CELLCEPT (R) Oral Suspension
Material Safety Data Sheet
1. Product and Company Identification
Product name CELLCEPT (R) Oral Suspension
Product code 25 0205 4
Company information Enquiries: Local representation:
Hoffmann-La Roche Inc.
340 Kingsland Street
USA-Nutley, N.J. 07110-1199
United States of America
Phone 001-973/235 50 00
US Emergency phone: (800)-827-6243
US Chemtrec phone: (800)-424-9300
Roche Nutley Inventory Code 25753196
2. Composition/Information on ingredients
Ingredients Concentration
Mycophenolate mofetil 10-20 %
CAS: 128794-94-5
3. Hazards identification
Emergency Overview
Form liquid
Color white to off-white
Hazard Overview - Harmful if swallowed.
- May cause blood system changes.
- May cause lymphatic system effects.
- May cause birth defects based on animal data.
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CELLCEPT (R) Oral Suspension
Potential Health Effects - Exposure: Inhalation, Ingestion, Skin contact, Eye contact
- Target Organs: gastrointestinal system, Hematopoietic/blood
system, Lymphatic system, Immune System
- Acute Effects: This material has not been tested as a whole;
therefore, the information described below is based on one or
more of its ingredients., May cause gastrointestinal effects.
- Chronic Effects: May cause blood system changes., May cause
lymphatic system effects., May cause immune system suppression.
- Carcinogenicity: formulation not listed by NTP, IARC or OSHA
Additional Health Information - Reproduction Toxicity: May cause birth defects. Since this
material may affect the developing fetus, females planning to have
a child and pregnant women should exercise caution regarding
exposure.
- It is also advisable for nursing mothers to exercise caution
regarding exposure.
4. First-aid measures
Eye contact - in case of contact with eyes rinse thoroughly with plenty of water
and get medical advice
Skin contact - remove immediately contaminated clothes, wash affected skin with
plenty of water
Inhalation - in case of inhalation remove to fresh air and seek medical aid
Ingestion - consult physician
5. Fire-fighting measures
Suitable extinguishing media - water spray jet, dry powder, foam, carbon dioxide
Flash point (liquid)
Flash point not established
Protection of fire-fighters - use self-contained breathing apparatus
6. Accidental release measures
Personal precautions - ensure adequate ventilation
Methods for cleaning up - Absorb small spills with noncombustible absorbent material
- Put saturated absorbent material into a suitable labeled open head
drum.
- Mop or flush the area with water
- Collect wash with a noncombustible absorbent material and
transfer to labeled container for treatment and disposal.
- Check area for residual material and repeat clean up if detected
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CELLCEPT (R) Oral Suspension
7. Handling and storage
Handling
Technical measures - Use with adequate ventilation
Note - Store constituted suspension at 25 C (77 F); excursions permitted
to 15 to 30 C (59 to 86 F) for 60 days. Storage in a refrigerator
at 2 to 8 C (36 to 46 F) is acceptable.
Storage
Storage conditions - room temperature
- dry and ventilated place
- do not freeze
8. Exposure controls/Personal protection
Engineering Measures - see 7.
- IOEL: 0.1 mg/m3 (Internal Occupational Exposure Limit, men)
Threshold value (Roche) air *1
- IOEL: 0.01 mg/m3 (women of childbearing age) *1
Personal protective equipment
Respiratory protection - Respiratory protection is recommended as a precaution to minimze
exposure. Effective engineering controls are considered to be the
primary means to control worker exposure. Respiratory protection
should not substitute for feasible engineering controls.
- respiratory protection not necessary during normal operations
Hand protection - protective gloves
Eye protection - tightly fitting safety glasses
Body protection - protective clothing
General protective and - instruction of employees mandatory
hygiene measures - shower after work recommended
*1 referring to: Mycophenolate mofetil
9. Physical and chemical properties
Color white to off-white
Form liquid
10. Stability and reactivity
Stability - stable under normal conditions
Materials to avoid - strong oxidizing agents
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CELLCEPT (R) Oral Suspension
11. Toxicological information
Acute toxicity - LD50 > 4鈥?000 mg/kg (oral, mouse) *1
- LD50 250 to 500 mg/kg (oral, rat) *1
Local effects - skin: non-irritant *1
- eye: non-irritant *1
Sensitization - non-sensitizing *1
Mutagenicity - not mutagenic (various in vivo and in vitro test systems) *1
Carcinogenicity - not carcinogenic (several species) *1
Reproduction toxicity - teratogenic (several species) *1
*1 referring to: Mycophenolate mofetil
12. Ecological information
Ecotoxicity - barely toxic for planktonic crustaceans (Daphnia magna)
EC50 ~ 755 mg/l *1
*1 referring to: Mycophenolate mofetil
13. Disposal considerations
Waste from residues - observe local/national regulations regarding waste disposal
- incinerate in qualified installation with flue gas scrubbing
RCRA waste - not regulated under RCRA
14. Transport information
Note - not classified by transport regulations, proper shipping name
non-regulated
15. Regulatory information
TSCA Status - FDA Exemption - not on inventory
Reporting Requirements - The United States Environmental Protection Agency (USEPA) has
not established a Reportable Quantity (RQ) for releases of this
material.
- In New Jersey, report all releases which are likely to endanger the
public health, harm the environment or cause a complaint to the
NJDEPE Hotline (1-609-292-5560) and to local officials.
- State and local regulations vary and may impose additional
reporting requirements.
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CELLCEPT (R) Oral Suspension
16. Other information
Use - Therapeutic Category: Immunosuppressant
Edition documentation - first edition
The information in this safety data sheet is based on current scientific knowledge. It should not be
taken as expressing or implying any warranty concerning product characteristics.
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