of FMC 54800 using (A) Male or (B) Female Swiss-Webster Mice or (C) Male Sprague-Dawley Rat Liver S-9. Company: Microtest Research Ltd; UK Document No.: (Microtest Study No. MFC1/MET) GLP/GEP: yes unpublished

Y FMC

A6.3.1 (01) Rand, G.M.

1983b Twenty Eight Day Range Finding Study in Mice with FMC 54800 Technical Company: FMC Corporation Document No.: A83-839/A83-839A GLP/GEP: yes unpublished

Y FMC

A6.3.1 (02) Rand, G.M.

1983c 28-Day Range-Finding Study in Rats with FMC 54800 Technical Company: FMC Corporation Document No.: A83-817 GLP/GEP: yes unpublished

Y FMC


1984a Twenty-one Day Repeated Dose Dermal Toxicity Study in Rabbits With FMC 54800. Company: FMC Corporation Document No.: A83-1041 GLP/GEP: yes unpublished

Y FMC

A6.3.2 (02) Watt B. and C. Freeman

2000 Bifenthrin technical: 21-day repeated-dose dermal toxicity study in rat Company: FMC Corporation Document No.: A2000-5162 GLP/GEP: yes unpublished

Y FMC

A6.4.1 (01) Rand, G.M.

1984 Ninety Day Feeding Study in Rats with FMC 54800 Technical Company: FMC Corporation Document No.: A83-818 GLP/GEP: yes unpublished

Y FMC

A6.4.1 (02) Serota, D.G.

1984 13-Week Sub-chronic Oral Toxicity Study in Dogs with FMC 54800, Technical Company: Hazleton Laboratories America Inc.; 9200 Leesburg Turnpike, Virginia; USA Document No.: A83-820

Y FMC


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A6.5 (02) Serota, D.G.

1985 52-Week Chronic Oral Toxicity Study in Dogs Company: Hazleton Laboratories America, Inc.; 9200 Leesburg Turnpike, Vienna, Virginia 22180; USA Document No.: A83-821 GLP/GEP: yes unpublished

Y FMC

A6.5 (01), A6.7 (01)

McCarty, J.D.

1986 Combined chronic oral toxicity and oncogenicity study of FMC 54800: 2-year feeding study in albino rats Company: FMC Corporation Document No.: A83-952 GLP/GEP: yes unpublished

Y FMC

A6.6.1 (01) Kennelly, J.C.

1988 Study to Determine the Ability of FMC 54800 to Induce Mutation in Four Histidine-Requiring Strains of Salmonella Typhimurium Using Liver S-9 from (a) Male or (b) Female Swiss Webster Mice or (c) Male Sprague Dawley Rats Company: Microtest Research Ltd; UK Document No.: (Microtest Study No. MFC 1/S) GLP/GEP: yes unpublished

Y FMC

A6.6.1 (02) Haworth, S.R.

1983 Salmonella/Mammalian-Microsome Plate Incorporation Mutagenicity Assay (AMES Test) Company: Microbiological Associates, 1530 East Jefferson Street, Rockville, Maryland Document No.: A83-838 GLP/GEP: yes unpublished

Y FMC

A6.6.2 (01) Kennelly, J.C.

1986 Study to Determine the Ability of FMC 54800 to Induce Mutations to 6-Thioguanine Resistance in Mouse Lymphoma L5178Y Cells Using a Fluctuation Assay Company: Microtest Research Ltd; UK Document No.: A86-2059 GLP/GEP: yes unpublished

Y FMC

A6.6.2 (02) Thilagar, A.

1984b Chromosome Aberrations in Chinese Hamster Ovary (CHO) Cells. Company: Microbiological Associates, 5221 River Road, Bethesda, Maryland 20816 Document No.: A83-1105 GLP/GEP: yes unpublished

Y FMC

A6.6.2 (03) Heideman 1989b Sister Chromatid Exchange Assay in Chinese Y FMC


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n, A. Hamster Ovary (CHO) cells in vitro with bifenthrin. Company: Cytotest Cell Research GmbH & Co. Kg.; Germany Document No.: (CCR Project No. 144011) GLP/GEP: yes unpublished


1984a CHO/HGPRT Mutation Assay in the Presence and Absence of Exogenous Metabolic Activation Company: Microbiological Associates, 5221 River Road, Bethesda, Maryland 20816 Document No.: A83-1144 GLP/GEP: yes unpublished

Y FMC

A6.6.2 (05) Putman, D.L.

1983a Activity of FMC 54800 technical in the Morphological Transformation of BALB/3T3 Mouse Embryo Cells in the Absence of Exogenous Metabolic Activation. Company: Microbiological Associates, 5221 River Road, Bethesda, Maryland 20816 Document No.: A83-980 GLP/GEP: yes unpublished

Y FMC

A6.6.3 (01) Heidemann, A.

1989a Gene Mutation Assay in Chinese Hamster Ovary (CHO) cells in vitro with bifenthrin Company: Cytotest Cell Research; Germany Document No.: (CCR Project No. 144022) GLP/GEP: yes unpublished

Y FMC


1983b Unscheduled DNA Synthesis in Rat Primary Hepatocytes Company: Microbiological Associates, 5221 River Road, Bethesda, Maryland 20816 Document No.: A83-1043 GLP/GEP: yes unpublished

Y FMC


1983a Unscheduled DNA Synthesis in Rat Primary Hepatocytes Company: Microbiological Associates, 5221 River Road, Bethesda, Maryland 20816 Document No.: A83-985 GLP/GEP: Yes unpublished

Y FMC

A6.6.3 (04) Fautz, R. 1990 Unscheduled DNA Synthesis in Primary Hepatocytes of Male Rats in vitro with bifenthrin Company: Cytotest Cell Research GmbH & Co. Kg.; Germany Document No.: 175408

Y FMC


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A6.6.3 (05) Kirby, P.E.

1983 L5178Y TK+/- Mouse Lymphoma Mutagenesis Assay Company: Microbiological Associates, 1530 East Jefferson Street, Rockville, Maryland 20852 Document No.: A83-978 GLP/GEP: yes unpublished

Y FMC

A6.6.4 (01) Putman, D.L.

1983b Activity of FMC 54800 technical (A83-979) in the subchronic in vivo cytogenetics assay in Sprague-Dawley rats. Company: Microbiological Associates, 5221 River Road, Bethesda, Maryland 20816 Document No.: A83-979 GLP/GEP: yes unpublished

Y FMC

A6.6.5 (01) DeGraff, W.G.; Sky Benson, E.

1984 Mutagenicity Evaluation of FMC 54800 Technical, Notebook No. E-3292-105, FMC Study No. A83/1104 in the Sex-Linked Recessive Lethal Test in Drosophila Melanogaster Company: Litton Bionetics, Inc., 5516 Nicholson Lane, Kensington, Maryland 20895 Document No.: A83-1104 GLP/GEP: no unpublished

Y FMC

A6.6.5 (02) Krsmanovic L.; T. Hudson

2005 Mammalian erythrocytes micronucleus test Company: BioReliance, Rockville MD – USA Document No.: A2004-5859 GLP/GEP: yes unpublished

Y FMC

A6.6.5 (03) Kamala Pant, M.S.; J. E. Sly

2005 Unscheduled DNA Synthesis (UDS) Test with Mammalian Cells In Vivo Company: BioReliance, Rockville MD – USA Document No.: A2005-5907 GLP/GEP: yes unpublished

Y FMC

A6.7 (01), A6.5 (01)

McCarty, J.D.

1986 Combined chronic oral toxicity and oncogenicity study of FMC 54800: 2-year feeding study in albino rats Company: FMC Corporation Document No.: A83-952 GLP/GEP: yes unpublished

Y FMC

A6.7 (02) Geiger, L.E.

1986 Oncogenicity Study of FMC 54800: Lifetime Feeding Study in Albino Mice Company: FMC Corporation Document No.: A83-974

Y FMC


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A6.7 (02) addendumA

Wilborn, W.H.; Hyde, B.M.

1988 Transmission Electron Microscopy of Formalin-Fixed, Chemically-Induced Tumors of the Mouse Urinary Bladder Showing the Origin of the Tumor from Smooth Muscle. Company: Electron Microscopy Center, University of South Alabama Document No.: A83-974 GLP/GEP: not relevant unpublished

Y FMC

A6.7 (02) addendumB

Butler, W.H.

1991a FMC 54800 Technical – Oncogenicity Lifetime Feeding Study in Albino Mice Histopathological Review of Selected Sections of Liver, Lung and Urinary Bladder Company: FMC Corporation Document No.: A83-974 GLP/GEP: yes unpublished

Y FMC

A6.7 (02) addendumC

Butler, W.H.

1991b FMC 54800 Technical – Oncogenicity Lifetime Feeding Study in Albino Mice Histopathological Review of Selected Sections of Liver, Lung and Urinary Bladder - Addendum Company: FMC Corporation Document No.: A83-974 GLP/GEP: yes unpublished

Y FMC


1984c Teratology Study in Rabbits with FMC 54800 Technical Company: FMC Corporation Document No.: A83-1092 GLP/GEP: yes unpublished

Y FMC


1984b Teratology Study in Rats with FMC 54800 Technical. Company: FMC Corporation Document No.: A83-1091 GLP/GEP: yes unpublished

Y FMC

A6.8.1 (03) Watt B. and C. Freeman

2001 Bifenthrin technical: Prenatal Developmental Toxicity Study in Rat Company: FMC Corporation Document No.: A2000-5263 GLP/GEP: yes unpublished

Y FMC


1986 Multi-Generation Reproduction Study with FMC 54800 Technical in Rats. Company: FMC Corporation

Y FMC


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Document No.: A83-977 GLP/GEP: yes unpublished

A6.9 (01) Watt, B.A.

1998a FMC 54800 Technical – Acute Neurotoxicity Screen in Rats. Company: FMC Corporation Document No.: A97-4643 GLP/GEP: yes unpublished

Y FMC

A6.9 (02) Roberts, N.L.; Hakin, B.; Gopinath, C.; Rao R.S.

1984 The Acute Oral Toxicity (LD50) and Neurotoxic Effects of FMC 54800 Technical to the Domestic Hen. Company: Huntingdon Research Centre plc, Huntingdon, Cambridgeshire, England Document No.: A83-1081 GLP/GEP: yes unpublished

Y FMC

A6.9 (03) Algate, D.R.; Munt, P.L; Leach, R.M.; Goor, K.L.

1985 FMC 54800 – An Investigation of the Possible Delayed Neurological Effects Using the Tilting-Plane Test. Company: Huntingdon Research Centre Ltd., Huntingdon, Cambridgeshire, England Document No.: 87&88/85657 GLP/GEP: no unpublished

Y FMC

A6.9 (04) Watt, B.A.

1998b FMC 54800 Technical – Twenty-Eight Day Neurotoxicity Range-Finding Study in Rats Company: FMC Corporation Document No.: A97-4699 GLP/GEP: yes unpublished

Y FMC

A6.9 (05) Freeman, C.

1998 FMC 54800 Technical – Subchronic Neurotoxicity Screen in Rats Company: FMC Corporation Document No.: A97-4700 GLP/GEP: yes unpublished

Y FMC

A6.9 (06) Nemee, M.D.

2006 A Dietary Feasibility and Range Finding Study of Bifenthrin Technical in Rats. FMC Corporation Company: FMC Corporation Document No.: A2003-5721 and WIL-105019 GLP/GEP: yes unpublished

Y FMC

A6.9 (07) Nemee, M.D.

2006 A Dietary Developmental Neurotoxicity Study of Bifenthrin Technical in Rats. FMC Corporation Company: FMC Corporation Document No.: A2004-5860 and WIL-105021 GLP/GEP: yes

Y FMC


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unpublished A6.11 (01) Kedderis,

L.B. 1986 Acute Intraperitoneal Toxicity of FMC 54800

Technical in Rats. Company: FMC Corporation Document No.: A85-1923 GLP/GEP: yes unpublished

Y FMC

A6.12.1 Reference to A2.10 Y FMC A6.12.2 (included in confidential information)

Summary of emergency calls GLP/GEP: N.A. unpublished

Y FMC

A6.12.3 Reference to A2.10 Y FMC A6.12.4 (included in confidential information)

Summary of emergency calls GLP/GEP: N.A. unpublished

Y FMC


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no. Author(s) Year



Data protection Y/N

Owner

A7.0(01) Verhaar, H.J.M.

2006 Bifenthrin, PBT status Company: ENVIRON Corporation Report n°: FM-BIQ-20060038 GLP: N.A. Unpublished

Y FMC

A7.1.1.1.1 (01)

Herbst R.M., 1983b Hydrolysis of bifenthrin Company: FMC Corporation Report n°: P-0701 GLP: yes Unpublished

Y FMC

A7.1.1.1.2 (01)

Wu J., 1986 Photodegradation of FMC 54800 in aqueous solution Company: FMC Corporation Report n°: P-1349 GLP: yes Unpublished

Y FMC

A7.1.1.1.2 (02)

Curry, S.J. 2006 Photodegradation of Bifenthrin in Buffered Aqueous Solution at pH 7 by Simulated Sunlight Company: FMC Corporation Report n°: 182E1205E1 GLP: yes Unpublished

Y FMC

A7.1.1.2.1 (01)

Handley, J.W., Horton M.R.

1991 Assessment of the ready biodegradability (Modified Sturm Test) of bifenthrin Company: Safepharm Laboratories Limited Document No.: 240/49 GLP/GEP: yes unpublished

Y FMC

A7.1.2.2.2 (01)

Cresswell, D.G., Hopkins, R.

1986 (14C)-FMC 54800: Degradation in river and pond waters and their associated sediments Company: Hazleton Laboratories Europe Ltd. Document No.: 5128-73/47 GLP/GEP: yes unpublished

Y FMC

A7.1.2.2.2 (02)

ElNaggar S., 2003 14C-bifenthrin: aerobic aquatic degradation in 2 water/sediment systems Company: FMC Corporation Document n °: P3600 GLP: yes unpublished

Y FMC

A7.1.2.2.2 (03)

Verhaar H. 2003 Bifenthrin: Aquatic risk assessment Company: OpdenKamp Registration & Notification Document n °: bifentrhin_DE.fm GLP: not applicable Unpublished

Y FMC


Page 71 of 77


no. Author(s) Year



Data protection Y/N

Owner

A7.1.3 (01) Froelich, L.W.

1984 Soil adsorption/desorption characteristics of FMC 54800 Company: FMC Corporation Document No.: P-0797 GLP/GEP: no unpublished

Y FMC

A7.2.1 (01) Smith, A.D. 1991 Metabolism studies: aerobic soil metabolism of bifenthrin (FMC 54800) in a silt loam soil Company: FMC Corporation Document No.: P-1978 GLP/GEP: yes unpublished

Y FMC

A7.2.1 (02) Reynolds, J.L.

1984a Aerobic soil metabolism of FMC 54800 – fate of alcohol (phenyl)-14C FMC 54800 in a sandy loam soil after 21 days Company: FMC Corporation Document No.: P-1009 GLP/GEP: no unpublished

Y FMC

A7.2.2.1 (01) Bixler, T.A. 1983 FMC 54800 aerobic soil degradation Company: FMC Corporation Document No.: P-0712 GLP/GEP: no unpublished

Y FMC

A7.2.2.1 (02) Bixler, T.A. 1984 Fate of alcohol (phenyl)-14C FMC 54800 in soil after 120 days Company: FMC Corporation Document No.: P-0800 GLP/GEP: no unpublished

Y FMC

A7.2.2.1 (03) Reynolds, J.L.

1986a Characterisation of metabolites and bound residues obtained from soil treated with alcohol (phenyl ring) – 14C FMC 54800 Company: FMC Corporation Document No.: P-1343 GLP/GEP: no unpublished

Y FMC

A7.2.2.1 (04) Reynolds, J.L.

1984b Aerobic soil metabolism of FMC 54800 – fate of acid (cyclopropyl ring) 14C FMC 54800 and metabolite characterisation Company: FMC Corporation Document No.: P-0872 GLP/GEP: no unpublished

Y FMC

A7.2.2.1 (05) Taylor, D.T. 1986 Study of the decomposition of FMC 54800 in soil Company: Hazleton Laboratories Europe Ltd. Document No.: 5102-73/45

Y FMC


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Owner


A7.2.2.2(01) Stearns, J.W. 1984 Dissipation of residues of FMC 54800 in soils treated with CAPTURE 2.0EC Company: FMC Corporation Document No.: RAN-0141 GLP/GEP: no unpublished

Y FMC

A7.2.2.2(02) Pejovich, R.J.

1985 Determination of residues of bifenthrin in soils treated with BRIGADE 10WP Company: FMC Corporation Document No.: RAN-0166 GLP/GEP: no unpublished

Y FMC

A7.2.2.2(03) Culligan Jr., J.F.

1990 Terrestrial field dissipation – magnitude of the residue of bifenthrin and 4’-hydroxy bifenthrin in soil Company: FMC Corporation Document No.: P-2491 GLP/GEP: yes unpublished

Y FMC

A7.2.2.2(04) Culligan Jr., J.F.

1991 Terrestrial field dissipation – bifenthrin and 4’-hydroxy bifenthrin in soil Company: FMC Corporation Document No.: P-2566 GLP/GEP: yes unpublished

Y FMC

A7.2.2.2(05) Rotondaro, A

1990 Bifenthrin field dissipation study Company: FMC Corporation Document n°: EF-88-46 GLP/GEP: yes unpublished

Y FMC

A7.2.2.2(06) Stenzel, J.I.; Culligan Jr., J.F.

1991 Final report of the 1989 study of the terrestrial field dissipation of bifenthrin and 4’-hydroxy bifenthrin in/on bare soil in Champaign, IL Company: FMC Corporation Document No.: P-2639 GLP/GEP: yes unpublished

Y FMC

A7.2.2.2(07) Dumont de Chassars T.

1999a Curve of degradation of TALSTAR 10EC in soil Company: Redened BV, Netherlands Document n°: G01-98 GLP/GEP: yes Unpublished

Y FMC

A7.2.2.2(08) Dumont de Chassars T.

199b Curve of degradation of SEMAFOR 200FS in soil Company: Redened BV, Netherlands Document n°: G02-98 GLP/GEP: yes

Y FMC


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no. Author(s) Year



Data protection Y/N

Owner

Unpublished A7.2.2.2(09) Mol H. 2003 Talstar SC (bifenthrin) field dissipation study

Company: TNO, The NL Document n°: V3615 GLP/GEP: yes unpublished

Y FMC

A7.2.2.2(10) Price, O. 2006 Evaluation of the Degradation Kinetics of Bifenthrin in Field Dissipation Studies using Modelmaker 4.0 Company: Cambridge Environmental Assessments-ADAS Document n°: PC-0333 GLP/GEP: N.A. unpublished

Y FMC

A7.4.1.1 (01) Le Blanc, G.A.

1983c Acute toxicity of FMC 54800 technical to rainbow trout (Salmo gairdneri) Company: EG&G, Bionomics Document No.: BW–83-8-1446 GLP/GEP: yes unpublished

Y FMC

A7.4.1.1 (02) Le Blanc, G.A.

1983b Acute toxicity of FMC 54800 technical to bluegill (Lepomis macrochirus) Company: EG&G, Bionomics Document No.: BW–83-8-1445 GLP/GEP: yes unpublished

Y FMC

A7.4.1.1 (03) Surprenant, D.C.

1985a Acute toxicity of 14C-FMC 54800 to bluegill (Lepomis macrochirus) under flow-through conditions Company: Springborn Bionomics, Inc. Document No.: BW-85-2-1730 GLP/GEP: yes unpublished

Y FMC


1985c Acute toxicity of 14C-FMC 54800 to rainbow trout (Salmo gairdneri) under flow-through conditions Company: Springborn Bionomics, Inc. Document No.: BW-85-2-1732 GLP/GEP: yes unpublished

Y FMC

A7.4.1.1 (05) Aufderheide, J.A.

1999a Bifenthrin: Bioassay procedure for determining the toxicity to rainbow trout (Oncorhynchus mykiss) in a static pond water/sediment system under repeated simulated spray conditions Company: ABC Laboratories Europe Ltd. Document No.: ABC Report No. 70152 GLP/GEP: yes unpublished

Y FMC


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no. Author(s) Year



Data protection Y/N

Owner


1999b Bifenthrin: Bioassay procedure for determining the toxicity to rainbow trout (Oncorhynchus mykiss) in a static pond water/sediment system under simulated spray conditions Company: ABC Laboratories Europe Ltd. Document No.: ABC Report No. 70097 GLP/GEP: yes unpublished

Y FMC

A7.4.1.2 (01) Le Blanc, G.A.

1983a Acute toxicity of FMC 54800 technical to Daphnia magna Company: EG&G, Bionomics Document No.: BW–83-8-1444 GLP/GEP: yes unpublished

Y FMC


1985b Acute toxicity of 14C-FMC 54800 to Daphnia magna under flow through conditions Company: Springborn Bionomics, Inc. Document No.: BW-85-2-1731 GLP/GEP: yes unpublished

Y FMC


1999c Bifenthrin: Bioassay procedure for determining the toxicity to Daphnia magna in a static pond water/sediment system under simulated spray conditions Company: ABC Laboratories Europe Ltd. Document No.: ABC Report No. 70193 GLP/GEP: yes unpublished

Y FMC

A7.4.1.2(04), A7.4.1.2(05), A7.4.1.2(06), A7.4.1.2(07), A7.4.1.2(08), A7.4.1.2(09),

Hooftman R.N.

2002 Static acute toxicity tests with the insecticide bifenthrin technical and 6 arthropods species Company: TNO Chemistry - The Netherlands Document No.: TNO Report No. 01-2424/01 GLP/GEP: yes unpublished

Y FMC

A7.4.1.3(01), A7.4.1.3(02)

Plummer, M.J.

1985 Bifenthrin toxicity to algae Company: FMC Corporation Document No.: ---- GLP/GEP: no unpublished

Y FMC

A7.4.1.4 (01) Baumann, J. 1999 Effect of bifenthrin to sewage sludge Company: BATELLE Document No.: E-17-99-47 GLP/GEP: yes unpublished

Y FMC


1985f The toxicity of 14C-FMC 54800 to rainbow trout (Salmo gairdneri) embryos and larvae. Company: Springborn Bionomics, Inc. Document No.: BW-85-4-1766

Y FMC


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no. Author(s) Year



Data protection Y/N

Owner


A7.4.3.2 (02) McAllister, W.A..

1988 Full life cycle toxicity of 14C FMC 54800 to fathead minnow (Pimephales promelas) in a flow-through system Company: ABC Laboratories Inc. Missouri Document No.: A86-2100 GLP/GEP: yes unpublished

Y FMC

A7.4.3.3.1 (01)

Surprenant, D.C.

1985e Accumulation and elimination of 14C-residues by bluegill (Lepomis macrochirus) exposed to 14C-FMC 54800 Company: Springborn Bionomics, Inc. Document No.: BW-85-4-1765 GLP/GEP: yes unpublished

Y FMC

A7.4.3.3.1 (02)

Hotaka S. 1993 Bioaccumulation study of FMC 54800 with carp (Cyprinus carpio) Company: Yokohama Laboratory Document No.: 2B479G GLP/GEP: yes unpublished

Y FMC

A7.4.3.3.1 (03)

Surprenant, D.C.

1988 Bioavailability, accumulation and aquatic toxicity of 14C-FMC 54800 residues incorporated into soil Company: Springborn Bionomics, Inc. Document No.: BW-85-12-1894 GLP/GEP: yes unpublished

Y FMC

A7.4.3.3.1 (04)

Weidell, H.-J.

2006 White paper on the fish bioconcentration of bifenthrin Company: Smithers Research Laboratories (Schweiz) AG Document No.: N.A. GLP/GEP: N.A. unpublished

Y FMC

A7.4.3.3.1 (05)

Gries, Th. 2006 Status report; bifenthrin: bioconcentration study with bluegill sunfish (Lepomis macrochirus) under semi-static conditions Company: Springborn Smithers Research Laboratories (Europe) AG Document No.: 1084.008.135 GLP/GEP: yes unpublished

Y FMC

A7.4.3.4 (01) Burgess, D. 1989 Chronic Toxicity of 14C-FMC 54800 to Daphnia magna under flow-through test conditions Company: Analytical Biochemistry Laboratories, Inc.

Y FMC


Page 76 of 77


no. Author(s) Year



Data protection Y/N

Owner

Document No.: ABC 36980 GLP/GEP: yes unpublished


1985d The chronic toxicity of 14C-FMC 54800 to Daphnia magna under flow-through conditions Company: Springborn Bionomics, Inc. Document No.: BW-85-3-1747 GLP/GEP: yes unpublished

Y FMC

A7.4.3.4 (03) Boeri, R.L., Ward, T.J.

1991 Life cycle toxicity of bifenthrin (FMC 54800) to the mysid, Mysidopsis bahia Company: FMC Corporation Document No.: A90-3318 GLP/GEP: yes unpublished

N FMC

A7.4.3.5.1 (01)

Kelly C. R. 2002 14C-bifenthrin: determination of acute toxicity (EC50) to Chironomus riparius (28 days, static) Company: Inveresk Research - Scotland Document No.: 19781 GLP/GEP: yes Unpublished

Y FMC

A7.4.3.5.1 (02)

Mitchell, G.C.; Nissen-Meyer, S.; ElNaggar, S.

2006 FMC’s Response to INERIS (National Institute of the Industrial Environmental and Risks) Request for New Assays for bifenthrin (CASE no. 82657-04-3): Effects on sediment-burrowing organisms (Section A7.4.3.5.1.of document IIIA) Company: FMC Corporation Document No.: P-3839 GLP/GEP: N.A. Unpublished

Y FMC

A7.4.3.5.1 (03)

Putt, A.E 2005 Bifenthrin - Toxicity to Midge (Chironomus tentans) During a 10-Day Sediment Exposure Company: Springborn Smithers Laboratories Document No.: 13656.6106 GLP/GEP: yes Unpublished

Y FMC

A7.4.3.5.1 (04)

ElNaggar, S.F.

2006 Ecological irrelevance of 4’-OH’bifenthrin metabolite Company: FMC Corporation Document No.: GLP/GEP: N.A. Unpublished

Y FMC

A7.5.1.1 (01) Kölzer U. 2002 Assessment of the side effects of TALSTAR 8SC on the activity of the soil microflora Company: GAB Biotechnologies - Germany

Y FMC


Page 77 of 77


no. Author(s) Year



Data protection Y/N

Owner

Document n°: 20021228/01-ABMF GLP/GEP: yes unpublished

A7.5.1.2 (01) Roberts, N.L., & B. Hakin

1985 The acute toxicity (LC50) of FMC 54800 to the earthworm Eisenia foetida Company: Huntingdon Research centre Ltd. Document No.: FCC 82/85693 GLP/GEP: yes unpublished

Y FMC

A7.5.2.1 (01) Stäbler D. 2002 TALSTAR 8SC assessment of effects on reproduction and growth on Eisenia fetida in artificial soil Company: GAB Biotechnologies - Germany Document n°: 20021228/01-NREf GLP/GEP: yes unpublished

Y FMC

A7.5.5 Verhaar, H.J.M.

2006 Bifenthrin; bioconcentration in earthworms Company: ENVIRON Corporation Document n°: FM-BIQ-20060039 GLP/GEP: no

Y FMC

A8 (01) Anonym. 2004

Material Safety Data Sheet of Bifenthrin technical Company: FMC Report n°: - GLP: - published

No FMC

A8 (02) Anonym. 2003

Fiche de données de sécurité bifenthrine Company: FMC Report n°: - GLP: - published

No FMC

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