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99-66-1 139-33-3 1310-73-2 7732-18-5

File Name: 99-66-1_139-33-3_1310-73-2_7732-18-5.asp

300 Northfield Road
MATERIAL SAFETY DATA SHEET
Bedford, OH 44146
Telephone: (440) 232-3320
-or- (800) 562-4797

Section I - IDENTITY

Common/Trade Name: Valproate Sodium Injection, 100 mg/mL
Chemical Names: Vaperic acid, 2-propyl Solution,
Synonyms: Pentanoic acid, 2-propyl-; Valproic Acid, 2-propyl-; Depakote? Dipropylacetic acid;
Valproic Acid
Manufacturer's Name: BEN VENUE LABORATORIES, INC.
Address: 300 NORTHFIELD ROAD
BEDFORD, OH 44146
Emergency Telephone Number: Chemtrec: 1(800)424-9300
Telephone Number for Info.: (440)232-3320 -or- (800)562-4797
Medical Emergency: Professional Services 1(800)521-5169
Date Prepared: December 12, 2002
Date Revised: July 20, 2007

Section II - HAZARDOUS INGREDIENTS/COMPOSITION INFORMATION
Other Limits
Component % CAS# OSHA PEL ACGIH TLV Recommended
Valproic Acid 10 99-66-1 NONE NONE NONE
Edetate Disodium 0.04 139-33-3 NONE NONE NONE
3 3
Sodium Hydroxide 2.6 1310-73-2 2 mg/m * 2 mg/m * NONE
Water for Injection 87.36 7732-18-5 NONE NONE NONE
* Ceiling
Sodium Hydroxide and Hydrochloric Acid is used to adjust the pH of the Formulation.
Valproate Sodium is a sterile injectable liquid drug provided in a vial.

Section III - HEALTH HAZARD DATA

Routes of Entry: Exposure may result from skin contact, inhalation and ingestion.
Health Hazard (Acute & Chronic): Valproate Sodium is used to treat epilepsy and convulsive
disorders. It affects the digestive and central nervous systems as well as the liver and kidneys.
Short-term contact may cause dermal, eye, gastrointestinal tract, and respiratory irritation. Long
term exposure can possibly result in hair loss, trembling hands and arms, mood or mental changes,
tiredness and weakness, swelling of face, yellow eyes or skin, vision disturbances or uncontrolled
eye movement, unusual bleeding or bruising, clumsiness or unsteadiness, dizziness, headaches,
skin rash and unusual excitement, restlessness or irritability. Possible allergic reaction to material
if inhaled, ingested or in contact with the skin
Carcinogenicity: NTP? NO IARC Monographs? NONE OSHA Regulated? NO

1
Signs & Symptoms of Exposure: Possible irritation to eyes, skin and respiratory tract. Ingestion may
result in nausea, vomiting, abdominal cramps diarrhea.
Medical Conditions Generally Aggravated by Exposure: Liver conditions (especially in children),
pancreatitis, allergic reaction, liver or kidney disorders
BVL Hazard Category: 3


Section IV - FIRST AID MEASURES

Eye Exposure: Flush eyes with large volumes of water for 15 or more minutes.
Skin Exposure: Wash skin with cool, soapy water for 15 minutes.
Ingestion: If ingestion occurs, flush mouth with water and seek medical attention immediately.
If person is conscious, induce vomiting. Never induce vomiting on an unconscious person.
Inhalation: Remove from exposure. If difficulty breathing, administer oxygen. Seek attention of a
physician immediately. When appropriate and trained in CPR, provide artificial respiration.


Section V - FIRE AND EXPLOSION HAZARD DATA

Flash Point (Method Used): Not Applicable LEL: Not Applicable UEL: Not Applicable
Flammable Limits: Not Applicable
Extinguishing Media: Use water or an ABC multi-purpose extinguisher for surrounding materials.
Special Fire Fighting Procedures: As with all fires, evacuate personnel to a safe area. Fire fighters
should wear self-contained breathing apparatus to avoid inhalation of smoke. Product is aqueous-
based and is not expected to present a fire hazard concern.
Unusual Fire/Explosion Hazards: Heat of the fire could cause vials to burst.


Section VI - ACCIDENTAL RELEASE INFORMATION

Release to Land: Absorb Valproate Sodium with absorbent materials and dispose according to local,
state, and federal guidelines.
Release to Air: If aerosolized, reduce exposures by ventilating area; clean up spill immediately to
prevent evaporation
Release to Water: Refer to local water authority. Drain disposal is not recommended; however,
refer to local, state, and federal disposal guidelines.


Section VII - PRECAUTIONS FOR SAFE HANDLING AND USE

Steps to be taken in case material is released or spilled: See Section VI above.
Wear latex or nitrile gloves and safety glasses when cleaning spills. A dust/mist respirator (N95)
may be necessary if excessive aerosols are generated.
Waste Disposal Method: Incineration in an approved incinerator is recommended. Refer to local, state,
and federal rules.
Precautions to be taken in handling and storing: Store between 15-25癈. Follow instructions
provided in packaging.
Other Precautions: NONE


2
Section VIII - CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT

Respiratory Protection: Under normal use, respirators are not required. If aerosols are generated, a
disposable dust/mist respirator (N95) may be used. Personnel wearing respirators should be fit
tested and approved for respirator use under the OSHA Respiratory Protection Standard 29 CFR
1910.134.
Ventilation: Handle product in a well-ventilated area.
Protective Gloves: Latex or nitrile
Eye Protection: Safety glasses
Other Protective Clothing or Equipment: Lab Coat
Work/Hygienic Practices: Wash hands following use. No eating, drinking, or smoking while
handling this product.


Section IX - PHYSICAL/CHEMICAL CHARACTERISTICS

Physical State: Liquid Specific Gravity: Approx. to water
Appearance and Odor: Colorless to
Pale-yellow solution Melting Point: Approx. 0癈
Boiling Point: Approx. 100癈 Evaporation Rate: Approx. to water
Vapor Pressure: Not available Solubility in Water: Soluble
Vapor Density: Not available pH: neutral


Section X - STABILITY AND REACTIVITY DATA

Stability: Stable
Incompatibility (Materials to Avoid): Water-reactive materials.
Hazardous Decomposition or Byproducts: Decomposition products of this compound may include
potentially hazardous byproducts, acrid and toxic fumes.
Hazardous Polymerization: Will not occur
Conditions to Avoid: Storage near water reactive materials


Section XI - TOXICOLOGICAL INFORMATION

For Valproic Acid (active ingredient) RTECS Number YV7875000
LD50 rat, oral = 670 mg/kg
LD50 mouse, oral = 1098 mg/kg
LD50 mouse, intraperitoneal = 470 mg/kg
LD50 mouse, subcutaneous = 860 mg/kg
LDLo Human women, oral = 100 mg/kg

Additional reproductive health data is available from the National Institute for Occupational Safety and
Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS).




3
Section XII - ENVIRONMENTAL IMPACT INFORMATION

Information is currently not available on the environmental impact of Valproic Acid. Handle in a manner
to prevent spills or releases to the environment.


Section XIII - DISPOSAL INFORMATION

Dispose by incineration at an approved/permitted incinerator.
Review local, state, and federal regulations for your regulatory area.


Section XIV - TRANSPORTATION INFORMATION

Valproate Sodium is not a DOT hazardous material.
Valproate Sodium is not a DOT Marine Pollutant.


Section XV - REGULATORY INFORMATION

SARA 313 listed?: NO
CERCLA listed?: NO
RCRA listed?: NO
Listed on the California Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65)
Code ?D
Massachusetts Hazardous Substance code - T1


Section XVI - OTHER DATA

1. Use of this product should be through or under the direction of a physician.
This MSDS does not address therapeutic use of this material.

2. Persons administering this drug to patients must be careful to avoid needle sticks to syringes and
other sharps used in the administration. All needle sticks must be reported to your company
management.

3. BVL Hazard Category Definitions (internal hazard ranking used by Ben Venue Laboratories):
1 = Low Toxicity
2 = Moderate Toxicity
3 = Potent or Toxic
4 = Highly Potent or Toxic
5 = Extremely Potent or Toxic

4. OEL=Occupational Exposure Limit. An internal limit set by Ben Venue Laboratories for the
recommended limit of employee exposure to airborne dusts or aerosols that should not be
exceeded over an eight-hour time-weighted average.




4
5. Valproate Sodium may be considered a Hazardous Drug as described in the NIOSH Alert:
Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care
Settings. Employees who prepare or administer hazardous drugs or who work in areas where
these drugs are used should follow specific handling guidelines in order to prevent exposure to
these agents in the air or on work surfaces, clothing, or equipment.


6. The Following Guidance Information is excerpted from the NIOSH Alert:

Elements of a Hazardous Drug Handling Program include:
?Establishment and implementation of written policies and protocols to ensure the safe
handling of oncolytic and/or potent drugs, including receipt of product.
?Training and education of employees on the recognition, evaluation and control of
Hazardous Drugs
?Effective Planning and design of the workplace
?Use of best practice control measures and specialized equipment such as ventilated
cabinets or isolators designed for worker protection
?Wearing recommended personal protective equipment
?An integrated health surveillance program that: includes the assessment and counseling of
prospective employees before they commence any work involving oncolytic and/or potent
drugs and related waste


7. Published guidance on the handling and transport of cytotoxic drugs:

NIOSH Alert ?Preventing occupational exposures to antineoplastic and other hazardous drugs in
health care settings
http://www.cdc.gov/niosh/docs/2004-165/

National Study Commission on Cytotoxic Exposure: Recommendation for handling Cytotoxic
Agents:
http://www.nih.gov/od/ors/ds/pubs/cyto/index.htm



This document is generated to distribute health, safety and environmental data. It is not a specification sheet and none of the
displayed data should be construed as a specification. Information on this MSDS sheet was obtained from sources which we
believe are reliable, and we believe that the information is complete and accurate. However, the information is provided
without any warranty, express or implied, regarding its correctness. Some of the information presented and conclusions drawn
are from sources other than direct test data of the substance. The conditions or methods of handling, storage, use and disposal
of the product are beyond our control and may also be beyond our knowledge. It is the user's responsibility to determine the
suitability of any material for a specific purpose and to adopt such safety precautions as may be necessary. If the product is
used as a component in another product, this MSDS information may not be applicable. For these reasons, we do not assume
any responsibility and expressly disclaim liability for any loss, damage or expense arising out of or in any way connected with
the handling, storage, use or disposal of this product




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