Material Safety Data Sheet
Doxorubicin hydrochloride

ACC# 91384
Section 1 - Chemical Product and Company Identification

MSDS Name: Doxorubicin hydrochloride
Catalog Numbers: BP2516-1, BP2516-10, BP2516-5, BP2516-50
Synonyms: Hydroxydaunorubicin hydrochloride; Adriamycin hydrochloride; cytotoxic drug; immunosuppressive agent; anthracycline antibiotic used in antimitotic chemotherapy.
Company Identification:
              Fisher Scientific
              1 Reagent Lane
              Fair Lawn, NJ 07410
For information, call: 201-796-7100
Emergency Number: 201-796-7100
For CHEMTREC assistance, call: 800-424-9300
For International CHEMTREC assistance, call: 703-527-3887

Section 2 - Composition, Information on Ingredients

CAS# Chemical Name Percent EINECS/ELINCS
25316-40-9 Doxorubicin hydrochloride >95 246-818-3

Section 3 - Hazards Identification

EMERGENCY OVERVIEW

Appearance: reddish powder.
Warning! Suspect cancer hazard. May cause cancer. Causes severe eye and skin irritation. May cause allergic skin reaction. May be harmful if swallowed, inhaled, or absorbed through the skin. Causes severe respiratory tract irritation. Possible risk of impaired fertility. Possible risk of harm to the unborn child.
Target Organs: Blood, kidneys, heart, respiratory system, eyes, bone marrow, immune system, skin, nerves.


Potential Health Effects
Eye: Causes severe eye irritation.
Skin: Causes skin irritation. This material is a vesicant, that is, it will induce blistering. May cause an allergic reaction in certain individuals.
Ingestion: May cause gastrointestinal irritation with nausea, vomiting and diarrhea. Human fatalities have been reported from acute poisoning.
Inhalation: Causes respiratory tract irritation. Can produce delayed pulmonary edema.
Chronic: Prolonged or repeated exposure may cause adverse reproductive effects. Cancer suspect agent. Prolonged and/or repeated skin exposure may cause allergic dermatitis. Intermittent intravenous injections in man of 12 mg/kg over 26 week period caused cardiomyopathy including infarction and acute pulmonary edema. Intravenous injections in man have also caused acute renal failure.

Section 4 - First Aid Measures


Eyes: In case of contact, immediately flush eyes with plenty of water for a t least 15 minutes. Get medical aid immediately.
Skin: In case of contact, immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Get medical aid immediately. Wash clothing before reuse.
Ingestion: If swallowed, do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Get medical aid.
Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical aid.
Notes to Physician: Treat symptomatically and supportively.

Section 5 - Fire Fighting Measures


General Information: As in any fire, wear a self-contained breathing apparatus in pressure-demand, MSHA/NIOSH (approved or equivalent), and full protective gear. During a fire, irritating and highly toxic gases may be generated by thermal decomposition or combustion.
Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or appropriate foam.
Flash Point: Not applicable.
Autoignition Temperature: Not applicable.
Explosion Limits, Lower:Not available.
Upper: Not available.
NFPA Rating: (estimated) Health: 2; Flammability: 1; Instability: 0

Section 6 - Accidental Release Measures


General Information: Use proper personal protective equipment as indicated in Section 8.
Spills/Leaks: Vacuum or sweep up material and place into a suitable disposal container. Clean up spills immediately, observing precautions in the Protective Equipment section. Avoid generating dusty conditions. Provide ventilation.

Section 7 - Handling and Storage


Handling: Wash thoroughly after handling. Remove contaminated clothing and wash before reuse. Minimize dust generation and accumulation. Do not get in eyes, on skin, or on clothing. Keep container tightly closed. Do not breathe dust. Use only with adequate ventilation.
Storage: Store in a tightly closed container. Store in a cool, dry, well-ventilated area away from incompatible substances.

Section 8 - Exposure Controls, Personal Protection


Engineering Controls: Facilities storing or utilizing this material should be equipped with an eyewash facility and a safety shower. Use adequate ventilation to keep airborne concentrations low.
Exposure Limits
Chemical Name ACGIH NIOSH OSHA - Final PELs
Doxorubicin hydrochloride none listed none listed none listed
Adriamycin none listed none listed none listed

OSHA Vacated PELs: Doxorubicin hydrochloride: No OSHA Vacated PELs are listed for this chemical. Adriamycin: No OSHA Vacated PELs are listed for this chemical.
Personal Protective Equipment
Eyes: Wear appropriate protective eyeglasses or chemical safety goggles as described by OSHA's eye and face protection regulations in 29 CFR 1910.133 or European Standard EN166.
Skin: Wear appropriate protective gloves to prevent skin exposure.
Clothing: Wear appropriate protective clothing to prevent skin exposure.
Respirators: A respiratory protection program that meets OSHA's 29 CFR 1910.134 and ANSI Z88.2 requirements or European Standard EN 149 must be followed whenever workplace conditions warrant respirator use.

Section 9 - Physical and Chemical Properties


Physical State: Powder
Appearance: orange - reddish
Odor: none reported
pH: Not available.
Vapor Pressure: Not available.
Vapor Density: Not available.
Evaporation Rate:Not available.
Viscosity: Not available.
Boiling Point: Not available.
Freezing/Melting Point:216 deg C (dec)
Decomposition Temperature:216 deg C
Solubility: Soluble.
Specific Gravity/Density:Not available.
Molecular Formula:C27H29NO11.HCl
Molecular Weight:580.03

Section 10 - Stability and Reactivity


Chemical Stability: Stable at room temperature in closed containers under normal storage and handling conditions.
Conditions to Avoid: Light, dust generation, moisture, excess heat.
Incompatibilities with Other Materials: Strong oxidizing agents.
Hazardous Decomposition Products: Hydrogen chloride, nitrogen oxides, carbon monoxide, carbon dioxide.
Hazardous Polymerization: Will not occur.

Section 11 - Toxicological Information


RTECS#:      
CAS# 25316-40-9: QI9295900      
CAS# 23214-92-8: AV9800000
LD50/LC50:
CAS# 25316-40-9:
     Oral, mouse: LD50 = 698 mg/kg;
     Oral, mouse: LD50 = 570 mg/kg;
.

CAS# 23214-92-8:
     Oral, mouse: LD50 = 570 mg/kg;
.

Carcinogenicity:
CAS# 25316-40-9:

CAS# 23214-92-8:
  • ACGIH: Not listed.
  • California: carcinogen, initial date 7/1/87
  • NTP: Not listed.
  • IARC: Group 2A carcinogen

Epidemiology: No epidemiological study of Adriamycin alone was available for review. However, in one study of cancer patients receiving Adriamycin in combination with alkylating agents and radiotherapy, the patients developed leukemia and bone cancer.
Teratogenicity: Increased frequencies of gastrointestinal anomalies, cardiovascular malformations, bladder hypoplasia, dilatation of the renal pelvis & ureter, skeletal anomalies, & other abnormalities were observed among the offspring of rats treated during pregnancywith doxorubicin in doses 5 times those used in humans. With doses that were within human therapeutic range, malformations weren't increased among the offspring of pregnant rodents treated with doxorubicin, but fetal loss & growth retardation were common
Reproductive Effects: Doxorubicin demonstrates dose & age dependent testicular toxicity in rats & testicular toxicity in mice. Genetic abnormalities & dominant lethal mutations have been reported in pregnancies fathered by treated male rodents. In men, doxorubicin treatment iassociated with reversible testicular toxicity. There are no data with which to evaluate whether the pregnancies conceived after male doxorubicin therapy have an increased incidence of abnormal outcome.
Mutagenicity: See actual entry in RTECS for complete information.
Neurotoxicity: Doxorubicin injures neurons in the PNS, specifically those of the dorsal root ganglia and autonomic ganglia.
Other Studies:

Section 12 - Ecological Information

No information available.

Section 13 - Disposal Considerations

Chemical waste generators must determine whether a discarded chemical is classified as a hazardous waste. US EPA guidelines for the classification determination are listed in 40 CFR Parts 261.3. Additionally, waste generators must consult state and local hazardous waste regulations to ensure complete and accurate classification.
RCRA P-Series: None listed.
RCRA U-Series: None listed.

Section 14 - Transport Information

US DOT Canada TDG
Shipping Name: Not regulated as a hazardous material No information available.
Hazard Class:
UN Number:
Packing Group:

Section 15 - Regulatory Information

US FEDERAL
TSCA
     CAS# 25316-40-9 is not listed on the TSCA inventory. It is for research and development use only.
     CAS# 23214-92-8 is not listed on the TSCA inventory. It is for research and development use only.
Health & Safety Reporting List
     None of the chemicals are on the Health & Safety Reporting List.
Chemical Test Rules
     None of the chemicals in this product are under a Chemical Test Rule.
Section 12b
     None of the chemicals are listed under TSCA Section 12b.
TSCA Significant New Use Rule
     None of the chemicals in this material have a SNUR under TSCA.
CERCLA Hazardous Substances and corresponding RQs
     None of the chemicals in this material have an RQ.
SARA Section 302 Extremely Hazardous Substances
     None of the chemicals in this product have a TPQ.
SARA Codes
     CAS # 23214-92-8: delayed.
Section 313      No chemicals are reportable under Section 313.
Clean Air Act:
     This material does not contain any hazardous air pollutants.
     This material does not contain any Class 1 Ozone depletors.
     This material does not contain any Class 2 Ozone depletors.
Clean Water Act:
     None of the chemicals in this product are listed as Hazardous Substances under the CWA.
     None of the chemicals in this product are listed as Priority Pollutants under the CWA.
     None of the chemicals in this product are listed as Toxic Pollutants under the CWA.
OSHA:
     None of the chemicals in this product are considered highly hazardous by OSHA.
STATE
     CAS# 25316-40-9 can be found on the following state right to know lists: Pennsylvania.
     CAS# 23214-92-8 can be found on the following state right to know lists: California, New Jersey, Pennsylvania, Minnesota, Massachusetts.

California Prop 65
WARNING: This product contains Adriamycin, a chemical known to the state of California to cause cancer. WARNING: This product contains Adriamycin, a chemical known to the state of California to cause male reproductive toxicity.
California No Significant Risk Level: None of the chemicals in this product are listed.

European/International Regulations
European Labeling in Accordance with EC Directives
Hazard Symbols:
     T
Risk Phrases:
     R 22 Harmful if swallowed.
     R 37/38 Irritating to respiratory system and skin.
     R 41 Risk of serious damage to eyes.
     R 45 May cause cancer.
     R 46 May cause heritable genetic damage.
     R 62 Possible risk of impaired fertility.
     R 63 Possible risk of harm to the unborn child.

Safety Phrases:
     S 26 In case of contact with eyes, rinse immediately with plenty of
     water and seek medical advice.
     S 36/37/39 Wear suitable protective clothing, gloves and eye/face pr
     otection.
     S 45 In case of accident or if you feel unwell, seek medical advice
     immediately (show the label where possible).
     S 53 Avoid exposure - obtain special instructions before use.

WGK (Water Danger/Protection)
     CAS# 25316-40-9: No information available.
     CAS# 23214-92-8: No information available.
Canada - DSL/NDSL
     CAS# 23214-92-8 is listed on Canada's DSL List.
Canada - WHMIS
     This product has a WHMIS classification of D2A, D2B.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations and the MSDS contains all of the information required by those regulations.
Canadian Ingredient Disclosure List

Section 16 - Additional Information

MSDS Creation Date: 2/01/2000
Revision #4 Date: 6/29/2007

The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no event shall Fisher be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if Fisher has been advised of the possibility of such damages.