Doxorubicin Safety Data Sheets
SAFETY DATA SHEETS
According to the UN GHS revision 8
SECTION 1: Identification
1.1 GHS Product identifier
| Product name | Doxorubicin |
|---|
1.2 Other means of identification
| Product number | - |
|---|---|
| Other names | adriamycine; Doxil; Adriblastin |
1.3 Recommended use of the chemical and restrictions on use
| Identified uses | Industrial and scientific research uses. |
|---|---|
| Uses advised against | no data available |
1.4 Supplier's details
| Company | Echemi.com |
|---|---|
| Address | Echemi.com |
| Telephone | Echemi.com |
1.5 Emergency phone number
| Emergency phone number | Echemi.com |
|---|---|
| Service hours | Monday to Friday, 9am-5pm (Standard time zone: UTC/GMT +8 hours). |
SECTION 2: Hazard identification
2.1 Classification of the substance or mixture
Acute toxicity - Category 4, Oral
Carcinogenicity, Category 1B
2.2 GHS label elements, including precautionary statements
| Pictogram(s) | |
|---|---|
| Signal word | Danger |
| Hazard statement(s) | H302 Harmful if swallowed H350 May cause cancer |
| Precautionary statement(s) | |
| Prevention | P264 Wash ... thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P203 Obtain, read and follow all safety instructions before use. P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/... |
| Response | P301+P317 IF SWALLOWED: Get medical help. P330 Rinse mouth. P318 IF exposed or concerned, get medical advice. |
| Storage | P405 Store locked up. |
| Disposal | P501 Dispose of contents/container to an appropriate treatment and disposal facility in accordance with applicable laws and regulations, and product characteristics at time of disposal. |
2.3 Other hazards which do not result in classification
no data available
SECTION 3: Composition/information on ingredients
3.1 Substances
| Chemical name | Common names and synonyms | CAS number | EC number | Concentration |
|---|---|---|---|---|
| Doxorubicin | Doxorubicin | 23214-92-8 | 245-495-6 | 100% |
SECTION 4: First-aid measures
4.1 Description of necessary first-aid measures
If inhaled
Move the victim into fresh air. If breathing is difficult, give oxygen. If not breathing, give artificial respiration and consult a doctor immediately. Do not use mouth to mouth resuscitation if the victim ingested or inhaled the chemical.
Following skin contact
Take off contaminated clothing immediately. Wash off with soap and plenty of water. Consult a doctor.
Following eye contact
Rinse with pure water for at least 15 minutes. Consult a doctor.
Following ingestion
Rinse mouth with water. Do not induce vomiting. Never give anything by mouth to an unconscious person. Call a doctor or Poison Control Center immediately.
4.2 Most important symptoms/effects, acute and delayed
no data available
4.3 Indication of immediate medical attention and special treatment needed, if necessary
Treatment of acute overdosage consists of treatment of the severely myelosuppressed patient with hospitalization, antimicrobials, platelet transfusions and symptomatic treatment of mucositis. Use of hemopoietic growth factor (G-CSF, GM-CSF) may be considered. The 150 mg doxorubicin hydrochloride for injection and the 75 mL and 100 mL (2 mg/mL) doxorubicin hydrochloride injection vials are packaged as multiple dose vials and caution should be exercised to prevent inadvertent overdosage. Cumulative dosage with doxorubicin increases the risk of cardiomyopathy and resultant congestive heart failure. Treatment consists of vigorous management of congestive heart failure with digitalis preparations, diuretics, and after-load reducers such as ACE inhibitors.
SECTION 5: Fire-fighting measures
5.1 Suitable extinguishing media
Use dry chemical, carbon dioxide or alcohol-resistant foam.
5.2 Specific hazards arising from the chemical
no data available
5.3 Special protective actions for fire-fighters
Wear self-contained breathing apparatus for firefighting if necessary.
SECTION 6: Accidental release measures
6.1 Personal precautions, protective equipment and emergency procedures
Avoid dust formation. Avoid breathing mist, gas or vapours.Avoid contacting with skin and eye. Use personal protective equipment.Wear chemical impermeable gloves. Ensure adequate ventilation.Remove all sources of ignition. Evacuate personnel to safe areas.Keep people away from and upwind of spill/leak.
6.2 Environmental precautions
Prevent further spillage or leakage if it is safe to do so. Do not let the chemical enter drains. Discharge into the environment must be avoided.
6.3 Methods and materials for containment and cleaning up
PRECAUTIONS FOR "CARCINOGENS": A high-efficiency particulate arrestor (HEPA) or charcoal filters can be used to minimize amt of carcinogen in exhausted air ventilated safety cabinets, lab hoods, glove boxes or animal rooms ... Filter housing that is designed so that used filters can be transferred into plastic bag without contaminating maintenance staff is avail commercially. Filters should be placed in plastic bags immediately after removal ... The plastic bag should be sealed immediately ... The sealed bag should be labelled properly ... Waste liquids ... should be placed or collected in proper containers for disposal. The lid should be secured & the bottles properly labelled. Once filled, bottles should be placed in plastic bag, so that outer surface ... is not contaminated ... The plastic bag should also be sealed & labelled. ... Broken glassware ... should be decontaminated by solvent extraction, by chemical destruction, or in specially designed incinerators. Chemical Carcinogens
SECTION 7: Handling and storage
7.1 Precautions for safe handling
Handling in a well ventilated place. Wear suitable protective clothing. Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Use non-sparking tools. Prevent fire caused by electrostatic discharge steam.
7.2 Conditions for safe storage, including any incompatibilities
Commercially available doxorubicin hydrochloride lyophilized powder for injection should be stored in a dry place protected from sunlight. When stored at 15-30 deg C, Adriamycin RDF or Rubex has an expiration date of 3 or 2 years, respectively, following the date of manufacture. Doxorubicin hydrochloride conventional (nonencapsulated) injection should be protected from light and refrigerated at 2-8 deg C; when stored under these conditions, the injection is stable for 18 months
SECTION 8: Exposure controls/personal protection
8.1 Control parameters
Occupational Exposure limit values
no data available
Biological limit values
no data available
8.2 Appropriate engineering controls
Ensure adequate ventilation. Handle in accordance with good industrial hygiene and safety practice. Set up emergency exits and the risk-elimination area.
8.3 Individual protection measures, such as personal protective equipment (PPE)
Eye/face protection
Wear tightly fitting safety goggles with side-shields conforming to EN 166(EU) or NIOSH (US).
Skin protection
Wear fire/flame resistant and impervious clothing. Handle with gloves. Gloves must be inspected prior to use. Wash and dry hands. The selected protective gloves have to satisfy the specifications of EU Directive 89/686/EEC and the standard EN 374 derived from it.
Respiratory protection
If the exposure limits are exceeded, irritation or other symptoms are experienced, use a full-face respirator.
Thermal hazards
no data available
SECTION 9: Physical and chemical properties and safety characteristics
| Physical state | Solid |
|---|---|
| Colour | Red, crystalline solid |
| Odour | no data available |
| Melting point/freezing point | 205ºC |
| Boiling point or initial boiling point and boiling range | no data available |
| Flammability | no data available |
| Lower and upper explosion limit/flammability limit | no data available |
| Flash point | 443.8ºC |
| Auto-ignition temperature | no data available |
| Decomposition temperature | no data available |
| pH | no data available |
| Kinematic viscosity | no data available |
| Solubility | Soluble |
| Partition coefficient n-octanol/water | no data available |
| Vapour pressure | 9.64E-28mmHg at 25°C |
| Density and/or relative density | 1.61 g/cm3 |
| Relative vapour density | no data available |
| Particle characteristics | no data available |
SECTION 10: Stability and reactivity
10.1 Reactivity
no data available
10.2 Chemical stability
Neutral aq soln are stable at room temp
10.3 Possibility of hazardous reactions
no data available
10.4 Conditions to avoid
no data available
10.5 Incompatible materials
Doxorubicin hydrochloride solution is chemically incompatible with heparin sodium injection, and a precipitate may form if the solutions are mixed. Doxorubicin hydrochloride solution also is reportedly incompatible with fluorouracil, and a precipitate may form if the solutions are mixed. The manufacturers recommend that doxorubicin hydrochloride solutions or doxorubicin liposomal dispersion generally not be mixed with other drugs; specialized references should be consulted for specific compatibility information.
10.6 Hazardous decomposition products
When heated to decomposition /temp unspecified/, adriamycin emits toxic fumes of ... /nitrogen oxides/ and hydrochloric acid.
SECTION 11: Toxicological information
Acute toxicity
- Oral: LD50 Mouse oral 570 mg/kg
- Inhalation: no data available
- Dermal: no data available
Skin corrosion/irritation
no data available
Serious eye damage/irritation
no data available
Respiratory or skin sensitization
no data available
Germ cell mutagenicity
no data available
Carcinogenicity
Inadequate evidence of carcinogenicity in humans. Sufficient evidence of carcinogenicity in animals. OVERALL EVALUATION: Group 2A: The agent is probably carcinogenic to humans.
Reproductive toxicity
no data available
STOT-single exposure
no data available
STOT-repeated exposure
no data available
Aspiration hazard
no data available
SECTION 12: Ecological information
12.1 Toxicity
- Toxicity to fish: no data available
- Toxicity to daphnia and other aquatic invertebrates: EC50; Species: Daphnia magna (Water flea); Concentration: 2.0 mg/L; Effect: immobilization /Conditions of bioassay not specified in source examined
- Toxicity to algae: no data available
- Toxicity to microorganisms: no data available
12.2 Persistence and degradability
no data available
12.3 Bioaccumulative potential
An estimated BCF of 0.5 was calculated in fish for doxorubicin(SRC), using a log Kow of 1.27(1) and a regression-derived equation(2). According to a classification scheme(3), this BCF suggests the potential for bioconcentration in aquatic organisms is low(SRC).
12.4 Mobility in soil
Using a structure estimation method based on molecular connectivity indices(1), the Koc of doxorubicin can be estimated to be 6,000(SRC). According to a classification scheme(2), this estimated Koc value suggests that doxorubicin is expected to be immobile in soil. Estimated values for pKa1, pKa2, and pKa3 of 7.34, 8.46, and 9.46, respectively(3), indicate that this compound will exist almost entirely in the cation form in the environment and cations generally adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(4).
12.5 Other adverse effects
no data available
SECTION 13: Disposal considerations
13.1 Disposal methods
Product
The material can be disposed of by removal to a licensed chemical destruction plant or by controlled incineration with flue gas scrubbing. Do not contaminate water, foodstuffs, feed or seed by storage or disposal. Do not discharge to sewer systems.
Contaminated packaging
Containers can be triply rinsed (or equivalent) and offered for recycling or reconditioning. Alternatively, the packaging can be punctured to make it unusable for other purposes and then be disposed of in a sanitary landfill. Controlled incineration with flue gas scrubbing is possible for combustible packaging materials.
SECTION 14: Transport information
14.1 UN Number
| ADR/RID: no data available | IMDG: no data available | IATA: no data available |
14.2 UN Proper Shipping Name
| ADR/RID: no data available | IMDG: no data available | IATA: no data available |
14.3 Transport hazard class(es)
| ADR/RID: no data available | IMDG: no data available | IATA: no data available |
14.4 Packing group, if applicable
| ADR/RID: no data available | IMDG: no data available | IATA: no data available |
14.5 Environmental hazards
| ADR/RID: No | IMDG: No | IATA: No |
14.6 Special precautions for user
no data available
14.7 Transport in bulk according to IMO instruments
no data available
SECTION 15: Regulatory information
15.1 Safety, health and environmental regulations specific for the product in question
| Chemical name | Common names and synonyms | CAS number | EC number |
|---|---|---|---|
| Doxorubicin | Doxorubicin | 23214-92-8 | 245-495-6 |
| European Inventory of Existing Commercial Chemical Substances (EINECS) | Listed. | ||
| EC Inventory | Listed. | ||
| United States Toxic Substances Control Act (TSCA) Inventory | Not Listed. | ||
| China Catalog of Hazardous chemicals 2015 | Not Listed. | ||
| New Zealand Inventory of Chemicals (NZIoC) | Listed. | ||
| Philippines Inventory of Chemicals and Chemical Substances (PICCS) | Not Listed. | ||
| Vietnam National Chemical Inventory | Not Listed. | ||
| Chinese Chemical Inventory of Existing Chemical Substances (China IECSC) | Not Listed. | ||
| Korea Existing Chemicals List (KECL) | Not Listed. | ||
SECTION 16: Other information
Information on revision
| Creation Date | July 15, 2019 |
|---|---|
| Revision Date | July 15, 2019 |
Abbreviations and acronyms
- CAS: Chemical Abstracts Service
- ADR: European Agreement concerning the International Carriage of Dangerous Goods by Road
- RID: Regulation concerning the International Carriage of Dangerous Goods by Rail
- IMDG: International Maritime Dangerous Goods
- IATA: International Air Transportation Association
- TWA: Time Weighted Average
- STEL: Short term exposure limit
- LC50: Lethal Concentration 50%
- LD50: Lethal Dose 50%
- EC50: Effective Concentration 50%
References
- IPCS - The International Chemical Safety Cards (ICSC), website: http://www.ilo.org/dyn/icsc/showcard.home
- HSDB - Hazardous Substances Data Bank, website: https://toxnet.nlm.nih.gov/newtoxnet/hsdb.htm
- IARC - International Agency for Research on Cancer, website: http://www.iarc.fr/
- eChemPortal - The Global Portal to Information on Chemical Substances by OECD, website: http://www.echemportal.org/echemportal/index?pageID=0&request_locale=en
- CAMEO Chemicals, website: http://cameochemicals.noaa.gov/search/simple
- ChemIDplus, website: http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp
- ERG - Emergency Response Guidebook by U.S. Department of Transportation, website: http://www.phmsa.dot.gov/hazmat/library/erg
- Germany GESTIS-database on hazard substance, website: http://www.dguv.de/ifa/gestis/gestis-stoffdatenbank/index-2.jsp
- ECHA - European Chemicals Agency, website: https://echa.europa.eu/
Disclaimer: The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. The information in this document is based on the present state of our knowledge and is applicable to the product with regard to appropriate safety precautions. It does not represent any guarantee of the properties of the product. We as supplier shall not be held liable for any damage resulting from handling or from contact with the above product.
Doxorubicin is included in Antineoplastics category.
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