SAFETY DATA SHEETS

According to the UN GHS revision 10

Version: 1.0

Creation Date: July 15, 2019

Revision Date: July 15, 2019

SECTION 1: Identification

1.1GHS Product identifier

Product name	Bleomycin, sulfate (salt)

1.2Other means of identification

Product number	-
Other names	Blenmycins;Blocamicina;BLEO

1.3Recommended use of the chemical and restrictions on use

Identified uses	Industrial and scientific research use.
Uses advised against	no data available

 

SECTION 2: Hazard identification

2.1Classification of the substance or mixture

Germ cell mutagenicity, Category 1B

Carcinogenicity, Category 2

Reproductive toxicity, Category 2

2.2GHS label elements, including precautionary statements

Pictogram(s)
Signal word	Danger
Hazard statement(s)	H340 May cause genetic defects H351 Suspected of causing cancer H361 Suspected of damaging fertility or the unborn child
Precautionary statement(s)
Prevention	P203 Obtain, read and follow all safety instructions before use. P280 Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/...
Response	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.

2.3Other hazards which do not result in classification

no data available

SECTION 3: Composition/information on ingredients

3.1Substances

Chemical name	Common names and synonyms	CAS number	EC number	Concentration
Bleomycin, sulfate (salt)	Bleomycin, sulfate (salt)	9041-93-4	232-925-2	100%

SECTION 4: First-aid measures

4.1Description 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.

4.2Most important symptoms/effects, acute and delayed

SYMPTOMS: Symptoms of exposure to this compound may include mucocutaneous reactions such as mouth ulcerations; skin redness, ulceration and blistering; headache, mental confusion, fever, chills, cough, wheezing, pneumonitis, nausea, vomiting, abdominal pain, hypotension, cardiorespiratory collapse, hair loss, and pulmonary fibrosis. ACUTE/CHRONIC HAZARDS: Toxic: primarily in the skin and lungs. (NTP, 1992)

4.3Indication of immediate medical attention and special treatment needed, if necessary

Maintain an open airway and assist ventilation if necessary. Treat coma, seizures, hypotension, and arrhythmias if they occur. Treat nausea and vomiting with metoclopramide and fluid loss caused by gastroenteritis with intravenous crystalloid fluids. Bone marrow depression should be treated with the assistance of an experienced hematologist or oncologist. Extravasation; immediately stop the infusion and withdraw as much fluid as possible by negative pressure on the syringe. ... Very few specific treatments or antidotes are available. Administer activated charcoal orally if conditions are appropriate. Gastric lavage is not necessary after small to moderate ingestions if activated charcoal can be given promptly. Because of the rapid intracellular incorporation of most of these agents, dialysis and other extracorporeal removal procedures are generally not effective. Antineoplastic agents

SECTION 5: Fire-fighting measures

5.1Suitable extinguishing media

Fires involving this material can be controlled with a dry chemical, carbon dioxide or Halon extinguisher. (NTP, 1992)

5.2Specific hazards arising from the chemical

Flash point data for this compound are not available. It is probably nonflammable. (NTP, 1992)

5.3Special protective actions for fire-fighters

Wear self-contained breathing apparatus for firefighting if necessary.

SECTION 6: Accidental release measures

6.1Personal 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.

6.2Environmental 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.

6.3Methods and materials for containment and cleaning up

PRECAUTIONS FOR ANTINEOPLASTIC AGENTS:/ Spill kits containing all materials needed to clean up spills of hazardous drugs should be assembled or purchased. These kits should be readily available in all areas where hazardous drugs are routinely handled. If hazardous drugs are being prepared or administered in a nonroutine area (home setting or unusual patient-care area), a spill kit should be obtained by the drug handler. The kit should include two pairs of disposable gloves (one outer pair of utility gloves and one inner latex pair); low-permeability, disposable protective garments (coveralls or gown and shoe covers); safety glasses or splash goggles; respirator; absorbent, plastic-backed sheets or spill pads; disposable toweling; at least 2 sealable thick plastic hazardous waste disposal bags (prelabeled with an appropriate warning label); a disposable scoop for collecting glass fragments; and a puncture-resistant container for glass fragments. All individuals who routinely handle hazardous drugs must be trained in proper spill management and cleanup procedures. Spills and breakages must be cleaned up immediately according to the following procedures. If the spill is not located in a confined space, the spill area should be identified and other people should be prevented from approaching and spreading the contamination. Wearing protective apparel from the spill kit, workers should remove any broken glass fragments and place them in the puncture-resistant container. Liquids should be absorbed with a spill pad; powder should be removed with damp disposable gauze pads or soft toweling. The hazardous material should be completely removed and the area rinsed with water and then cleaned with detergent. The spill cleanup should proceed progressively from areas of lesser to greater contamination. The detergent should be thoroughly rinsed and removed. All contaminated materials should be placed in the disposal bags provided and sealed and transported to a designated containment receptacle. Spills occurring in the biohazard cabinet should be cleaned up immediately; a spill kit should be used if the volume exceeds 150 ml or the contents of one drug vial or ampule. If there is broken glass, utility gloves should be worn to remove it and place it in the puncture-resistant container located in the biohazard cabinet. The biological safety cabinet, including the drain spillage trough, should be thoroughly cleaned. If the spill is not easily and thoroughly contained, the biological safety cabinet should be decontaminated after cleanup. If the spill contaminates the high efficiency particulate air filter, use of the biological safety cabinet should be suspended until the cabinet has been decontaminated and the high efficiency particulate air filter replaced. Antineoplastic agents

SECTION 7: Handling and storage

7.1Precautions 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.

7.2Conditions for safe storage, including any incompatibilities

Store the container tightly closed in a dry, cool and well-ventilated place. Store apart from foodstuff containers or incompatible materials.

SECTION 8: Exposure controls/personal protection

8.1Control parameters

Occupational Exposure limit values

no data available

Biological limit values

no data available

8.2Appropriate engineering controls

Ensure adequate ventilation. Handle in accordance with good industrial hygiene and safety practice. Set up emergency exits and the risk-elimination area.

8.3Individual 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	PHYSICAL DESCRIPTION: Colorless or yellowish powder. Possible bluish color depending on copper content. (NTP, 1992)
Colour	Colorless to yellow powder
Odour	no data available
Melting point/freezing point	-1°C(lit.)
Boiling point or initial boiling point and boiling range	156°C
Flammability	no data available
Lower and upper explosion limit/flammability limit	no data available
Flash point	51°C(lit.)
Auto-ignition temperature	no data available
Decomposition temperature	no data available
pH	no data available
Kinematic viscosity	no data available
Solubility	Soluble (NTP, 1992)
Partition coefficient n-octanol/water	no data available
Vapour pressure	no data available
Density and/or relative density	no data available
Relative vapour density	no data available
Particle characteristics	no data available

SECTION 10: Stability and reactivity

10.1Reactivity

no data available

10.2Chemical stability

In vitro, bleomycin is inactivated by agents containing sulfhydryl groups, hydrogen peroxide, and ascorbic acid. Bleomycin sulfate sterile powder is stable under refrigeration at 2-8 deg C and should not be used after the expiration date is reached.

10.3Possibility of hazardous reactions

no data available

10.4Conditions to avoid

no data available

10.5Incompatible materials

no data available

10.6Hazardous decomposition products

no data available

SECTION 11: Toxicological information

Acute toxicity

• Oral: no data available
• 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

Evaluation: There is limited evidence in humans for the carcinogenicity of etoposide. There is sufficient evidence in humans for the carcinogenicity of etoposide given in combination with cisplatin and bleomycin. There is inadequate evidence in experimental animals for the carcinogenicity of etoposide. Overall evaluation: Etoposide is probably carcinogenic to humans (Group 2A). In reaching this evaluation, the Working Group noted that etoposide causes distinctive cytogenetic lesions in leukemic cells that can be readily distinguished from those induced by alkylating agents. The short latency of these leukemias contrasts with that of leukemia induced by alkylating agents. Potent protein masked DNA breakage and clastogenic effects occur in human cells in vitro and animal cells in vivo. Etoposide in combination with cisplatin or bleomycin is carcinogenic to humans. Etoposide in combination with cisplatin or bleomycin

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

12.1Toxicity

• Toxicity to fish: no data available
• Toxicity to daphnia and other aquatic invertebrates: no data available
• Toxicity to algae: no data available
• Toxicity to microorganisms: no data available

12.2Persistence and degradability

no data available

12.3Bioaccumulative potential

no data available

12.4Mobility in soil

no data available

12.5Other adverse effects

no data available

SECTION 13: Disposal considerations

13.1Disposal 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

14.1UN Number

ADR/RID: UN2514 (For reference only, please check.)

IMDG: UN2514 (For reference only, please check.)

IATA: UN2514 (For reference only, please check.)

14.2UN Proper Shipping Name

ADR/RID: BROMOBENZENE (For reference only, please check.)

IMDG: BROMOBENZENE (For reference only, please check.)

IATA: BROMOBENZENE (For reference only, please check.)

14.3Transport hazard class(es)

ADR/RID: 3 (For reference only, please check.)

IMDG: 3 (For reference only, please check.)

IATA: 3 (For reference only, please check.)

14.4Packing group, if applicable

ADR/RID: III (For reference only, please check.)

IMDG: III (For reference only, please check.)

IATA: III (For reference only, please check.)

14.5Environmental hazards

ADR/RID: No

IMDG: No

IATA: No

14.6Special precautions for user

no data available

14.7Transport in bulk according to IMO instruments

no data available

SECTION 15: Regulatory information

15.1Safety, health and environmental regulations specific for the product in question

Chemical name	Common names and synonyms	CAS number	EC number
Bleomycin, sulfate (salt)	Bleomycin, sulfate (salt)	9041-93-4	232-925-2
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)			Not 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

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