Nycomed US Inc.
MATERIAL SAFETY DATA SHEET
Prepared to U.S. OSHA, CMA, ANSI, and Canadian WHMIS
PART I What is the material and what do I need to know in an emergency?
1. PRODUCT IDENTIFICATION
TRADE NAME/MATERIAL NAME: Metronidazole Cream 0.75%
Metronidazole Cream
DESCRIPTION:
0168-0323-46
NDC #:
2-Methyl-5-nitroimidazole-1-ethanol
CHEMICAL NAME (for active ingredient):
Nitroimidazole
CHEMICAL FAMILY (for active ingredient):
0.75% Cream
HOW SUPPLIED:
C6H9N3O3
FORMULA (for active ingredient):
Pharmaceutical for Human Use
PRODUCT USE:
SUPPLIER/MANUFACTURER'S NAME: NYCOMED US INC.
60 Baylis Road
ADDRESS:
Melville, NY 11747
1-631-454-7677
BUSINESS PHONE/GENERAL MSDS INFORMATION:
EMERGENCY PHONE (U.S./Canada/Puerto Rico): 1-800-424-9300 (24-hr)
EMERGENCY PHONE (OUTSIDE U.S.): +1-631-454-7677
NOTE: ALL United States Occupational Safety and Health Administration Standard (29 CFR 1910.1200), U.S. State equivalent Standards, and Canadian WHMIS [Controlled
Products Regulations] required information is included in appropriate sections based on the U.S. ANSI Z400.1-2004 format. This product has been classified in accordance
with the hazard criteria of the countries listed above.
2. HAZARD IDENTIFICATION
EMERGENCY OVERVIEW: Product Description: This product is a slightly white to slightly yellow, odorless cream.
Health Hazards: The chief health hazard associated with exposure during normal use and handling is the potential for
irritation of contaminated skin. Metronidazole, the active ingredient in this product, is a potential carcinogen, based on
animal data. Individuals who have had allergic reactions to products containing the active ingredient, Metronidazole, or
any other components of this product may experience allergic reactions following use or exposure. Flammability
Hazards: If heated to high temperatures for a prolonged period, the water in this product can evaporate off and the
residue may ignite. When involved in a fire, this material may decompose and produce irritating vapors and toxic
compounds (including carbon oxides and nitrogen oxides). Reactivity Hazards: This product is not reactive.
Environmental Hazards: This product has not been tested for environmental effects. Large quantities released to the
aquatic and terrestrial environment may have an adverse effect. Emergency Considerations: Emergency responders
should wear appropriate protection for situation to which they respond.
3. COMPOSITION and INFORMATION ON INGREDIENTS
CHEMICAL NAME CAS # % w/w
Metronidazole 443-48-1 0.75%
Benzyl Alcohol 100-51-6 Proprietary
Cetearyl Alcohol 67762-27-0 Proprietary
Glycerin 56-81-5 Proprietary
Isopropyl Palmitate 142-91-6 Proprietary
Polysorbate 60 9005-67-8 Proprietary
Sorbitol 50-70-4 Proprietary
Water and other components. Each of the other components is present in less than The remaining components do not contribute any significant Balance
additional hazards.
1 percent concentration (0.1% concentration for potential carcinogens, reproductive
toxins, respiratory tract sensitizers, and mutagens).
PART II What should I do if a hazardous situation occurs?
4 FIRST-AID MEASURES
Persons developing hypersensitivity reactions should receive medical attention. If breathing is difficult, give oxygen. If
not breathing, give artificial respiration. Take a copy of label and MSDS to physician or health professional with the
contaminated individual.
METRONIDAZOLE CREAM 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 1 OF 11
Nycomed US Inc.
4 FIRST-AID MEASURES (Continued)
SKIN EXPOSURE: If adverse skin effects occur, discontinue use. Seek medical attention.
EYE EXPOSURE: If this product contaminates the eyes, rinse eyes under gently running water. Use sufficient force to
open eyelids and then "roll" eyes while flushing. Minimum flushing is for 15 minutes. The contaminated individual must
seek medical attention if any adverse effect continues after rinsing.
INHALATION: If vapors of this product are inhaled, causing irritation, remove victim to fresh air. If necessary, use
artificial respiration to support vital functions.
INGESTION: If this product is swallowed, CALL PHYSICIAN OR POISON CONTROL CENTER FOR MOST CURRENT
INFORMATION. If professional advice is not available, do not induce vomiting. Never induce vomiting or give diluents
(milk or water) to someone who is unconscious, having convulsions, or unable to swallow. If victim is convulsing,
maintain an open airway and obtain immediate medical attention.
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: Pre-existing skin conditions and blood dyscrasia may be
aggravated by repeated overexposures to this product.
RECOMMENDATIONS TO PHYSICIANS: This product should only be given to patients by persons experienced in
management of patients receiving the type of therapy intended for this product. Treat symptoms and eliminate
exposure.
5. FIRE-FIGHTING MEASURES
FLASH POINT: Not established.
NFPA RATING
AUTOIGNITION TEMPERATURE: Not established.
FLAMMABLE LIMITS (in air by volume, %): FLAMMABILITY
Lower (LEL): Not applicable. Upper (UEL): Not applicable.
Use extinguishing media 0
FIRE EXTINGUISHING MATERIALS:
appropriate for surrounding fire.
2 0
Water Spray: OK Carbon Dioxide: OK HEALTH INSTABILITY
Dry Chemical: OK Foam: OK
Halon: OK Other: Any "ABC" Class
FIRE EXTINGUISHING MATERIALS NOT TO BE USED: None known.
UNUSUAL FIRE AND EXPLOSION HAZARDS: This product contains OTHER
known and suspect skin sensitizers so this product presents a contact Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
hazard to firefighters. If heated to high temperatures for a prolonged 3 = Serious 4 = Severe
period, the water in this product can evaporate off and the residue may
ignite. When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds
(including carbon oxides and nitrogen oxides).
Explosion Sensitivity to Mechanical Impact: Not sensitive.
Explosion Sensitivity to Static Discharge: Not sensitive.
SPECIAL FIRE-FIGHTING PROCEDURES: Incipient fire responders should wear eye protection. Structural
firefighters must wear Self-Contained Breathing Apparatus (SCBA) and full protective equipment. If protective
equipment is contaminated by this product, it should be thoroughly washed with running water prior to removal of
SCBA respiratory protection. Firefighters whose protective equipment becomes contaminated should thoroughly
shower with warm, soapy water and should receive medical evaluation if they experience any adverse effects.
6. ACCIDENTAL RELEASE MEASURES
SPILL AND LEAK RESPONSE: Proper protective equipment should be used. In the event of a spill, clear the area
and protect people. The atmosphere must have levels of components lower than those listed in Section 8, (Exposure
Controls and Personal Protective Equipment) if applicable, and have at least 19.5 percent oxygen before personnel can
be allowed into the area without Self-Contained Breathing Apparatus (SCBA).
Small Spills: Wear goggles and gloves while wiping up small spills of this product with polypad or sponge.
Large Spills: Trained personnel following pre-planned procedures should handle non-incidental releases. Access to the spill
areas should be restricted. Protective apparel should be used with a respirator when there is any danger of mists or sprays
being generated. Minimum Personal Protective Equipment should be rubber gloves, rubber boots, face shield, and Tyvek suit.
Dispersing mists or sprays into surrounding air and possibly inhaling them is a serious matter and should be treated as such.
Minimum level of personal protective equipment for releases in which the level of oxygen is less than 19.5% or is unknown must
be Level B: triple-gloves (rubber gloves and nitrile gloves over latex gloves), chemical resistant suit and boots, hard
hat, and Self-Contained Breathing Apparatus. Absorb spilled liquid using polypads or other suitable absorbent material.
Prevent material from entering sewer or confined spaces, waterways, soil or public waters. Monitor area and confirm levels are
bellow exposure limits given in Section 8 (Exposure Controls-Personal Protection), if applicable, before non-response personnel are
allowed into the spill area.
METRONIDAZOLE CREAM 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 2 OF 11
Nycomed US Inc.
6. ACCIDENTAL RELEASE MEASURES (Continued)
SPILL AND LEAK RESPONSE (continued): Decontaminate the spill area using detergent and water. Place all spill
residue in an appropriate container and seal. Dispose of in accordance with Federal, State, and local procedures
(see Section 13, Disposal Considerations).
PART III How can I prevent hazardous situations from occurring?
7. HANDLING and USE
WORK PRACTICES AND HYGIENE PRACTICES: As with all chemicals, avoid getting this product ON YOU or IN
YOU. Do not eat, drink, smoke, or apply cosmetics while handling this product. Wash hands thoroughly after
handling this product or equipment and containers that contain this product. Follow SPECIFIC USE INSTRUCTIONS
supplied with this product. Particular care in working with this product must be practiced in pharmacies and other
preparation areas, during manufacture of this product, and during patient administration.
STORAGE AND HANDLING PRACTICES: Employees must be trained to properly use this product. Use of this
product should be performed in a designated area for working with drugs. Ensure product is properly labeled. Store
this product away from incompatible materials. Store this product in original container.
PRODUCT PREPARATION INSTRUCTIONS FOR MEDICAL PERSONNEL: Handle this material following standard
medical practices and following the recommendations presented on the Package Insert.
SPECIFIC USE(S): This product is a human pharmaceutical. Follow all industry standards for use of this product.
PROTECTIVE PRACTICES DURING MAINTENANCE OF CONTAMINATED EQUIPMENT: When cleaning non-
disposable equipment, wear latex or butyl rubber (double gloving is recommended), goggles, and lab coat. Wash
equipment with soap and water. Wipe equipment down with damp sponge or polypad. Collect all rinsates and dispose
of according to applicable U.S. Federal, State, and local hazardous waste disposal regulations or waste disposal
regulations of Canada. All disposable items contaminated with this product should be disposed of properly.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION
VENTILATION AND ENGINEERING CONTROLS: Use with adequate ventilation. Follow standard medical product
handling procedures. During decontamination of work surfaces, workers should wear the same equipment
recommended in Section 6 (Accidental Release Measures) of this MSDS.
EXPOSURE LIMITS/GUIDELINES:
CAS # EXPOSURE LIMITS IN AIR
CHEMICAL
NAME ACGIH-TLVs OSHA-PELs NIOSH-RELs NIOSH OTHER
TWA STEL TWA STEL TWA STEL IDLH
mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3
Metronidazole 443-48-1 NE NE NE NE NE NE NE NE
Benzyl Alcohol 100-51-6 NE NE NE NE NE NE NE AIHA WEELs:
TWA = 10 ppm
Cetearyl Alcohol 67762-27-0 NE NE NE NE NE NE NE NE
Glycerin 56-81-5 10 NE 15 (Total dust) 5 NE NE NE NE DFG MAKs:
(mist) (Resp. fraction) TWA = 50 (Inhalable fraction)
PEAK = 2稭AK 15 min, average
10 (Total) 5 (Resp.
value, 1-hr interval, 4 per shift
fraction) [vacated
DFG MAK Pregnancy Risk
1989 PEL]
Classification: C
Isopropyl 142-91-6 NE NE NE NE NE NE NE NE
Palmitate
Polysorbate 60 9005-67-8 NE NE NE NE NE NE NE NE
Sorbitol 50-70-4 NE NE NE NE NE NE NE NE
NE = Not Established. See Section 16 for Definitions of Terms Used.
The following information on appropriate Personal Protective Equipment is provided to assist employers in complying with OSHA
regulations found in 29 CFR Subpart I (beginning at 1910.132) or equivalent standards of Canada (including CSA Standard Z94.4-
02 and CSA Standard Z94.3-07). Please reference applicable regulations and standards for relevant details.
RESPIRATORY PROTECTION: A respirator is not required for routine conditions of use of this product. If respiratory
protection is needed, use only respiratory protection authorized in the U.S. Federal OSHA Respiratory Protection
Standard (29 CFR 1910.134), equivalent U.S. State standards, or Canadian CSA Standard Z94.4-02. Oxygen levels
below 19.5% are considered IDLH by OSHA. In such atmospheres, use of a full-facepiece pressure/demand SCBA or
a full facepiece, supplied air respirator with auxiliary self-contained air supply is required under OSHA's Respiratory
Protection Standard (1910.134-1998).
EYE PROTECTION: Not normally needed during normal use. If necessary, refer to U.S. OSHA 29 CFR 1910.133 or
Canadian CSA Standard Z94.3-07.
METRONIDAZOLE CREAM 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 3 OF 11
Nycomed US Inc.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION (Continued)
HAND PROTECTION: For situations in which prolonged skin contact is anticipated, double glove, using latex, nitrile,
or rubber gloves. Check gloves for leaks. Wash hands before putting on gloves and after removing gloves.
Gloves should cover the gown cuff. If necessary, refer to U.S. OSHA 29 CFR 1910.138 or appropriate standards of
Canada.
BODY PROTECTION: During patient administration, use of lightweight cotton gown or other medical attire is
recommended. If a hazard of injury to the feet exists due to falling objects, rolling objects, where objects may pierce
the soles of the feet or where employee's feet may be exposed to electrical hazards, use foot protection, as described
in U.S. OSHA 29 CFR 1910.136 and the Canadian CSA Standard Z195-02, Protective Footwear.
9. PHYSICAL and CHEMICAL PROPERTIES
BOILING POINT: Not established. FREEZING/MELTING POINT: Not established.
EVAPORATION RATE (nBuAc = 1): Not established. SOLUBILITY IN WATER: Slightly soluble.
VAPOR PRESSURE (air = 1): Not established. SPECIFIC GRAVITY @ 50癈 (water = 1): Approx. 0.94
ODOR THRESHOLD: Not established. pH: 4-6
COEFFICIENT WATER/OIL DISTRIBUTION: Not established.
APPEARANCE AND COLOR: This product is a slightly white to slightly yellow, odorless cream.
HOW TO DETECT THIS SUBSTANCE (warning properties): The appearance of this product is a distinguishing
characteristic to identify the product in event of accidental release.
10. STABILITY and REACTIVITY
STABILITY: This product is stable.
DECOMPOSITION PRODUCTS: Combustion: Carbon oxides and nitrogen oxides. Hydrolysis: None known.
MATERIALS WITH WHICH SUBSTANCE IS INCOMPATIBLE: This product is generally compatible with other
common materials in a medical facility. Acids, caustics, and other chemicals that could affect its performance should
be avoided.
HAZARDOUS POLYMERIZATION: Will not occur.
CONDITIONS TO AVOID: Avoid heat, light, and contact with incompatible chemicals.
PART IV Is there any other useful information about this material?
11. TOXICOLOGICAL INFORMATION
SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: The
HAZARDOUS MATERIAL IDENTIFICATION SYSTEM
health hazard information provided below is pertinent to medical
employees handling this product in an occupational setting. This
product is designed for application on the skin. The following
(BLUE) 2*
HEALTH HAZARD
paragraphs describe the symptoms of exposure by route of exposure.
INHALATION: Although unlikely due to form of product, inhalation of
vapors of this product may slightly irritate the nose, throat, and lungs.
Symptoms are generally alleviated upon breathing fresh air.
(RED) 0
FLAMMABILITY HAZARD
CONTACT WITH SKIN or EYES: Skin contact can cause mild
moderate irritation, which is alleviated upon rinsing with soap and
water. Due the presence of Benzyl Alcohol (a weak skin sensitizer)
and Cetearyl Alcohol (a suspect skin sensitizer) skin contact may
PHYSICAL HAZARD (YELLOW) 0
cause an allergic reaction in sensitive individuals; subsequent
exposure to very small amounts may cause an allergic reaction in
sensitive individuals, with symptoms of redness, itching, welts and
irritation. Eye contact may cause mild to moderate irritation, redness, PROTECTIVE EQUIPMENT
and tearing.
SKIN ABSORPTION: The Benzyl Alcohol component of this product EYES HANDS BODY
RESPIRATORY
may be absorbed through the skin. Skin absorption is not expected to
contribute significantly to overall exposure.
S SE
EE CTION 8
INGESTION: Ingestion is not a significant route of occupational SE SEC
E TION 8
overexposure. Acute ingestion of large quantities of this product or
chronic ingestion caused by poor hygiene practices may cause For Routine Industrial Use and Handling Applications
adverse symptoms. Symptoms of ingestion overexposure may include
nausea, vomiting, loss of coordination, seizures, muscle weakness, Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
muscle atrophy, pain, and numbness. 3 = Serious 4 = Severe * = Chronic hazard
METRONIDAZOLE CREAM 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 4 OF 11
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
INJECTION: Though not anticipated to be a significant route of overexposure for this product, injection (via punctures or
lacerations by contaminated objects) may cause redness at the site of injection. Symptoms may include those
described for "Ingestion".
GENERAL TOXICITY INFORMATION: Metronidazole, the active ingredient in this product, is a potential carcinogen,
based on animal data. Individuals who have had allergic reactions to products containing the active ingredient,
Metronidazole, or any other components of this product may experience allergic reactions following use or exposure.
Symptoms described in patients given therapeutic doses of this substance include the following.
For Males and Females: Persons using the product in therapeutic doses may experience burning, stinging, swelling,
irritation, itching, worsening of rosacea, dryness, transient redness, metallic taste, tingling or numbness of extremities,
and nausea.
IRRITANCY OF PRODUCT: This product may irritate contaminated tissue.
SENSITIZATION OF PRODUCT: Due the presence of Benzyl Alcohol (a weak skin sensitizer) and Cetearyl Alcohol (a
suspect skin sensitizer) skin contact may cause an allergic reaction in sensitive individuals; subsequent exposure to
very small amounts may cause an allergic reaction in sensitive individuals, with symptoms of redness, itching, welts and
irritation.
HEALTH EFFECTS OR RISKS FROM EXPOSURE: An Explanation in Lay Terms. Overexposure to this product may
cause the following health effects:
Acute: The primary health effects that may be experienced by medical personnel exposed to this product is mild
irritation of contaminated skin. Accidental ingestion may cause adverse effects. Although unlikely, inhalation may
slightly irritate the respiratory system. Eye contact will cause irritation.
Chronic: Metronidazole, the active ingredient in this product, is a potential carcinogen, based on animal data. Due to
the presence of known and potential skin sensitizers, susceptible persons may experience allergic reaction.
TARGET ORGANS:
Acute: Occupational Exposure: Skin, eyes. Therapeutic Doses: Skin.
Chronic: Occupational Exposure: Skin. Therapeutic Doses: Skin.
TOXICITY DATA: The toxicity data available for the active component of this product, Metronidazole, is presented in this
MSDS. Additional data are available for the excipient components of this product, but are not presented in this MSDS;
Contact Nycomed US Inc. for more information.
METRONIDAZOLE: METRONIDAZOLE (continued): METRONIDAZOLE (continued):
Standard Draize Test (Skin-Human) 0.75%/3 weeks- TDLo (Oral-Rat) 34 g/kg/34 days-continuous: TD (Oral-Rat) 3 g/kg/14 weeks-continuous:
continuous: Mild Kidney/Ureter/Bladder: hematuria; Related to Tumorigenic: neoplastic by RTECS criteria; Skin
TDLo (Oral-Woman) 40 mg/kg: Behavioral: Chronic Data: death, changes in testicular weight and Appendages: tumors
hallucinations, distorted perceptions TDLo (Oral-Rat) 219 g/kg/2 years-continuous: TD (Oral-Mouse) 8 g/kg/14 weeks-continuous:
TDLo (Oral-Woman) 12 mg/kg: Eye: effect, not Tumorigenic: carcinogenic by RTECS criteria; Tumorigenic: neoplastic by RTECS criteria;
otherwise specified, Behavioral: tremor Liver: tumors Skin and Appendages: tumors Lungs, Thorax, or Respiration: tumors; Blood:
TDLo (Oral-Man) 3570 礸/kg/day: Liver: jaundice, TDLo (Oral-Rat) 16,800 mg/kg: male 42 day(s) pre- lymphoma, including Hodgkin's disease
other or unclassified, other changes; Nutritional mating: Reproductive: Fertility: male fertility index TD (Oral-Mouse) 21,800 mg/kg/2 years-intermittent:
and Gross Metabolic: body temperature increase (e.g. # males impregnating females per # males Tumorigenic: carcinogenic by RTECS criteria;
TDLo (Oral-Woman) 85.8 mg/kg/14 days- exposed to fertile non-pregnant females) Liver: tumors
intermittent: Gastrointestinal: nausea or vomiting, TDLo (Oral-Rat) 22,400 mg/kg: male 56 day(s) pre- TD (Oral-Mouse) 1680 mg/kg: Tumorigenic:
other changes mating: Reproductive: Paternal Effects: carcinogenic by RTECS criteria; Reproductive:
TDLo (Oral-Man) 1030 mg/kg/8 weeks: Peripheral spermatogenesis (incl. genetic material, sperm trans-placental tumorigenesis; Lungs, Thorax, or
Nerve and Sensation: paresthesis, structural morphology, motility, and count), testes, Respiration: tumors
change in nerve or sheath epididymis, sperm duct Cytogenetic Analysis (Unreported-Human) 86
TDLo (Oral-Human) 39,600 mg/kg/4 weeks- TDLo (Oral-Mouse) 6500 mg/kg/26 days- mg/kg/30 days
intermittent: Peripheral Nerve and Sensation: intermittent: Brain and Coverings: other Cytogenetic Analysis (Human-Lymphocyte) 500
sensory change involving peripheral nerve Sense degenerative changes; Nutritional and Gross mg/L
Organs and Special Senses (Taste): change in Metabolic: weight loss or decreased weight gain; Cytogenetic Analysis (Oral-Human) 250 mg/kg/10
function; Behavioral: headache Related to Chronic Data: death days-continuous
TDLo (Intravenous-Woman) 100 mg/kg/5 days: TDLo (Oral-Mouse) 181 g/kg/72 weeks-continuous: DNA Damage (Oral-Human) 214.3 mg/kg/10 days
intermittent: Behavioral: hallucinations, distorted Tumorigenic: carcinogenic by RTECS criteria; DNA Damage (Human-Lymphocyte) 10 mg/L/30
perceptions, toxic psychosis, irritability Lungs, Thorax, or Respiration: tumors; Blood: minutes
LD50 (Oral-Rat) 3 g/kg: Behavioral: somnolence lymphoma, including Hodgkin's disease Body Fluid Assay (Human Bacteria-Salmonella
(general depressed activity); Lungs, Thorax, or TDLo (Intraperitoneal-Rat) 1750 mg/kg: female 7 typhimurium) 10 mg/kg
Respiration: cyanosis Nutritional and Gross day(s) pre-mating: Reproductive: Fertility: post- Mutation in Microorganisms (Bacteria-Salmonella
Metabolic - body temperature decrease implantation mortality (e.g. dead and/or resorbed typhimurium) 25 礸/plate
LD50 (Oral-Mouse) 3800 mg/kg: Biochemical: implants per total number of implants) Mutation in Microorganisms (Bacteria-Salmonella
Enzyme inhibition, induction, or change in blood TDLo (Intraperitoneal-Mouse) 60 mg/kg: female 8- typhimurium) 50 礸/plate
or tissue levels: other oxidoreductases 14 day(s) after conception: Reproductive: Effects Mutation in Microorganisms (Bacteria-Escherichia
LD50 (Oral-Mammal) 2074 mg/kg on Fetus: fetal death; Specific Developmental coli) 100 祄ol/L
LD50 (Intraperitoneal-Rat) 870 mg/kg Abnormalities: other developmental abnormalities Mutation in Microorganisms (Bacteria-Escherichia
LD50 (Intraperitoneal-Mammal) 492 mg/kg TDLo (Unreported) 750 mg/kg: female 30 day(s) coli) 1 g/L
LD50 (Subcutaneous-Mouse) 3640 mg/kg: pre-mating: Reproductive: Maternal Effects: Mutation in Microorganisms (Bacteria-Klebsiella
Behavioral: somnolence (general depressed uterus, cervix, vagina pneumoniae) 20 祄ol/L/20 hours
activity), tremor, convulsions or effect on seizure TD (Oral-Rat) 27 g/kg/35 weeks-continuous: Mutation in Microorganisms (Bacteria-Salmonella
threshold Tumorigenic: equivocal tumorigenic agent by typhimurium) 156 礸/plate/20 minutes
TDLo (Oral-Rat) 2500 mg/kg: Reproductive: RTECS criteria; Skin and Appendages: tumors; Mutation in Microorganisms (Bacteria-Salmonella
Paternal Effects: testes, epididymis, sperm duct; Reproductive: Tumorigenic effects: uterine tumors typhimurium) 156 礸/plate/20 minutes
Related to Chronic Data: changes in testicular
weight
METRONIDAZOLE CREAM 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 5 OF 11
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
TOXICITY DATA (continued):
METRONIDAZOLE (continued): METRONIDAZOLE (continued): METRONIDAZOLE (continued):
Mutation in Microorganisms (Mold-Neurospora DNA Inhibition (Microorganism-Not Otherwise Body Fluid Assay (Rat Bacteria-Salmonella
crassa) 8800 mg/L Specified) 1 mg/L typhimurium) 800 mg/kg
Mutation in Microorganisms (Microorganism-Not DNA Inhibition (Microorganism-Not Otherwise Body Fluid Assay (Rat Bacteria-Salmonella
Otherwise Specified) 25 祄ol/L Specified) 5 mg/L typhimurium) 100 mg/kg
Mutation Test Systems-Not Otherwise Specified DNA Inhibition (Mouse-Lymphocyte) 30 mmol/L/1 Cytogenetic Analysis (Oral-Mouse) 1200 mg/kg
(Bacteria-Escherichia coli) 4 mg/L hour-continuous Cytogenetic Analysis (Hamster-Lung) 10 mmol/L
Mutation Test Systems-Not Otherwise Specified DNA Inhibition (Mouse Cells-Not Otherwise Sister Chromatid Exchange (Oral-Hamster) 125
(Microorganism-Not Otherwise Specified) 5 mg/L Specified) 100 mg/L mg/kg
DNA Repair (Bacteria-Escherichia coli) 200 礸/disc DNA Inhibition (Hamster-Lung) 1 mmol/L/6 days- Host-Mediated Assay (Mouse Bacteria-Salmonella
DNA Repair (Bacteria-Bacillus subtilis) 200 礸/disc continuous typhimurium) 400 mg/kg/5 days
DNA Adduct (Bacteria-Escherichia coli) 2 祄ol DNA Damage (Rat-Liver) 3 mmol/L Host-Mediated Assay (Mouse Bacteria-Escherichia
DNA Adduct (Mammal-Species Unspecified DNA Damage (Mouse-Lymphocyte) 30 mmol/L/4 coli) 4 mg/kg/2 hours
Lymphocyte) 60 祄ol/L hours-continuous Host-Mediated Assay (Mouse Yeast-
Phage Inhibition Capacity (Bacteria-Escherichia coli) DNA Damage (Mouse-Fibroblast) 300 祄ol/L Saccharomyces cerevisiae) 25 mmol/kg
500 礸/plate Host-Mediated Assay (Hamster-Embryo) 200 mg/kg
CARCINOGENIC INFORMATION: Metronidazole has shown evidence of carcinogenic activity in a number of studies
involving chronic, oral administration in mice and rats but not in studies involving hamsters.
The remaining components of this product are not found on the following lists: U.S. EPA, U.S. NTP, U.S. OSHA, U.S.
NIOSH, GERMAN MAK, IARC, or ACGIH and therefore are neither considered to be nor suspected to be cancer-
causing agents by these agencies.
REPRODUCTIVE TOXICITY INFORMATION: The active component of this product, Metronidazole is rated as
Pregnancy Category B (NO EVIDENCE OF RISK, Human evidence is negative, but animal evidence is positive.
Alternately, there is no human evidence and animal evidence is negative). Listed below is information concerning
the effects of this compound on animal or human reproductive systems.
Mutagenicity: Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a
dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in
chromosomal aberrations have been reported in patients with Crohn's disease who were treated with 200-1200 mg/day of
Metronidazole for 1 to 24 months; however, no excess chromosomal aberrations in circulating human lymphocytes have been
observed in patients treated for 8 months.
Embryotoxicity: The components of this product are not reported to cause human embryotoxic effects.
Teratogenicity: The components of this product are not reported to cause human teratogenic effects
Reproductive Toxicity: Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was
observed after oral Metronidazole in rats or mice.
A mutagen is a chemical that causes permanent changes to genetic material (DNA) such that the changes will propagate through generation lines. An
embryo toxin is a chemical that causes damage to a developing embryo (i.e. within the first eight weeks of pregnancy in humans), but the damage
does not propagate across generational lines. A teratogen is a chemical that causes damage to a developing fetus, but the damage does not
propagate across generational lines. A reproductive toxin is any substance that interferes in any way with the reproductive process.
ACGIH BIOLOGICAL EXPOSURE INDICES (BEIs): Currently, ACGIH Biological Exposure Indices (BEIs) have not
been determined for the components of this product.
12. ECOLOGICAL INFORMATION
ALL WORK PRACTICES MUST BE AIMED AT ELIMINATING ENVIRONMENTAL CONTAMINATION.
ENVIRONMENTAL STABILITY: The components of this product will slowly degrade in the environment and form a
variety of organic materials.
BENZYL ALCOHOL:
Persistence and Biodegradability: If released to air, a vapor pressure of 0.094 mm Hg at 25癈 indicates Benzyl Alcohol will exist solely as a vapor in the ambient
atmosphere. Vapor-phase Benzyl Alcohol will be degraded in the atmosphere by reaction with photochemically-produced hydroxyl radicals; the half-life for this
reaction in air is estimated to be 17 hours. If released to soil, Benzyl Alcohol is expected to have very high mobility based upon Koc values of less than 5 to 15
measured in various soils. Volatilization from moist soil surfaces is not expected to be an important fate process based upon an estimated Henry's Law constant of
3.1X10-7 atm-cu m/mole. Benzyl Alcohol is not expected to volatilize rapidly from dry soil surfaces based on its vapor pressure. Benzyl Alcohol is expected to
undergo biodegradation under both aerobic and anaerobic conditions based upon results in a number of aqueous biodegradation tests. If released into water,
Benzyl Alcohol is not expected to adsorb to suspended solids and sediment based upon the Koc data. Volatilization from water surfaces is not expected to be an
important fate process based upon this compound's estimated Henry's Law constant. Estimated volatilization half-lives for a model river and model lake are 75 days
and 2.2 years, respectively. An estimated BCF of 1 suggests the potential for bioconcentration in aquatic organisms is low. Hydrolysis is not expected to be an
important environmental fate process since Benzyl Alcohol lacks hydrolyzable functional groups.
Bioconcentration: An estimated BCF of 1 was calculated for Benzyl Alcohol, using a log Kow of 1.1 and a regression-derived equation. According to a classification
scheme, this BCF suggests the potential for bioconcentration in aquatic organisms is low.
Soil Adsorption/Mobility: Experimental Koc values for Benzyl Alcohol are < 5 for three different soils; Apison (0.11% organic carbon), Fullerton (0.06% organic carbon),
and Dormont (1.2% organic carbon). An experimental Koc of 15 was determined for Benzyl Alcohol on a red-brown Australian soil (1.09% organic carbon).
According to a classification scheme, these Koc values suggest that Benzyl Alcohol is expected to have very high mobility in soil.
GLYCERIN:
Persistence and Biodegradability: If released to soil, glycerin is expected to undergo rapid biodegradation under aerobic conditions. It is expected to display very high
mobility in soil and it is not expected to significantly volatilize to the atmosphere. If released to water, glycerin is expected to rapidly degrade under aerobic
conditions. Biodegradation in seawater and under anaerobic conditions is also expected. Glycerin is not expected to bioconcentrate is fish and aquatic organisms nor
is it expected to adsorb to sediment and suspended organic matter. Volatilization to the atmosphere is expected to be slower then for water itself. If released to the
atmosphere, Glycerin may undergo a gas-phase oxidation with photochemically produced hydroxyl radicals with a half-life of 33 hrs. It may also undergo
atmospheric removal by wet deposition processes.
Bioconcentration: Based on an experimental log octanol/water partition coefficient of -1.76 and its water solubility, 1,220,000 mg/L at 5癈, bioconcentration factors for
Glycerin can be estimated at 3 and 0.2, respectively, using regression-derived equations. The magnitude of these values indicate that bioconcentration of Glycerin in
fish and aquatic organisms will not be significant. Log KOW = -1.76.
METRONIDAZOLE CREAM 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 6 OF 11
Nycomed US Inc.
12. ECOLOGICAL INFORMATION (Continued)
ENVIRONMENTAL STABILITY (continued):
GLYCERIN (continued):
Soil Adsorption/Mobility: Based on an experimental log octanol/water partition coefficient of -1.76 and its water solubility, 1,220,000 mg/L at 5癈, soil adsorption
coefficients for Glycerin can be estimated at 3 and 2, respectively, using regression-derived equations. The magnitude of these values indicate that glycerin will
display very high mobility in soil.
ISOPROPYL PALMITATE:
Persistence and Biodegradability: If released to air, an estimated vapor pressure of 5.6X10-5 mm Hg at 25癈 indicates Isopropyl Palmitate will exist in both the vapor
and particulate phases in the ambient atmosphere. Vapor-phase Isopropyl Palmitate will be degraded in the atmosphere by reaction with photochemically-produced
hydroxyl radicals; the half-life for this reaction in air is estimated to be 17 hours. Particulate-phase Isopropyl Palmitate will be removed from the atmosphere by wet
and dry deposition. If released to soil, Isopropyl Palmitate is expected to have no mobility based upon an estimated KOC of 52,000. Volatilization from moist soil
surfaces is expected to be an important fate process based upon an estimated Henry's Law constant of 0.016 atm-cu m/mole. However, adsorption to soil is
expected to attenuate volatilization. Isopropyl Palmitate is expected to rapidly biodegrade in aerobic soils as suggested by the rapid biodegradation of structurally
similar long-chain fatty acid esters. If released into water, Isopropyl Palmitate is expected to adsorb to suspended solids and sediment in the water column based
upon the estimated Koc. Isopropyl Palmitate is expected to rapidly biodegrade in aerobic waters as suggested by the rapid biodegradation of structurally similar long-
chain fatty acid esters. Volatilization from water surfaces is expected to be an important fate process based upon this compound's estimated Henry's Law constant.
Estimated volatilization half-lives for a model river and model lake are 5 hours and 7 days, respectively. However, volatilization from water surfaces is expected to be
attenuated by adsorption to suspended solids and sediment in the water column. The volatilization half-life from a model pond is estimated to be about 61 hours
ignoring adsorption; when considering maximum adsorption the volatilization half-life increases to 15 months. An estimated BCF of 53 suggests the potential for
bioconcentration in aquatic organisms is moderate. An estimated base-catalyzed second-order hydrolysis rate constant of 0.021 L/mole-sec corresponds to half-lives
of 10 and 1 years at pH values of 7 and 8, respectively.
Bioconcentration: An estimated BCF of 53 was calculated for Isopropyl Palmitate using an estimated log KOW of 8.16 and a regression-derived equation. According to
a classification scheme, the estimated BCF suggests the potential for bioconcentration in aquatic organisms is moderate.
Soil Adsorption/Mobility: Using a structure estimation method based on molecular connectivity indices, the KOC for Isopropyl Palmitate can be estimated to be about
52,000. According to a classification scheme, this estimated KOC value suggests that Isopropyl Palmitate is expected to be immobile in soil.
SORBITOL:
Persistence and Biodegradability: If released to air, an estimated vapor pressure of 4.9X10-9 mm Hg at 25癈 indicates Sorbitol will exist in the particulate phase.
Particulate-phase Sorbitol will be removed from the atmosphere by wet and dry deposition. If released to soil, Sorbitol is expected to have very high mobility based
upon an estimated Koc of 2. Volatilization from moist soil surfaces is not expected to be an important fate process based upon an estimated Henry's Law constant of
7.3X10-13 atm-cu m/mole. Sorbitol is a simple sugar alcohol and should be readily biodegraded in the environment. If released into water, Sorbitol is not expected to
adsorb to suspended solids and sediment in the water column based upon the estimated Koc. Volatilization from water surfaces is not expected to be an important
fate process based upon this compound's estimated Henry's Law constant. An estimated BCF of 1 suggests bioconcentration in aquatic organisms is low.
Bioconcentration: An estimated BCF of 1 was calculated for Sorbitol, using a log Kow of -2.2 and a regression-derived equation. According to a classification scheme,
this BCF suggests the potential for bioconcentration in aquatic organisms is low.
Soil Adsorption/Mobility: The Koc of Sorbitol is estimated as approximately 2, using a log Kow of -2.2 and a regression-derived equation. According to a classification
scheme, this estimated Koc value suggests that Sorbitol is expected to have very high mobility in soil.
EFFECT OF MATERIAL ON PLANTS or ANIMALS: No specific information is currently available on the effect of this
product on plants or animals in the environment. This product may be harmful to contaminated plant and animal life,
especially in large quantities.
EFFECT OF CHEMICAL ON AQUATIC LIFE: No information is currently available on the effect of this product on
aquatic plants or animals in the environment. Release of this product to an aquatic environment may be harmful to
aquatic plant and animal life in contaminated bodies of water, especially in large quantities.
BENZYL ALCOHOL: BENZYL ALCOHOL (continued):
LC0 (Scenedesmus quadricauda) 96 hours = 640 ppm EC0 (Anabaena inaequalis) 3 hours = 30 mg/L
LC0 (Lepomis macrochirus bluegill sunfish) 24 hours = >5 mg/L EC0 (E. coli) 48 hours = 1,000 mg/L
LC0 (Leuciscus idus) 48 hours = 630 mg/L EC10 (Pseudomonas putida) 16 hours = 658 mg/L
LC0 (Salmo trutta) 24 hours = >5 mg/L EC50 (Photobacterium phosphoreum) 30 minutes = 71 mg/L
LC0 (Carassius auratus) 24 hours = > 5 mg/L EC50 (Photobacterium phosphoreum) 5 minutes = 50 mg/L
LC0 (Daphnia) 48 hours = 369 ppm EC50 (Scenedesmus quadricauda) 3 hours = 79 mg/L
LC50 (Pimephales promelas fathead minnows) 24 hours = 770 mg/L EC50 (Haematococcus pluvialis) 4 hours = 2,600 mg/L
LC50 (Pimephales promelas fathead minnows) 48 hours = 770 mg/L (static bioassay EC50 (Anabaena cylindrica) 3 hours = 90 mg/L
in Lake Superior water at 18-22癈) EC50 (Anabaena variabilis) 3 hours = 35 mg/L
LC50 (Pimephales promelas fathead minnows) 72 hours = 480 mg/L (static bioassay EC50 (Chlorella pyrenoidosa) 3 hours = 95 mg/L
in Lake Superior water at 18-22癈) (Lepomis macrochirus bluegill sunfish) static bioassay in fresh water at 23癈, mild
LC50 (Pimephales promelas fathead minnows) 96 hours = 460 mg/L (static bioassay aeration applied after 24 hours: 100% survival after 5 ppm/96 hours, 20% survival
in Lake Superior water at 18-22癈) after 18 ppm/96 hours, 20% survival after 32 ppm/48 hours
LC50 (Lepomis macrochirus bluegill sunfish) 96 hours = 10 ppm/L (static bioassay in (Menidia beryllina tidewater silverside fish) : static bioassay in synthetic seawater at
fresh water at 23癈, mild aeration after 24 hours) 23癈: mild aeration applied after 24 hours, 80% survival after 10 ppm/96 hours,
LC50 (Medina beryllina tidewater silverside fish) 96 hours = 15 ppm (static bioassay 20% survival after 32 ppm/96 hours
in synthetic seawater at 23癈, mild aeration after 24 hours) GLYCERIN:
LC50,S (Lepomis macrochirus bluegill sunfish) 96 hours = 10 mg/L EC0 (Pseudomonas putida bacteria) 16 hours = >10,000 mg/L
LC50, S (Medina beryllina tidewater silverside fish) 96 hours = 15 mg/L EC0 (Microcystis aeruginosa algae) 8 days = 2,900 mg/L
LC50 (Daphnia) 24 hours = 55; 400 mg/L EC0 (Scenedesmus quadricauda green algae) 7 days = > 10,000 mg/L
LC50 (Petromyzon marinus larvae) 24 hours = >5 mg/L EC0 (Entosiphon sulcatum protozoa) 72 hours = 3,200 mg/L
LC100 (Daphnia) 24 hours = 100 mg/L EC0 (Uronema parduczi Chatton-Lwoff protozoa) = > 10,000 mg/L
EC0 (Daphnia) 24 hours = 26; 300 mg/L LC50 (goldfish) 24 hours = > 5,000 mg/
ENVIRONMENTAL EXPOSURE CONTROLS: Controls should be engineered to prevent release to the environment,
including procedures to prevent spills, atmospheric release and release to waterways.
OTHER ADVERSE EFFECTS: No component of this product is known to have ozone depletion potential.
13. DISPOSAL CONSIDERATIONS
DISPOSAL METHODS: It is the responsibility of the generator to determine at the time of disposal whether the product
meets the criteria of a hazardous waste per regulations of the area in which the waste is generated and/or disposed of.
Waste disposal must be in accordance with appropriate Federal, State, and local regulations. This product, if unaltered
by use, may be disposed of by treatment at a permitted facility or as advised by your local hazardous waste regulatory
authority. Shipment of wastes must be done with appropriately permitted and registered transporters.
METRONIDAZOLE CREAM 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 7 OF 11
Nycomed US Inc.
13. DISPOSAL CONSIDERATIONS (Continued)
DISPOSAL CONTAINERS: Waste materials must be placed in and shipped in appropriate 5-gallon or 55-gallon poly or
metal waste pails or drums. Permeable cardboard containers are not appropriate and should not be used. Ensure that
any required marking or labeling of the containers be done to all applicable regulations.
PRECAUTIONS TO BE FOLLOWED DURING WASTE HANDLING: Wear proper protective equipment when handling
waste materials.
PREPARING WASTES FOR DISPOSAL: Waste disposal must be in accordance with appropriate U.S. Federal, State,
and local regulations or with regulations of Canada. This product, if unaltered by handling, may be disposed of by
treatment at a permitted facility or as advised by your local hazardous waste regulatory authority. All gowns, gloves,
and disposable materials used in the preparation or handling of this drug should be disposed of in accordance with
established hazardous waste disposal procedures. Handle as if capable of transmitting infectious agents.
Incineration is recommended. Reusable equipment should be cleaned with soap and water.
U.S. EPA WASTE NUMBER: Not applicable to wastes consisting only of this product.
14. TRANSPORTATION INFORMATION
U.S. DEPARTMENT OF TRANSPORTATION SHIPPING REGULATIONS: This product is not classified as hazardous
under regulations of U.S. DOT 49 CFR 172.101.
TRANSPORT CANADA TRANSPORTATION OF DANGEROUS GOODS REGULATIONS: This product is not
classified as Dangerous Goods, per regulations of Transport Canada.
15. REGULATORY INFORMATION
UNITED STATES REGULATIONS:
U.S. SARA REPORTING REQUIREMENTS: The components of this product are not subject to the reporting
requirements of Sections 302, 304, and 313 of Title III of the Superfund Amendments and Reauthorization Act.
U.S. SARA THRESHOLD PLANNING QUANTITY: There are no specific Threshold Planning Quantities for any
component of this product. The default Federal MSDS submission and inventory requirement filing threshold of 10,000
lb (4,540 kg) therefore applies, per 40 CFR 370.20.
U.S. CERCLA REPORTABLE QUANTITIES (RQ): Not applicable.
U.S. TSCA INVENTORY STATUS: This product is regulated by the Food and Drug Administration; it is not subject to
requirements under TSCA.
CALIFORNIA SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT (PROPOSITION 65): Metronidazole,
the active component of this product is on the Proposition 65 list. WARNING! This product contains a chemical
known to the State of California to cause cancer.
OTHER U.S. FEDERAL REGULATIONS: Not applicable.
ANSI LABELING (Based on 129.1, Provided to Summarize Occupational Exposure Hazards): CAUTION!
CONTAINS A SUSPECT CANCER HAZARD-MAY CAUSE CANCER. Cancer hazard depends on duration and
concentration of exposure. MAY CAUSE ALLERGIC REACTION. MAY CAUSE SKIN AND EYE IRRITATION. Avoid
contact with skin, eyes, and clothing. Wash thoroughly after handling. Wear gloves, goggles, and appropriate body
protection during handling or administration. FIRST-AID: In case of contact, flush skin or eyes with plenty of water. If
adverse respiratory reaction occurs from allergic reaction, give oxygen and seek immediate medical attention. If
ingested, DO NOT induce vomiting-seek immediate medical attention. IN CASE OF FIRE: Use water fog, dry
chemical, CO2, or "alcohol" foam. IN CASE OF SPILL: Wipe up spilled product. Place residual in appropriate
container and seal. Dispose of according to applicable regulations. Consult Material Safety Data Sheet for additional
information.
CANADIAN REGULATIONS:
CANADIAN DSL/NDSL INVENTORY STATUS: This product regulated by the Therapeutic Products Programme (TPP)
of Health Canada and so it exempt from requirements of the DSL/NDSL Inventory.
CANADIAN ENVIRONMENTAL PROTECTION ACT (CEPA) PRIORITIES SUBSTANCES LISTS: The components of
this product are not on the CEPA Priorities Substances Lists.
OTHER CANADIAN REGULATIONS: Not applicable.
CANADIAN WHMIS CLASSIFICATION AND SYMBOLS: Class D2A (Materials Causing Other Toxic Effects-Contains
an IARC-2B material in greater than 0.1%)
METRONIDAZOLE CREAM 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 8 OF 11
Nycomed US Inc.
16. OTHER INFORMATION
This Material Safety Data Sheet is offered pursuant to OSHA's Hazard Communication Standard, 29 CFR, 1910.1200. Other government regulations must be reviewed
for applicability to this product. To the best of Nycomed US Inc.'s knowledge, the information contained herein is reliable and accurate as of this date; however, accuracy,
suitability or completeness are not guaranteed and no warranties of any type, either express or implied, are provided. The information contained herein relates only to this
specific product. If this product is combined with other materials, all component properties must be considered. Data may be changed from time to time. Be sure to
consult the latest edition.
CHEMICAL SAFETY ASSOCIATES, Inc.
PREPARED BY:
PO Box 3519, La Mesa, CA 91944-3519
(800) 441-3365 / (619) 670-0609
May 14, 2009
DATE OF PRINTING:
DEFINITION OF TERMS
A large number of abbreviations and acronyms appear on a MSDS. Some of these, which are commonly used, include the following:
CAS #: This is the Chemical Abstract Service Number that uniquely identifies each EXPOSURE LIMITS IN AIR (continued):
constituent. TWA: Time Weighted Average exposure concentration for a conventional 8-hr
(TLV, PEL) or up to a 10-hr (REL) workday and a 40-hr workweek.
EXPOSURE LIMITS IN AIR:
CEILING LEVEL: The concentration that shall not be exceeded during any part of WEEL: Workplace Environmental Exposure Limits from the AIHA.
the working exposure. HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
DFG MAKs: Federal Republic of Germany Maximum Concentration Values in the RATINGS: This rating system was developed by the National Paint and Coating
workplace. Exposure limits are given as TWA (Time-Weighted Average) or PEAK Association and has been adopted by industry to identify the degree of chemical
(short-term exposure) values. hazards.
DFG MAK Germ Cell Mutagen Categories: 1: Germ cell mutagens that have HEALTH HAZARD: 0 Minimal Hazard: No significant health risk, irritation of skin or
been shown to increase the mutant frequency in the progeny of exposed humans. eyes not anticipated. Skin Irritation: Essentially non-irritating. Mechanical irritation
2: Germ cell mutagens that have been shown to increase the mutant frequency in may occur. PII or Draize = 0. Eye Irritation: Essentially non-irritating, minimal
the progeny of exposed mammals. 3A: Substances that have been shown to effects clearing in < 24 hours. Mechanical irritation may occur. Draize = 0. Oral
induce genetic damage in germ cells of human of animals, or which produce Toxicity LD50 Rat: > 5000 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 2000
mutagenic effects in somatic cells of mammals in vivo and have been shown to mg/kg. Inhalation Toxicity 4-hrs LC50 Rat: > 20 mg/L. 1 Slight Hazard: Minor
reach the germ cells in an active form. 3B: Substances that are suspected of reversible injury may occur; may irritate the stomach if swallowed; may defat the
being germ cell mutagens because of their genotoxic effects in mammalian skin and exacerbate existing dermatitis. Skin Irritation: Slightly or mildly irritating.
somatic cell in vivo; in exceptional cases, substances for which there are no in PII or Draize > 0 < 5. Eye Irritation: Slightly to mildly irritating, but reversible within
vivo data, but that are clearly mutagenic in vitro and structurally related to known 7 days. Draize > 0 25. Oral Toxicity LD50 Rat: > 500?000 mg/kg. Dermal
in vivo mutagens. 4: Not applicable (Category 4 carcinogenic substances are Toxicity LD50 Rat or Rabbit: > 1000?000 mg/kg. Inhalation Toxicity LC50 4-hrs
those with non-genotoxic mechanisms of action. By definition, germ cell mutagens Rat: > 2?0 mg/L. 2 Moderate Hazard: Temporary or transitory injury may occur;
are genotoxic. Therefore, a Category 4 for germ cell mutagens cannot apply. At prolonged exposure may affect the CNS. Skin Irritation: Moderately irritating;
some time in the future, it is conceivable that a Category 4 could be established primary irritant; sensitizer. PII or Draize 5, with no destruction of dermal tissue.
for genotoxic substances with primary targets other than DNA [e.g. purely Eye Irritation: Moderately to severely irritating; reversible corneal opacity; corneal
aneugenic substances] if research results make this seem sensible.) 5: Germ cell involvement or irritation clearing in 8?1 days. Draize = 26?00, with reversible
mutagens, the potency of which is considered to be so low that, provided the MAK effects. Oral Toxicity LD50 Rat: > 50?00 mg/kg. Dermal Toxicity LD50 Rat or
value is observed, their contribution to genetic risk for humans is expected not to Rabbit: > 200?000 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 0.5? mg/L. 3
be significant. Serious Hazard: Major injury likely unless prompt action is taken and medical
DFG MAK Pregnancy Risk Group Classification: Group A: A risk of damage to treatment is given; high level of toxicity; corrosive. Skin Irritation: Severely irritating
the developing embryo or fetus has been unequivocally demonstrated. Exposure and/or corrosive; may cause destruction of dermal tissue, skin burns, and dermal
of pregnant women can lead to damage of the developing organism, even when necrosis. PII or Draize > 5?, with destruction of tissue. Eye Irritation: Corrosive,
MAK and BAT (Biological Tolerance Value for Working Materials) values are irreversible destruction of ocular tissue; corneal involvement or irritation persisting
observed. Group B: Currently available information indicates a risk of damage to for more than 21 days. Draize > 80 with effects irreversible in 21 days. Oral
the developing embryo or fetus must be considered to be probable. Damage to Toxicity LD50 Rat: > 1?0 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 20?00
the developing organism cannot be excluded when pregnant women are exposed, mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 0.05?.5 mg/L. 4 Severe Hazard: Life-
even when MAK and BAT values are observed. Group C: There is no reason to threatening; major or permanent damage may result from single or repeated
fear a risk of damage to the developing embryo or fetus when MAK and BAT exposures; extremely toxic; irreversible injury may result from brief contact. Skin
values are observed. Group D: Classification in one of the groups A瑿 is not yet Irritation: Not appropriate. Do not rate as a 4, based on skin irritation alone. Eye
possible because, although the data available may indicate a trend, they are not Irritation: Not appropriate. Do not rate as a 4, based on eye irritation alone. Oral
sufficient for final evaluation. Toxicity LD50 Rat: 1 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: 20 mg/kg.
IDLH: Immediately Dangerous to Life and Health. This level represents a Inhalation Toxicity LC50 4-hrs Rat: 0.05 mg/L.
concentration from which one can escape within 30-minutes without suffering FLAMMABILITY HAZARD: 0 Minimal Hazard: Materials that will not burn in air
escape-preventing or permanent injury. when exposure to a temperature of 815.5癈 (1500癋) for a period of 5 minutes. 1
LOQ: Limit of Quantitation. Slight Hazard: Materials that must be pre-heated before ignition can occur.
NE: Not Established. When no exposure guidelines are established, an entry of Material requires considerable pre-heating, under all ambient temperature
NE is made for reference. conditions before ignition and combustion can occur. This usually includes the
NIC: Notice of Intended Change. following: Materials that will burn in air when exposed to a temperature of 815.5癈
NIOSH CEILING: The exposure that shall not be exceeded during any part of the (1500癋) for a period of 5 minutes or less; Liquids, solids and semisolids having a
workday. If instantaneous monitoring is not feasible, the ceiling shall be assumed flash point at or above 93.3癈 (200癋) (i.e. OSHA Class IIIB); and Most ordinary
as a 15-minute TWA exposure (unless otherwise specified) that shall not be combustible materials (e.g. wood, paper, etc.). 2 Moderate Hazard: Materials that
exceeded at any time during a workday. must be moderately heated or exposed to relatively high ambient temperatures
NIOSH RELs: NIOSH's Recommended Exposure Limits. before ignition can occur. Materials in this degree would not, under normal
PEL: OSHA's Permissible Exposure Limits. This exposure value means exactly conditions, form hazardous atmospheres in air, but under high ambient
the same as a TLV, except that it is enforceable by OSHA. The OSHA temperatures or moderate heating may release vapor in sufficient quantities to
Permissible Exposure Limits are based in the 1989 PELs and the June, 1993 Air produce hazardous atmospheres with air. This usually includes the following:
Contaminants Rule (Federal Register: 58: 35338-35351 and 58: 40191). Both the Liquids having a flash-point at or above 37.8癈 (100癋); Solid materials in the form
current PELs and the vacated PELs are indicated. The phrase, "Vacated 1989 of course dusts that may burn rapidly but that generally do not form explosive
PEL" is placed next to the PEL that was vacated by Court Order. atmospheres; Solid materials in a fibrous or shredded form that may burn rapidly
SKIN: Used when a there is a danger of cutaneous absorption. and create flash fire hazards (e.g. cotton, sisal, hemp); and Solids and semisolids
STEL: Short Term Exposure Limit, usually a 15-minute time-weighted average (e.g. viscous and slow flowing as asphalt) that readily give off flammable vapors.
(TWA) exposure that should not be exceeded at any time during a workday, even 3 Serious Hazard: Liquids and solids that can be ignited under almost all ambient
if the 8-hr TWA is within the TLV-TWA, PEL-TWA or REL-TWA. temperature conditions. Materials in this degree produce hazardous atmospheres
TLV: Threshold Limit Value. An airborne concentration of a substance that with air under almost all ambient temperatures, or, unaffected by ambient
represents conditions under which it is generally believed that nearly all workers temperature, are readily ignited under almost all conditions.
may be repeatedly exposed without adverse effect. The duration must be
considered, including the 8-hour.
METRONIDAZOLE CREAM 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 9 OF 11
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
RATINGS (continued): RATINGS (continued):
FLAMMABILITY HAZARD (continued): 3 (continued): This usually includes the PHYSICAL HAZARD (continued): 4 (continued): Compressed Gases: No Rating.
following: Liquids having a flash point below 22.8癈 (73癋) and having a boiling Pyrophorics: Add to the definition of Flammability 4. Oxidizers: No 4 rating.
point at or above 38癈 (100癋) and those liquids having a flash point at or above Unstable Reactives: Substances that may polymerize, decompose, condense, or
22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. OSHA Class IB and IC); Materials self-react at ambient temperature and/or pressure and have a high potential (or
that on account of their physical form or environmental conditions can form high risk) to cause significant heat generation or explosion.
explosive mixtures with air and are readily dispersed in air (e.g., dusts of NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS:
combustible solids, mists or droplets of flammable liquids); and Materials that burn HEALTH HAZARD: 0 Materials that, under emergency conditions, would offer no
extremely rapidly, usually by reason of self-contained oxygen (e.g. dry hazard beyond that of ordinary combustible materials. Gases and vapors with an
nitrocellulose and many organic peroxides). LC50 for acute inhalation toxicity greater than 10,000 ppm. Dusts and mists with an
4 Severe Hazard: Materials that will rapidly or completely vaporize at atmospheric LC50 for acute inhalation toxicity greater than 200 mg/L. Materials with an LD50 for
pressure and normal ambient temperature or that are readily dispersed in air, and acute dermal toxicity greater than 2000 mg/kg. Materials with an LD50 for acute
that will burn readily. This usually includes the following: Flammable gases; oral toxicity greater than 2000 mg/kg. Materials essentially non-irritating to the
Flammable cryogenic materials; Any liquid or gaseous material that is liquid while respiratory tract, eyes, and skin. 1 Materials that, under emergency conditions,
under pressure and has a flash point below 22.8癈 (73癋) and a boiling point can cause significant irritation. Gases and vapors with an LC50 for acute inhalation
below 37.8癈 (100癋) (i.e. OSHA Class IA); and Materials that ignite toxicity greater than 5,000 ppm but less than or equal to 10,000 ppm. Dusts and
spontaneously when exposed to air at a temperature of 54.4癈 (130癋) or below mists with an LC50 for acute inhalation toxicity greater than 10 mg/L but less than
(pyrophoric). or equal to 200 mg/L. Materials with an LD50 for acute dermal toxicity greater than
PHYSICAL HAZARD: 0 Water Reactivity: Materials that do not react with water. 1000 mg/kg but less than or equal to 2000 mg/kg. Materials that slightly to
Organic Peroxides: Materials that are normally stable, even under fire conditions moderately irritate the respiratory tract, eyes and skin. Materials with an LD50 for
and will not react with water. Explosives: Substances that are Non-Explosive. acute oral toxicity greater than 500 mg/kg but less than or equal to 2000 mg/kg. 2
Compressed Gases: No Rating. Pyrophorics: No Rating. Oxidizers: No 0 rating. Materials that, under emergency conditions, can cause temporary incapacitation
Unstable Reactives: Substances that will not polymerize, decompose, condense, or residual injury. Gases with an LC50 for acute inhalation toxicity greater than
or self-react.). 1 Water Reactivity: Materials that change or decompose upon 3,000 ppm but less than or equal to 5,000 ppm. Any liquid whose saturated vapor
exposure to moisture. Organic Peroxides: Materials that are normally stable, but concentration at 20癈 (68癋) is equal to or greater than one-fifth its LC50 for acute
can become unstable at high temperatures and pressures. These materials may inhalation toxicity, if its LC50 is less than or equal to 5000 ppm and that does not
react with water, but will not release energy violently. Explosives: Division 1.5 & meet the criteria for either degree of hazard 3 or degree of hazard 4. Dusts and
1.6 explosives. Substances that are very insensitive explosives or that do not have mists with an LC50 for acute inhalation toxicity greater than 2 mg/L but less than or
a mass explosion hazard. Compressed Gases: Pressure below OSHA definition. equal to 10 mg/L. Materials with an LD50 for acute dermal toxicity greater than 200
Pyrophorics: No Rating. Oxidizers: Packaging Group III oxidizers; Solids: any mg/kg but less than or equal to 1000 mg/kg. Compressed liquefied gases with
material that in either concentration tested, exhibits a mean burning time less than boiling points between -30癈 (-22癋) and -55癈 (-66.5癋) that cause severe tissue
or equal to the mean burning time of a 3:7 potassium bromate/cellulose mixture damage, depending on duration of exposure. Materials that are respiratory
and the criteria for Packing Group I and II are not met. Liquids: any material that irritants. Materials that cause severe, but reversible irritation to the eyes or are
exhibits a mean pressure rise time less than or equal to the pressure rise time of a lachrymators. Materials that are primary skin irritants or sensitizers. Materials
1:1 nitric acid (65%)/cellulose mixture and the criteria for Packing Group I and II whose LD50 for acute oral toxicity is greater than 50 mg/kg but less than or equal
are not met. Unstable Reactives: Substances that may decompose condense, or to 500 mg/kg. 3 Materials that, under emergency conditions, can cause serious or
self-react, but only under conditions of high temperature and/or pressure and have permanent injury. Gases with an LC50 for acute inhalation toxicity greater than
little or no potential to cause significant heat generation or explosion hazard. 1,000 ppm but less than or equal to 3,000 ppm. Any liquid whose saturated vapor
Substances that readily undergo hazardous polymerization in the absence of concentration at 20癈 (68癋) is equal to or greater its LC50 for acute inhalation
inhibitors. 2 Water Reactivity: Materials that may react violently with water. toxicity, if its LC50 is less than or equal to 3000 ppm and that does not meet the
Organic Peroxides: Materials that, in themselves, are normally unstable and will criteria for degree of hazard 4. Dusts and mists with an LC50 for acute inhalation
readily undergo violent chemical change, but will not detonate. These materials toxicity greater than 0.5 mg/L but less than or equal to 2 mg/L. Materials with an
may also react violently with water. Explosives: Division 1.4 explosives. Explosive LD50 for acute dermal toxicity greater than 40 mg/kg but less than or equal to 200
substances where the explosive effects are largely confined to the package and mg/kg. Materials that are corrosive to the respiratory tract. Materials that are
no projection of fragments of appreciable size or range are expected. An external corrosive to the eyes or cause irreversible corneal opacity. Materials corrosive to
fire must not cause virtually instantaneous explosion of almost the entire contents the skin. Cryogenic gases that cause frostbite and irreversible tissue damage.
of the package. Compressed Gases: Pressurized and meet OSHA definition but < Compressed liquefied gases with boiling points below -55癈 (-66.5癋) that cause
514.7 psi absolute at 21.1癈 (70癋) [500 psig]. Pyrophorics: No Rating. Oxidizers: frostbite and irreversible tissue damage. Materials with an LD50 for acute oral
Packing Group II oxidizers. Solids: any material that, either in concentration toxicity greater than 5 mg/kg but less than or equal to 50 mg/kg. 4 Materials that,
tested, exhibits a mean burning time of less than or equal to the mean burning under emergency conditions, can be lethal. Gases with an LC50 for acute
time of a 2:3 potassium bromate/cellulose mixture and the criteria for Packing inhalation toxicity less than or equal to 1,000 ppm. Any liquid whose saturated
Group I are not met. Liquids: any material that exhibits a mean pressure rise time vapor concentration at 20癈 (68癋) is equal to or greater than ten times its LC50 for
less than or equal to the pressure rise of a 1:1 aqueous sodium chlorate solution acute inhalation toxicity, if its LC50 is less than or equal to 1000 ppm. Dusts and
(40%)/cellulose mixture and the criteria for Packing Group I are not met. mists whose LC50 for acute inhalation toxicity is less than or equal to 0.5 mg/L.
Reactives: Substances that may polymerize, decompose, condense, or self-react Materials whose LD50 for acute dermal toxicity is less than or equal to 40 mg/kg.
at ambient temperature and/or pressure, but have a low potential (or low risk) for Materials whose LD50 for acute oral toxicity is less than or equal to 5 mg/kg.
significant heat generation or explosion. Substances that readily form peroxides FLAMMABILITY HAZARD: 0 Materials that will not burn under typical fire
upon exposure to air or oxygen at room temperature. 3 Water Reactivity: Materials conditions, including intrinsically noncombustible materials such as concrete,
that may form explosive reactions with water. Organic Peroxides: Materials that stone, and sand. Materials that will not burn in air when exposed to a temperature
are capable of detonation or explosive reaction, but require a strong initiating of 816癈 (1500癋) for a period of 5 minutes in according with Annex D of NFPA
source or must be heated under confinement before initiation; or materials that 704. 1 Materials that must be preheated before ignition can occur. Materials in this
react explosively with water. Explosives: Division 1.3 explosives. Explosive degree require considerable preheating, under all ambient temperature conditions,
substances that have a fire hazard and either a minor blast hazard or a minor before ignition and combustion can occur: Materials that will burn in air when
projection hazard or both, but do not have a mass explosion hazard. Compressed exposed to a temperature of 816癈 (1500癋) for a period of 5 minutes in according
Gases: Pressure 514.7 psi absolute at 21.1癈 (70癋) [500 psig]. Pyrophorics: No with Annex D of NFPA 704. Liquids, solids, and semisolids having a flash point at
Rating. Oxidizers: Packing Group I oxidizers. Solids: any material that, in either or above 93.4癈 (200癋) (i.e. Class IIIB liquids). Liquids with a flash point greater
concentration tested, exhibits a mean burning time less than the mean burning than 35癈 (95癋) that do not sustain combustion when tested using the Method of
time of a 3:2 potassium bromate/cellulose mixture. Liquids: any material that Testing for Sustained Combustibility, per 49 CFR 173, Appendix H or the UN
spontaneously ignites when mixed with cellulose in a 1:1 ratio, or which exhibits a Recommendations on the Transport of Dangerous Goods, Model Regulations
mean pressure rise time less than the pressure rise time of a 1:1 perchloric acid (current edition) and the related Manual of Tests and Criteria (current edition).
(50%)/cellulose mixture. Unstable Reactives: Substances that may polymerize, Liquids with a flash point greater than 35癈 (95癋) in a water-miscible solution or
decompose, condense, or self-react at ambient temperature and/or pressure and dispersion with a water non-combustible liquid/solid content of more than 85% by
have a moderate potential (or moderate risk) to cause significant heat generation weight. Liquids that have no fire point when tested by ASTM D 92, Standard Test
or explosion. 4 Water Reactivity: Materials that react explosively with water Method for Flash and Fire Points by Cleveland Open Cup, up to the boiling point
without requiring heat or confinement. Organic Peroxides: Materials that are of the liquid or up to a temperature at which the sample being tested shows an
readily capable of detonation or explosive decomposition at normal temperature obvious physical change. Combustible pellets with a representative diameter of
and pressures. Explosives: Division 1.1 & 1.2 explosives. Explosive substances greater than 2 mm (10 mesh). Most ordinary combustible materials. Solids
that have a mass explosion hazard or have a projection hazard. A mass explosion containing greater than 0.5% by weight of a flammable or combustible solvent are
is one that affects almost the entire load instantaneously. rated by the closed cup flash point of the solvent.
METRONIDAZOLE CREAM 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 10 OF 11
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS FLAMMABILITY LIMITS IN AIR:
(continued): Much of the information related to fire and explosion is derived from the National
FLAMMABILITY HAZARD (continued): 2 (continued): 2 Materials that must be Fire Protection Association (NFPA). Flash Point: Minimum temperature at which a
moderately heated or exposed to relatively high ambient temperatures before liquid gives off sufficient vapor to form an ignitable mixture with air near the
ignition can occur. Materials in this degree would not under normal conditions form surface of the liquid or within the test vessel used. Autoignition Temperature:
hazardous atmospheres with air, but under high ambient temperatures or under Minimum temperature of a solid, liquid, or gas required to initiate or cause self-
moderate heating could release vapor in sufficient quantities to produce sustained combustion in air with no other source of ignition. LEL: Lowest
hazardous atmospheres with air. Liquids having a flash point at or above 37.8癈 concentration of a flammable vapor or gas/air mixture that will ignite and burn with
(100癋) and below 93.4癈 (200癋) (i.e. Class II and Class IIIA liquids.) Solid a flame. UEL: Highest concentration of a flammable vapor or gas/air mixture that
materials in the form of powders or coarse dusts of representative diameter will ignite and burn with a flame.
between 420 microns (40 mesh) and 2 mm (10 mesh) that burn rapidly but that TOXICOLOGICAL INFORMATION:
generally do not form explosive mixtures with air. Solid materials in fibrous or Human and Animal Toxicology: Possible health hazards as derived from human
shredded form that burn rapidly and create flash fire hazards, such as cotton, data, animal studies, or from the results of studies with similar compounds are
sisal, and hemp. Solids and semisolids that readily give off flammable vapors. presented. LD50: Lethal Dose (solids & liquids) that kills 50% of the exposed
Solids containing greater than 0.5% by weight of a flammable or combustible animals. LC50: Lethal Concentration (gases) that kills 50% of the exposed animals.
solvent are rated by the closed cup flash point of the solvent. 3 Liquids and solids ppm: Concentration expressed in parts of material per million parts of air or water.
that can be ignited under almost all ambient temperature conditions. Materials in mg/m3: Concentration expressed in weight of substance per volume of air. mg/kg:
this degree produce hazardous atmospheres with air under almost all ambient Quantity of material, by weight, administered to a test subject, based on their body
temperatures or, though unaffected by ambient temperatures, are readily ignited weight in kg. TDLo: Lowest dose to cause a symptom. TCLo: Lowest
under almost all conditions. Liquids having a flash point below 22.8癈 (73癋) and concentration to cause a symptom. TDo, LDLo, and LDo, or TC, TCo, LCLo, and
having a boiling point at or above 37.8癈 (100癋) and those liquids having a flash LCo: Lowest dose (or concentration) to cause lethal or toxic effects. Cancer
point at or above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. Class IB and IC Information: IARC: International Agency for Research on Cancer. NTP: National
liquids). Materials that on account of their physical form or environmental Toxicology Program. RTECS: Registry of Toxic Effects of Chemical Substances.
conditions can form explosive mixtures with air and are readily dispersed in air. IARC and NTP rate chemicals on a scale of decreasing potential to cause human
Flammable or combustible dusts with representative diameter less than 420 cancer with rankings from 1 to 4. Subrankings (2A, 2B, etc.) are also used. Other
microns (40 mesh). Materials that burn with extreme rapidity, usually by reason of Information: BEI: ACGIH Biological Exposure Indices, represent the levels of
self-contained oxygen (e.g. dry nitrocellulose and many organic peroxides). Solids determinants which are most likely to be observed in specimens collected from a
containing greater than 0.5% by weight of a flammable or combustible solvent are healthy worker who has been exposed to chemicals to the same extent as a
rated by the closed cup flash point of the solvent. 4 Materials that will rapidly or worker with inhalation exposure to the TLV.
completely vaporize at atmospheric pressure and normal ambient temperature or ECOLOGICAL INFORMATION:
that are readily dispersed in air and will burn readily. Flammable gases. EC: Effect concentration in water. BCF: Bioconcentration Factor, which is used to
Flammable cryogenic materials. Any liquid or gaseous materials that is liquid while determine if a substance will concentrate in life forms that consume contaminated
under pressure and has a flash point below 22.8癈 (73癋) and a boiling point plant or animal matter. TLm: Median threshold limit. log KOW or log KOC: Coefficient
below 37.8癈 (100癋) (i.e. Class IA liquids). Materials that ignite when exposed to of Oil/Water Distribution is used to assess a substance's behavior in the
air, Solids containing greater than 0.5% by weight of a flammable or combustible environment.
solvent are rated by the closed cup flash point of the solvent.
REGULATORY INFORMATION:
INSTABILITY HAZARD: 0 Materials that in themselves are normally stable, even
U.S.:
under fire conditions. Materials that have an instantaneous power density (product
EPA: U.S. Environmental Protection Agency. ACGIH: American Conference of
of heat of reaction and reaction rate) at 250癈 (482癋) below 0.01 W/mL.
Governmental Industrial Hygienists, a professional association that establishes
Materials that do not exhibit an exotherm at temperatures less than or equal to
exposure limits. OSHA: U.S. Occupational Safety and Health Administration.
500癈 (932癋) when tested by differential scanning calorimetry. 1 Materials that in
NIOSH: National Institute of Occupational Safety and Health, which is the
themselves are normally stable, but that can become unstable at elevated
research arm of OSHA. DOT: U.S. Department of Transportation. TC: Transport
temperatures and pressures. Materials that have an instantaneous power density
Canada. SARA: Superfund Amendments and Reauthorization Act. TSCA: U.S.
(product of heat of reaction and reaction rate) at 250癈 (482癋) at or above 0.01
Toxic Substance Control Act. CERCLA: Comprehensive Environmental
W/mL and below 10 W/mL. 2 Materials that readily undergo violent chemical
Response, Compensation, and Liability Act. Marine Pollutant status according to
change at elevated temperatures and pressures. Materials that have an
the DOT; CERCLA or Superfund; and various state regulations. This section also
instantaneous power density (product of heat of reaction and reaction rate) at
includes information on the precautionary warnings that appear on the material's
250癈 (482癋) at or above 10 W/mL and below 100W/mL. 3 Materials that in
package label.
themselves are capable of detonation or explosive decomposition or explosive
CANADA:
reaction, but that require a strong initiating source or that must be heated under
WHMIS: Canadian Workplace Hazardous Materials Information System. TC:
confinement before initiation. Materials that have an estimated instantaneous
Transport Canada. DSL/NDSL: Canadian Domestic/Non-Domestic Substances
power density (product of heat of reaction and reaction rate) at 250癈 (482癋) at
List.
or above 100 W/mL and below 1000 W/mL. Materials that are sensitive to thermal
or mechanical shock at elevated temperatures and pressures. 4 Materials that in
themselves are readily capable of detonation or explosive decomposition or
explosive reaction at normal temperatures and pressures. Materials that are
sensitive to localized thermal or mechanical shock at normal temperatures and
pressures. Materials that have an estimated instantaneous power density (product
of heat of reaction and reaction rate) at 250癈 (482癋) of 1000 W/mL or greater.
METRONIDAZOLE CREAM 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 11 OF 11
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