Msds_acyclovir_sodium_injection_092711.pdf

MATERIAL SAFETY DATA SHEET

Product Name: Acyclovir Sodium Injection
1. CHEMICAL PRODUCT AND COMPANY INFORMATION
Manufacturer Name And
275 North Field Drive Lake Forest, Illinois USA 60045 Emergency Telephone
CHEMTREC: North America: 800-424-9300; International 1-703-527-3887; Australia (02) 8014 4880 Hospira, Inc., Non-Emergency 224-212-2000
Product Name

Synonyms
6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl] 2. COMPOSITION/INFORMATION ON INGREDIENTS
Active Ingredient Name
Chemical Formula
Preparation
Non-hazardous ingredients include Water for Injection. Sodium hydroxide and/or hydrochloric acid may be added for pH adjustment. Formulation also contain acyclovir sodium. Component
Approximate Percent
by Weight
CAS Number
RTECS Number
3. HAZARD INFORMATION
Carcinogen List
Substance
Emergency Overview
Acyclovir Sodium Injection is a sterile injectable drug that contains acyclovir, a synthetic guanine nucleoside. Clinically, it is an anti-viral drug used to treat mucosal or cutaneous herpes simplex (HSV-1 and HSV-2), herpes zoster (shingles), and varicella-zoster (chickenpox) infections. In the workplace, this material should be considered potentially irritating to the eyes and respiratory tract and a potential sensitizer. Based on clinical use, possible target organs include the central nervous system and kidneys.
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
None known from workplace exposures. In clinical use, adverse effects may include local effects at the site of injection (cutaneous irritation, erythema, or pain) following parenteral administration. Other adverse effects have included headache, dizziness, fatigue, insomnia, confusion, depression, agitation, tremors, seizures, nausea/vomiting, diarrhea, abdominal pain, Product Name: Acyclovir Sodium Injection

increased BUN, decreased creatinine clearance, impaired renal function, obstructive nephropathy and acute renal failure, elevated liver function tests, rash and urticaria. Rarely anemia, neutropenia, thrombocytopenia, thrombocytosis, leukocytosis, and neutrophilia have been reported.
Medical Conditions
Pre-existing hypersensitivity to acyclovir, valacyclovir, or related compounds; pre-existing Aggravated by Exposure renal or hematological 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 for this aqueous product. Fire & Explosion Hazard
No special provisions required beyond normal fire fighting equipment such as flame and chemical resistant clothing and self contained breathing apparatus. Extinguishing media
As with any fire, use extinguishing media appropriate for primary cause of fire. Special Fire Fighting
No special provisions required beyond normal fire fighting 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. Dispose of spill materials according to the applicable federal, state, or local regulations. 7. HANDLING AND STORAGE
Handling
No special handling required under conditions of normal product use. 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. Product Name: Acyclovir Sodium Injection

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 formulation 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 normal 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:
Vapor Pressure:
Vapor Density:
Specific Gravity:
Solubility:
Partition coefficient: n-octanol/water: NA
Auto-ignition temperature:
Decomposition temperature:
Product Name: Acyclovir Sodium Injection

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)
Test Type
Administration

Aspiration Hazard
None anticipated from normal handling of this product. Dermal Irritation/Corrosion
None anticipated from normal handling of this product. Ocular Irritation/Corrosion
None anticipated from normal handling of this product. However, inadvertent contact of this product with eyes may produce irritation with redness and tearing. Dermal or Respiratory
None anticipated from normal handling of this product. Sensitization

Reproductive Effects
Acyclovir did not impair fertility or reproduction in mice (450 mg/kg/day, PO) or in rats (25 mg/kg/day, SC). In the mouse study, plasma levels were the same as human levels, while in the rat study, they were 1 to 2 times human levels. At higher doses (50 mg/kg/day, SC) in rats and rabbits (1 to 2 and 1 to 3 times human levels, respectively) implantation efficacy, but not litter size, was decreased. In a rat peri and post-natal study at 50 mg/kg/day, SC, there was a statistically significant decrease in group mean numbers of corpora lutea, total implantation sites, and live fetuses. Acyclovir administered during organogenesis was not teratogenic in the mouse (450 mg/kg/day, PO), rabbit (50 mg/kg/day, SC and IV), or rat (50 mg/kg/day, SC). No testicular abnormalities were seen in dogs given 50 mg/kg/day, IV for 1 month (1 to 3 times human levels) or in dogs given 60 mg/kg/day orally for 1 year (the same Product Name: Acyclovir Sodium Injection

as human levels). Testicular atrophy and aspermatogenesis were observed in rats and dogs at higher dose levels. Mutagenicity
Acyclovir was tested in 16 in vitro and in vivo genetic toxicity assays. Acyclovir was positive in 5 of the assays. Carcinogenicity
Acyclovir was tested in lifetime bioassays in rats and mice at single daily doses of up to 450 mg/kg administered by gavage. There was no statistically significant difference in the incidence of tumors between treated and control animals, nor did acyclovir shorten the latency of tumors. Target Organ Effects
Based on clinical use, possible target organs include the central nervous system
12. ECOLOGICAL INFORMATION
Aquatic Toxicity
Not determined for product IC50: > 100 mg/l, 3 Hours, Activated sludge for acyclovir. The active ingredient acyclovir is not toxic to activated sludge microorganisms. space MIC (minimum inhibition concentration: > 993 mg/l, 5 Days, Aspergillus flavus > 993 mg/l, 5 Days, Azotobacter chroococcum > 993 mg/l, 5 Days, Chaetomium globosum > 993 mg/l, 5 Days, Nostoc sp. > 993 mg/l, 5 Days, Pseudomonas fluorescens Acyclovir is not toxic to these microorganisms. ace IC50: > 99 mg/l, 96 Hours, Selenastrum capricornutum, green algae, Static test. Acyclvir is not toxic to algae. pace EC50: > 93 mg/l, 48 Hours, Daphnia magna, Static test Chronic LOEC: > 10 mg/l, 7 Days, Ceriodaphnia dubia Chronic NOEC: 10 mg/l, 7 Days, Ceriodaphnia dubia Acyclovir is not toxic to daphnids or harmful to daphnids in chronic toxicity studies. EC50: > 95 mg/l, 96 Hours, Static renewal test, Juvenile Pimephales promelas, fathead minnow. Acyclovir is not toxic to fish. * GSK MSDS for Zovirax Suspension Persistence/Biodegradability
Not determined for product. Hydrolysis: Half-Life, Neutral: > 1 Years, Measured Acyclovir has been shown to be chemically stable in water. Hydrolysis is unlikely to be a significant depletion mechanism. Photolysis: Half-Life, Aqueous: 3.55 Hours, Measured, pH 7 Buffer Solution Acyclovir has been shown to be chemically unstable in water when exposed to light. Aqueous photolysis may be a significant depletion mechanism. Biodegradation: Aerobic – Ready: Percent Degradation: 0.7 %, 28 days, Sturm test Aerobic – Inherent: Percent Degradation: 50 %, < 1 day, Modified Zahn-Wellens, Activated sludge Acyclovir has been tested and is expected to be biodegradable. It is not expected to persist in the environment. * GSK MSDS for Zovirax Suspension Bioaccumulation
Not determined for product. The octanol/water partition coefficient data that suggests that acyclovir will not have the tendency to distribute into fats. Acyclovir is not anticipated to bioaccumulate in the food chain. * GSK MSDS for Zovirax Suspension Mobility in Soil
Not determined for product. Soil Sediment Sorption (log Koc): 2.6 to 2.64, Measured Sludge Biomass Distribution Coefficient (log Kd): 2.33 to 2.37 Estimated Acyclovir is not anticipated to adsorb to sludge or biomass. * GSK MSDS for Zovirax Suspension Product Name: Acyclovir Sodium Injection

13. DISPOSAL CONSIDERATIONS
Waste Disposal
All waste materials must be properly characterized. Further, 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

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. Product Name: Acyclovir Sodium Injection

EU Classification*
*Medicinal products are exempt from the requirements of the EU Dangerous Preparations Directive. Information provided below is
for the pure drug substance Acyclovir
.
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: 09/27/2011
Obsolete Date: 10/21/2008
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.

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