PharmacyCodes

Endoxan-Asta

Material Safety Data Sheet
Cyclophosphamide monohydrate, 97%

ACC# 77640
Section 1 - Chemical Product and Company Identification
MSDS Name: Cyclophosphamide monohydrate, 97%
Catalog Numbers: AC203960000, AC203960010, AC203960050
Synonyms: N,N-Bis(2-chloroethyl)tetrahydro-2H-1,3,2-oxazaphosphorin-2-amine 2-oxide monohydrate; 2-[Bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazophosphorine 2-oxide monohydrate; Cancer research tool.
Company Identification:
              Acros Organics N.V.
              One Reagent Lane
              Fair Lawn, NJ 07410
For information in North America, call: 800-ACROS-01
For emergencies in the US, call CHEMTREC: 800-424-9300

Section 2 - Composition, Information on Ingredients

CAS# Chemical Name Percent EINECS/ELINCS
6055-19-2 Cyclophosphamide monohydrate 97 unlisted

Section 3 - Hazards Identification

EMERGENCY OVERVIEW

Appearance: white to almost white solid.
Danger! Causes eye burns. May cause harm to the unborn child. Harmful if swallowed. May be harmful if absorbed through skin or if inhaled. May cause cancer in humans.
Target Organs: Eyes, bone marrow, reproductive system, bladder.


Potential Health Effects
Eye: Causes severe eye irritation and possible injury.
Skin: May cause skin irritation. May be harmful if absorbed through the skin.
Ingestion: May cause irritation of the digestive tract. Poison by ingestion. May cause nausea and vomiting.
Inhalation: May cause respiratory tract irritation. May be harmful if inhaled. May cause nausea and possible vomiting.
Chronic: May cause cancer in humans. May cause reproductive and fetal effects. In case of a therapeutical use of the product, typical side effects are: myelosuppression (suppression of bone marrow activity resulting in reduction in the number of platelets, red cells, and white cells), gastrointestinal complaints, cystitis (inflammation of the urinary bladder), hair loss, disorders of spermatogenesis or ovulation.

Section 4 - First Aid Measures


Eyes: Immediately flush eyes with plenty of water for at least 15 minutes, occasionally lifting the upper and lower eyelids. Get medical aid imme diately.
Skin: Get medical aid immediately. Immediately flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes.
Ingestion: Get medical aid immediately. Wash mouth out with water.
Inhalation: Get medical aid immediately. Remove from exposure and move to fresh air immediately. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
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. Will burn if involved in a fire. This material in sufficient quantity and reduced particle size is capable of creating a dust explosion.
Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or chemical foam.
Flash Point: > 112 deg C (> 233.60 deg F)
Autoignition Temperature: Not available.
Explosion Limits, Lower:Not available.
Upper: Not available.
NFPA Rating: (estimated) Health: 3; Flammability: 1; Instability: 1

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. 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. Take precautionary measures against static discharges. Do not breathe dust. Use only with adequate ventilation.
Storage: Store in a cool, dry place. Store in a tightly closed container. Keep under an argon blanket.

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
Cyclophosphamide monohydrate none listed none listed none listed
Cyclophosphamide (anhydrous form) none listed none listed none listed

OSHA Vacated PELs: Cyclophosphamide monohydrate: No OSHA Vacated PELs are listed for this chemical. Cyclophosphamide (anhydrous form): 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: Follow the OSHA respirator regulations found in 29 CFR 1910.134 or European Standard EN 149. Use a NIOSH/MSHA or European Standard EN 149 approved respirator if exposure limits are exceeded or if irritation or other symptoms are experienced.

Section 9 - Physical and Chemical Properties


Physical State: Solid
Appearance: white to almost white
Odor: odorless
pH: 4 - 6 (2% aq soln)
Vapor Pressure: 0.000033 HPa @ 20 deg C
Vapor Density: Not available.
Evaporation Rate:Not available.
Viscosity: Not available.
Boiling Point: Not available.
Freezing/Melting Point:49 - 53 deg C
Decomposition Temperature:90 deg C
Solubility: 40 g/l water
Specific Gravity/Density:Not available.
Molecular Formula:C7H15Cl2N2O2P.H2O
Molecular Weight:279.09

Section 10 - Stability and Reactivity


Chemical Stability: Stable at room temperature in closed containers under normal storage and handling conditions. Exothermic decomposition at 90�C (Method VDI 2263).
Conditions to Avoid: Dust generation, excess heat.
Incompatibilities with Other Materials: Strong oxidizing agents, acids, bases.
Hazardous Decomposition Products: Hydrogen chloride, nitrogen oxides, phosphine, carbon monoxide, oxides of phosphorus, carbon dioxide.
Hazardous Polymerization: Has not been reported.

Section 11 - Toxicological Information


RTECS#:      
CAS# 6055-19-2: RP6157750      
CAS# 50-18-0: RP5950000
LD50/LC50:
CAS# 6055-19-2:
     Oral, mouse: LD50 = 350 mg/kg;
     Oral, rat: LD50 = 94 mg/kg;
.

CAS# 50-18-0:
     Oral, mouse: LD50 = 137 mg/kg;
     Oral, rat: LD50 = 100 mg/kg;
.
Primary irritative effect to the eyes: Corrosive, rabbit, OECD 405.
Carcinogenicity:
CAS# 6055-19-2:
  • ACGIH: Not listed.
  • California: carcinogen, initial date 2/27/87
  • NTP: Not listed.
  • IARC: Group 1 carcinogen
CAS# 50-18-0:
  • ACGIH: Not listed.
  • California: carcinogen, initial date 2/27/87
  • NTP: Known carcinogen
  • IARC: Group 1 carcinogen

Epidemiology: No data available.
Teratogenicity: No data available.
Reproductive Effects: No data available.
Mutagenicity: No data available.
Neurotoxicity: No data available.
Other Studies:

Section 12 - Ecological Information


Ecotoxicity: No data available. No information available.
Environmental: Degradation (28 days) <1%, not easily biodegradable, OECD 301 E.
Physical: No information available.
Other: 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:
CAS# 50-18-0: waste number U058.

Section 14 - Transport Information

US DOT Canada TDG
Shipping Name: DOT regulated - small quantity provisions apply (see 49CFR173.4) TOXIC SOLID, ORGANIC, N.O.S.
Hazard Class: 6.1
UN Number: UN2811
Packing Group: III

Section 15 - Regulatory Information

US FEDERAL
TSCA
     CAS# 6055-19-2 is not listed on the TSCA inventory. It is for research and development use only.
     CAS# 50-18-0 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
     CAS# 50-18-0: 10 lb final RQ; 4.54 kg final RQ
SARA Section 302 Extremely Hazardous Substances
     None of the chemicals in this product have a TPQ.
SARA Codes
     CAS # 6055-19-2: immediate, 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# 6055-19-2 can be found on the following state right to know lists: California.
     CAS# 50-18-0 can be found on the following state right to know lists: California, New Jersey, Pennsylvania, Minnesota, Massachusetts.

California Prop 65
The following statement(s) is(are) made in order to comply with the California Safe Drinking Water Act:
WARNING: This product contains Cyclophosphamide monohydrate, a chemical known to the state of California to cause cancer. WARNING: This product contains Cyclophosphamide monohydrate, a chemical known to the state of California to cause male reproductive toxicity. WARNING: This product contains Cyclophosphamide (anhydrous fo, a chemical known to the state of California to cause cancer. WARNING: This product contains Cyclophosphamide (anhydrous fo, a chemical known to the state of California to cause male reproductive toxicity.
California No Significant Risk Level: CAS# 6055-19-2: 1 �g/day NSRL CAS# 50-18-0: 1 �g/day NSRL

European/International Regulations
European Labeling in Accordance with EC Directives
Hazard Symbols:
     T
Risk Phrases:
     R 25 Toxic if swallowed.
     R 41 Risk of serious damage to eyes.
     R 45 May cause cancer.
     R 46 May cause heritable genetic damage.
     R 48/23/24/25 Toxic : danger of serious damage to health by
     prolonged exposure through inhalation, contact with skin and if
     swallowed.
     R 61 May cause harm to the unborn child.

Safety Phrases:
     S 15 Keep away from heat.
     S 26 In case of contact with eyes, rinse immediately with plenty of
     water and seek medical advice.
     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# 6055-19-2: 3
     CAS# 50-18-0: No information available.
Canada - DSL/NDSL
     CAS# 50-18-0 is listed on Canada's DSL List.
Canada - WHMIS
     This product has a WHMIS classification of D2A, D1B.
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: 1/18/2000
Revision #4 Date: 10/03/2005

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.