Msds_ondansetron_hydrochloride_injection_101912.pdf

MATERIAL SAFETY DATA SHEET

Product Name: Ondansetron Hydrochloride Injection, Solution
1. CHEMICAL PRODUCT AND COMPANY INFORMATION
Manufacturer Name And
275 North Field Drive Lake Forest, Illinois USA 60045 Hospira Australia Pty Ltd 1 Lexia Place Mulgrave, VIC 3170 Australia Emergency Telephone
CHEMTREC: North America: 800-424-9300; International 1-703-527-3887; Australia - 61-290372994; UK - 44-870-8200418 Hospira, Inc., Non-Emergency 224-212-2000
Product Name
Ondansetron Hydrochloride Injection, Solution
Synonyms
Ondansetron Hydrochloride Dihydrate; (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. 2. COMPOSITION/INFORMATION ON INGREDIENTS
Active Ingredient Name
Chemical Formula
Preparation
Non-hazardous ingredients include Water for Injection. Hazardous ingredients present at less than 1% may include sodium chloride, methylparaben, NF and propylparaben, NF. Sodium citrate dihydrate and citric acid anhydrous are added as buffers. Component
Approximate Percent
by Weight
CAS Number
RTECS Number
3. HAZARD INFORMATION
Carcinogen List
Substance
Emergency Overview
ONDANSETRON - ondansetron hydrochloride injection, is a solution containing ondansetron hydrochloride, a serotonin-blocking drug used intravenously or orally to prevent nausea and vomiting associated with the use of emetogenic cancer chemotherapy drugs, radiation induced nausea and vomiting, and to prevent post-operative nausea and vomiting. In the workplace, ondansetron hydrochloride should be considered a potent drug, possibly irritating to skin, and possibly severely irritating to the eyes and respiratory tract. Possible target organs include the central nervous system and liver. Product Name: Ondansetron Hydrochloride Injection, Solution


Occupational Exposure
Information on the absorption of this product via inhalation or skin contact is not available. Potential
Avoid liquid aerosol generation and skin contact.
Signs and Symptoms
In the workplace, this material should be considered potentially irritating to the skin, and possibly severely irritating to the eyes and respiratory tract. Respiratory sensitization and allergy-like effects have also been reported following occupational exposures. In clinical use, adverse effects may include headache, restlessness, dizziness, hypotension, fever, malaise, fatigue, and diarrhea or constipation. Infrequently, elevations in liver function parameters and extrapyramidal symptoms have been reported. Also, rash, hypersensitivity, fever, bronchospasm and wheezing have been reported.
Medical Conditions
Pre-existing hypersensitivity to ondansetron hydrochloride or other components in this product. Aggravated by Exposure Pre-existing central nervous system or liver ailments.

4. FIRST AID MEASURES
Eye contact
Remove from source of exposure. Flush with copious amounts of water. If irritation persists or signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as necessary. Skin contact
Remove from source of exposure. Flush with copious amounts of water. If irritation persists or signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as necessary. Inhalation
Remove from source of exposure. If signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as necessary. Ingestion
Remove from source of exposure. If signs of toxicity occur, seek medical attention. Provide symptomatic/supportive care as necessary.
5. FIRE FIGHTING MEASURES
Flammability
None anticipated from this aqueous product. Fire & Explosion Hazard
None anticipated from this aqueous product. Extinguishing media
As with any fire, use extinguishing media appropriate for primary cause of fire. Special Fire Fighting
No special provisions required beyond normal firefighting equipment such as Procedures
flame and chemical resistant clothing and self contained breathing apparatus. 6. ACCIDENTAL RELEASE MEASURES
Spill Cleanup and Disposal
Isolate area around spill. Put on suitable protective clothing and equipment as specified by site spill procedures. Absorb the liquid with suitable material and clean affected area with soap and water. Prevent entry into sewers and surface drainage systems. Dispose of spill materials according to the applicable federal, state, or local regulations. Product Name: Ondansetron Hydrochloride Injection, Solution

7. HANDLING AND STORAGE
Handling
No special handling is required for hazard control under conditions of normal No special storage required for hazard control. For product protection, follow storage recommendations noted on the product case label, the primary container label, or the product insert. Special Precautions
No special precautions required for hazard control. 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure Guidelines
Exposure limits
Component
Respiratory
Respiratory protection is normally not needed during intended product use. However, if the protection
generation of aerosols is likely, and engineering controls are not considered adequate to control potential airborne exposures, the use of an approved air-purifying respirator with a HEPA cartridge (N95 or equivalent) is recommended under conditions where airborne aerosol concentrations are not expected to be excessive. For uncontrolled release events, or if exposure levels are not known, provide respirators that offer a high protection factor such as a powered air purifying respirator or supplied air. A respiratory protection program that meets OSHA's 29 CFR 1910.134 and ANSI Z88.2 requirements must be followed whenever workplace conditions require respirator use. Personnel who wear respirators should be fit tested and approved for respirator use as required. Skin protection
If skin contact with the product solution is likely, the use of latex or nitrile gloves is Eye protection
Eye protection is normally not required during intended product use. However, if eye contact is likely to occur, the use of chemical safety goggles (as a minimum) is recommended. Engineering Controls
Engineering controls are normally not needed during the intended use of this product.
9. PHYSICAL/CHEMICAL PROPERTIES
Appearance/Physical State
Odor Threshold:
Melting point/Freezing point:
Initial Boiling Point/Boiling Point
Range:
Evaporation Rate:
Flammability (solid, gas):
Upper/Lower Flammability or
Explosive Limits:
Product Name: Ondansetron Hydrochloride Injection, Solution

Vapor Pressure:
Vapor Density:
Specific Gravity:
Solubility:
Partition coefficient: n-octanol/water: Not determined
Auto-ignition temperature:
Decomposition temperature:
10. STABILITY AND REACTIVITY
Reactivity
Chemical Stability
Stable under standard use and storage conditions. Hazardous Reactions
Conditions to avoid
Incompatibilities
Hazardous decomposition
Not determined. During thermal decomposition, it may be possible to generate products
irritating vapors and/or toxic fumes of carbon oxides (COx), nitrogen oxides Hazardous Polymerization
Not anticipated to occur with this product.
11. TOXICOLOGICAL INFORMATION

Acute Toxicity
Not determined for the product formulation. Information for the ingredients is as follows:
Ingredient(s)
Administration

Aspiration Hazard
None anticipated from normal handling of this product. Dermal Irritation/Corrosion
None anticipated from normal handling of this product. Aqueous solutions of the active ingredient, ondansetron hydrochloride, are reported to be severely irritating/corrosive to the skin. Inadvertent contact of this product with skin may produce mild irritation. Ocular Irritation/Corrosion
None anticipated from normal handling of this product. Aqueous solutions of the active ingredient, ondansetron hydrochloride, are reported to be a severely irritating to the eyes. Inadvertent contact of this product with eyes or mucus membranes may produce irritation. Dermal or Respiratory
None anticipated from normal handling of this product. The active ingredient, Sensitization
ondansetron hydrochloride, was negative in a sensitization study in guinea Product Name: Ondansetron Hydrochloride Injection, Solution

pigs. However, in the workplace, possible effects of overexposure may include: symptoms of hypersensitivity (such as skin rash, hives, itching, and difficulty breathing). Reproductive Effects
Oral administration of ondansetron at dosages up to 15 mg/kg per day did not affect fertility or general reproductive performance of male and female rats. Reproduction studies in pregnant rats and rabbits using intravenous dosages up to 4 mg/kg per day have revealed no evidence of impaired fertility or harm to the fetus due to ondansetron. Mutagenicity
Ondansetron was not mutagenic in a standard battery of tests for mutagenicity. Carcinogenicity
Carcinogenic effects were not seen in 2-year studies in rats and mice with oral ondansetron dosages up to 10 and 30 mg/kg per day, respectively. Target Organ Effects
Based on clinical use, possible target organs include the central nervous system
12. ECOLOGICAL INFORMATION
Aquatic Toxicity
Not determined for product. Information of ondansetron hydrochloride is provided below. *Activated Sludge Respiration - This material contains an active pharmaceutical ingredient that is not toxic to activated sludge microorganisms. IC50: > 1000 mg/l, 3 hours, activated sludge *Algal - This material contains an active pharmaceutical ingredient that is very toxic to algae. IC50: 0.87 mg/l, 72 Hours, Selenastrum capricornutum (green algae); measured NOEL: 0.31 mg/l, 72 Hours, , Static test *Daphnia - This material contains an active pharmaceutical ingredient that is harmful to daphnia. EC50: 28 mg/l, 48 Hours, Daphnia pulex, Static test NOEL: 16 mg/l, 48 Hours, Daphnia pulex, Static test *Fish – This material contains an active pharmaceutical ingredient that is toxic to fish. Adult Oncorhyncus mykiss, rainbow trout EC50: 6.5 mg/l, 96 Hours, Static test NOEL: 2.6 mg/l, 96 Hours, Measured *GlaxoSmithKline MSDS Persistence/Biodegradability
Not determined for product. Information of ondansetron hydrochloride is provided below. *Hydrolysis: Ondansetron has been shown to be chemically stable in water with a half-life (neutral pH) of > 1 year. Hydrolysis is unlikely to be a significant depletion mechanism. *Photolysis: Ondansetron is likely to undergo photodegradation, *Biodegradation - Ondansetron is not readily biodegradable (as defined by 1993 OECD Testing Guidelines). Aerobic - Inherent Percent Degradation: 18.9 Product Name: Ondansetron Hydrochloride Injection, Solution

%, 28 days, Semi-continuous activated sludge (SCAS), activated sludge. Aerobic - Soil Percent Degradation: 20.3 to 99.9 %, 64 days. *GlaxoSmithKline MSDS Bioaccumulation
Mobility in Soil
Not determined for product. Information of ondansetron hydrochloride is provided below. This material contains an active pharmaceutical ingredient that is likely to adsorb to sludge and/or other biomass. 13. DISPOSAL CONSIDERATIONS
Waste Disposal
All waste materials must be properly characterized. Disposal should be performed in accordance with the federal, state or local regulatory requirements. Container Handling and
Dispose of container and unused contents in accordance with federal, state and Disposal

14. TRANSPORTATION INFORMATION
ADR/ADG/ DOT STATUS:
IMDG STATUS:
ICAO/IATA STATUS:
Transport Comments:

15. REGULATORY INFORMATION
USA Regulations
Substance
TSCA
Status

RCRA Status
U.S. OSHA
Classification
*In the EU, classification under GHS/CLP does not apply to certain substances and mixtures, such as Classification
medicinal products as defined in Directive 2001/83/EC, which are in the finished state, intended for the final user:
Hazard Class
Category
Signal Word
Product Name: Ondansetron Hydrochloride Injection, Solution

Prevention
P260 - Do not breathe dust/fume/gas/mist/vapors/spray. Statement
Response:
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists, get medical attention. Wash hands after handling. Get medical attention if you feel unwell.
EU Classification*
*Medicinal products are exempt from the requirements of the EU Dangerous Preparations Directive. Information provided below is
for the pure drug substance Ondansetron Hydrochloride Dihydrate
.
Classification(s):
Indication of Danger:

Risk Phrases:
Safety Phrases:
S23 - Do not breathe vapor. S24/25 - Avoid contact with skin and eyes. S37/39 - Wear suitable gloves and eye/face protection. 16. OTHER INFORMATION:
Notes:
ACGIH TLV
American Conference of Governmental Industrial Hygienists – Threshold Limit Value US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act US Department of Transportation Regulations National Institute for Occupational Safety and Health US Occupational Safety and Health Administration – Permissible Exposure Limit US EPA, Resource Conservation and Recovery Act Registry of Toxic Effects of Chemical Substances Superfund Amendments and Reauthorization Act MSDS Coordinator: Hospira GEHS Date Prepared: 10/19/2012 Obsolete Date: 10/28/2011 Product Name: Ondansetron Hydrochloride Injection, Solution

Disclaimer:
The information and recommendations contained herein are based upon tests believed to be reliable. However,
Hospira does not guarantee their accuracy or completeness NOR SHALL ANY OF THIS INFORMATION
CONSTITUTE A WARRANTY, WHETHER EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE
GOODS, THE MERCHANTABILITY OF THE GOODS, OR THE FITNESS OF THE GOODS FOR A
PARTICULAR PURPOSE. Adjustment to conform to actual conditions of usage may be required. Hospira
assumes no responsibility for results obtained or for incidental or consequential damages, including lost profits,
arising from the use of these data. No warranty against infringement of any patent, copyright or trademark is made
or implied.

Source: http://www.medpluspro.com/medfiles/MSDS_Ondansetron_Hydrochloride_Injection_101912_32-90755_1.pdf