SYNTEX INC -- SYNAREL NASAL SOLUTION 2 MG/ML -- 6505-01-318-9365
===================== Product Identification =====================
Product ID:SYNAREL NASAL SOLUTION 2 MG/ML
MSDS Date:10/09/1992
FSC:6505
NIIN:01-318-9365
MSDS Number: BXPCX
=== Responsible Party ===
Company Name:SYNTEX INC
Address:3401 HILLVIEW AVE
City:PALO ALTO
State:CA
ZIP:94304-5000
Country:US
Info Phone Num:415-796-5050
Emergency Phone Num:415-796-5050
CAGE:0Y3S3
=== Contractor Identification ===
Company Name:SYNTEX (U.S.A.) INC
Address:3401 HILLVIEW AVENUE
Box:City:PALO ALTO
State:CA
ZIP:94304
Country:US
Phone:415-796-5050
CAGE:26282
Company Name:SYNTEX INC
Address:3401 HILLVIEW AVE
City:PALO ALTO
State:CA
ZIP:94304-5000
Country:US
Phone:415-855-5050
CAGE:0Y3S3
============= Composition/Information on Ingredients =============
Ingred Name:NAFARELIN ACETATE
CAS:86220-42-0
Fraction by Wt: 0.2%
Ingred Name:ALKYL DIMETHYLBENZYL AMMONIUM CHLORIDE; BENZALKONIUM
CHLORIDE; QUARTERNARY AMMONIUM CHLORIDES
CAS:8001-54-5
RTECS #:BO3150000
Ingred Name:ACETIC ACID (GLACIAL)
CAS:64-19-7
RTECS #:AF1225000
OSHA PEL:25 MG/CUM
ACGIH TLV:25 MG/CUM
EPA Rpt Qty:5000 LBS
DOT Rpt Qty:5000 LBS
Ingred Name:WATER
CAS:7732-18-5
RTECS #:ZC0110000
Ingred Name:SODIUM HYDROXIDE, CAUSTIC SODA, LYE
CAS:1310-73-2
RTECS #:WB4900000
Other REC Limits:2MG/M3 CEILING NIOSH
OSHA PEL:2 MG/CUM
ACGIH TLV:2 MG/CUM CEILING
EPA Rpt Qty:1000 LBS
DOT Rpt Qty:1000 LBS
Ingred Name:HYDROCHLORIC ACID, HYDROGEN CHLORIDE, MURIATIC ACID
HYDROCHLORIDE
CAS:7647-01-0
RTECS #:MW4025000
Other REC Limits:7 PPM
OSHA PEL:5 PPM
ACGIH TLV:C 11 MG/CUM
EPA Rpt Qty:5000 LBS
DOT Rpt Qty:5000 LBS
Ingred Name:SORBITOL
CAS:50-70-4
RTECS #:LZ4290000
===================== Hazards Identification =====================
Routes of Entry: Inhalation:YES Skin:NO Ingestion:YES
Reports of Carcinogenicity:NTP:NO IARC:NO OSHA:NO
Health Hazards Acute and Chronic:ABSORPTION THROUGH THE EYES MAY RESULT
IN SYSTEMIC EFFECTS. MAY STIMULATE/INHIBIT OVULATION & THE
PRODUCTION OF MALE SEX HORMONES. REPEATED EXPOSURE MAY CAUSE
DISRUPTION OF THE MENSTRUAL CYCLE, AMENOR RHEA, SUPPRESSION OF
SPERMATOGENESIS & DECREASES SERUM TESTOSTERONE.
Explanation of Carcinogenicity:NONE
Effects of Overexposure:WOMEN-MENSTRUAL BLEEDING AT AN UNEXPECTED TIME,
INTERMENSTRUAL BLEEDING/SPOTTING, PROLONGATION OF MENSTRUAL CYCLE,
HOT FLASHES. MEN-DECREASED FERTILITY/TESTICULAR
SIZE/POTENCY/LIBIDO, HOT FLASHES.
Medical Cond Aggravated by Exposure:PREGNANCY.
======================= First Aid Measures =======================
First Aid:EYES: IMMEDIATELY FLUSH THOROUGHLY W/WATER FOR 15 MINS. SKIN:
IMMEDIATELY WASH THOROUGHLY W/SOAP & WATER FOR 15 MINS. INHALATION:
IMMEDIATELY REMOVE TO FRESH AIR. INGESTION: DRINK A MODERATE
AMOUNT/8- 12 OUNCES OF WATER. OBTAIN MEDICAL ATTENTION IN ALL
CASES.
===================== Fire Fighting Measures =====================
Extinguishing Media:ALCOHOL FOAM, CO2, MULTIPURPOSE DRY CHEMICAL, HALON
FIRE EXTINGUISHER.
Fire Fighting Procedures:WEAR A NIOSH/MSHA APPROVED POSITIVE PRESSURE
SELF CONTAINED BREATHING APPARATUS & FULL PROTECTIVE CLOTHING. WASH
ALL EQUIPMENT THOROUGHLY AFTER USE.
================== Accidental Release Measures ==================
Spill Release Procedures:WEAR APPROPRIATE PERSONAL PROTECTIVE
EQUIPMENT. ISOLATE AREA/MINIMIZE SPREADING. SOAK UP
W/ABSORBENT/PAPER TOWELS. WASH AREA THOROUGHLY W/SOAP & WATER.
COLLECT MATERIAL/ABSORBENT/RINSEWATER INTO SUITA BLE CONTAINERS FOR
PROPER DISPOSAL.
====================== Handling and Storage ======================
Handling and Storage Precautions:STORE IN A COOL, WELL VENTILATED AREA.
AVOID CONTACT W/SKIN, EYES & CLOTHING.
============= Exposure Controls/Personal Protection =============
Respiratory Protection:WEAR A NIOSH/MSHA APPROVED HALF-FACE AIR
PURIFYING RESPIRATOR W/HEPA FILTER IF INHALATION EXPOSURE IS
LIKELY.
Ventilation:NORMAL ROOM VENTILATION SHOULD BE ADEQUATE. LOCAL EXHAUST
WHEN HANDLING FOR LONG DURATIONS WHEN AEROSOLIZATION POSSIBLE.
Protective Gloves:RECOMMENDED
Eye Protection:SAFETY GLASSES W/SIDE SHIELDS
Other Protective Equipment:LAB COAT/OTHER PROTECTIVE OVERGARMENT
Work Hygienic Practices:WASH THOROUGHLY AFTER HANDLING.
Supplemental Safety and Health
PRODUCT CONTAINS SYNTHETIC ANALOG OF NATURALLY OCCURING GONADOTROPIN
RELEASING HORMONE. MAY AFFECT REPRODUCTIVE SYSTEM IF IMPROPERLY
HANDLED & EXCESSIVE EXPOSURE OCCURS. MATERIAL INTENDED FOR HUMAN PH
ARMACEUTICAL USE AS NASAL SPRAY AS PRESCRIBED BY PHYSICIAN.
================== Physical/Chemical Properties ==================
pH:5-5.4
Appearance and Odor:CLEAR LIQUID.
================= Stability and Reactivity Data =================
Stability Indicator/Materials to Avoid:YES
STRONG OXIDIZING AGENTS, PEROXIDES, PERMANGANATES, NITRIC ACID.
Stability Condition to Avoid:PHARMACOLOGIC STABILITY NOT GUARANTEED
BEYOND EXPIRATION DATE IMPRINTED ON PACKAGE.
Hazardous Decomposition Products:CO & CO2.
==================== Disposal Considerations ====================
Waste Disposal Methods:ALL WASTES CONTAINING MATERIAL SHOULD BE
PROPERLY LABELED & STORED SEPARATELY FROM OTHER WASTES. DISPOSE OF
IAW/FEDERAL, STATE & LOCAL REGULATIONS. RINSEWATER SHOULD BE
DISCHARGED TO AN APPROPRIATELY PERMITTED WASTEWATER TREATMENT
FACILITY.
Disclaimer (provided with this information by the compiling agencies):
This information is formulated for use by elements of the Department
of Defense. The United States of America in no manner whatsoever,
expressly or implied, warrants this information to be accurate and
disclaims all liability for its use. Any person utilizing this
document should seek competent professional advice to verify and
assume responsibility for the suitability of this information to their
particular situation.