Attachment 3 - Diazepam.pdf

1. IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND THE COMPANY/UNDERTAKING

Material Name: Diazepam Injectable Emulsion

Trade Name: Diazemuls Chemical Family: Mixture Intended Use: Pharmaceutical product used as antianxiety agent

2. HAZARDS IDENTIFICATION

Appearance: Liquid

Statement of Hazard: Non-hazardous in accordance with international standards for workplace safety.

Short Term: Harmful if swallowed (based on animal data) .

Long Term: Use of this drug is habit forming. Addiction may occur. Animal studies have shown a potential to cause adverse effects on the fetus.

Known Clinical Effects: Therapeutic use of this substance has resulted in weakness, dizziness, drowsiness, ataxia, confusion, tremors, headache, and gastrointestinal disturbances.

EU Indication of danger: Not classified

Australian Hazard Classification

(NOHSC):

Non-Hazardous Substance. Non-Dangerous Goods.

Note: This document has been prepared in accordance with standards for workplace safety, which require the inclusion of all known hazards of the active substance or its intermediates regardless of the potential risk. The precautionary statements and warnings included may not apply in all cases. Your needs may vary depending upon the potential for exposure in your workplace.

3. COMPOSITION/INFORMATION ON INGREDIENTS

Hazardous Ingredient CAS Number EU EINECS/ELINCS List Classification %

PZ00145

Emergency telephone number:

ChemSafe (24 hours): +44 (0)208 762 8322

Contact E-Mail: pfizer-MSDS@pfizer.com

Version: 1.2

MATERIAL SAFETY DATA SHEET

Pfizer Inc Pfizer Pharmaceuticals Group 235 East 42nd Street New York, New York 10017 1-212-573-2222

Pfizer Ltd Ramsgate Road Sandwich, Kent

CT13 9NJ

United Kingdom +00 44 (0)1304 616161

Emergency telephone number:

CHEMTREC (24 hours): 1-800-424-9300

Revision date: 01-Sep-2009

MATERIAL SAFETY DATA SHEET

3. COMPOSITION/INFORMATION ON INGREDIENTS

Diazepam 439-14-5 207-122-5 Xn;R22

Repr.Cat.3;R63-64 0.5

Glycerol 56-81-5 200-289-5 Not Listed * Sodium hydroxide 1310-73-2 215-185-5 C;R35 **

Ingredient CAS Number EU EINECS/ELINCS List Classification % Fractionated Soya Oil Not assigned Not listed Not Listed * Acetylated monoglycerides Not assigned Not listed Not Listed * Fractionated egg lecithin Not assigned Not listed Not Listed *

Additional Information: * Proprietary ** to adjust pH Ingredient(s) indicated as hazardous have been assessed under standards for workplace safety.

For the full text of the R phrases mentioned in this Section, see Section 16

4. FIRST AID MEASURES

Eye Contact: Flush with water while holding eyelids open for at least 15 minutes. Seek medical attention immediately.

Skin Contact: Remove contaminated clothing. Flush area with large amounts of water. Use soap. Seek medical attention.

Ingestion: Never give anything by mouth to an unconscious person. Wash out mouth with water. Do not induce vomiting unless directed by medical personnel. Seek medical attention immediately.

Inhalation: Remove to fresh air and keep patient at rest. Seek medical attention immediately.

Symptoms and Effects of Exposure: For information on potential signs and symptoms of exposure, See Section 2 - Hazards Identification and/or Section 11 - Toxicological Information.

5. FIRE FIGHTING MEASURES

Extinguishing Media: Use carbon dioxide, dry chemical, or water spray.

Hazardous Combustion Products: Formation of toxic gases is possible during heating or fire.

Fire Fighting Procedures: During all fire fighting activities, wear appropriate protective equipment, including self-contained breathing apparatus.

Fire / Explosion Hazards: Fine particles (such as dust and mists) may fuel fires/explosions.

6. ACCIDENTAL RELEASE MEASURES

Health and Safety Precautions: Personnel involved in clean-up should wear appropriate personal protective equipment (see Section 8). Minimize exposure.

Measures for Cleaning / Collecting: Contain the source of spill if it is safe to do so. Collect spill with absorbent material. Clean spill area thoroughly.

PZ00145

Revision date: 01-Sep-2009 Material Name: Diazepam Injectable Emulsion

Version: 1.2

Measures for Environmental Protections:

Place waste in an appropriately labeled, sealed container for disposal. Care should be taken to avoid environmental release.

Additional Consideration for Large Spills:

Non-essential personnel should be evacuated from affected area. Report emergency situations immediately. Clean up operations should only be undertaken by trained personnel.

7. HANDLING AND STORAGE

General Handling: Eliminate possible ignition sources (e.g., heat, sparks, flame, impact, friction, electricity), and follow appropriate grounding and bonding procedures. Avoid contact with eyes, skin and clothing. Avoid breathing vapor or mist. Use with adequate ventilation.

Storage Conditions: Store at room temperature in properly labeled containers. Keep away from heat, sparks and flames.

Storage Temperature: 15 - 25°C

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Refer to available public information for specific member state Occupational Exposure Limits.

PZ00145

Glycerol

Greece OEL - TWA Listed

Ireland OEL - TWAs Listed OSHA - Final PELS - TWAs: 15 mg/m3 total

5 mg/m3

ACGIH Threshold Limit Value (TWA) 10 mg/m3 TWA

Poland OEL - TWA Listed

Diazepam

Portugal OEL - TWA Listed

Australia TWA

Spain OEL - TWA Listed

10 mg/m3

Sodium hydroxide ACGIH Ceiling Threshold Limit: 2 mg/m3

Belgium OEL - TWA Listed

Australia PEAK 2 mg/m3

Austria OEL - MAKs Listed

Pfizer OEL TWA-8 Hr:

Bulgaria OEL - TWA Listed

Czech Republic OEL - TWA Listed

Czech Republic OEL - TWA Listed

7µg/m3

Revision date: 01-Sep-2009

Estonia OEL - TWA Listed

Estonia OEL - TWA

France OEL - TWA Listed

Listed

Greece OEL - TWA Listed

Material Name: Diazepam Injectable Emulsion

Hungary OEL - TWA Listed

Finland OEL - TWA Listed

Japan - OELs - Ceilings 2 mg/m3

Bulgaria OEL - TWA

Latvia OEL - TWA Listed

Listed

OSHA - Final PELS - TWAs: 2 mg/m³

France OEL - TWA Listed Germany (DFG) - MAK 50 mg/m3 MAK

8. EXPOSURE CONTROLS / PERSONAL PROTECTION

Analytical Method: Analytical method available for Diezepam. Contact Pfizer Inc for further information.

Engineering Controls: Engineering controls should be used as the primary means to control exposures. Local exhaust ventilation is required unless used in a closed system.

Environmental Exposure Controls: Refer to specific Member State legislation for requirements under Community environmental legislation.

Personal Protective Equipment: Refer to applicable national standards and regulations in the selection and use of personal protective equipment (PPE).

Hands: Wear impervious gloves if skin contact is possible.

Eyes: Wear safety glasses or goggles if eye contact is possible.

Skin: Wear protective clothing with long sleeves to avoid skin contact. Wash hands and arms thoroughly after handling this product.

Respiratory protection: If the applicable Occupational Exposure Limit (OEL) is exceeded, wear an appropriate respirator with a protection factor sufficient to control exposures to below the OEL.

9. PHYSICAL AND CHEMICAL PROPERTIES

pH: 8

10. STABILITY AND REACTIVITY

Stability: Stable under normal conditions of use.

Conditions to Avoid: Fine particles (such as dust and mists) may fuel fires/explosions.

Incompatible Materials: As a precautionary measure, keep away from strong oxidizers

11. TOXICOLOGICAL INFORMATION

General Information: There are no data for this formulation. The remaining information describes the potential hazards of the individual ingredients.

Acute Toxicity: (Species, Route, End Point, Dose)

PZ00145

Slovenia OEL - TWA Listed

Diazepam

Revision date: 01-Sep-2009

Rat Oral LD 50 710 mg/kg

Sweden OEL - TWAs Listed

Rat Intravenous LD 50 32 mg/kg

Material Name: Diazepam Injectable Emulsion

Rat Intraperitoneal LD 50 46.5 mg/kg

Physical State: Liquid

Mouse Oral LD 50 48 mg/kg Mouse Intravenous LD 50 25 mg/kg

Color: No data available.

Sodium hydroxide

Version: 1.2

Mouse IP LD50 40 mg/kg

Molecular Formula: Mixture

Molecular Weight: Mixture

Poland OEL - TWA Listed

11. TOXICOLOGICAL INFORMATION

Irritation / Sensitization: (Study Type, Species, Severity)

Repeated Dose Toxicity: (Duration, Species, Route, Dose, End Point, Target Organ)

Reproduction & Developmental Toxicity: (Study Type, Species, Route, Dose, End Point, Effect(s))

Genetic Toxicity: (Study Type, Cell Type/Organism, Result)

Carcinogenicity: (Duration, Species, Route, Dose, End Point, Effect(s))

PZ00145

Embryo / Fetal Development Rat Oral 100 mg/kg LOAEL Embryotoxicity

Sodium hydroxide

Embryo / Fetal Development Dog Oral 5 mg/kg/day NOAEL Not Teratogenic

Diazepam

Embryo / Fetal Development Hamster Intraperitoneal 280 mg/kg LOAEL Teratogenic

Version: 1.2

Embryo / Fetal Development Rabbit Oral 8 mg/kg NOAEL Not Teratogenic

6 Week(s) Mouse Oral 0.5 mg/kg LOAEL Male reproductive system

Glycerol

Eye Irritation Rabbit Severe

Reproductive & Fertility-Males Rat Oral 100 mg/kg LOEL Fertility

3 Month(s) Rat Oral 100 mg/kg/day NOAEL None identified

Glycerol

Diazepam

3 Month(s) Non-human Primate Oral 5 mg/kg/day LOAEL None identified

Bacterial Mutagenicity (Ames) Salmonella , E. coli Negative

Skin Irritation Rabbit Severe

In Vitro Micronucleus Mouse Positive

6 Month(s) Dog Oral 20 mg/kg/day LOAEL Liver

In Vivo Chromosome Aberration Mouse Negative In Vivo Micronucleus Mouse Negative

6 Month(s) Rat Oral 162 mg/kg/day LOAEL Kidney

In Vivo Direct DNA Damage Rat Negative

Glycerol

Glycerol

Diazepam

Rat Oral LD 50 12600 mg/kg

2 Year(s) Rat Liver, Tumors

28 Day(s) Rat Oral 16800 mg/kg LOAEL Endocrine system

2 Year(s) Mouse Not carcinogenic

Skin Irritation Rabbit Mild

2 Year(s) Hamster Not carcinogenic

Revision date: 01-Sep-2009

80 Week(s) Male Mouse Oral 75 mg/kg/day LOAEL Malignant tumors

Diazepam

Eye Irritation Rabbit Mild

Embryo / Fetal Development Mouse Oral 100 mg/kg/day NOAEL Teratogenic, Fetotoxicity

11. TOXICOLOGICAL INFORMATION

Carcinogen Status: None of the components of this formulation are listed as a carcinogen by IARC, NTP or OSHA.

See below

At increase risk from exposure: This material has been shown to be secreted in low concentrations in human breast milk.

Adverse effects on nursing infants have been seen.

12. ECOLOGICAL INFORMATION

Environmental Overview: Environmental properties have not been thoroughly investigated. Releases to the environment should be avoided.

13. DISPOSAL CONSIDERATIONS

Disposal Procedures: Dispose of waste in accordance with all applicable laws and regulations. Member State specific and Community specific provisions must be considered. Considering the relevant known environmental and human health hazards of the material, review and implement appropriate technical and procedural waste water and waste disposal measures to prevent occupational exposure and environmental release. It is recommended that waste minimization be practiced. The best available technology should be utilized to prevent environmental releases. This may include destructive techniques for waste and wastewater.

14. TRANSPORT INFORMATION

Not regulated for transport under USDOT, EUADR, IATA, or IMDG regulations.

15. REGULATORY INFORMATION

EU Indication of danger: Not classified

OSHA Label:

Non-hazardous in accordance with international standards for workplace safety.

Canada - WHMIS: Classifications

WHMIS hazard class:

Class D, Division 2, Subdivision A

PZ00145

Group 3

Revision date: 01-Sep-2009 Material Name: Diazepam Injectable Emulsion

Diazepam

IARC:

15. REGULATORY INFORMATION

16. OTHER INFORMATION

Text of R phrases mentioned in Section 3

R22 - Harmful if swallowed.

R63 - Possible risk of harm to the unborn child.

R64 - May cause harm to breastfed babies.

R35 - Causes severe burns.

Reasons for Revision: Updated Section 2 - Hazard Identification. Updated Section 3 - Composition / Information on

Ingredients. Updated Section 4 - First Aid Measures. Updated Section 6 - Accidental Release Measures. Updated Section 8 - Exposure Controls / Personal Protection. Updated Section 11 - Toxicology Information. Updated Section 13 - Disposal Considerations. Updated Section 15 - Regulatory Information.

Prepared by: Toxicology and Hazard Communication Pfizer Global Environment, Health, and Safety Operations

Pfizer Inc believes that the information contained in this Material Safety Data Sheet is accurate, and while it is provided in good faith, it is without warranty of any kind, expressed or implied. If data for a hazard are not included in this document there is no known information at this time.

End of Safety Data Sheet

PZ00145

CERCLA/SARA Hazardous Substances and their Reportable Quantities:

1000 lb final RQ 454 kg final RQ

Inventory - United States TSCA - Sect. 8(b) Listed

Inventory - United States TSCA - Sect. 8(b) Listed

Version: 1.2

Australia (AICS): Listed

Australia (AICS):

Standard for the Uniform Scheduling for Drugs and Poisons:

Schedule 5 Schedule 6

Listed

EU EINECS/ELINCS List 215-185-5

Diazepam

Standard for the Uniform Scheduling for Drugs and Poisons:

Schedule 4

EU EINECS/ELINCS List 207-122-5

California Proposition 65

Glycerol developmental toxicity, initial date 1/1/92

Inventory - United States TSCA - Sect. 8(b) Listed

Revision date: 01-Sep-2009

Australia (AICS): Listed

U.S. Drug Enforcement Administration: Schedule IV Controlled Substance

EU EINECS/ELINCS List 200-289-5

Sodium hydroxide