Material Safety Data Sheet
Material Name: Melphalan Hydrochloride for Injection
* * * Section 1 - Chemical Product and Company Identification * * *
Manufacturer Information
Bioniche Pharma Phone: 888-258-4199
272 E Deerpath Road
Suite 304 Emergency # 888-875-1671
Lake Forest, IL 60045
* * * Section 2 - Hazards Identification * * *
Emergency Overview
Very toxic: danger of very serious irreversible effects if swallowed. May also have serious irreversible effects
through skin contact or inhalation.
Potential Health Effects: Eyes
Risk of serious damage to eyes
Potential Health Effects: Skin
Harmful: danger of serious damage to health by prolonged skin contact.
Potential Health Effects: Ingestion
Very toxic: danger of very serious irreversible effects if swallowed.
Potential Health Effects: Inhalation
Possible risk of irreversible effects through inhalation.
HMIS Ratings: Health: 2 Fire: 0 HMIS Reactivity 0
Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate 3 = Serious 4 = Severe * = Chronic hazard
* * * Section 3 - Composition / Information on Ingredients * * *
CAS # Component
3223-07-2 4-[Bis(2-chloroethyl)amino]-L-phenylalanine hydrochloride; p-di(2-chloroethyl)amino-L-phenylalanine
hydrochloride; L-phenylalanine mustard hydrochloride; alanine nitrogen mustard hydrochloride.
68-04-2 Sodium citrate
64-17-5 Ethyl alcohol
57-55-6 1,2-Propylene glycol
7732-18-5 Water
* * * Section 4 - First Aid Measures * * *
First Aid: Eyes
Flush eye(s) immediately with plenty of water. Rinse immediately with plenty of water, also under the eyelids, for
at least 15 minutes.
First Aid: Skin
Rinse immediately with plenty of water for at least 15 minutes.
First Aid: Ingestion
Call a physician immediately. Do not induce vomiting without medical advice. Never give anything by mouth to an
unconscious person. Drink 1 or 2 glasses of water. Induce vomiting, but only if victim is fully conscious. Induce
vomiting if person is conscious.
First Aid: Inhalation
Move to fresh air. Call a physician immediately.
* * * Section 5 - Fire Fighting Measures * * *
General Fire Hazards
See Section 9 for Flammability Properties.
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Material Safety Data Sheet
Material Name: Melphalan Hydrochloride for Injection
Burning produces irritant fumes.
Hazardous Combustion Products
Fumes of unknown toxicity
Extinguishing Media
Use dry powder, CO2, water spray or alcohol foam.
Fire Fighting Equipment/Instructions
As in any fire, wear self-contained breathing apparatus pressure-demand, MSHA/NIOSH (approved or equivalent)
and full protective gear. Water mist may be used to cool closed containers.
NFPA Ratings: Health: 2 Fire: 0 Reactivity: 0
Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate 3 = Serious 4 = Severe
* * * Section 6 - Accidental Release Measures * * *
Containment Procedures
Prevent product from entering drains.
Clean-Up Procedures
Sweep up and shovel into suitable containers for disposal.
Evacuation Procedures
Isolate area. Keep unnecessary personnel away.
Special Procedures
Wear appropriate personal protective equipment.
* * * Section 7 - Handling and Storage * * *
Handling Procedures
Wear personal protective equipment. Remove and wash contaminated clothing before reuse.
Storage Procedures
Store at 20-25癈 (68-77癈). Keep container tightly closed in a dry and well ventilated place.
* * * Section 8 - Exposure Controls / Personal Protection * * *
A: Component Exposure Limits
Ethyl alcohol (64-17-5)
ACGIH: 1000 ppm TWA
OSHA: 1000 ppm TWA; 1900 mg/m3 TWA
NIOSH: 1000 ppm TWA; 1900 mg/m3 TWA
Engineering Controls
Ensure adequate ventilation, especially in confined areas.
PERSONAL PROTECTIVE EQUIPMENT
Personal Protective Equipment: Eyes/Face
Safety glasses with side-shields
Personal Protective Equipment: Skin
PVC or other plastic material gloves
Personal Protective Equipment: Respiratory
Breathing apparatus only if aerosol or dust is formed.
Personal Protective Equipment: General
Eye wash fountain is recommended.
* * * Section 9 - Physical & Chemical Properties * * *
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Material Safety Data Sheet
Material Name: Melphalan Hydrochloride for Injection
Appearance: Odor:
White/off-white None
Physical State: pH:
Lyophilized powder NA
Vapor Pressure: Vapor Density:
ND ND
Boiling Point: Melting Point:
ND NA
Solubility (H2O): Specific Gravity:
Practically insoluble ND
Evaporation Rate: VOC:
ND ND
Octanol/H2O Coeff.: Flash Point:
ND ND
Flash Point Method: Upper Flammability Limit
ND ND
(UFL):
Lower Flammability Limit (LFL): Burning Rate:
ND ND
Auto Ignition: ND
Material Name: Sterile Diluent:
Appearance: Odor:
Clear None
Physical State: pH:
Liquid NA
Vapor Pressure: Vapor Density:
ND ND
Boiling Point: Melting Point:
ND NA
Solubility (H2O): Specific Gravity:
Soluble ND
Evaporation Rate: VOC:
ND ND
Octanol/H2O Coeff.: Flash Point:
ND ND
Flash Point Method: Upper Flammability Limit
ND ND
(UFL):
Lower Flammability Limit (LFL): Burning Rate:
ND ND
Auto Ignition: ND
* * * Section 10 - Chemical Stability & Reactivity Information * * *
Chemical Stability
This is a stable material.
Chemical Stability: Conditions to Avoid
Exposure to air or moisture over prolonged periods.
Incompatibility
Strong oxidizing agents
Hazardous Decomposition
Chloride/Hydrochloric acid, Nitrogen oxides (NOx)/ammonia/CN.
Possibility of Hazardous Reactions
Will not occur.
* * * Section 11 - Toxicological Information * * *
Acute Dose Effects
A: General Product Information
Melphalan Oral LD50 Rat: 11200 g/kg
B: Component Analysis - LD50/LC50
Ethyl alcohol (64-17-5)
Oral LD50 Rat: 7060 mg/kg
1,2-Propylene glycol (57-55-6)
Oral LD50 Rat: 20000 mg/kg; Dermal LD50 Rabbit:20800 mg/kg
Water (7732-18-5)
Oral LD50 Rat: >90 mL/kg
Carcinogenicity
A: General Product Information
Contains material classified as a carcinogen. Human carcinogen (IARC); (NTP). Reproductive and cytotoxic
agent.
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Material Safety Data Sheet
Material Name: Melphalan Hydrochloride for Injection
B: Component Carcinogenicity
Ethyl alcohol (64-17-5)
ACGIH: A4 - Not Classifiable as a Human Carcinogen
IARC: Monograph 96 [2007] (in alcoholic beverages) (Group 1 (carcinogenic to humans))
* * * Section 12 - Ecological Information * * *
Ecotoxicity
A: General Product Information
No information available for the product.
B: Component Analysis - Ecotoxicity - Aquatic Toxicity
Sodium citrate (68-04-2)
Test & Species Conditions
96 Hr LC50 Poecilia reticulata 18000-32000 mg/L
96 Hr EC50 Chlorella vulgaris 1800-3200 mg/L
48 Hr EC50 Daphnia magna 5600 mg/L
Ethyl alcohol (64-17-5)
Test & Species Conditions
96 Hr LC50 Oncorhynchus mykiss 12900 mg/L [flow- 30 days old
through]
96 Hr LC50 Pimephales promelas 14.2 mg/L
48 Hr EC50 Daphnia magna 9268 mg/L
24 Hr EC50 Daphnia magna 10800 mg/L
1,2-Propylene glycol (57-55-6)
Test & Species Conditions
96 Hr LC50 Oncorhynchus mykiss 51600 mg/L [static]
96 Hr LC50 Pimephales promelas 51400 mg/L[ static ]
96 Hr EC50 Selenastrum 19000 mg/L
capricornutum
48 Hr EC50 water flea >10000 mg/L
* * * Section 13 - Disposal Considerations * * *
US EPA Waste Number & Descriptions
Component Waste Numbers
No EPA Waste Numbers are applicable for this product's components.
Disposal Instructions
All wastes must be handled in accordance with local, state and federal regulations.
See Section 7 for Handling Procedures. See Section 8 for Personal Protective Equipment recommendations.
* * * Section 14 - Transportation Information * * *
US DOT Information
Shipping Name: Toxic solid, organic, Melphalan Hydrochloride
UN/NA #: 3249 Hazard Class: 6.1 Packing Group: II
* * * Section 15 - Regulatory Information * * *
US Federal Regulations
Component Analysis
None of this products components are listed under SARA Section 302 (40 CFR 355 Appendix A), SARA Section
313 (40 CFR 372.65), or CERCLA (40 CFR 302.4).
State Regulations
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Material Safety Data Sheet
Material Name: Melphalan Hydrochloride for Injection
Component Analysis - State
The following components appear on one or more of the following state hazardous substances lists:
Component CAS CA MA MN NJ PA RI
Ethyl alcohol 64-17-5 Yes Yes Yes Yes Yes Yes
1,2-Propylene glycol 57-55-6 No No Yes Yes Yes Yes
The following statement(s) are provided under the California Safe Drinking Water and Toxic Enforcement Act of
1986 (Proposition 65):
WARNING! This product contains a chemical known to the state of California to cause
reproductive/developmental effects.
Component Analysis - WHMIS IDL
The following components are identified under the Canadian Hazardous Products Act Ingredient Disclosure List:
CAS # Minimum Concentration
Component
Ethyl alcohol 64-17-5 0.1 %
1,2-Propylene glycol 57-55-6 1%
Additional Regulatory Information
Component Analysis - Inventory
Component CAS # TSCA CAN EEC
4-[Bis(2-chloroethyl)amino]-L-phenylalanine 3223-07-2 No No No
hydrochloride; p-di(2-chloroethyl)amino-L-
phenylalanine hydrochloride; L-phenylalanine mustard
hydrochloride; alanine nitrogen mustard
hydrochloride.
Sodium citrate 68-04-2 Yes DSL EINECS
Ethyl alcohol 64-17-5 Yes DSL EINECS
1,2-Propylene glycol 57-55-6 Yes DSL EINECS
Water 7732-18-5 Yes DSL EINECS
* * * Section 16 - Other Information * * *
Other Information
The information herein is presented in good faith and believed to be accurate as of the effective date given.
However, no warranty, expressed or implied, is given. It is the buyer's responsibility to ensure that its activities
comply with Federal, State or provincial, and local laws.
Key/Legend
EPA = Environmental Protection Agency; TSCA = Toxic Substance Control Act; ACGIH = American Conference
of Governmental Industrial Hygienists; IARC = International Agency for Research on Cancer; NIOSH = National
Institute for Occupational Safety and Health; NTP = National Toxicology Program; OSHA = Occupational Safety
and Health Administration., NJTSR = New Jersey Trade Secret Registry.
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