Mixture classification - exercises Seminar for Baltic States
Outi Tunnela
ECHA Helpdesk
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Examples: How are cut-off values used?
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Cut-off values
Ingredient w%
LD50(mg/kg)
Classification
Anionic surfactant
9.2 >5000 Not classified
Thickening agent
0.8 3600 Skin Irrit. 2
Water 90 Not classified
Example 1: Below cut-off value 1%. The mixture is not classified as Skin Irrit. 2.
Ingredient w% LD50(mg/kg)
Classification
Anionic surfactant
8.2
>5000
Not classified
Thickening agent
1.8
Skin Irrit. 2
Water 90 Not classified
Example 2: Above cut-off value 1%. The mixture might be classified.
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Sum of ingredients classified as:
Concentration triggering classification of a mixture as:
Skin Corrosive Skin Irritant
Category 1 Category 2
Skin Corrosive Categories 1A, 1B, 1C ≥ 5 % ≥ 1 % but < 5 %
Skin irritant Category 2 ≥ 10 %
(10* x Skin Corrosive Category 1A, 1B, 1C) + Skin irritant Category 2 ≥ 10 %
Generic concentration limits for skin corrosion/irritation Additivity approach applies Generic concentration limits of ingredients classified that trigger classification of the mixture (Table 3.2.3 of Annex I)
* Weighting factor of 10 if Category 1 component ≥ 1% but ≤ 5% in a mixture
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Ingredient classified as:
Concentration triggering classification of a mixture as:
Repr. tox cat. 1A Repr. tox cat. 1B
Repr.tox cat.2
Effects on or via lactation
Repro cat. 1A ≥ 0,3 %
Repro cat. 1B ≥ 0,3 %
Repro cat. 2 ≥ 3,0 %
Effects on or via lactation
≥ 0,3 %
Generic concentration limits for reproduction toxicity/effects on or via lactation Additivity approach does not apply Generic concentration limits of classified ingredients that trigger classification of the mixture (Table 3.7.2 of Annex I)
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Acute toxicity, when Data available for all ingredients: • In order to ensure that classification of the mixture is accurate and
that the calculation need only be performed once, the acute toxicity estimate (ATE) of ingredients shall be considered:
• Include ingredients with a known acute toxicity, which fall into any of the
acute toxicity categories shown in Table 3.1.1 • Ignore ingredients that are presumed not acutely toxic (e.g., water,
sugar) • Ignore ingredients, if the oral limit test does not show acute toxicity at 2
000 mg/kg bodyweight.
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Calculation Method - Additivity formula
Acute Toxicity
Total concentration of the ingredient(s) with unknown toxicity is <= 10 %;
Total concentration of the ingredient(s) with unknown toxicity is >10 %;
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Exposure route Classification category or experimentally obtained acute toxicity range estimate
Converted acute toxicity point estimate
Oral (mg/kg bw)
0 < category 1 ≤ 5 5 < category 2 ≤ 50
50 < category 3 ≤ 300 300 < category 4 ≤ 2000
0,5 5
100 500
Table 3.1.2
Conversion values Where an ATE is not available for an ingredient of a mixture, but available information can provide a value derived from the conversion table, this conversion value may be used for calculation. Conversion from experimentally obtained acute toxicity range values (or acute toxicity hazard categories) to acute toxicity point estimates for classification of the respective routes of exposure
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EXAMPLE: How mixture A is classified?
MIXTURE A Concentration LD50 oral Classification
Substance 1 1% 225 mg/kg
Substance 2 3% 100 mg/kg
Substance 3 10% Acute tox. category 3, oral
Water 76%
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1. Step: conversion from hazard category to point estimate:
Table 3.1.2 (Annex 1)
Exposure route Classification category or experimentally obtained acute toxicity range estimate
Converted acute toxicity point estimate
Oral (mg/kg bw)
0 < category 1 ≤ 5 5 < category 2 ≤ 50
50 < category 3 ≤ 300 300 < category 4 ≤ 2000
0,5 5
100 500
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2. Step: calculation of ATEmixture
100
ATEmixture =∑
Ci
ATEi n
Concentration LD50 oral Classification
Substance 1 1% 225 mg/kg
Substance 2 3% 100 mg/kg
Substance 3 10% Acute tox, cat 3
Water 76%
100
ATEmixture
1
225
+ 3
100
+ 10
100 ATEmixture = 743 mg/kg bw =
ATE: 100
ATE: - LD50 or LC50-value, or - Converted value (point estimate) for acute toxicity from Table 3.1.2 in Annex I,
relating to a value from a range test or to a classification category
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3. Step:conversion from hazard category to point estimate:
Table 3.1.2 Exposure route Classification category or
experimentally obtained acute toxicity range estimate
Converted acute toxicity point estimate
Oral (mg/kg bw)
0 < category 1 ≤ 5 5 < category 2 ≤ 50
50 < category 3 ≤ 300 300 < category 4 ≤ 2000
0,5 5
100 500
ATEmixture = 743 mg/kg bw
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4. Step: classification of a mixture
100
ATEmixture =∑
Ci
ATEi n
Concentration LD50 oral Classification
Substance 1 1% 225 mg/kg
Substance 2 3% 100 mg/kg
Substance 3 10% Acute tox, cat 3
Water 76%
100
ATEmixture
1
225
+ 3
100
+ 10
100 ATEmixture = 743 mg/kg bw =
Classification: Acute tox. cat 4, oral
ATE: 100
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Example: Bridging principles
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Determine classification for the following mixture (substantially similar mixtures)
Bridging principles
• Starting point: 2 mixtures, ingredients [A], [B] and [C] • Mixture 1: [A] + [B] • Mixture 2: [C] + [B]
• Concentration of [A] ≅ [C] • Concentration of [B] similar in both mixtures
• B is a sensitiser! • A and C are not sensitisers
• If either mixture (1) or (2) has been tested, the other can be classified using bridging principles (substantially similar mixtures)
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0.1 Substance 5 0.1 Substance 5
0.9 Substance 4 0.9 Substance 4
3.0 Substance 3 3.0 Substance 3
91.2 Substance 2b 91.0 Substance 2a
4.8 Substance 1* 5.0 Substance 1*
weight % Ingredient weight % Ingredient
Not tested mixture (Product 6)
Tested mixture (Product 1)
* Skin sensitiser
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Additional information on the tested mixture
Product
Weight % of substance 1* in
product
Patch-tests in humans occurrence of
sensitision
Product 1 5.0 0/298
Product 2 6.0 0/198
Product 3 6.0 0/307
Product 4 5.0 0/197
Product 5 2.5 0/103
Sum: 0/1103
* Skin sensitiser
All 5 products tested in animals without a sensitising result
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solution
Non-tested product 6 is not classified as sensitising, based on the test results on product 1 and the additional information that supports this decision.
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solution
Tiered approach to classification of mixtures for acute toxicity
1) Testing (test data as primary source) • whole mixture tested • classification criteria applied as for substances
2) Bridging principles (Annex I, part 1) – sufficient data available for similar mixture • diluting • batching • concentrating of highly toxic mixtures • interpolation within one toxicity category • substantially similar mixtures • aerosols
3) Classification based on concentration of ingredients • formulas (acute toxicity) • concentration limits (tables; other hazards apart from acute tox)
If no data
If even this is not possible Also this is a possibility -> would result in product 6 being a sensitiser, because the conc. of substance 1* is over 1%
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EXAMPLE: Classification for ENV hazards
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Environmental hazard: Chronic Categories 1,2,3 and 4 - summation method (1)
Ingr. A
1%
Ingr. C
10%
Ingr. B
10%
Mixture:
Chronic Cat. 1 Chronic Cat. 1
Chronic Cat. 2
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EXAMPLE: Classification for ENV hazards (Chronic Categories 1,2,3 and 4) - summation method (2)
Ingr. A
1%
Ingr. C
10%
Ingr. B
10%
Step 1: use Table 4.1.2 of Annex 1(Classification of a mixture for chronic (long term) hazards, based on summation of classified components Mixture classified as Category Chronic 1, if ∑(Chronic Category 1 x M) ≥ 25%
Mixture:
Chronic Cat. 1 Chronic Cat. 1 Chronic Cat. 2
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24
25
50
75
100
1% x 10 = 10%
10% x 1 = 10%
Step 2: use the formula ∑(Chronic Category 1 x M)
Chronic 3
Chronic 2
Chronic 1, M1
Chronic 1, M10
Chronic 1, M100
Ingr. A
1%
Ingr. C
10%
Ingr. B
10%
10% + 10% = 20%, which is < 25%. Hence, mixture is not classified as Chronic 1.
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Step 3: use Table 4.1.2 of Annex 1(Classification of a mixture for chronic (long term) hazards, based on summation of classified components Mixture classified as Category Chronic 2, if ∑(Chronic Category 1 x M x 10) + ∑(Chronic Category 2) ≥ 25%
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Step 4: use the formula ∑(Chronic Category 1 x M x 10) + ∑(Chronic Category 2)
Chronic 3
Chronic 2
Chronic 1, M1
Chronic 1, M10
Chronic 1, M100
Igr. A
1%
Ingr. C
10%
Ingr. B
10%
100
200
300
1% x 10 x 10 = 100%
10% x 1 x 10 = 100%
10%
100% + 100% + 10% = 210%, which is ≥ 25%. Hence, mixture is classified as Chronic 2.
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CHRONIC
CATEGORY 2, H411
Step 5: final classification (according Table 4.1.2., Annex I):
Ingr. A
1%
Ingr. C
10%
Ingr. B
10%
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Example: Translation - Mixtures
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Example: Old (classification): Mixture is not classified and contains: 98% water 2% of substance with R34 (causes burns) New (translated classification): 1. Step: use the translation table – cannot be used 2. Step: use table 3.2.3 of Annex 1 to get Category: NOTE: the NEW generic concentration limit is 1% but the corresponding limit of OLD system is 5%!
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Table 3.2.3
Sum of ingredients classified as:
Concentration triggering classification of a mixture as:
Skin Corrosive Skin Irritant
Category 1 (see note below)
Category 2
Skin Corrosive Categories 1A, 1B, 1C
≥ 5 % ≥ 1 % but < 5 %
Skin irritant Category 2 ≥ 10 %
(10 × Skin Corrosive Category 1A, 1B, 1C) + Skin irritant Category 2
≥ 10 %
Generic concentration limits of ingredients classified for skin corrosive/irritant hazard (Category 1 or 2) that trigger classification of the mixture as corrosive/irritant to skin
Skin Irritant; Cat.2
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3. Step: use table 3.2.5 of Annex 1 to get H statement : 4. Step: determine the final classification Skin Irritant; Cat 2; H315 (Causes skin irritation)
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Mixture classification exercises
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Environmental hazard
Mixture X with components A to F: Classification data is available for all components of the mixture Guidance on the Application of CLP Criteria, section 4.1.4
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Acute aquatic hazard
M Long-term aquatic hazard
M C (%)
A Acute 1 10 Chronic 1 10 1
B Acute 1 1 Chronic 2 - 3
C Not classified
- Chronic 2 - 10
D Not classified
- Chronic 3 - 10
E
Not classified
- Not classified
- 10
F Not classified
- Not classified
- 66
Information on ingredients, classification and concentration
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Which approach will you use?
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• Valid test data on the mixture as a whole (for all three trophic levels) is not available.
• Valid test data on similar tested mixtures is not available, either, meaning that any bridging principle cannot be used.
Therefore, classification should be considered based on
individual components using the summation method.
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Acute aquatic hazard:
• Information on classification & associated M-factors and the % of the components in the mixture are available.
• Classify for acute hazard if: Σ (Acute 1 x M) ≥ 25%
• Is it?
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(1 x 10) + (3 x 1) = 13 which is <25%. Hence, no classification for acute aquatic hazard.
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Long-term aquatic hazard Step 1: Classify as Chronic 1 if: Σ (Chronic 1 x M) ≥ 25% (if not, then go to
Step 2). Step 2: Classify as Chronic 2 if: Σ (10 x Chronic 1 x M) + Σ (Chronic 2) ≥
25% (if not, then go to Step 3). Step 3: Classify as Chronic 3 if: Σ (100 x Chronic 1 x M) + Σ (10 x Chronic 2)
+ Σ (Chronic 3) ≥ 25% (if not, then go to Step 4). Step 4: Classify as Chronic 4 if: Σ (Chronic 1) + Σ (Chronic 2) + Σ (Chronic 3) + Σ (Chronic 4) ≥ 25%
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Using the classification of the components of the mixture: Step 1: (1 x 10) = 10 (which is < 25% → Step 2).
Step 2: (10 x 1 x 10) + 3+10 = 113 (which is > 25%). Hence, classify as Category Chronic 2.
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Labelling elements based on the classification:
Element Aquatic hazard information that could appear on
the label
GHS Pictogram
Signal Word
Hazard Statement
Precautionary statement(s)
GHS09
-
H411
P273, P391, P501
Acute aquatic hazard:
Long-term aquatic hazard:
Not classified.
Category Chronic 2.
Aquatic hazard classification
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Mixture classification exercise 1: classification for acute toxicity
Mixture ingredients
Classification (by ingredient)
Conc. (% w/w) Info on testing
Animal tests (rat, oral)
1 ? 4 LD50: 125 mg/kg
2 - 92 N/A
3 ? 3 LD50: 1500 mg/kg
4 - 0,8 N/A
5 ? 0,2 LD50: 10 mg/kg
Physical properties have been tested -> no phys. hazards. No other test data.
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Mixture classification exercise 1: instructions
Check in CLP Annex I (pp. 81-87) the criteria for classification for acute toxicity
1) Check component classifications in table 3.1.1 (based on LD50-values):
• Component 1: Component 3: Component 5:
2) Consider if formula 3.1.3.6.1 or 3.1.3.6.2.3 should be used? • Unknown: ATEmixture
3) When you have ATEmixture, see table 3.1.1 for the classification of the mixture 4) Note the relevant ingredients from section 3.1.3.3 (p. 83) and table 1.1 (p. 38): Additional labelling?
Hazard class Generic cut-off values to be taken into account
Acute Toxicity: – Category 1-3 – Category 4
0,1 % 1 %
Skin corrosion/Irritation 1 %[1]
Serious damage to eyes/eye irritation
1 %[2]
Hazardous to Aquatic Environment – Acute Category 1 – Chronic Category 1 – Chronic Category 2-4
0,1 %[3] 0,1 %[4]
1 %
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Mixture classification exercise 1
3.1 Acute toxicity - ATE
• ATE: Acute Toxicity Estimate • LD50- or LC50 -value [mg/kg bw] OR • Converted acute toxicity point estimate for the classification of mixtures
when using ATEmixture formulas • Experimentally obtained acute toxicity range estimated • Classification category
• If LD50 or LC50 for mixture or its components is not known, but classification is known, a numerical value derived from classification can be used (for calculating acute toxicity)
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Mixture classification exercise 1
3.1 Acute toxicity - ATE
Table 3.1.1 Acute toxicity hazard categories and
acute toxicity estimates (ATE) defining the respective categories
Exposure Route Category 1 Category 2 Category 3 Category 4
Oral (mg/kg bodyweight) See Note (a) ATE ≤ 5 5 < ATE ≤ 50 50 < ATE ≤ 300 300 < ATE ≤ 2000
Dermal (mg/kg bodyweight) See Note (a)
ATE ≤ 50 50 < ATE ≤ 200
200 < ATE ≤ 1000
1000 < ATE ≤ 2000
Gases (ppmV[1]) see: Note (a) Note (b)
ATE ≤ 100 100 < ATE ≤ 500
500 < ATE ≤ 2500
2500 < ATE ≤ 20000
Vapours (mg/l) see: Note (a) Note (b) Note (c)
ATE ≤ 0,5 0,5 < ATE ≤ 2,0
2,0 < ATE ≤ 10,0
10,0 < ATE ≤ 20,0
Dusts and Mists (mg/l) see: Note (a) Note (b)
ATE ≤ 0,05 0,05 < ATE ≤ 0,5 0,5 < ATE ≤ 1,0 1,0 < ATE ≤ 5,0
[1] Gas concentrations are expressed in parts per million per volume (ppmV)
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Mixture classification exercise 1 3.1 Acute toxicity - ATE
Table 3.1.2 Conversion from experimentally obtained acute toxicity range values (or acute toxicity hazard categories) to acute toxicity point estimates for classification for the respective routes of exposure
Exposure routes Classification Category or experimentally obtained acute toxicity range estimate
Converted acute toxicity point
estimate (see Note 1)
Oral (mg/kg bodyweight)
0 < Category 1 ≤ 5 5 < Category 2 ≤ 50 50 < Category 3 ≤ 300 300 < Category 4 ≤ 2000
0,5 5
100 500
Dermal (mg/kg bodyweight)
0 < Category 1 ≤ 50 50 < Category 2 ≤ 200 200 < Category 3 ≤ 1000 1000 < Category 4 ≤ 2000
5 50 300 1100
Gases (ppmV)
0 < Category 1 ≤ 100 100 < Category 2 ≤ 500 500 < Category 3 ≤ 2500 2500 < Category 4 ≤ 20000
10 100 700 4500
Vapours (mg/l)
0 < Category 1 ≤ 0,5 0,5 < Category 2 ≤ 2,0 2,0 < Category 3 ≤ 10,0 10,0 < Category 4 ≤ 20,0
0,05 0,5 3 11
Dust/mist (mg/l)
0< Category 1 ≤ 0,05 0,05 < Category 2 ≤ 0,5 0,5 < Category 3 ≤ 1,0 1,0 < Category 4 ≤ 5,0
0,005 0,05 0,5 1,5
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Mixture classification exercise 1
3.1 Acute toxicity – ATE Data available for all ingredients ⇒ Formula 1:
• Ci= concentration of ingredient i • ATEi = Acute Toxicity Estimate of ingredient i • ATEmix = Acute Toxicity Estimate of mixture • n = number of ingredients
i ∑ = n i mix ATE
C
ATE
100
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Mixture classification exercise 1
3.1 Acute toxicity - ATE
Data is not available for all ingredients (ATE is not known) and the conc of such an ingredient is > 10% ⇒ Formula 2:
• Ci= concentration of ingredient i • Cunknown= conc. of ingredient of unknown acute toxicity • ATEi = Acute Toxicity Estimate of ingredient i • ATEmix = Acute Toxicity Estimate of mixture • n = number of ingredients
100 – ( Σ Cunknown >10 %) _______________________
ATE mix
= Ci _____
ATE i Σ n
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Mixture classification exercise 1: solution
Tiered approach to classification of mixtures for acute toxicity
1) Testing (test data as primary source) • whole mixture tested • classification criteria applied as for substances
2) Bridging principles (Annex I, part 1) – sufficient data available for similar mixture • diluting • batching • concentrating of highly toxic mixtures • interpolation within one toxicity category • substantially similar mixtures • aerosols
3) Classification based on concentration of ingredients • formulas (acute toxicity) • concentration limits (tables; other hazards apart from acute tox)
If no data
If even this is not possible
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Mixture classification exercise 1: solution
General strategy
• Relevant concentration limits for each hazard • For mixtures that must be classified according to the additivity principle (additive
effects: acute toxicity, skin and eye corrosion) • Table 1.1 is not always enough • Always check also criteria for mixture classif under respective hazard
• For each hazard: check possibilities to remove factors
• Ignore what is not relevant for the hazard in question • Conc. below the value taken into account / generic cut-off value • Not classified for that hazard • Is the conc. to be classified using additivity formula (additive effects: acute
toxicity, skin and eye corrosion)
• Remember the limit values relevant for SDS
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Mixture classification exercise 1: solution Ingredient classification from Table 3.1.1: • 1: category 3 (50-300 mg/kg) • 3: category 4 (300-2000 mg/kg) • 5: category 2 (5-50 mg/kg)
Mixture classification formula (Section 3.1.3.6.2.3, unknown ingredients > 10%): (100 – (Σ Cunknown if >10%))/ ATEmix = Σn Ci/ATEi 100 – 92/ ATEmix = 4/125 + 3/1500 + 0.2/10 8/ATEmix= 0.032 + 0.002 + 0.02 = 0.054 ATEmix = 148 mg/kg –> category 3 (acute toxicity)
• Additional labelling: ”92 % of the mixture consists of ingredients of
unknown toxicity” (Table 3.1.3, Note 2)
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Mixture classification exercise 1: solution
Justification: 1. No available test data for mixture
2. Use of bridging principles is not possible (no classified similar mixture; section
3.1.3.5.1)
3. Classification can be based on section 3.1.3.6: mixture classification when data NOT available for all components
4. Applying section 3.1.3.3(a), ”relevant ingredients” -> ingredient 4 is not taken into account in calculating ATEmix, because its conc. is < 1%, and other info is not available
5. Justification 4 cannot be used for ingredient 5, because the cut-off value for a category 2 substance is 0.1% in Table 1.1
6. Total conc. of ingredients, whose toxicity is unknown (i.e. ingredient 2), is 92% -> ATEmix formula in section 3.1.3.6.2.3 must be used (the over 10% rule)
7. ingredients 1, 3 and 5 are included in the formula, because their classification is one of acute tox categories (3.1.3.6.1 a).
8. Calculation uses real LD50 values for substances 1, 3 and 5 (Table 3.1.1, note a)
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Labelling for the classification obtained
• Choose the pictograms, signal word, hazard- and precautionary statements from Table 3.1.3
• Choose appr. 6 most suitable P-statements
• What else should there be on the label?
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Labelling
Acute toxicity cat. 3 + additional labelling ”92% of the mixture consists of ingredients of unknown toxicity”
Statements from Table 3.1.3:
• P501 • P-statement on disposal
• P405 • P-statement on storage
• P301 + P310 P321, P330
• P-statement on response
• P264, P270 • P-statement on prevention
• H301: Toxic if swallowed
• Hazard statement
• Danger • Signal word
• GHS-pictogram
• Acute toxicity category 3
• classification
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Labelling
MODEL Ingredient 1 Ingredient 3 Ingredient 5 92% of the mixture consists of ingredients of unknown toxicity
Toxic if swallowed. (Keep out of reach of children.) Do not eat, drink or smoke when using this product. IF SWALLOWED: Immediately call a POISON CENTER or doctor/physician. Store locked up. Dispose of contents/container according to local regulations. (5L)
Oy Tehdas Ab Tehdaskatu 1 33100 Tampere Tel. 03 111111
DANGER
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Labelling
Justification: • Elements from Table 3.1.3 • Most reasonable P-statements (CLP guidance (p.510), Art. 22+28, and
Guidance on labelling). • Volume must be mentioned if the product goes to consumer use, and if it not
mentioned elsewhere on the package. To products for consumer use also the statement ”Keep out of reach of children” must be added. (Annex IV, Table 6.1).
• Remember the child-resistant fastening and the tactile warning.
CLP, Art. 18: Product identifiers: 3. ... shall consist of both the following:
• The trade name or the designation of the mixture; • The identity of all substances in the mixture that contribute to the classification
of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT) or aspiration hazard.
If, in the case referred to in (b), this requirement leads to the provision of
multiple chemical names, a maximum of four chemical names shall suffice, unless more than four names are needed to reflect the nature and the severity of the hazards.
http://guidance.echa.europa.eu/docs/guidance_document/clp_en.pdf
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Mixture classification exercise 2 Classify for skin corrosion /irritation – mixture pH 2.5
Component Skin corrosion/ irritation class.
Conc. (% w/w)
SCL (specific conc. limit)
Surfactant C Cat 2 0,4
Surfactant D Cat 2 3.0
Surfactant A Cat 2 0,7
Hydrogen peroxide Cat 1A 3,0 C ≥ 70 %: skin Cat 1A 50 % ≤ C < 70 %: skin Cat
1B 35 % ≤ C < 50 %: skin Cat
2
Ethanol Not classified 2
Water Not classified 90.9
Mixture pH: 2.5 – 3.0 Mixture contains three surfactants, none of which are corrosive/ irritant under 1% (CLP Annex VI does not have specific concentration levels), and classification is determined by additivity principle
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Mixture classification exercise 2 Guide to solution
Decision logic in CLP guidance (p.238):
CLP Table 3.2.3
Note relevant ingredients!
GCL :
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Mixture classification exercise 2 Guide to solution
If the classification of a mixture can be determined with the additivity approach, and if some of the components have specific concentration limits, the following formula can be used:
Mixture is classified skin corrosive / irritant, if • Sum (ConcA / clA) + (ConcB / clB) + ….+ (ConcZ / clZ) on ≥ 1
• Where ConcA = conc of substance A in the mixture
clA = conc limit (specific or generic) of substance A ConcB = conc of substance B in the mixture clB = conc limit (specific or generic) of substance B
etc. • This formula can be found in the CLP Guidance (p.234) and in Directive 1999/45/EC.
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Mixture classification exercise 2 Guide to solution
General strategy • Concentration limits to be taken into account for each hazard class
• For mixtures that must be classified using the additivity principle (additive effects: acute toxicity, skin and eye corrosion /irritation)
• table 1.1. is not always enough • Always check also the criteria for that hazard under ”classification criteria for mixtures”
• For each hazard check the possibilities to remove factors • ”off with what is not relevant for the hazard class”
• Concentration under the relevant concentration limits • Not classified in that hazard class • Should that concentration be classified using the additivity principle (additive effects: acute toxicity, skin and eye corrosion
/irritation)
• Remember the concentration limits that must be given on the SDS
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Mixture classification exercise 2: solution
• Classification according to pH is not applicable as pH>2
• Ethanol and water can be ignored, as they are not classified for the hazard in question. Also surfactants A and C can be ignored, because their concentration is below 1% (3.2.3.3.1. relevant ingredients = concentration > 1%)
• No SCL has been determined for Surfactant D, so the generic concentration limits from Table 3.2.3 will be used.
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Mixture classification exercise 2: solution
Sum of ingredients classified as Concentration triggering classification of a mixture as:
Skin Corrosive Skin Irritant
Category 1 (see note below) Category 2
Skin corrosive Categories 1A, 1B, 1C
≥ 5% ≥ 1% but < 5%
Skin irritant Category 2 ≥ 10%
(10 x Skin corrosive Category 1A, 1B, 1C) + Skin irritant Category 2
≥ 10%
Determine whether mixture belongs to skin category 1: Mixture contains 3% hydrogen peroxide, which is the only substance in the mix in Cat. 1. As this is below 50% (see SCL for hydrogen peroxide), the mixture is not classified Cat. 1 for skin corrosion. Determine whether mixture belongs to skin category 2: (% hydrogen peroxide / SCL) + (% surfactant D / GCL) = (3/35) + (3/10) = 0.39 < 1 thus mixture is not classified in Cat. 2 for skin irritation.
(eye irritant?)
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Mixture classification exercise 2: labelling according to classification
• Not classified => not hazardous
Thank You. Outi Tunnela [email protected]