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									- - - - - - - - - - - - - - - - MATERIAL SAFETY DATA SHEET - - - - - - - - - - - - - - Lafayette
HAZARD MATERIAL IDENTIFICATION SYSTEM: HEALTH HAZARD: 1 - Slight FLAMMABILITY HAZARD: 0 - Minimal REACTIVITY HAZARD: 0 - Minimal PERSONAL PROTECTION: E - Glasses, Gloves, Dust Resp. ----------------------------------------------------------SECTION I MATERIAL IDENTIFICATION ----------------------------------------------------------MANUFACTURER'S NAME: LAFAYETTE PHARMACEUTICALS INCORPORATED P.O. BOX 4499 LAFAYETTE, IN 47903 EMERGENCY PHONE NUMBER: 1-800-428-7843 TRADE NAME: Various product names for barium sulfate powder formulations, which have basically the same barium sulfate and additives content. COMMON NAME: Barium Sulfate for Suspension ----------------------------------------------------------SECTION II INGREDIENTS AND HAZARDS ----------------------------------------------------------Ingredient Name CAS Number Percent ----------------------------------------------------------Barium Sulfate 7727-43-7 NLT 90% Exposure Limits: ACGIH TLV: 10 mg/m3 TWA total dust OSHA PEL: 5 mg/m3 TWA respirable 10 mg/m3 total dust Silica - Quartz 14808-60-7 0.1-1.0% Exposure Limits: ACGIH TLV & OSHA PEL: 0.1 mg/m3 TWA respirable dust Suspending and Dispersing Agents (Not 1-10% Listed) Exposure Limits: Flavors and Sweeteners (Not 1-10% Listed) Exposure Limits: There may be extremely small, but detectable amount of substances regulated under the California Safe Drinking Water and Toxic Enforcement Act (Proposition 65). Arsenic Less than 3 ppm Cadmium Less than 2 ppm Lead Not more than 380 ppm Beryllium Less than 2 ppm Chromium (VI) Less than 0.1 ppm The term "Less Than" indicates that the substances have been detected, but that the amount was less than the quantifiable limit. The above levels may vary from one lot to another. SARA TITLE III: SECTION 313 SUPPLIER NOTIFICATION: This product contains the following chemical which was subject to the reporting requirements of Section 313 of the Emergency Planning and Community Right-To-Know Act of 1986 and of 40 CFR 372: Barium compounds CAS#: 7727-43-7 Barium sulfate has been specifically deleted from the category "barium compounds" and the Section 313 reporting requirements (June 28, 1994 Federal Register, Vol. 59, No. 123, pages 33205-33208). ----------------------------------------------------------SECTION III PHYSICAL/CHEMICAL CHARACTERISTICS ----------------------------------------------------------BOILING POINT: Not applicable VAPOR PRESSURE: Not applicable MELTING POINT: Not applicable VAPOR DENSITY: Not applicable SPECIFIC GRAVITY (H2O = 1): Approximately 4.4 EVAPORATION RATE: 0 SOLUBILITY (H2O): Insoluble % VOLATILES BY VOLUME: 0 APPEARANCE AND ODOR: White to Off-White; no odor, light fruit odor or vanillin odor

----------------------------------------------------------SECTION IV FIRE AND EXPLOSION DATA ----------------------------------------------------------FLASH POINT (method): Not flammable LIMITS: L.E.L.%: Not applicable U.E.L.%: Not applicable EXTINGUISHING MEDIA: As appropriate for surrounding combustibles. Does not burn or support combustion. No fire or explosion hazard. UNUSUAL FIRE OR EXPLOSION HAZARDS: None SPECIAL FIREFIGHTING PROCEDURES: Firefighters should wear self-contained breathing apparatus. ----------------------------------------------------------SECTION V REACTIVITY DATA ----------------------------------------------------------STABILITY: Material is stable. INCOMPATIBILITY: None known. HAZARDOUS DECOMPOSITION OR BYPRODUCT: Will Not Occur HAZARDOUS POLYMERIZATION: Will Not Occur ----------------------------------------------------------SECTION VI HEALTH HAZARD DATA ----------------------------------------------------------HEALTH RISKS SUMMARY AND EXPOSURE SYMPTOMS: Barium Sulfate is an inert material, practically non-toxic and chemically non-irritating. Skin contact may cause mechanical irritation due to the abrasion. Eye contact will result in no specific effects other than general particulate irritation in the eye. Barium sulfate is not absorbed by the body. Excessive exposure above the TLV can give mild pulmonary irritation. PRINCIPAL ROUTES OF ENTRY: Ingestion, inhalation, skin and eye contact. ACUTE EFFECTS: Inhalation of the dust may cause mechanical irritation to the respiratory tract. Skin and eye contact may cause a mechanical abrasion irritation. CHRONIC HEALTH EFFECTS: Heavy extended industrial exposure to barium sulfate dust may produce a benign Pneumoconiosis, termed "Baritosis". The reaction results in no impairment of ventilatory function. Mild bronchial irritation may occur. Long term exposure to silica causes silicosis, a form of pulmonary fibrosis. Continued exposure to silica can lead to cardiopulmonary impairment. Crystalline silica has been reviewed by IARC. IARC found limited evidence for carcinogenicity of crystalline silica in humans and sufficient evidence in experimental animals. EMERGENCY AND FIRST AID PROCEDURES: EYE CONTACT: Flush thoroughly with plenty of water for at least 15 minutes. Get medical help if irritation persists. SKIN CONTACT: Wash from skin with mild soap and water. INHALATION: Remove to fresh air. Get medical help for any breathing difficulty. INGESTION: If conscious, give large quantities of water to induce vomiting. Get medical attention. ----------------------------------------------------------SECTION VII PRECAUTIONS FOR SAFE HANDLING, USE OR DISPOSAL ----------------------------------------------------------SPILL AND LEAK PROCEDURES: Those involved in the clean-up of spill should use respiratory protection for airborne dust. Vacuum or scoop up spilled material for recovery and disposal, avoiding dusting conditions and using good ventilation. Wetting the spill with a water spray may help to keep the airborne dust levels down. SPILL REPORTING: Barium sulfate is not a CERCLA hazardous substance as referenced in 40 CFR 302.4. It is not on the list of hazardous substances under the Clean Water Act (40 CFR 116 and 40 CFR 117). Barium sulfate is not included on the list of Extremely Hazardous Substances under SARA, 40 CFR 355 Appendix A. Therefore, there is no Federal reporting requirements in the event of material release.

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- - - - - - - - - - - - - - - - MATERIAL SAFETY DATA SHEET - - - - - - - - - - - - - - Lafayette
SUPERFUND REPORTING: Barium sulfate is not subject to the reporting requirements of SARA Section 304. Barium sulfate for suspension formulations are drug products and, therefore, are exempt from the Section 311 and 312 reporting requirements. Barium sulfate no longer has to be reported under Section 313 as a "Barium Compound". WASTE MANAGEMENT AND DISPOSAL: Barium sulfate is not considered to be a RCRA hazardous waste as referenced in 40 CFR 261.24 or 261.3. However, the user should consult with their state environmental regulatory agency before disposing of this material. PRECAUTIONS TO BE TAKEN IN HANDLING AND STORING: For transportation emergencies, call CHEMTREC, 24 hour information service (800) 424-9300. NOTE: The Federal regulation requirements for barium sulfate are listed. State agencies may impose more restrictive regulations than the US EPA and should be reviewed to insure compliance. ----------------------------------------------------------SECTION VIII SPECIAL PROTECTION INFORMATION ----------------------------------------------------------PERSONAL PROTECTIVE EQUIPMENT: GOGGLES: Wear safety glasses with side shields or dust tight goggles. GLOVES: Leather or rubber gloves RESPIRATOR: If exposure limits are exceeded, an appropriate NIOSH approved dust respirator should be used. WORKPLACE CONSIDERATIONS: VENTILATION: Provide adequate exhaust ventilation to meet TLV requirements in the workplace. An exhaust filter system may be required to avoid environmental contamination. SAFETY STATIONS: An eye wash station should be available to the area of use. ----------------------------------------------------------SECTION IX SPECIAL PRECAUTIONS ----------------------------------------------------------OTHER PRECAUTIONS: Good industrial hygiene practice requires that employee exposure be maintained below the recommended TLV. This is preferably achieved through the provision of adequate ventilation where necessary. Where dust cannot be controlled in this way, personal respiratory protection should be employed. DOT CLASS: Not regulated. ----------------------------------------------------------DATE: September 1995 The data and recommendations presented herein are based upon a review of published MSDS's and standard reference sources. Lafayette Pharmaceuticals Incorporated makes no guarantee or warranty, either express or implied, as to the accuracy or completeness of the data and recommendations. ----------------------------------------------------------APPROVED BY: Robert A. Sharp REPRESENTING: Lafayette Pharmaceuticals Incorporated DATE: 09/08/95 COMPAS Code: 13140012


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