Material Safety Data Sheet
Material Name: Enlon (Edrophonium Chloride Injection,
USP)
* * * 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
May be harmful if swallowed. Cardiovascular effects. Respiratory effects. Neurologic effects. Gastrointestinal
effects. Musculoskeletal effects.
Potential Health Effects: Eyes
May cause irritation and/or allergic reactions.
Potential Health Effects: Skin
May cause irritation and/or allergic reactions.
Potential Health Effects: Ingestion
May be harmful if swallowed.
Potential Health Effects: Inhalation
Inhalation not likely under normal use conditions.
HMIS Ratings: Health: 1 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 Percent
7732-18-5 Water >98
116-38-1 Edrophonium chloride 1
7757-83-7 Sodium sulfite <0.5
108-95-2 Phenol <0.5
* * * Section 4 - First Aid Measures * * *
First Aid: Eyes
In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Get medical attention if
irritation develops.
First Aid: Skin
In case of contact, immediately flush skin with plenty of water. Remove contaminated clothing and shoes. Wash
clothing before reuse. Get medical attention if irritation develops.
First Aid: Ingestion
Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an
unconscious person. If large quantities of this material are swallowed, call a physician immediately.
First Aid: Inhalation
If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get
medical attention if symptoms appear.
First Aid: Notes to Physician
See patient package insert in shipping carton for complete information.
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Material Safety Data Sheet
Material Name: Enlon (Edrophonium Chloride Injection, USP)
* * * Section 5 - Fire Fighting Measures * * *
General Fire Hazards
See Section 9 for Flammability Properties.
None
Hazardous Combustion Products
Not Determined
Extinguishing Media
Use foam or all purpose dry chemicals to extinguish.
Fire Fighting Equipment/Instructions
Fire fighters should wear positive pressure self-contained breathing apparatus (SCBA) and full turnout gear.
NFPA Ratings: Health: 1 Fire: 0 Reactivity: 0
Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate 3 = Serious 4 = Severe
* * * Section 6 - Accidental Release Measures * * *
Personal Precautions
Keep unnecessary personnel away. Use suitable protective equipment (Section 8). Follow all fire fighting
procedures (Section 5).
Containment Procedures
Contain the discharged material.
Clean-Up Procedures
For small spills add absorbent (soil may be used in the absence of other suitable materials) scoop up material and
place in a sealed, liquid-proof container for disposal. For large spills dike spilled material or otherwise contain
material to ensure runoff does not reach a waterway. Place spilled material in an appropriate container for
disposal.
Evacuation Procedures
Isolate area. Keep unnecessary personnel away.
Special Procedures
None necessary.
* * * Section 7 - Handling and Storage * * *
Handling Procedures
Wash thoroughly after handling.
Storage Procedures
Keep containers tightly closed in a cool, well-ventilated place. Store between 15-30癈 (59 to 86癋).
* * * Section 8 - Exposure Controls / Personal Protection * * *
A: Component Exposure Limits
Phenol (108-95-2)
ACGIH: 5 ppm TWA
Skin - potential significant contribution to overall exposure by the cutaneous route
OSHA: 5 ppm TWA; 19 mg/m3 TWA
Prevent or reduce skin absorption
NIOSH: 5 ppm TWA; 19 mg/m3 TWA
15.6 ppm Ceiling (15 min); 60 mg/m3 Ceiling (15 min)
Potential for dermal absorption
Engineering Controls
No special containment is required. Good general ventilation should be sufficient to control airborne levels.
PERSONAL PROTECTIVE EQUIPMENT
Personal Protective Equipment: Eyes/Face
Safety glasses. Goggles, face shield, or other full-face protection if potential exists for direct exposure to aerosols
or splashes.
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Material Safety Data Sheet
Material Name: Enlon (Edrophonium Chloride Injection, USP)
Personal Protective Equipment: Skin
Work uniform or laboratory coat. Additional body garments should be used based upon the task being performed
(e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces. Use chemical resistant,
impervious gloves.
Personal Protective Equipment: Respiratory
Perform exposure monitoring for this product and its components to ensure that employees are not exposed to
levels greater than applicable regulatory limits. If exposure levels exceed regulatory limits, implement a
respiratory protection program including respiratory protection that is in compliance with OSHA 29 CFR1910.134
(in the US) or equivalent regulation in other regions. Fire fighting requires the use of a self-contained breathing
apparatus with full face piece and positive pressure mode.
Personal Protective Equipment: General
Eye wash fountain is recommended.
* * * Section 9 - Physical & Chemical Properties * * *
Appearance: Odor:
Aqueous solution NA
Physical State: pH:
Liquid 5.4
Vapor Pressure: Vapor Density:
NA NA
Boiling Point: Melting Point:
NA NA
Solubility (H2O): Specific Gravity:
Soluble NA
Evaporation Rate: VOC:
NA NA
Octanol/H2O Coeff.: Flash Point:
NA NA
Flash Point Method: Upper Flammability Limit
NA NA
(UFL):
Lower Flammability Limit Burning Rate:
NA NA
(LFL):
Auto Ignition: NA
* * * Section 10 - Chemical Stability & Reactivity Information * * *
Chemical Stability
Stable under recommended storage conditions.
Chemical Stability: Conditions to Avoid
None
Incompatibility
None
Hazardous Decomposition
Not available.
Possibility of Hazardous Reactions
Will not occur.
* * * Section 11 - Toxicological Information * * *
Acute Dose Effects
A: General Product Information
Gastrointestinal effects (may include nausea/vomiting, abdominal pain, diarrhea, dry mouth, colic). Cardiovascular
effects (may include fluctuations in heart rate, changes in blood pressure, chest pain). Respiratory effects (may
include shortness of breath, bronchospasms, laryngospasms).
B: Component Analysis - LD50/LC50
Water (7732-18-5)
Oral LD50 Rat: >90 mL/kg
Phenol (108-95-2)
Oral LD50 Rat: 317 mg/kg; Dermal LD50 Rat:525 mg/kg; Dermal LD50 Rabbit:630 mg/kg; Inhalation LC50
Rat:316 mg/m3/4H
Sodium sulfite (7757-83-7)
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Page 3 of 5 Issue Date: 09/05/08 Revision: 1.0000 Print Date: 9/5/2008
Material Safety Data Sheet
Material Name: Enlon (Edrophonium Chloride Injection, USP)
Inhalation LC50 Rat: >5.5 mg/L/4H; Inhalation LC50 Rat:>22 mg/L/1H; Oral LD50 Rat:820 mg/kg
Carcinogenicity
A: General Product Information
No information available for the product.
B: Component Carcinogenicity
Phenol (108-95-2)
ACGIH: A4 - Not Classifiable as a Human Carcinogen
IARC: Monograph 71 [1999], Monograph 47 [1989] (Group 3 (not classifiable))
Sodium sulfite (7757-83-7)
IARC: Monograph 54 [1992] (listed under Sulfur dioxide and some sulfites bisulfites and metabisulfites)
(Group 3 (not classifiable))
* * * Section 12 - Ecological Information * * *
Ecotoxicity
A: General Product Information
No information available for the product.
B: Component Analysis - Ecotoxicity - Aquatic Toxicity
Phenol (108-95-2)
Test & Species Conditions
96 Hr LC50 Pimephales promelas 24 mg/L [flow-
through]
96 Hr LC50 Oncorhynchus mykiss 8.9 mg/L [flow-
through]
96 Hr LC50 Lepomis macrochirus 23.88 mg/L [static]
96 Hr LC50 Oncorhynchus mykiss 5-12 mg/L [flow-
through]
96 Hr LC50 Poecilia reticulata 40 mg/L [static]
96 Hr LC50 Brachydanio rerio 27.8 mg/L
96 Hr EC50 Selenastrum 150 mg/L
capricornutum
48 Hr EC50 water flea 23.0 mg/L
48 Hr LC50 Daphnia magna 13 mg/L
Sodium sulfite (7757-83-7)
Test & Species Conditions
96 Hr LC50 Leuciscus idus 220-460 mg/L
[static]
24 Hr LC50 Psammechinus miliaris 330 mg/L
* * * Section 13 - Disposal Considerations * * *
US EPA Waste Number & Descriptions
Component Waste Numbers
Phenol (108-95-2)
RCRA: waste number U188
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: Not Regulated
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Page 4 of 5 Issue Date: 09/05/08 Revision: 1.0000 Print Date: 9/5/2008
Material Safety Data Sheet
Material Name: Enlon (Edrophonium Chloride Injection, USP)
* * * Section 15 - Regulatory Information * * *
US Federal Regulations
Component Analysis
This material contains one or more of the following chemicals required to be identified under SARA Section 302
(40 CFR 355 Appendix A), SARA Section 313 (40 CFR 372.65) and/or CERCLA (40 CFR 302.4).
Phenol (108-95-2)
SARA 302: 500 lb lower threshold TPQ; 10000 lb upper threshold TPQ
CERCLA: 1000 lb final RQ; 454 kg final RQ
State Regulations
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
Phenol 108-95-2 Yes Yes Yes Yes Yes Yes
Component Analysis - WHMIS IDL
No components are listed in the WHMIS IDL.
Additional Regulatory Information
Component Analysis - Inventory
Component CAS # TSCA CAN EEC
Water 7732-18-5 Yes DSL EINECS
Edrophonium chloride 116-38-1 No No EINECS
Phenol 108-95-2 Yes DSL EINECS
Sodium sulfite 7757-83-7 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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