SPECTRUM CHEMICAL MFG. CORP. -- PROGESTERONE -- -
===================== Product Identification ===================== Product ID:PROGESTERONE MSDS Date:09/16/1991 FSC:NIIN:Submitter:N EN Status Code:A === Responsible Party === Company Name:SPECTRUM CHEMICAL MFG. CORP. Address:14422 SOUTH SAN PEDRO STREEET City:GARDENA State:CA ZIP:90248-2027 Country:US Info Phone Num:310-516-8000 Emergency Phone Num:(800)424-9300 Chemtrec Ind/Phone:(800)424-9300 CAGE:63415 === Contractor Identification === Company Name:SPECTRUM LABORATORY PRODUCTS INC Address:14422 S SAN PEDRO ST Box:City:GARDENA State:CA ZIP:90248-2027 Country:US Phone:310-516-8000/FAX: 310-516-9843 CAGE:63415 ============= Composition/Information on Ingredients ============= Ingred Name:PROGESTERONE CAS:57-83-0 RTECS #:TW0175000 = Wt:100. ===================== Hazards Identification ===================== Routes of Entry: Inhalation:YES Skin:YES Ingestion:YES Reports of Carcinogenicity:NTP:YES IARC:YES OSHA:NO Health Hazards Acute and Chronic:INHALATION: PROGESTERONE: ACUTE EXPOSURE - AIRBORNE PARTICLES OF SEX HORMONES MAY BE ABSORBED THRU INHALATION. EXCESS PROGESTAGENS IN WOMEN MAY CAUSE WEIGHT GAIN, ACNE, MASTALGIA, GYNECOMASTIA, RECURR ENT MONOLIAL VAGINITIS. OTHER SYMPTOMS MAY INCLUDE HEADACHE, NAUSEA, PHOTOSENSITIVITY, CHLOASMA, LOSS OF LIBIDIO, BREAKTHROUGH BLEEDING, HYPERTENSION, PORPHYRIA, CHOLESTATIC LIVER DAMAGE AND STERILITY . EXCESS PROGESTAGEN IN MEN MAY RESULT IN SOME OF GENERAL SYMPTOMS EXHIBITED BY WOMEN AND MAY ALSO INHIBIT SPERMATOGENESIS. FETAL EXPOSURE TO PROGESTERONE MAY RESULT IN CONGENITAL HEART DEFECTS, LIMB (SIGNS & SYMPTOMS OF OVEREXPOSURE) Explanation of Carcinogenicity:PROGESTERONE: IARC GROUP 2B, SUPPLEMENT 7, PAGE 289, 1987. NTP 9TH REPORT ON CARCINOGENS, REASONABLY ANTICIPATED TO BE HUMAN CARCINOGENS LIST. Effects of Overexposure:HEALTH HAZARDS ACUTE AND CHRONIC (CONT): REDUCTION DEFECTS, VIRILIZATION AND GENITAL ABNORMALITIES. CHRONIC EXPOSURE - SEX HORMONES MAY ACCUMULATE AND REACH HIGH LEVELS EVEN IF ABSORPTION IS INTERMIT TENT. CONTINUOUS ADMINISTRATION OF PROGESTIN IN SUFFICIENT DOSE LEADS TO OVARIAN AND ENDOMETRIAL ATROPHY. VERY SMALL DOSES MAY ALTER THE STRUCTURE OF THE ENDOMETRIUM. PROLONGED OR REPEATED EXPOSURE IN MEN MAY RESULT IN GYNECOMASTIA. REPRODUCTIVE EFFECTS HAVE BEEN REPORTED IN ANIMALS. SKIN CONTACT: PROGESTERONE: ACUTE EXPOSURE - AIRBORNE PARTICLES OF SEX HORMONES MAY BE ABSORBED THROUGH INTACT SKI N. EXCESS PROGESTAGENS IN (SARA III) ======================= First Aid Measures ======================= First Aid:INHALATION: MOVE TO FRESH AIR IMMED. IF BREATHING STOPPED, GIVE ARTF RESP. KEEP VICTIM WARM & AT REST. TREAT SYMPTOMATICALLY/SUPPORTIVELY. GET MED ATTN IMMED. SKIN: REMOVE CONTAM CLOTHING/SHOES IMMED. WASH AFFECTED AREA W/SOAP & WATER UNTIL NO EVIDENCE OF CHEMICAL REMAINS (15-20 MIN). GET MED ATTN IMMED. EYES: WASH WITH LARGE AMOUNTS WATER/NORMAL SALINE, LIFTING EYELIDS OCCAS. FOR APPROX 15-20 MIN . GET MED ATTN IMMED. INGESTION: TREAT SYMPTOMATICALLY/SUPPORTIVELY. IF VOMITING OCCURS, KEEP HEAD LOWER THAN HIPS TO PREVENT ASPIRATION. GET MEDICAL ATTN IMMEDIATELY. ANTIDOTE: NO SPECIFIC ANTIDOTE. TREAT SYMPTOMATICALLY/SUPPORTIVELY. ===================== Fire Fighting Measures ===================== Extinguishing Media:DRY CHEMICAL, CARBON DIOXIDE, WATER SPRAY OR REGULAR FOAM (1990 EMERGENCY RESPONSE GUIDEBOOK, DOT P 5800.5). USE AGENTS (UNUSUAL FIRE/EXP HAZARD) Fire Fighting Procedures:MOVE CONTAINER FROM FIRE AREA IF IT CAN BE DONE WITHOUT RISK. DO NOT SCATTER SPILLED MATERIAL WITH HIGH-PRESSURE WATER STREAMS. DIKE FIRE-CONTROL WATER FOR LATER DISPOSAL (1990 EMER RESP GUIDEBOOK, DO T P 5800.5, PG 31). USE NIOSH-APPROVED SCBA AND FULL PROTECTIVE EQUIPMENT . Unusual Fire/Explosion Hazard:NEGLIGIBLE FIRE HAZARD WHEN EXPOSED TO HEAT OR FLAME. AVOID BREATHING HAZARDOUS VAPORS, KEEP UPWIND. EXTINGUISHING MEDIA (CONT): SUITABLE FOR TYPE OF SURROUNDING FIRE. FOR LARGER FIRES, USE WATER S PRAY, FOG OR REGULAR FOAM (1990 EMERGENCY RESPONSE GUIDEBOOK, DOT P 5800.5). ================== Accidental Release Measures ================== Spill Release Procedures:WATER SPILL: THE CALIFORNIA SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT OF 1986 (PROPOSITION 65) PROHIBITS CONTAMINATING ANY KNOWN SOURCE OF DRINKING WATER WITH SUBSTANCES KNOWN TO CAUSE CANCER AND/ OR REPRODUCTIVE TOXICITY. OCCUPATIONAL SPILL: NO SPECIAL PRECAUTIONS INDICATED. ====================== Handling and Storage ====================== Handling and Storage Precautions:OBSERVE ALL FEDERAL, STATE AND LOCAL REGULATIONS WHEN STORING OR DISPOSING OF THIS SUBSTANCE. FOR ASSISTANCE, CONTACT THE DISTRICT DIRECTOR OF THE ENVIRONMENTAL PROTECTION AGENCY. ============= Exposure Controls/Personal Protection ============= Respiratory Protection:THE FOLLOWING RESPIRATORS RECOMMENDED BASED ON INFO FOUND IN THE PHYSICAL DATA, TOXICITY AND HEALTH EFFECTS SECTIONS. THEY ARE RANKED IN ORDER FROM MINIMUM TO MAXIMUM RESP PROTECTION. SPECIFIC RESPIRA TOR SELECTED MUST BE BASED ON CONTAM LEVELS FOUND IN WORKPLACE, SPECIFIC OPERATION, NOT EXCEED WORKING LIMITS OF RESP & BE APPROVED (WORK / HYGIENE PRACTICES) Ventilation:PROVIDE LOCAL EXHAUST OR PROCESS ENCLOSURE VENTILATION SYSTEM. Protective Gloves:WEAR APPROPRIATE PROTECTIVE GLOVES TO PREVENT CONTACT WITH THIS SUSTANCE. Eye Protection:WEAR SPLASH-PROOF OR DUST-RESISTANT SAFETY GOGGLES (ANSI APPROVED - ). Other Protective Equipment:EYEWASH AND DELUGE SHOWER MEETING ANSI DESIGN CRITERIA . APPROPRIATE PROTECTIVE (IMPERVIOUS) CLOTHING AND EQUIPMENT TO PREVENT REPEATED/PROLONGED SKIN CONTACT WITH THIS SUBSTANCE. Work Hygienic Practices:RESPIRATORY PROT (CONT): BY NIOSH. ANY TYPE 'C' SUPPLIED-AIR RESP WITH FULL FACEPIECE OPERATED IN PRESSURE-DEMAND / OTHER POSITIVE PRESSURE MODE OR WITH FULL FACEPIECE, HELMET OR HOOD (TRANSPORT INFO) Supplemental Safety and Health CHEMICAL FAMILY: STEROID. MOLECULAR FORMULS: C21-H30-O2. MOLECULAR WEIGHT: 314.51. NFPA RATINGS (SCALE 0-4): HEALTH = 3, FIRE = 3, REACTIVITY = 0. EXPOSURE LIMITS: NO OCCUPATIONAL EXPOSURE LIMITS E STABLISHED BY OSHA, ACGIH OR NIOSH. PHYSICAL/CHEMICAL PROPERTIES (CONT): SOLVENT SOLUBILITY: ALCOHOL, ACETONE, DIOXANE. ================== Physical/Chemical Properties ================== Melt/Freeze Pt:=127.2C, 261.F Spec Gravity:1.17 @ 23 C Solubility in Water:PRACTICALLY INSOLUBLE. Appearance and Odor:WHITE CRYSTALLINE POWDER, ODORLESS, LIGHT SENSITIVE. ================= Stability and Reactivity Data ================= Stability Indicator/Materials to Avoid:YES STRONG OXIDIZERS: FIRE & EXPLOSION HAZARD. Stability Condition to Avoid:STABLE UNDER NORMAL TEMPERATURES AND PRESSURES. CONDITIONS TO AVOID: NONE REPORTED. Hazardous Decomposition Products:THERMAL DECOMPOSITION PRODUCTS MAY INCLUDE TOXIC OXIDES OF CARBON. Conditions to Avoid Polymerization:HAZARDOUS POLYMERIZATION NOT BEEN REPORTED TO OCCUR UNDER NORMAL TEMPERATURES AND PRESSURES. =================== Toxicological Information =================== Toxicological Information:PROGESTERONE: TOXICITY DATA: 100 MG/KG INTRAVENOUS-MOUSE LDLO: 327 MG/KG. INTRAPERITONEAL-RAT LDLO: MUTAGENIC DATA (RTECS); REPRODUCTIVE EFFECTS DATA (RTECS); TUMORIGENIC DATA (RTECS). CARCINOGEN STAT US: ANTICIPATED HUMAN CARCINOGEN (NTP); HUMAN INADEQUATE EVIDENCE (IARC GROUP 2B FOR PROGESTINS); ANIMAL SUFFICIENT EVIDENCE (IARC). IN ABSENCE OF EPIDEMIOLOGICAL DATA, NO EVALUATION OF CARCINOGENICIT Y OF PROGESTERONE TO HUMANS CAN BE MADE. PROGESTERONE WAS TESTED BY SUBCUTANEOUS AND INTRAMUSCULAR INJECTION IN RATS, MICE, RABBITS AND DOGS AND SUCUTANEOUS IMPLANTATION IN MICE AND RATS. IT WAS TESTE D ALONE IN MICE AND (ECOLOGICAL INFO) ===================== Ecological Information ===================== Ecological:N/P. TOXICOLOGICAL INFO (CONT): DOGS; IN RATS AND RABBITS IT WAS ALWAYS GIVEN IN COMBINATION WITH OTHER SEX HORMONES. WHEN GIVEN ALONE, IT INCREASED THE INCIDENCE OF OVARIAN, UTERINE AND MAMMARY TUM ORS IN MICE. NEONATAL TREATMENT WITH PROGESTERONE ENHANCED THE OCCURRENCE OF PRECANCEROUS AND CANCEROUS LESIONS OF THE GENITAL TRACT AND RESULTED IN INCREASED MAMMARY TUMORIGENESIS IN FEMALE RATS. AC UTE TOXICITY LEVEL: INSUFFICIENT DATA. TARGET EFFECTS: POISONING MAY AFFECT THE LIVER. ==================== Disposal Considerations ==================== Waste Disposal Methods:OBSERVE ALL FEDERAL, STATE AND LOCAL REGULATIONS WHEN STORING OR DISPOSING OF THIS SUBSTANCE. FOR ASSISTANCE, CONTACT THE DISTRICT DIRECTOR OF THE ENVIRONMENTAL PROTECTION AGENCY. =================== MSDS Transport Information =================== Transport Information:N/P. WORK HYGIENE PRACTICES (CONT): OPERATED IN CONTINUOUS-FLOW MODE. ANY SELF-CONTAINED BREATHING APPARATUS WITH A FULL FACEPIECE OPERATED IN PRESS-DEMAND MODE OR OTHER POS PRESSURE MODE. FOR FIREFI GHTING & OTHER IMMED DANGEROUS TO LIFE OR HEALTH CONDITIONS: ANY SELF-CONTAINED BREATHING APP W/FULL FACEPIECE & OPERATED IN PRESSURE-DEMAND/OTHER POSITIVE-PRESSURE MODE. ANY SUPPLIED-AIR RESP W/FULL FACEPIECE & OPERATED IN PRESSURE DEMAND/OTHER POSITIVE-PRESSURE MODE IN COMBINATION WITH AN AUXILIARY SELF-CONTAINED BREATHING APPARATUS OPERATED IN PRESSURE-DEMAND OR OTHER POSITIVE-PRESSURE MODE. ===================== Regulatory Information ===================== SARA Title III Information:N/P. SIGNS & SYMPTOMS OF OVEREXP (CONT): WOMEN MAY CAUSE WEIGHT GAIN, ACNE, MASTALGIA, GYNECOMASTIA & RECURRENT MONOLIAL VAGINITIS. OTHER SYMPS MAY INCL HEADACHE, NAUSEA, PHOTOSENSITIVITY, CHLOASMA, LOSS OF LIBIDO, BREAKTHROUGH BLEEDING, HYPERTENSION, PORPHYRIA, CHOLESTATIC LIVER DAMAGE & STERILITY. EXCESS PROGESTAGENS IN MEN MAY RESULT IN SOME GENERAL SYMPTOMS EXHIBITED BY WOMEN, & MAY ALSO INH IBIT SPERMATOGENISIS. FETAL EXPOSURE TO PROGESTERONE MAY RESULT IN COGENITAL HEAT DEFECTS, LIMB REDUCTION DEFECTS, VIRILIZATION & GENITAL ABNORM. CHRONIC EXPOSURES - SEX HORMONES MAY ACCUM & REACH HI GH LEVELS EVEN IF ABSORPTION (FED REGS) Federal Regulatory Information:CERCLA RATINGS: (SCALE 0-3): HEALTH-3, FIRE-0, REACTIVITY-0, PERSISTENCE-3. SARA III (CONT): IS INTERMITTENT. CONTINUOUS ADMIN OF A PROGESTIN IN SUFFICIENT DOSES LEADS TO OVARIAN & ENDOMETRIAL ATROPH Y. VERY SMALL DOSES MAY ALTER THE STRUCTURE OF THE ENDOMETRIUM. REPROD EFFECTS HAVE BEEN REPORTED IN ANIMALS. EYE CONTACT: PROGESTERONE: ACUTE EXPOSURE - NO DATA AVAIL. CONTACT WITH THE DUST OR POWDER MAY BE IRRITATING. CHRONIC EXPOSURE - NO DATA AVAIL. INGESTION: PROGESTERONE: ACUTE EXPOSURE - EXC ESS PROGESTAGENS IN WOMEN MAY CAUSE WEIGHT GAIN, ACNE, MASTALGIA, GYNECOMASTIA & RECURRENT MONOLIAL VAGINITIS. OTHER SYMPTOMS (STATE REGS) State Regulatory Information:SUBJECT TO CALIFORNIA PROPOSITION 65 CANCER AND/OR REPRODUCTIVE TOXICITY WARNING AND RELEASE REQUIREMENTS-(JANUARY 1, 1988). FED REGS (CONT): MAY INCL HEADACHE, NAUSEA, PHOTOSENSITIVITY, CHLOASMA, LOSS OF LIBIDO, BREAKTHROUGH BLEEDING, HYPERTENSION, PORPHYRIA, CHOLESTATIC LIVER DAMAGE & STERILITY. EXCESS PROGESTAGENS IN MEN MAY RESULT IN SOME GENERAL SYMPS EXHIBITED BY WOMEN, & MAY ALSO INHIBIT SPERMATOGENISIS. FETAL EXPOSURE TO PROGESTERONE MAY RESULT IN COGENITAL HEART DEFECTS, LIMB REDUCTI ON DEFECTS, VIRILIZATION & GENITAL ABNORM. CONTINUOUS ADMIN OF A PROGESTIN IN SUFF DOSE LEADS TO OVARIAN & ENDOMETRIAL ATROPHY. (OTHER INFO) ======================= Other Information ======================= 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.'