1.Identification

1.1 GHS Product identifier

1.2 Other means of identification

1.3 Recommended use of the chemical and restrictions on use

1.4 Supplier's details

1.5 Emergency phone number

2.Hazard identification

2.1 Classification of the substance or mixture

Acute toxicity - Oral, Category 3

Germ cell mutagenicity, Category 1B

Carcinogenicity, Category 1B

Reproductive toxicity, Category 1A

2.2 GHS label elements, including precautionary statements

Pictogram(s)
Signal word	Danger
Hazard statement(s)	H301 Toxic if swallowed H340 May cause genetic defects H350 May cause cancer H360 May damage fertility or the unborn child
Precautionary statement(s)
Prevention	P264 Wash ... thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P280 Wear protective gloves/protective clothing/eye protection/face protection.
Response	P301+P310 IF SWALLOWED: Immediately call a POISON CENTER/doctor/… P321 Specific treatment (see ... on this label). P330 Rinse mouth. P308+P313 IF exposed or concerned: Get medical advice/ attention.
Storage	P405 Store locked up.
Disposal	P501 Dispose of contents/container to ...

2.3 Other hazards which do not result in classification

none

3.Composition/information on ingredients

3.1 Substances

4.First-aid measures

4.1 Description of necessary first-aid measures

General advice

Consult a physician. Show this safety data sheet to the doctor in attendance.

If inhaled

Fresh air, rest. Refer for medical attention.

In case of skin contact

Remove contaminated clothes. Rinse skin with plenty of water or shower. Refer for medical attention .

In case of eye contact

First rinse with plenty of water for several minutes (remove contact lenses if easily possible), then refer for medical attention.

If swallowed

Rinse mouth. Induce vomiting (ONLY IN CONSCIOUS PERSONS!). Refer for medical attention .

4.2 Most important symptoms/effects, acute and delayed

SYMPTOMS: Symptoms of exposure to this compound may include nausea, vomiting, leukopenia, thrombocytopenia, alopecia and anorexia. Other symptoms may include pigmentation of the skin, oral mucosal ulcerations and sterile hemorrhagic cystitis. It can cause non-specific dermatitis, pigmentation of the nails, regrowth of hair, anemia, hematuria, fibrosis of the ovaries, gonadal suppression resulting in amenorrhea or azoospermia, hemorrhagic colitis and jaundice. It can also cause damage to the hair follicles, dizziness of short duration, transverse ridging of the nails and hepatic toxicity. Secondary neoplasia and nephrotoxicity have been reported. Other symptoms may include irritation of the skin, gastrointestinal disturbances and hepatic dysfunction. High doses over a prolonged period can cause interstitial pulmonary fibrosis. Other symptoms of exposure may include granulocytopenia, myocardial damage, interstitial pneumonia and hypoplasia of all elements of bone marrow. It has been known to cause blurred vision, pulmonary fibrosis, cardiomyopathy and sterility. Fetal abnormalities can occur if ingested while pregnant. Eye contact can cause transient blurring of vision, dry eye syndrome, viral and other keratitis and severe keratoconjunctivitis associated with graft-versus-host disease leading to scarring of the corneas. It may also cause lymphocytopenia. ACUTE/CHRONIC HAZARDS: This compound is a skin irritant. When heated to decomposition it emits highly toxic fumes of POx, NOx and chloride ion.

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

Basic treatment: Establish a patent airway. Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if needed. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for pulmonary edema and treat if necessary ... . Monitor for shock and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with normal saline during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 ml/kg up to 200 ml of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool ... . Cover skin burns with dry sterile dressings after decontamination ... . /Poison A and B/

5.Fire-fighting measures

5.1 Extinguishing media

Suitable extinguishing media

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

5.2 Specific hazards arising from the chemical

Flash point data for this chemical are not available; however, it is probably combustible.

5.3 Special protective actions for fire-fighters

Wear self-contained breathing apparatus for firefighting if necessary.

6.Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures

Use personal protective equipment. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust. For personal protection see section 8.

6.2 Environmental precautions

Consult an expert! Personal protection: particulate filter respirator adapted to the airborne concentration of the substance. Sweep spilled substance into covered sealable containers. If appropriate, moisten first to prevent dusting. Carefully collect remainder. Then store and dispose of according to local regulations.

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 available 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/

7.Handling and storage

7.1 Precautions for safe handling

Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Avoid exposure - obtain special instructions before use.Provide appropriate exhaust ventilation at places where dust is formed. For precautions see section 2.2.

7.2 Conditions for safe storage, including any incompatibilities

Separated from food and feedstuffs. See Chemical Dangers. Dry. Keep in the dark. Well closed.Cyclophosphamide should be preserved in tight containers, at a temperature between 2 & 32°C.

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

Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday.

8.3 Individual protection measures, such as personal protective equipment (PPE)

Eye/face protection

Safety glasses with side-shields conforming to EN166. Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).

Skin protection

Wear impervious clothing. The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace. Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique(without touching glove's outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. 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

Wear dust mask when handling large quantities.

Thermal hazards

no data available

9.Physical and chemical properties

10.Stability and reactivity

10.1 Reactivity

no data available

10.2 Chemical stability

AQ SOLN KEEPS FOR A FEW HR @ ROOM TEMP, BUT HYDROLYSIS OCCURS ABOVE 30 DEG C, REMOVES CHLORINE ATOMS; DARKENS ON EXPOSURE TO LIGHT /MONOHYDRATE/

10.3 Possibility of hazardous reactions

CYCLOPHOSPHAMIDE is sensitive to exposure to light (darkens). Also sensitive to oxidation. Aqueous solutions may be kept for a few hours at room temperature, but hydrolysis occurs at temperatures above 30°C. Solutions in DMSO, 95% ethanol or acetone are stable for 24 hours under normal lab conditions. Incompatible with benzyl alcohol. Undergoes both acid and base hydrolysis at extreme pHs

10.4 Conditions to avoid

no data available

10.5 Incompatible materials

/It was/ reported that immersion of a needle with an aluminum component in cyclophosphamide 20 mg/ml resulted in a slight darkening of the aluminum & gas production after a few days at 24°C with protection from light.

10.6 Hazardous decomposition products

When heated to decomposition it emits highly toxic fumes of /phosphorus oxides, nitrogen oxides, & hydrogen chloride/.

11.Toxicological information

Acute toxicity

• Oral: LD50 Rat oral 160 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

Classification of carcinogenicity: 1) evidence in humans: sufficient; 2) evidence in animals: sufficient. Overall summary evaluation of carcinogenic risk to humans is Group 1: The agent is carcinogenic to humans. /From table/

Reproductive toxicity

no data available

STOT-single exposure

no data available

STOT-repeated exposure

no data available

Aspiration hazard

no data available

12.Ecological information

12.1 Toxicity

• 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

12.2 Persistence and degradability

AEROBIC: Cyclophosphamide has been shown to be non-biodegradable in a laboratory-scale sewage treatment studies(1-3). During 29 days of 10 ug/l compound addition, a mean effluent recovery of 83% was established(2). Cyclophosphamide, present at 160 mg/l, indicated no DOC elimination in four weeks using an activated sludge inoculum at 0.2 g/l and the Zahn-Wellens test(2). The compound is confirmed to be non-biodegradable according to the OECD confirmatory test using both single compound and compound mixtures run from a period of 10-14 days at concentrations ranging from 150 to 750 mg/l and that employs a sewage sludge inoculum(3).

12.3 Bioaccumulative potential

An estimated BCF of 3 was calculated for cyclophosphamide(SRC), using a log Kow of 0.63(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

The Koc of cyclophosphamide is estimated as 52(SRC), using a log Kow of 0.63(1) and a regression-derived equation(2). According to a classification scheme(3), this estimated Koc value suggests that cyclophosphamide is expected to have high mobility in soil.

12.5 Other adverse effects

no data available

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.

14.Transport information

14.1 UN Number

14.2 UN Proper Shipping Name

14.3 Transport hazard class(es)

14.4 Packing group, if applicable

14.5 Environmental hazards

14.6 Special precautions for user

no data available

14.7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code

no data available

15.Regulatory information

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

16.Other information

Information on revision

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.