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Phenytoin, USP Phenytoin, USP

SDS Preparation Date (10/17/2016): Page 1 of 13

SAFETY DATA SHEET

Section 1 Identification of the substance/mixture and of the company/undertaking

Product Identifier Identification on the label/ Tradename: Phenytoin, USP Identification of the Product: CAS# 57-41-0 RTECS No.: MU1050000 CI No.: Not Available Synonyms: 5,5-Diphenyl-2,4-imidazolidinedione; 5,5-Diphenylhydantoin; 5,5-Diphenylimidazolidin-2,4-dione 5,5-Dwufenylohydantoina (Polish); Difenilhidantoina (Spanish); Diphantoin; Diphedan; Diphenylhydantoin; Diphenylhydantoine (French); Fenitoina; Fentoin; Phentoin Relevant identified uses of the substance and uses advised against: Identified Uses: Medication Uses Advised Against: No information available Name, address, and telephone number of the manufacturer: Refer to Supplier Name, address, and telephone number of the supplier: Encore Scientific 801 West New Orleans Street Broken Arrow, OK, USA 74011 Supplier's Telephone # 800-454-2304 Monday to Friday 8:00 am to 6:00 pm (Central time) 24 Hr. Emergency Tel # INFOTRAC: (800) 535-5053 (Within Continental US and Canada); (352)323-3500 (International)

Section 2 Hazards Identification

Classification This chemical is considered hazardous according to the 2012 OSHA Hazard Communication Standard (29 CFR 1910.1200) Considered a dangerous substance or mixture according to the Globally Harmonized System (GHS)

Acute toxicity – Oral Category 4

Carcinogenicity Category 2

Reproductive toxicity Category 1B

Skin sensitization Category 1

Label Elements: Danger

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SAFETY DATA SHEET

Section 2 Hazards Identification (continued)

Hazard statements Harmful if swallowed May cause an allergic skin reaction May damage fertility or the unborn child Suspected of causing cancer

Hazards not otherwise classified (HNOC) Not applicable Other hazards Not available Precautionary Statements - Prevention Obtain special instructions before use Do not handle until all safety precautions have been read and understood Wear protective gloves/protective clothing/eye protection/face protection Wash face, hands and any exposed skin thoroughly after handling Do not eat, drink or smoke when using this product Avoid breathing dust/fume/gas/mist/vapors/spray Contaminated work clothing must not be allowed out of the workplace Precautionary Statements - Response IF exposed or concerned: Get medical advice/attention IF ON SKIN: Wash with plenty of water Wash contaminated clothing before reuse If skin irritation or rash occurs: Get medical advice/attention IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell Rinse mouth Precautionary Statements - Storage Store locked up Precautionary Statements - Disposal Dispose of contents/container to an approved waste disposal plant

Phenytoin, USP Phenytoin, USP

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SAFETY DATA SHEET

Section 3 Composition/information on ingredients

Components CAS No. Weight %

Phenytoin 57-41-0 100

Section 4 First aid measures

General Advice: National Capital Poison Center in the United States can provide assistance if you have a poison emergency and need

to talk to a poison specialist. Call 1-800-222-1222 Skin Contact: Wash off immediately with soap and plenty of water removing all contaminated clothes and shoes. Get medical

attention if irritation develops. Consult a physician if necessary. Eye Contact: Flush eyes with water for 15 minutes. Get medical attention if irritation occurs. If symptoms persist, call a physician. Inhalation: Move to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical

attention. Ingestion: Do not induce vomiting without medical advice. Never give anything by mouth to an unconscious person. Obtain

medical attention. Most important symptoms and effects, both acute and delayed Symptoms: May cause nausea, headache, vomiting. May cause eye/skin/respiratory tract irritation. Paresthesia (numbness and

tingling of the extremities). May cause constipation or diarrhea. Blurred vision. May cause involuntary eye movements. May affect the cardiovascular system. Central nervous system effects. May cause drowsiness or dizziness. Weakness. Tremors. Ataxia. Confusion. Convulsions. Hallucinations. May affect the blood. May affect the liver. It may affect the kidneys. May cause an allergic skin reaction. May cause allergic contact dermatitis.

Indication of any immediate medical attention and special treatment needed Notes to Physician: Treat symptomatically Protection of first-aiders First-Aid Providers: Avoid exposure to blood or body fluids. Wear gloves and other necessary protective clothing. Dispose of contaminated clothing and equipment as bio-hazardous waste

Section 5 Fire-Fighting measures

Extinguishing Media Suitable Extinguishing Media: Carbon dioxide (CO2). Dry chemical. Water spray, mist, or foam. Unsuitable Extinguishing Media: No information available.

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SAFETY DATA SHEET

Section 5 Fire-Fighting measures (continued)

Specific hazards arising from the chemical Hazardous Combustion Products: Carbon Monoxide. Carbon Dioxide. Nitrogen Oxides Specific hazards: May be combustible at high temperatures. Special Protective Actions for Firefighters Specific Methods: No information available. Special Protective Equipment for Firefighters: As in any fire, wear self-contained breathing apparatus pressure-demand,

MSHA/NIOSH (approved or equivalent) and full protective gear.

Section 6 Accidental release measures

Personal precautions, protective equipment and emergency procedures Personal Precautions: Ensure adequate ventilation. Keep people away from and upwind of spill/leak. Use personal protective

equipment. Avoid contact with skin, eyes and clothing. Do not touch damaged containers or spilled material unless wearing appropriate protective clothing. Remove all sources of ignition.

Environmental precautions: Prevent further leakage or spillage if safe to do so. Prevent entry into waterways, sewers, basements or confined areas.

Methods and material for containment and cleaning up Methods for containment: Stop leak if you can do it without risk. Cover with plastic sheet to prevent spreading. Methods for cleaning up: Sweep up and shovel into suitable containers for disposal. Use appropriate tools to put the spilled

solid in a suitable waste disposal container. Clean contaminated surface thoroughly.

Section 7 Handling and storage

Precautions for safe handling Technical Measures/Precautions: Provide sufficient air exchange and/or exhaust in work rooms. Keep away from incompatible

materials. Safe Handling Advice: Wear personal protective equipment. Avoid contact with skin, eyes and clothing. Keep away

from heat and sources of ignition. Do not ingest. Do not breathe dust. Conditions for safe storage, including any incompatibilities Technical Measures/Storage Conditions: Keep container tightly closed in a dry and well-ventilated place. Store at room

temperature in the original container. Store away from incompatible materials. Incompatible Materials: Strong oxidizing agents. Strong bases.

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SAFETY DATA SHEET

Section 8 Exposure Controls/Personal Protection

Control Parameters National occupational exposure limits United States

Components OSHA NIOSH ACGIH AIHA Wheel

Phenytoin 57-41-0

None None None None

Canada Canada Occupational Exposure Limits

Components Alberta British Columbia Ontario Quebec

Phenytoin 57-41-0

None None None None

Australia and Mexico Occupational Exposure Limits for Australia and Mexico

Components Australia Mexico

Phenytoin 57-41-0

None None

Appropriate engineering controls Engineering measures to reduce exposure: Ensure adequate ventilation. Use process enclosures, local exhaust ventilation, or

other engineering controls to keep airborne levels below recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to airborne contaminants below the exposure limit.

Individual protection measures, such as personal protective equipment Personal Protective Equipment Eye protection: Goggles or Safety glasses with side-shields. Skin and body protection: Long sleeved clothing. Gloves. Chemical resistant apron. Respiratory protection: Effective dust mask. Use a dust respirator under conditions where exposure to the substance is

apparent (e.g. generation of high concentration of dust (dust clouds), inadequate ventilation, development of respiratory tract irritation), and engineering controls are not feasible. Be sure to use an approved/certified respirator or equivalent.

Hygiene measures: Avoid contact with skin, eyes and clothing. When using, do not eat, drink or smoke. Wash hands before breaks and immediately after handling the product.

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SAFETY DATA SHEET

Section 9 Physical and chemical properties

Information on basic physical and chemical properties:

Physical state: Solid

Appearance: Powder.

Color: White.

Odor: Odorless.

Taste No information available

Formula: C15-H12-N2-O2

Molecular/Formula weight: 252.27 g/mole

Flammability: No information available

Flashpoint (°C/°F): No information available.

Flash Point Tested according to: Not available

Autoignition Temperature: No information available

Bulk density: No information available

pH: No information available

Decomposition temperature(°C/°F): No information available

Lower Explosion Limit (%): No information available

Upper Explosion Limit (%): No information available

Density (g/cm3): No information available

Vapor pressure @ 20°C (kPa): No information available

Melting point/range(°C/°F): 295-298 °C (563-568.4 °F)

Boiling point/range(°C/°F): No information available

Specific gravity: No information available

Odor threshold (ppm): No information available

Evaporation rate: No information available

Vapor density: No information available

VOC content (g/L): No information available

Partition coefficient (n-octanol/water): 2.47

Viscosity: No information available

Miscibility: No information available

Solubility: Practically insoluble in water Soluble in Acetic acid Slightly soluble in Ether Slightly soluble in Benzene Slightly soluble in chloroform

Section 10 Stability and reactivity

Reactivity: May react with strong oxidizers Chemical stability Stability: Stable under recommended storage conditions Possibility of Hazardous Reactions: Hazardous polymerization does not occur. Conditions to avoid: Excess Heat. Avoid dust formation. Incompatible materials. Incompatible Materials: Strong oxidizing agents. Strong bases. Hazardous decomposition products: No information available. Other Information Corrosivity: No information available Special Remarks on Corrosivity: No information available

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SAFETY DATA SHEET

Section 11 Toxicological information

Information on likely routes of exposure Principal Routes of Exposure: Ingestion. Inhalation. Acute Toxicity Component Information Phenytoin – 57-41-0 LD50/oral/rat = 1635 mg/kg Oral LD50 Rat LD50/oral/mouse = 150 mg/kg LD50/dermal/rat = No information available LD50/dermal/rabbit = No information available LC50/inhalation/rat = No information available LC50/inhalation/mouse = No information available Other LD50 or LC50information = No information available Product Information LD50/oral/rat = VALUE- Acute Tox Oral = 1635mg/kg LD50/oral/mouse = Value - Acute Tox Oral = 150mg/kg LD50/dermal/rabbit VALUE-Acute Tox Dermal = No information available LD50/dermal/rat VALUE -Acute Tox Dermal = No information available LC50/inhalation/rat VALUE-Vapor = No information available VALUE-Gas = No information available VALUE-Dust/Mist = No information available LC50/Inhalation/mouse VALUE-Vapor = No information available VALUE - Gas = No information available VALUE - Dust/Mist = No information available Symptoms Skin Contact: May cause skin irritation. Eye Contact: May cause eye irritation.

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SAFETY DATA SHEET

Section 11 Toxicological information (continued)

Inhalation: May cause irritation of respiratory tract. Ingestion: Harmful if swallowed. May cause headache, nausea, vomiting. May cause constipation. May cause diarrhea.

May cause blurred vision. May affect liver. May affect the cardiovascular system (cardiac arrhythmias). May affect the cardiovascular system (hypotension). May cause nystagmus (involuntary eye movements). May affect behavior/central nervous system (ataxia). May affect behavior/central nervous system (convulsions). May affect behavior/central nervous system (dizziness, drowsiness). May affect behavior/central nervous system (tremors). May affect behavior/central nervous system (confusion). May affect behavior/central nervous system (tiredness). May cause weakness. May affect behavior/central nervous system (hallucinations)

Aspiration: No information available. Delayed and immediate effects as well as chronic effects from short and long-term exposure Chronic Toxicity: Prolonged or repeated ingestion may affect the blood (thrombocytopenia). Prolonged or repeated ingestion

may affect behavior/central nervous system. Skin: Prolonged or repeated skin contact may cause allergic skin reaction. Chronic exposure may affect the liver and kidneys. Prolonged or repeated inhalation or ingestion may affect the peripheral nervous system (weakness, paresthesia - a tingling, pricking, or numbness of the skin (known as the feeling of "pins and needles) generally of the hands and feet (extremities)).

Sensitization: May cause sensitization by skin contact Mutagenic Effects: No information available. Carcinogenic effects: Possibly carcinogenic to humans. Suspected of causing cancer.

Components ACGIH-Carcinogens

IARC NTP OSHA HCS-Carcinogens

Australia-Prohibited Carcinogenic Substances

Australia-Notifiable Carcinogenic Substances

Phenytoin Not listed 2B – Monograph 66 [1996] Supplement 7 [1987]

Reasonably anticipate to be a human carcinogen

Present Not listed Not listed

IARC (International Agency for Research on Cancer) Group 2B - Possibly Carcinogenic to Humans NTP (National Toxicology Program) OSHA (Occupational Safety and Health Administration of the US Department of Labor)

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SAFETY DATA SHEET

Section 11 Toxicological information (continued)

Reproductive toxicity May damage fertility or the unborn child Reproductive Effects: May cause adverse reproductive effects Developmental Effects: May cause adverse developmental effects Teratogenic Effects: May cause birth defects (teratogenic effects) Specific Target Organ Toxicity STOT - single exposure No information available STOT - repeated exposure No information available Target Organs: Nervous system. Liver. Skin. Kidneys. Blood.

Section 12 Ecological information

Ecotoxicity Ecotoxicity effects: No data available Persistence and degradability: No information available Bioaccumulative potential: No information available Mobility: No information available

Section 13 Disposal considerations

Disposal Instruction Waste from residues / unused products: Waste must be disposed of in accordance with Federal, State and Local regulation. Contaminated packaging: Empty containers should be taken for local recycling, recovery or waste disposal

Components RCRA – F Series Wastes RCRA – K Series Wastes RCRA – P Series Wastes RCRA – U Series Wastes

Phenytoin None None None None

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SAFETY DATA SHEET

Section 14 Transport information

DOT UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: None ERG No: No information available Marine Pollutant No data available DOT RQ (lbs): No information available TDG (Canada) UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available Description: No information available ADR UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Packing Group: No information available Subsidiary Risk: No information available Classification Code: No information available Description: No information available CEFIC Tremcard No: No information available IMO / IMDG UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available

Subsidiary Risk: No information available Packing Group: No information available Description: No information available IMDG Page: No information available Marine Pollutant No information available MFAG: No information available Maximum Quantity: No information available RID UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available Classification Code: No information available Description: No information available ICAO UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available Description: No information available IATA UN-No: Not Regulated Proper Shipping Name: No information available Hazard Class: No information available Subsidiary Risk: No information available Packing Group: No information available Description: No information available

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SAFETY DATA SHEET

Section 15 Regulation information

International Inventories

Components U.S. TSCA Korea KECL Philippines PICCS Japan ENCS China Australia AICS EINECS – No.

Phenytoin Not listed Present KE-12074

Present Present (9)-621 Present Present Present 200-328-6

U.S. Regulations Phenytoin Massachusetts RTK: Present New Jersey RTK Hazardous Substance List: 1507 New Jersey (EHS) List: 1507 500 lb TPQ New Jersey - Discharge Prevention - List of Hazardous Substances: Present Pennsylvania RTK: Special hazardous substance Pennsylvania RTK - Special Hazardous Substances Present Minnesota - Hazardous Substance List: Present New York Release Reporting - List of Hazardous Substances: = 1 lb RQ California Directors List of Hazardous Substances: Present California Prop. 65: Safe Drinking Water and Toxic Enforcement Act of 1986. Chemicals Known to the State of California to Cause Cancer: WARNING: This product contains a chemical known to the State of California to cause cancer. (See table below) Chemicals Known to the State of California to Cause Reproductive Toxicity: WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm (See table below)

Components Carcinogen Developmental Toxicity Male Reproductive Toxicity Female Reproductive Toxicity

Phenytoin Carcinogen Developmental Toxicity Not listed Not listed

CERCLA/SARA

Components CERCLA – Hazardous Substances and their Reportable Quantities

Section 302 Extremely Hazardous Substances and TPQs

Section 302 Extremely Hazardous Substances and RQs

Section 313 – Chemical Category

Section 313 – Reporting de minimis

Phenytoin None None None None 0.1% de minimis concentration

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SAFETY DATA SHEET

Section 15 Regulation information (continued)

U.S. TSCA

Components TSCA Section 5(a)2 – Chemicals with Significant New Use Rules (SNURS)

TSCA 8(d) – Health and Safety Reporting

Phenytoin Not applicable Not applicable

Canada WHMIS hazard class: D2A Very toxic materials D2B Toxic materials Canada Controlled Products Regulation: This product has been classified according to the hazard criteria of the CPR (Controlled Products Regulation) and the MSDS contains all of the information required by the CPR. Inventory

Components Canada (DSL) Canada (NDSL)

Phenytoin Present Not Listed

Components CEPA Schedule I – Toxic Substances CEPA – 2010 Greenhouse Gases Subject to Mandatory

Reporting

Phenytoin Not listed Not listed

EU Classification R-phrase(s): R22 - Harmful if swallowed.

R40 - Limited evidence of a carcinogenic effect R43 - May cause sensitization by skin contact. R60 - May impair fertility. R61 - May cause harm to the unborn child.

S -phrase(s): S46 - If swallowed, seek medical advice immediately and show this container or label.

Components Classification Concentration Limits Safety Phrases

Phenytoin No information

The Product is classified in accordance with Annex VI to Directive 67/548/EEC Indication of Danger: Xn – Harmful; Xi – Irritant

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SAFETY DATA SHEET

Section 16 Other information

Further information: This information is based upon the present state of our knowledge. This SDS has been compiled and is

solely intended for this product. Notice to reader: Employers should use this information only as a supplement to other information gathered by them, and should make independent judgment of suitability of this information to ensure proper use and protect the health and safety of employees. This information is furnished without warranty, and any use of the product not in conformance with this Safety Data Sheet, or in combination with any other product or process, is the responsibility of the user.


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