Material Safety Data Sheet
Cisplatin 1mg/ml Injection
Section 1. Chemical Identification
Product Name: Chemical Family:
Cisplatin Heavy Metal Complex
Common Used Brand Names: Product Use:
Platinol?-AQ Antineoplastic Agent
Company : Contains the following ingredients:
Teva UK Limited Cisplatin
Leeds Business Park Hydrochloric Acid
18 Bruntcliffe Way Sodium Chloride
Leeds LS27 0JG Sodium Hydroxide
Water for Injection
Emergency Telephone Number: How Supplied:
0113 238 0099 (9am-5pm) 1mg/ml liquid in 10ml, 50ml and 100ml vials
0207 540 7000 (Out of hours)
Section 2. Composition & Information on Ingredients
Chemical CAS EC RTECS Concentration Empirical Molecular Symbol & Exposure
Name No. No. No. % Formula Weight Risk- Guideline
Phrases
R23
Cisplatin 15663 - - <1 H6Cl2N2Pt 300.05 -
R24
-27-1
R25
R36
R37
R38
R45
R46
R60
Hydrochloric 7647- - - <1 HCl 36.5 - -
Acid 01-0
Sodium 7647- - - <1 NaCl 58.5 - -
Chloride 14-5
Sodium 1310- - - <1 NaOH 40.0 R35 -
Hydroxide 73-2
Water for 7732- - - Balance H2O 18.0 - -
Injection 18-5
Section 3. Hazards Identification
EMERGENCY OVERVIEW: Material is a clear, slight yellow liquid. It is a cytotoxic agent and a probable
cancer hazard. Highly toxic if injected or swallowed. Eye and skin irritant. May cause damage to the
reproductive system, kidneys, blood, hearing and nervous system. Harmful to the fetus. May cause allergic
skin and/or respiratory reactions. Avoid contact with eyes, skin and clothing. Avoid exposure during
pregnancy and while breastfeeding. Do not taste or swallow. Wash thoroughly after handling.
Symptoms of Overexposure by Route of Exposure: This material is intended for injection under the
supervision of physicians.
Inhalation: Inhalation of significant amounts of the product is not anticipated to occur because of the small
size of individual containers.
Contact with Skin or Eyes: Contact may cause irritation. Effects may include stinging, watering, redness
swelling and damage to the eyes and redness, itching burning and damage to the skin. May cause allergic
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Material Safety Data Sheet
Cisplatin 1mg/ml Injection
skin reactions.
Ingestion: Ingestion is not an anticipated route of occupational exposure. However, the active ingredient,
Cisplatin, is highly toxic if swallowed. Symptoms similar to those identified under injection may occur.
Injection: Local redness and pain are the primary symptoms of accidental injection in an occupational
setting. Medical personnel are not anticipated to experience over-exposures to the therapeutic doses of this
product. However, effects including decreased blood platelets and white blood cells, nausea, vomiting,
diarrhea, anemia, skin rash, tinnitus, hearing loss, electrolyte disturbances, irritation of the respiratory tract
and hemolysis may occur. Severe injection overexposure may be fatal. See package insert for other
adverse reactions associated with therapeutic doses of this product.
Potential Health Hazards Acute and Chronic:
Acute: The primary health effects anticipated in an occupational setting include irritation of eyes and skin as
well as redness and local swelling after accidental injection. In case of over-exposure by injection, effects
such as decreased blood platelets and white blood cells, nausea, vomiting, diarrhea, anemia, skin rash,
tinnitus, hearing loss, electrolyte disturbances, irritation of the respiratory tract and hemolysis may occur.
Cancer: Cisplatin is considered probably carcinogenic (see Section 11).
Chronic: Cisplatin, is considered a potential reproductive and developmental toxicant (see Section 11).
Target Organs: Potential hazard to the kidneys, blood, hearing and nervous system (see Section 11).
Pre-Existing Medical Conditions: Pre-existing kidney, blood, hearing and nervous system disorders may be
aggravated by exposure to this material.
Section 4. First Aid Measures
Obtain Medical Attention in All cases ?show this MSDS!
Remove or cover gross contamination to avoid exposure to rescuers.
Inhalation: If respiratory symptoms develop, move victim away from source of exposure and into fresh air. If
symptoms persist, seek medical attention. If victim is not breathing, clear airway and immediately begin artificial
respiration. If breathing difficulties develop, oxygen should be administered by qualified personnel. Seek immediate
medical attention.
Skin: Remove contaminated shoes and clothing and cleanse affected area(s) thoroughly by washing with mild soap
and water. If irritation or redness develops and persists, seek medical attention.
Eyes: If irritation or redness develops, move victim away from exposure and into fresh air. Flush eyes with clean water
and seek medical attention. For direct contact, hold eyelids apart and flush the affected eye(s) with clean water for at
least 15 minutes. Seek medical attention.
Ingestion: If swallowed, seek emergency medical attention. If victim is drowsy or unconscious and vomiting, place on
the left side with the head down and DO NOT give anything by mouth. If not vomiting and professional advice is not
available, DO NOT induce vomiting. If possible, do not leave victim unattended and observe closely for adequacy of
breathing.
Section 5. Fire Fighting Measures
Extinguishing Media:
Water spray, foam, carbon dioxide or dry powder 璦s suitable for surrounding fire type.
Unusual Fire and Explosion Hazard:
No unusual fire or explosion hazards are expected.
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Material Safety Data Sheet
Cisplatin 1mg/ml Injection
Section 6. Accidental Release Measures
Spill & Leak Procedures
Use Personal Protective Equipment, ensure adequate ventilation. Evacuate personnel to safe areas.
Small releases: For small releases of this product, wear latex or nitrile gloves and safety glasses. Absorb
spilled liquid and rinse area thoroughly with soap and water.
Large releases: For large or uncontrolled releases, stay upwind and away from spill. Isolate immediate
hazard area and keep unauthorized personnel out. Contain spill if it can be done with minimal risk. Wear
appropriate protective equipment including respiratory protection as conditions warrant (see Section 8).
Prevent spilled material from entering sewers, storm drains, other unauthorized treatment drainage
systems, and natural waterways.
Waste: Spilled material may be absorbed into an appropriate absorbent material. Label as appropriate and
arrange for disposal as Hazardous Waste with a suitable licensed Waste Contractor.
Section 7. Handling & Storage
CISPLATIN IS A CYTOTOXIC AGENT. ALL WORK PRACTICES MUST BE DESIGNED TO REDUCE
HUMAN EXPOSURE TO THE LOWEST LEVEL.
Handling Precautions:
Employees must be trained to properly use the product. Ensure vials are properly labeled.
As with all chemicals, avoid getting this product ON YOU or IN YOU. Do not eat, drink, smoke or apply
cosmetics while handling the product. Wash hands thoroughly after handling.
Particular care in working with this product must be practiced in pharmacies and other preparation areas,
and during patient administration.
Storage Conditions:
Store only in approved containers. Keep away from any incompatible materials or conditions (see Section
10). Store at a temperature not exceeding 25癈. Do not refrigerate or freeze.
Section 8. Exposure Controls ?Personal Protection
Respiratory Protection: Not normally required for routine, medical administration of this product.
Hand Protection: Use latex, nitrile, or rubber gloves. Check gloves for leaks. Wash hands before and after using
gloves.
Eye Protection: Approved eye protection (e.g., safety glasses with side shields) to safeguard against potential eye
contact, irritation or injury is recommended.
Skin Protection: A full body gown which is closed at the front and has long sleeves is recommended.
Environmental Exposure Control & Work Hygienic Practices: Use with adequate ventilation. Follow
standard medical product handling procedures. Avoid contact with skin, eyes and clothing. Wash hands
before breaks and immediately after handling the product.
Section 9. Physical & Chemical Properties
Drug Product Appearance, Physical State and Colour:
Pale yellow sterile solution for injection.
pH: Relative density:
5-7 Not available
Boiling Point: Solubility in Water:
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Material Safety Data Sheet
Cisplatin 1mg/ml Injection
100癈 Not available
Flash Point: Freezing Point:
Not available 0癈
Partition coefficient:
Flammability:
Not available Not available
Explosive properties: Viscosity:
Not available Not available
Oxidising Properties: Relative Vapour Density:
Not available Not available
Vapour Pressure: Evaporation rate:
Not available Not available
Specific gravity: Melting Point:
Not available Not available
Section 10. Stability & Reactivity
Stability:
Stable under normal conditions of storage and handling.
Conditions to avoid:
Heat may cause this product to decompose, destroy the product and produce irritating vapors and toxic
gases. Store at temperatures not exceeding 25癈. Do not refrigerate or freeze.
Materials to avoid:
This product is generally compatible with other common materials in a medical facility. Keep away from
strong oxidizers and strong acids.
Hazardous Decomposition Products:
Carbon oxides, hydrogen chloride gas, nitrogen oxides.
Hazardous Polymerisation:
Will not occur
Section 11. Toxicological Information
Toxicity Information is for the Active Pharmaceutical ingredient: CISPLATIN
Corrosivity/irritation (eye, skin, respiratory tract):
This product is expected to be irritating to contaminated skin, eyes and other tissues.
Sensitisation (skin, respiratory):
Considered to be an allergen based on platinum compounds.
Mutagenicity:
In general, studies have produced positive (genotoxic) results. Cisplatin induced structural chromosomal
aberrations and sister chromatid exchanges in cells of rodents treated in vivo, but it did not induce
dominant lethal mutations in mice. It transformed Syrian hamster embryo cells; it induced chromosomal
aberrations, micronuclei and sister chromatid exchanges in both human and rodent cells in vitro, and
mutation and DNA damage (including DNA cross-links) in rodent cells in vitro. In Drosophila, cisplatin
induced aneuploidy and dominant lethal and sex-linked recessive lethal mutations. It induced chromosomal
aberrations and mutation in plants. Cisplatin induced mutation, gene conversion and DNA damage in fungi
and mutation and DNA damage in bacteria.
Carcinogenicity:
Multiple intraperitoneal administrations of cisplatin to mice significantly increased the incidence and number
of lung adenomas. Similar treatments caused a significant increase in the incidence of skin papillomas in
mice given promoting treatment of croton oil applied to the skin. The incidences of epidermoid carcinomas
and of both malignant and benign tumours in internal organs were increased by the same treatment, but
were not significantly different from those in controls. In two studies, multiple intraperitoneal injections of
cisplatin to rats induced leukemia. It is listed as carcinogenic by IARC.
Reproductive toxicity (fertility, developmental):
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Material Safety Data Sheet
Cisplatin 1mg/ml Injection
In men, the use of cisplatin in the chemotherapy of testicular tumors is frequently associated with
decreased spermatogenesis and abnormal Leydig cell function. Similar findings have also been reported in
experimental animal studies. Sperm production has been observed to return to normal levels in 50 to 60%
of treated men between 1 and 3 years after chemotherapy is discontinued. Although fertility is apparently
reduced, it is still possible for these patients to father children.
Section 12. Ecological Information
All work practices must be aimed at eliminating environmental contamination.
Ecotoxicity: No specific information is available on the effect of Cisplatin on plants or animals in the
environment.
Section 13. Disposal Considerations
Methods of Disposal:
Used vials and other items that have come into contact with the product must be treated as Hazardous
Waste.
The waste must be disposed of by a licensed waste contractor preferably by incineration.
Section 14. Transport Information
Transport information according to EU Guidelines
UN Number:
Not applicable
Hazard Class:
Not applicable
Proper Shipping Name:
Not applicable
Packing Group:
Not applicable
Marine Pollutant:
No component of this product is listed as a Marine Pollutant
Other applicable information:
Not applicable
Section 15. Regulatory Information
Labelling Labelling Directive (1999/45/EC) and REACH (EC1907/2006) do not apply to
medicinal products for human use
Hazard Symbols:
Classification
Not applicable
Risk Phrases:
Not applicable
Safety Phrases:
Not applicabe
Section 16. Other Information
This MSDS conforms to: 91/155/EEC; 93/112/EC; 2001/58/EC and EC1907/2006.
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Material Safety Data Sheet
Cisplatin 1mg/ml Injection
MSDS Creation Date: March 2009
Issue No. 001
Issue Date: March 2009
Disclaimer
The information contained in this MSDS is believed to be correct but does not claim to be all inclusive and
shall be used only as a guide.
It is hereby expressly stated that the use of this information shall be solely at users own risk, and that users
shall have no claim(s) against Teva UK Limited for any damage resulting from the use of this information
and / or the handling and or contact with the above product.
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