E R SQUIBB MEDATOPE DIV -- TESLAC TABLETS, 50 MG -- -
===================== Product Identification =====================
Product ID:TESLAC TABLETS, 50 MG
MSDS Date:04/06/1993
FSC:NIIN:Submitter:F BT
Status Code:A
MSDS Number: CLFKQ
=== Responsible Party ===
Company Name:E R SQUIBB MEDATOPE DIV
Address:5 GORDIS RD BLDG 124
Box:191
City:NEW BRUNSWICK
State:NJ
ZIP:08903
Country:US
Info Phone Num:609-921-4081
Emergency Phone Num:609-921-4081
CAGE:4T649
=== Contractor Identification ===
Company Name:E R SQUIBB MEDATOPE DIV
Address:5 GORDIS RD BLDG 124
Box:191
City:NEW BRUNSWICK
State:NJ
ZIP:08903
Country:US
Phone:609-921-4081
CAGE:4T649
============= Composition/Information on Ingredients =============
Ingred Name:TESTOLACTONE
CAS:968-93-4
= Wt:18.5
Ingred Name:LACTOSE
CAS:63-42-3
RTECS #:OD9625000
> Wt:1.
Ingred Name:CORN STARCH
CAS:9005-25-8
RTECS #:GM5090000
> Wt:1.
OSHA PEL:15 MG/M3
ACGIH TLV:10 MG/M3
Ingred Name:CALCIUM STEARATE
CAS:1592-23-0
RTECS #:WI3000000
< Wt:1.
Ingred Name:GELATIN
< Wt:1.
===================== Hazards Identification =====================
Routes of Entry: Inhalation:YES Skin:YES Ingestion:YES
Reports of Carcinogenicity:NTP:NO IARC:NO OSHA:NO
Health Hazards Acute and Chronic:ACUTE:INGESTION:TESTOLACTONE IS
MODERATELY TOXIC AFTER ACUTE INGESTION.ACUTE EXPOSURE MAY CAUSE
NAUSEA,VOMITING,AND DIARRHEA.INHALATION:IF TABLETS ARE CRUSHED, IF
THE RESULTING MATERIAL IS INHALED IN SUFFICIENT
QUANTITY,RESPIRATORY IRRITATION MAY OCCUR.EYE:IF TESLAC TABLETS ARE
CRUSHED,AND MATERIAL CONTACTS THE EYE,IT MAY CAUSE
IRRITATION.CHRONIC:TESLAC TABLETS ARE INTENDED FOR ORAL USE UNDER
THE SUPERVISION OF PHYSICIANS EXPERIENCED IN CANCER
CHEMOTHERAPY.ADVERSE EFFECTS ASSOCIATED WITH REPEATED SYSTEMIC
EXPOSURE TO THERAPEUTIC DOSES OF TESTOLACTONE MAY INCLUDE:FACIAL
RASH AND INCREASED BLOOD PRESSURE.
Explanation of Carcinogenicity:TARGET ORGANS: POSSIBLY THE PITUITARY
GLAND, AND MALE AND FEMALE REPRODUCTIVE ORGANS.
Effects of Overexposure:SEE HEALTH HAZARD SECTION.
Medical Cond Aggravated by Exposure:THERAPEUTIC DOSES OF THIS MATERIAL
MAY AGGRAVATE HYPERCALCEMIA.TESTOLACTONE IS NOT RECOMMENDED FOR
THERAPEUTIC USE DURING PREGNANCY SINCE SAFE USE OF THE DRUG HASN'T
BEEN DEMONSTRATED
======================= First Aid Measures =======================
First Aid:INGESTION: VOMITING MAY BE INDUCED IF PERSON IS CONSCIOUS AND
NOT EXPERIENCING CONVULSIONS. NEVER GIVE ANYTHING BY MOUTH TO AN
UNCONSCIOUS PERSON. INHALATION: REMOVE EXPOSED PERSON TO FRESH
AIR. IF PERSON IS NOT BREATHING GIVE ARTIFICIAL RESPIRATION. IF
BREATHING IS DIFFICULT ADMINISTER OXYGEN. SKIN: WASH THOROUGHLY
WITH SOAP AND WATER. EYE: HOLD EYELIDS APART AND FLUSH WITH PLENTY
OF WATER F OR 15 MINUTES. IN ALL CASES, SEEK MEDICAL ATTENTION.
===================== Fire Fighting Measures =====================
Lower Limits:N/D
Upper Limits:N/D
Extinguishing Media:IN CASE OF FIRE USE WATER, CARBON DIOXIDE, FOAM OR
DRY CHEMICAL.
Fire Fighting Procedures:FIREFIGHTERS SHOULD WEAR SELF-CONTAINED
BREATHING APPARATUS, FLAME AND CHEMICAL RESISTANT CLOTHING, BOOTS
AND GLOVES. EVACUATE PERSONNEL TO UPWIND DIRECTION, REMOVE
UNNEEDED MATERIAL AND COOL CONTAIN ER WITH WATER FROM A MAXIMUM
DISTANCE.
Unusual Fire/Explosion Hazard:NONE KNOWN.
================== Accidental Release Measures ==================
Spill Release Procedures:SCOOP UP TABLETS AND PLACE IN SUITABLE
CONTAINER. IF TABLETS ARE CRUSHED, CLEAN POWDER WITH DAMP CLOTH OR
TOWELS. TREAT PRODUCTS AND CONTAMINATED MATERIALS AS IF THEY WERE
HAZARDOUS WASTE. INCINERA TION IS RECOMMENDED.
====================== Handling and Storage ======================
Handling and Storage Precautions:AVOID INHALATION, SKIN OR EYE CONTACT
WITH CRUSHED OR BROKEN TABLETS. STORE IN TIGHT CONTAINERS AT 15-30
DEGREES C; EXPOSURE TO EXCESSIVE HEAT SHOULD BE AVOIDED.
============= Exposure Controls/Personal Protection =============
Respiratory Protection:NIOSH APPROVED RESPIRATORS WITH HEPA FILTERS ARE
RECOMMENDED WHEN HANDLING LARGE QUANTITIES OF BROKEN OR CRUSHED
TABLETS IN THE ABSENCE OF SUITABLE EXHAUST VENTILATION.
Ventilation:LOCAL EXHAUST RECOMMENDED WHEN HANDLING QUANTITIES OF
BROKEN OR CRUSHED TABLETS.
Protective Gloves:WEAR LATEX SURGICAL GLOVES WHEN HANDLING QUANTITIES
OF BROKEN OR CRUSHED TABLET
Eye Protection:WEAR SAFETY GLASSES
Other Protective Equipment:WEAR COVERALLS WHEN THE POTENTIAL FOR SEVERE
DUSTY CONDITIONS EXISTS.
Work Hygienic Practices:WASH HANDS AFTER HANDLING COMPOUND AND BEFORE
EATING, SMOKING, USING LAVATORY, AND AT END OF DAY.
Supplemental Safety and Health
NOTE TO PHYSICIANS: TESLAC TABLETS CONTAIN TESTOLACTONE, A SYNTHETIC
ANTINEOPLASTIC AGENT AND ANABOLIC AGENT. TESTOLACTONE IS A
POSSIBLE TERATOGEN AND A POSSIBLE REPRODUCTIVE TOXIN.
================== Physical/Chemical Properties ==================
Vapor Density:N/D
Spec Gravity:N/D
================= Stability and Reactivity Data =================
Stability Indicator/Materials to Avoid:YES
NONE KNOWN.
Hazardous Decomposition Products:CO, CO2
=================== Toxicological Information ===================
Toxicological Information:ACUTE: LD50: ACUTE ORAL LD50 (MOUSE)=1,630
MG/KG; ACUTE ORAL LD50 (DOG)=593 TO 926 MG/KG; ACUTE IP LD50
(MOUSE)=160 MG/KG REPRODUCTIVE EFFECTS: IN ANIMAL STUDIES
TESTOLACTONE PRODUCED ANABOLIC EFF ECTS. IT IS NOT KNOWN WHETHER
TESTOLACTONE IS DISTRIBUTED INTO MILK.
===================== Ecological Information =====================
Ecological:NO INFORMATION.
==================== Disposal Considerations ====================
Waste Disposal Methods:DISPOSE OF IN ACCORDANCE WITH NATIONAL, STATE,
LOCAL AND APPLICABLE COUNTRY REGULATIONS. TREAT PRODUCT AND
CONTAMINATED MATERIALS AS HAZARDOUS WASTE. INCINERATION AT AN
APPROVED FACILITY IS RECOMMEN DED.
===================== Regulatory Information =====================
Federal Regulatory Information:U.S. FEDERAL : TESTOLACTONE IS SUBJECT
TO THE FEDERAL CONTROLLED SUBSTANCES ACT OF 1970 AS AMMENDED BY THE
ANABOLIC STEROIDS CONTROL ACT OF 1990, AS A SCHEDULE III (C-III)
DRUG.
======================= 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.