SIGMA-ALDRICH Material Safety Data Sheet Date Printed: 09/OCT/2003 Date Updated: 15/MAY/2002 Version 1.1 According to 91/155/EEC 1 - Product and Company Information Product Name MELPHALAN Product Number 63648 Company Sigma-Aldrich Chemie GmbH Riedstrasse 2 89555 Steinheim Germany Technical Phone # 49-89-6513(0)-1444 Fax 49-7329-97-2319 Emergency Phone # 49 7329 97 2323 2 - Composition/Information on Ingredients Product Name CAS # EC no MELPHALAN 148-82-3 205-726-3 Formula C13H18Cl2N2O2 Molecular Weight 305.2 AMU Synonyms Alanine nitrogen mustard,Alkeran, L-3-(p-(Bis(2-chloroethyl)amino)phenyl)alanine, p-Bis(beta-chloroethyl)aminophenylalanine, p-N-Bis(2-chloroethyl)amino-L-phenylalanine, 3-(p-(Bis(2-chloroethyl)amino)phenyl)-L-alanine, 4-(Bis(2-chloroethyl)amino)-L-phenylalanine, CB 3025,3025 C.B., p-Di-(2-chloroethyl)amino-L-phenylalanine, p-N-Di(chloroethyl)aminophenylalanine, 3-p-(Di(2-chloroethyl)amino)-phenyl-L-alanine, Levofalan,Melfalan,Melphalan,NCI-C04853,L-PAM, L-Phenylalanine, 4-(bis(2-chloroethyl)amino)-, Phenylalanine mustard,L-Phenylalanine mustard, Phenylalanine nitrogen mustard, RCRA waste number U150,L-Sarcolysin, p-L-Sarcolysin,L-Sarcolysine,L-Sarkolysin, SK-15673 3 - Hazards Identification SPECIAL INDICATION OF HAZARDS TO HUMANS AND THE ENVIRONMENT May cause cancer. May cause heritable genetic damage. Very toxic by inhalation, in contact with skin and if swallowed. Possible risk of harm to the unborn child. 4 - First Aid Measures AFTER INHALATION If inhaled, remove to fresh air. If breathing becomes difficult, call a physician. AFTER SKIN CONTACT In case of skin contact, flush with copious amounts of water for at least 15 minutes. Remove contaminated clothing and shoes. Call a physician. AFTER EYE CONTACT In case of contact with eyes, flush with copious amounts of water for at least 15 minutes. Assure adequate flushing by separating the eyelids with fingers. Call a physician. AFTER INGESTION If swallowed, wash out mouth with water provided person is conscious. Call a physician. 5 - Fire Fighting Measures EXTINGUISHING MEDIA Suitable: Carbon dioxide, dry chemical powder, or appropriate foam. SPECIAL PROTECTIVE EQUIPMENT FOR FIREFIGHTERS Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. 6 - Accidental Release Measures PROCEDURE(S) OF PERSONAL PRECAUTION(S) Wear self-contained breathing apparatus, rubber boots, and heavy rubber gloves. METHODS FOR CLEANING UP Sweep up, place in a bag and hold for waste disposal. Avoid raising dust. Ventilate area and wash spill site after material pickup is complete. 7 - Handling and Storage 8 - Exposure Controls / Personal Protection ENGINEERING CONTROLS Use only in a chemical fume hood. PERSONAL PROTECTIVE EQUIPMENT Respiratory Protection: Government approved respirator. Hand Protection: Compatible chemical-resistant gloves. Eye Protection: Chemical safety goggles. 9 - Physical and Chemical Properties Appearance Color: Very faintly beige Form: Powder Property Value At Temperature or Pressure pH N/A BP/BP Range N/A MP/MP Range 180 °C Flash Point N/A Flammability N/A Autoignition Temp N/A Oxidizing Properties N/A Explosive Properties N/A FLUKA - 63648 www.sigma-aldrich.com Page 2 Explosion Limits N/A Vapor Pressure N/A Partition Coefficient N/A Viscosity N/A Vapor Density N/A Saturated Vapor Conc. N/A Evaporation Rate N/A Bulk Density N/A Decomposition Temp. N/A Solvent Content N/A Water Content < 10 % Surface Tension N/A Conductivity N/A Miscellaneous Data N/A Solubility N/A 10 - Stability and Reactivity STABILITY Stable: Stable. Conditions of Instability: Protect from light. HAZARDOUS DECOMPOSITION PRODUCTS Hazardous Decomposition Products: Carbon monoxide, Carbon dioxide, Nitrogen oxides. HAZARDOUS POLYMERIZATION Hazardous Polymerization: Will not occur 11 - Toxicological Information RTECS NUMBER: AY3675000 ACUTE TOXICITY LDLO Intravenous Child 4500 MG/KG Remarks: Behavioral:Anorexia (human). Gastrointestinal:Hypermotility, diarrhea. Blood:Agranulocytosis. LDLO Intravenous Man 8140 MG/KG Remarks: Behavioral:Anorexia (human). Gastrointestinal:Hypermotility, diarrhea. Blood:Agranulocytosis. LD50 Oral Rat 11.2 mg/kg LD50 Intraperitoneal Rat 4484 UG/KG LD50 Intravenous Rat FLUKA - 63648 www.sigma-aldrich.com Page 3 4100 UG/KG LD50 Intracerebral Rat 200 UG/KG LD50 Intravenous Mouse 20800 UG/KG Remarks: Behavioral:Somnolence (general depressed activity). Blood:Other changes. Nutritional and Gross Metabolic:Weight loss or decreased weight gain. LD50 Parenteral Mouse 6 MG/KG IRRITATION DATA Skin Rabbit 5 mg 24H Remarks: Rinsed Skin Rabbit 0.0001 ppm 24H Remarks: Mild irritation effect SENSITIZATION Sensitization: May cause allergic reactions and pulmonary toxicity ROUTE OF EXPOSURE Multiple Routes: May be fatal if inhaled, swallowed, or absorbed through skin. TARGET ORGAN INFORMATION Bone marrow. Reproductive system. CONDITIONS AGGRAVATED BY EXPOSURE The toxicological properties have not been thoroughly investigated. CHRONIC EXPOSURE - CARCINOGEN Result: Carcinogen. Woman Route of Application: Oral Exposure Time: D Result: Tumorigenic:Carcinogenic by RTECS criteria. Blood:Other changes. Blood:Lymphomas including Hodgkin's disease. Man Route of Application: Oral Exposure Time: D Result: Tumorigenic:Carcinogenic by RTECS criteria. Blood:Other FLUKA - 63648 www.sigma-aldrich.com Page 4 changes. Blood:Lymphomas including Hodgkin's disease. Woman Route of Application: Unreported Exposure Time: 2Y Result: Tumorigenic:Carcinogenic by RTECS criteria. Blood:Tumors. Rat Route of Application: Intraperitoneal Exposure Time: 26W Result: Tumorigenic:Neoplastic by RTECS criteria. Tumorigenic:Tumors at site or application. Mouse Route of Application: Skin Exposure Time: 9W Result: Tumorigenic:Equivocal tumorigenic agent by RTECS criteria. Lungs, Thorax, or Respiration:Tumors. Skin and Appendages: Other: Tumors. Mouse Route of Application: Intraperitoneal Exposure Time: 26W Result: Tumorigenic:Carcinogenic by RTECS criteria. Lungs, Thorax, or Respiration:Tumors. Blood:Lymphomas including Hodgkin's disease. Mouse Route of Application: Intraperitoneal Exposure Time: 6W Result: Tumorigenic:Neoplastic by RTECS criteria. Skin and Appendages: Other: Tumors. Man Route of Application: Oral Exposure Time: 4Y Result: Tumorigenic:Carcinogenic by RTECS criteria. Blood:Leukemia Man Route of Application: Oral Exposure Time: 2Y Result: Tumorigenic:Carcinogenic by RTECS criteria. Blood:Leukemia Woman Route of Application: Oral Exposure Time: 3Y Result: Tumorigenic:Carcinogenic by RTECS criteria. Blood:Leukemia Woman Route of Application: Oral Exposure Time: 2Y Result: Tumorigenic:Carcinogenic by RTECS criteria. Blood:Leukemia Man Route of Application: Oral Exposure Time: 4Y Result: Tumorigenic:Carcinogenic by RTECS criteria. Blood:Leukemia FLUKA - 63648 www.sigma-aldrich.com Page 5 IARC CARCINOGEN LIST Rating: Group 1 CHRONIC EXPOSURE - MUTAGEN Human 10 UMOL/L Cell Type: Other cell types DNA damage Human 1 MG/L 1H Cell Type: lymphocyte DNA damage Human 10 UMOL/L Cell Type: Other cell types DNA damage Human 10 UMOL/L Cell Type: lung DNA damage Human 5 UMOL/L Cell Type: lymphocyte DNA damage Human 800 UG/L Cell Type: fibroblast Unscheduled DNA synthesis Human 10 UMOL/L Cell Type: Other cell types Unscheduled DNA synthesis Human 10 UMOL/L Cell Type: leukocyte Unscheduled DNA synthesis Human 10 UMOL/L Cell Type: Bone marrow Unscheduled DNA synthesis Human 25 UMOL/L Cell Type: lymphocyte DNA inhibition Human 4 MG/L Cell Type: Other cell types DNA inhibition FLUKA - 63648 www.sigma-aldrich.com Page 6 Human 10 UMOL/L Cell Type: leukocyte Other mutation test systems Human 1 MMOL/L Cell Type: Other cell types Other mutation test systems Human 150 UG/L Cell Type: lymphocyte Other mutation test systems Human 1 MG/L Cell Type: Other cell types Cytogenetic analysis Human 500 UG/L Cell Type: lymphocyte Cytogenetic analysis Human 400 NMOL/L Cell Type: Other cell types Sister chromatid exchange Human 1 UMOL/L Cell Type: lymphocyte Sister chromatid exchange Human 1 UMOL/L Cell Type: fibroblast Sister chromatid exchange Human 100 UG/L Cell Type: lymphocyte Sister chromatid exchange Rat 160 NMOL/L Cell Type: Other cell types DNA inhibition Mouse 1250 UG/KG Intraperitoneal Micronucleus test Mouse 100 UG/L (+S9) Cell Type: lymphocyte Mutation in microorganisms Mouse FLUKA - 63648 www.sigma-aldrich.com Page 7 5 MG/KG Intraperitoneal specific locus test Mouse 100 UG/L Cell Type: Embryo Morphological transformation. Mouse 40 UMOL/L Cell Type: Other cell types DNA damage Mouse 2 MG/KG Unreported DNA damage Mouse 40 MG/KG Intraperitoneal DNA damage Mouse 37600 NMOL/KG Unreported Unscheduled DNA synthesis Mouse 37700 NMOL/KG Intraperitoneal DNA inhibition Mouse 2 MG/L Cell Type: lymphocyte DNA inhibition Mouse 2 UMOL/L Cell Type: Other cell types Sister chromatid exchange Mouse 1500 UG/KG Intraperitoneal Sister chromatid exchange Mouse 7500 UG/KG Intraperitoneal Dominant lethal test Mouse 100 UG/L Cell Type: lymphocyte Mutation in mammalian somatic cells. Mouse 7500 UG/KG Intraperitoneal FLUKA - 63648 www.sigma-aldrich.com Page 8 Heritable translocation test Hamster 1 MG/L Cell Type: lung DNA damage Hamster 3 MG/L Cell Type: ovary DNA damage Hamster 1 MG/L Cell Type: Embryo Cytogenetic analysis Hamster 5 UG/L Cell Type: fibroblast Sister chromatid exchange Mammal 2500 NMOL/L Cell Type: lymphocyte DNA damage CHRONIC EXPOSURE - REPRODUCTIVE HAZARD Result: Overexposure may cause reproductive disorder(s) based on tests with laboratory animals. Species: Woman Dose: 3750 UG/KG Route of Application: Oral Exposure Time: (25D PRE) Result: Maternal Effects: Menstrual cycle changes or disorders. Species: Child Dose: 8800 UG/KG Route of Application: Unreported Exposure Time: (1D PRE) Result: Maternal Effects: Ovaries, fallopian tubes. Maternal Effects: Other effects. Species: Woman Dose: 5946 UG/KG Route of Application: Unreported Exposure Time: (1D PRE) Result: Maternal Effects: Menstrual cycle changes or disorders. 12 - Ecological Information No data available. 13 - Disposal Considerations SUBSTANCE DISPOSAL Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all federal, state, and local environmental regulations. FLUKA - 63648 www.sigma-aldrich.com Page 9 14 - Transport Information RID/ADR UN#: 2811 Class: 6.1 PG: II Proper Shipping Name: Toxic solid, organic, n.o.s. IMDG UN#: 2811 Class: 6.1 PG: II EmS Number: 6.1-04 MFAG Number: 999 Proper Shipping Name: Toxic solid, organic, n.o.s. Marine Pollutant: No Severe Marine Pollutant: No Technical Name: X IATA UN#: 2811 Class: 6.1 PG: II Proper Shipping Name: Toxic solid, organic, n.o.s. Inhalation Packing Group I: No Technical Name: X 15 - Regulatory Information CLASSIFICATION AND LABELING ACCORDING TO EU DIRECTIVES INDICATION OF DANGER: T+ Very toxic. R-PHRASES: 45 46 26/27/28 63 May cause cancer. May cause heritable genetic damage. Very toxic by inhalation, in contact with skin and if swallowed. Possible risk of harm to the unborn child. S-PHRASES: 53 22 36/37/39 45 Avoid exposure - obtain special instructions before use. Do not breathe dust. Wear suitable protective clothing, gloves, and eye/face protection. In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). SWITZERLAND SWISS POISON CLASS: 1 16 - Other Information WARRANTY The above information is believed to be correct but does not purport to be all inclusive and shall be used only as a guide. Sigma-Aldrich Inc., shall not be held liable for any damage resulting from handling or from contact with the above product. See reverse side of invoice or packing slip for additional terms and conditions of sale. Copyright 2003 Sigma-Aldrich Co. License granted to make unlimited paper copies for internal use only. DISCLAIMER For R&D use only. Not for drug, household or other uses. FLUKA - 63648 www.sigma-aldrich.com Page 10