Page 1 of 4 ?Acetylcysteine Solution USP
IN CASE OF EMERGENCY
Emergency Phone: (614) 276-4000
Material Safety Data Sheet
1. CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
Common/Trade Name: Acetylcysteine Solution USP
Chemical Name: (R)-2-acetamido-3-mercaptopropanoic acid
Synonyms: None
Molecular Formula: C5H9NO3S
Molecular Weight: 163.19
CAS No: 616-91-1
Chemical Family: Mucolytic agent
Product Use: Treatment for excessive mucous production or paracetamol/acetaminophen overdose
Boehringer Ingelheim Roxane Inc.
Manufacturer's Name:
1809 Wilson Road
Address:
Columbus, Ohio 43228
2. COMPOSITION / INFORMATION ON INGREDIENTS
Composition CAS# Exposure Limit
Acetylcysteine (active ingredient) 616-91-1 None established
REFER to PHYSICIAN'S DESK REFERENCE for common components present as <1%
3. HAZARDS IDENTIFICATION
Emergency Physical State: Liquid solution administered through oral inhalation or oral ingestion.
Overview Clear to purple solution in 10 or 20% solutions. A slight color change to purple does not affect
the efficiency of this product.
Odor: Slight
WARNING!
May be harmful if inhaled or swallowed.
Accidental ingestion of large amounts may be fatal.
Primary Route(s)
of Entry Inhalation, Ingestion
Potential Health Inhalation: May be harmful if inhaled. Inhalation may cause irritation, headaches, runny nose,
Effects: and drowsiness.
Eye Contact: Not expected to be a hazard to the eye. Contact with eye may cause irritation,
burning and redness.
Skin Contact: Not expected to be a hazard to the skin. Can cause hypersensitive reactions
resulting in rash, redness, itching and inflammation.
Ingestion: May be harmful if ingested. Ingestion may cause nausea, vomiting, and other
systemic effects.
Toxicity Data: See Section 11
Effects of The potential for exposure is reduced in finished pharmaceutical form.
Overexposure: Overexposure by ingestion may cause nausea, vomiting, and other systemic effects. A rash
with or without a mild fever has been reported in rare cases.
Target Organs: Mucous membranes, lungs
4. FIRST AID MEASURES
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Eye Exposure Any material that contacts the eye should be washed out immediately with water. If easy to do,
remove contact lenses if worn. Get medical attention if symptoms persist.
Skin Exposure Wash with soap and water. Get medical attention if symptoms occur.
Ingestion Call a physician or poison control center immediately.
Inhalation Move to fresh air and treat symptomatically. If breathing is difficult, move to fresh air. Get
medical attention immediately.
5. FIRE AND EXPLOSION HAZARDS
Flammability N/A Upper: N/A
Lower:
Flash Point Not available
Extinguishing Media Use water spray, dry chemical, foam or material appropriate for fire in surrounding
area.
Special Fire Fighting
Procedures Wear full protective clothing and self-contained breathing apparatus.
Unusual Fire/Explosion
Hazards Not Applicable
Hazardous Combustion
Products Carbon dioxide, carbon monoxide, oxides of nitrogen, oxides of sulfur
6. ACCIDENTAL RELEASE INFORMATION
STEPS TO BE TAKEN IF SIGNIFICANT QUANTITIES OF LIQUID IS SPILLED:
Use appropriate personal protective equipment (see Section 8). Wipe up and containerize spill material in a
compatible container. Dispose according to applicable regulations. Incineration of the waste at an approved facility
is recommended.
7. PRECAUTIONS FOR SAFE HANDLING AND USE
Precautions Handling Observe good industrial hygiene practices.
Significant Quantities
of Liquid:
Storage Store at 15?and 30癈 (59?to 86癋). Keep container closed tightly. Store in refrigerator at 2?-
8癈 (36?- 46癋) after opening. Discard opened bottles after 96 hours.
8. CONTROL MEASURES AND PERSONAL PROTECTIVE EQUIPMENT
Exposure Limits None
Engineering Controls Not required when handling liquid or containers. Good ventilation should be used.
Ventilation should be matched to conditions.
Respiratory Not required when handling liquid or containers. NIOSH/MSHA approved respirators for
Protection protection should be used if respirators are found to be necessary. Ventilation should be
matched to conditions.
Personal Protection Not required when handling final product. If containers are compromised or exposure is
likely wear: Goggles, Lab Coat, Gloves
Recommended
Facilities Eye wash, washing facilities
9. PHYSICAL / CHEMICAL CHARACTERISTICS
Appearance Clear to purple Melting point Not available Solubility in Soluble
solution water
Odor Slight Boiling point Not available Specific Gravity Not available
Taste Not available Vapor Pressure Not available Flashpoint Not available
pH Not available Density Not available Flammability Not available
Limits
10. STABILITY AND REACTIVITY DATA
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Stability Stable
Incompatibility None known
Hazardous
Decomposition Oxides of carbon, oxides of nitrogen, oxides of sulfur
Conditions to
Avoid Excessive heat and light
Hazardous
Polymerization Will not occur.
11. TOXICOLOGICAL INFORMATION
Acute Toxicity:
Active Ingredient:
LD50 Oral (rat): 5050 mg/kg
LD50 Oral (mouse): 4400 mg/kg
Carcinogenicity: Not listed as a carcinogen by NTP, IARC Monographs or OSHA.
12. ENVIRONMENTAL IMPACT INFORMATION
No information is currently available on the environmental impact of this product.
13. DISPOSAL INFORMATION
Waste Disposal Considerations: Dispose of material according to federal, state and local disposal regulations or
company operating procedures. Disposal by incineration is recommended.
At home: Discard away from children's reach.
14. TRANSPORTATION INFORMATION
This product is not subject to the regulations for the safe transport of hazardous chemicals.
DOT: Not regulated
TDG: Not regulated
IATA: Not regulated
IMDG: Not regulated
15. REGULATORY INFORMATION
DEA: Acetylcysteine Solution is not a controlled substance.
FDA: Acetylcysteine Solution is an approved prescription medication.
Inventory Status:
This material is not listed on the US TSCA Inventory. Therefore, it can only be used for TSCA exempt purposes such
as R&D or drug use.
This material is not listed on the DSL Inventory but is exempt.
16. OTHER DATA
ABBEVIATIONS:
N/A ?not applicable
Prepared by: Boehringer Ingelheim Roxane Inc.
References:
1. Acetylcysteine Solution USP, Package Insert, Boehringer Ingelheim Roxane Inc., Columbus, Ohio
2. RTECS No. HA1660000 for N-acetyl-L-cysteine
3. Ariel Webinsight. Regulatory and ChemExpert Database.
4. PDR ?Physicians Desk Reference
Date: 09/13/2008 - New MSDS
SEE CURRENT PACKAGE INSERT FOR FURTHER INFORMATION
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The information provided is believed to be complete and accurate. If this product is combined with other materials, deteriorates or
becomes contaminated, it may pose hazards not mentioned in this MSDS. It is the users' responsibility to use the information
according to the application. Boehringer Ingelheim Roxane Inc. assumes no responsibility or liability resulting from the use of this
information.
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