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 Lotion 0.75%
Metronidazole Lotion
DESCRIPTION:
0168-0383-60
NDC #:
2-Methyl-5-nitroimidazole-1-ethanol
CHEMICAL NAME (for active ingredient):
Nitroimidazole
CHEMICAL FAMILY (for active ingredient):
0.75% Lotion
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 translucent, white to off-white, odorless lotion.
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
PEG 400 25322-68-3 Proprietary
Stearyl Alcohol 112-92-5 Proprietary
Glyceryl Stearate 123-94-4 Proprietary
PEG 100 Stearate 9004-99-3 Proprietary
Steareth-21 9005-00-9 Proprietary
Cyclomethicone 5 69430-24-6 Proprietary
Light Mineral Oil 8012-95-1 Proprietary
Glycerin 56-81-5 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).
METRONIDAZOLE LOTION 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 1 OF 11
Nycomed US Inc.
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.
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 a OTHER
known skin sensitizer so this product presents a contact hazard to
Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
firefighters. If heated to high temperatures for a prolonged period, the 3 = Serious 4 = Severe
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.
METRONIDAZOLE LOTION 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):
Large Spills (continued): 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.
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:
CHEMICAL NAME CAS # EXPOSURE LIMITS IN AIR
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
PEG 400 25322-68-3 NE NE NE NE NE NE NE DFG MAKs:
TWA = 1000 (Inhalable fraction)
PEAK = 8稭AK 15 min, average
value, 1-hr interval, 4 per shift
DFG MAK Pregnancy Risk
Classification: C
AIHA WEELs:
TWA = 10 (aerosol only)
Stearyl Alcohol 112-92-5 NE NE NE NE NE NE NE NE
Glyceryl Stearate 123-94-4 10 NE NE NE NE NE NE NE
(Exposure limits are for
Stearates)
PEG 100 Stearate 9004-99-3 10 NE NE NE NE NE NE NE
(Exposure limits are for
Stearates)
Steareth-21 9005-00-9 NE NE NE NE NE NE NE NE
Cyclomethicone 5 69430-24-6 NE NE NE NE NE NE NE NE
NE = Not Established. See Section 16 for Definitions of Terms Used.
METRONIDAZOLE LOTION 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 3 OF 11
Nycomed US Inc.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION (Continued)
EXPOSURE LIMITS/GUIDELINES (continued):
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
Light Mineral Oil 8012-95-1 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
fraction) [vacated
DFG MAK Pregnancy Risk
1989 PEL]
Classification: C
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.
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 @ 25癈 (water = 1): Approx. 1
ODOR THRESHOLD: Not established. pH: Approximately 5.
COEFFICIENT WATER/OIL DISTRIBUTION: Not established.
APPEARANCE AND COLOR: This product is a translucent, white to off-white, odorless lotion.
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 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 paragraphs describe the symptoms of exposure by route of exposure.
METRONIDAZOLE LOTION 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 4 OF 11
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
INHALATION: Inhalation of mists or sprays may slightly irritate the
nose, throat, and lungs. Symptoms are generally alleviated upon HAZARDOUS MATERIAL IDENTIFICAT IONSYSTEM
breathing fresh air.
CONTACT WITH SKIN or EYES: Skin contact can cause mild
(BLUE) 2*
HEALTH HAZARD
moderate irritation, which is alleviated upon rinsing with soap and
water. Due the presence of Benzyl Alcohol (a weak 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, FLAMMABI ITY HAZARD (RED) 0
L
welts and irritation. Eye contact may cause mild to moderate
irritation, redness, and tearing.
SKIN ABSORPTION: The Benzyl Alcohol component of this product
may be absorbed through the skin. Skin absorption is not expected to PHYSICAL HAZARD (YELLOW) 0
contribute significantly to overall exposure.
INGESTION: Ingestion is not a significant route of occupational
overexposure. Acute ingestion of large quantities of this product or
PROTECTIVE E QUIP MENT
chronic ingestion caused by poor hygiene practices may cause
adverse symptoms. Symptoms of ingestion overexposure may include
nausea, vomiting, loss of coordination, seizures, muscle weakness, EYES RESPIRATORY HANDS BODY
muscle atrophy, pain, and numbness.
INJECTION: Though not anticipated to be a significant route of SEE SECTION 8 SEE SECTION 8
overexposure for this product, injection (via punctures or lacerations by
contaminated objects) may cause redness at the site of injection.
For Routine In al Use and Han
dustri dling App lications
Symptoms may include those described for "Ingestion".
GENERAL TOXICITY INFORMATION: Metronidazole, the active Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
3 = Serious 4 = Severe * = Chronic hazard
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), 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-Woman) 85.8 mg/kg/14 days- TDLo (Intravenous-Woman) 100 mg/kg/5 days:
continuous: Mild intermittent: Gastrointestinal: nausea or vomiting, intermittent: Behavioral: hallucinations, distorted
TDLo (Oral-Woman) 40 mg/kg: Behavioral: other changes perceptions, toxic psychosis, irritability
hallucinations, distorted perceptions TDLo (Oral-Man) 1030 mg/kg/8 weeks: Peripheral LD50 (Oral-Rat) 3 g/kg: Behavioral: somnolence
TDLo (Oral-Woman) 12 mg/kg: Eye: effect, not Nerve and Sensation: paresthesis, structural (general depressed activity); Lungs, Thorax, or
otherwise specified, Behavioral: tremor change in nerve or sheath Respiration: cyanosis Nutritional and Gross
TDLo (Oral-Man) 3570 礸/kg/day: Liver: jaundice, TDLo (Oral-Human) 39,600 mg/kg/4 weeks- Metabolic - body temperature decrease
other or unclassified, other changes; Nutritional intermittent: Peripheral Nerve and Sensation: LD50 (Oral-Mouse) 3800 mg/kg: Biochemical:
and Gross Metabolic: body temperature increase sensory change involving peripheral nerve; Taste: Enzyme inhibition, induction, or change in blood
change in function; Behavioral: headache or tissue levels: other oxidoreductases
METRONIDAZOLE LOTION 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):
LD50 (Oral-Mammal) 2074 mg/kg TDLo (Unreported) 750 mg/kg: female 30 day(s) Mutation in Microorganisms (Bacteria-Salmonella
LD50 (Intraperitoneal-Rat) 870 mg/kg pre-mating: Reproductive: Maternal Effects: typhimurium) 156 礸/plate/20 minutes
LD50 (Intraperitoneal-Mammal) 492 mg/kg uterus, cervix, vagina Mutation in Microorganisms (Mold-Neurospora
LD50 (Subcutaneous-Mouse) 3640 mg/kg: TD (Oral-Rat) 27 g/kg/35 weeks-continuous: crassa) 8800 mg/L
Behavioral: somnolence (general depressed Tumorigenic: equivocal tumorigenic agent by Mutation in Microorganisms (Microorganism-Not
activity), tremor, convulsions or effect on seizure RTECS criteria; Skin and Appendages: tumors; Otherwise Specified) 25 祄ol/L
threshold Reproductive: Tumorigenic effects: uterine tumors Mutation Test Systems-Not Otherwise Specified
TDLo (Oral-Rat) 2500 mg/kg: Reproductive: TD (Oral-Rat) 3 g/kg/14 weeks-continuous: (Bacteria-Escherichia coli) 4 mg/L
Paternal Effects: testes, epididymis, sperm duct; Tumorigenic: neoplastic by RTECS criteria; Skin Mutation Test Systems-Not Otherwise Specified
Related to Chronic Data: changes in testicular and Appendages: tumors (Microorganism-Not Otherwise Specified) 5 mg/L
weight TD (Oral-Mouse) 8 g/kg/14 weeks-continuous: DNA Repair (Bacteria-Escherichia coli) 200 礸/disc
TDLo (Oral-Rat) 34 g/kg/34 days-continuous: Tumorigenic: neoplastic by RTECS criteria; DNA Repair (Bacteria-Bacillus subtilis) 200 礸/disc
Kidney/Ureter/Bladder: hematuria; Related to Lungs, Thorax, or Respiration: tumors; Blood: DNA Adduct (Bacteria-Escherichia coli) 2 祄ol
Chronic Data: death, changes in testicular weight lymphoma, including Hodgkin's disease DNA Adduct (Mammal-Species Unspecified
TDLo (Oral-Rat) 219 g/kg/2 years-continuous: TD (Oral-Mouse) 21,800 mg/kg/2 years-intermittent: Lymphocyte) 60 祄ol/L
Tumorigenic: carcinogenic by RTECS criteria; Tumorigenic: carcinogenic by RTECS criteria; Phage Inhibition Capacity (Bacteria-Escherichia coli)
Liver: tumors Skin and Appendages: tumors Liver: tumors 500 礸/plate
TDLo (Oral-Rat) 16,800 mg/kg: male 42 day(s) pre- TD (Oral-Mouse) 1680 mg/kg: Tumorigenic: DNA Inhibition (Microorganism-Not Otherwise
mating: Reproductive: Fertility: male fertility index carcinogenic by RTECS criteria; Reproductive: Specified) 1 mg/L
(e.g. # males impregnating females per # males trans-placental tumorigenesis; Lungs, Thorax, or DNA Inhibition (Microorganism-Not Otherwise
exposed to fertile non-pregnant females) Respiration: tumors Specified) 5 mg/L
TDLo (Oral-Rat) 22,400 mg/kg: male 56 day(s) pre- Cytogenetic Analysis (Unreported-Human) 86 DNA Inhibition (Mouse-Lymphocyte) 30 mmol/L/1
mating: Reproductive: Paternal Effects: mg/kg/30 days hour-continuous
spermatogenesis (incl. genetic material, sperm Cytogenetic Analysis (Human-Lymphocyte) 500 DNA Inhibition (Mouse Cells-Not Otherwise
morphology, motility, and count), testes, mg/L Specified) 100 mg/L
epididymis, sperm duct Cytogenetic Analysis (Oral-Human) 250 mg/kg/10 DNA Inhibition (Hamster-Lung) 1 mmol/L/6 days-
TDLo (Oral-Mouse) 6500 mg/kg/26 days- days-continuous continuous
intermittent: Brain and Coverings: other DNA Damage (Oral-Human) 214.3 mg/kg/10 days DNA Damage (Rat-Liver) 3 mmol/L
degenerative changes; Nutritional and Gross DNA Damage (Human-Lymphocyte) 10 mg/L/30 DNA Damage (Mouse-Lymphocyte) 30 mmol/L/4
Metabolic: weight loss or decreased weight gain; minutes hours-continuous
Related to Chronic Data: death Body Fluid Assay (Human Bacteria-Salmonella DNA Damage (Mouse-Fibroblast) 300 祄ol/L
TDLo (Oral-Mouse) 181 g/kg/72 weeks-continuous: typhimurium) 10 mg/kg Body Fluid Assay (Rat Bacteria-Salmonella
Tumorigenic: carcinogenic by RTECS criteria; Mutation in Microorganisms (Bacteria-Salmonella typhimurium) 800 mg/kg
Lungs, Thorax, or Respiration: tumors; Blood: typhimurium) 25 礸/plate Body Fluid Assay (Rat Bacteria-Salmonella
lymphoma, including Hodgkin's disease Mutation in Microorganisms (Bacteria-Salmonella typhimurium) 100 mg/kg
TDLo (Intraperitoneal-Rat) 1750 mg/kg: female 7 typhimurium) 50 礸/plate Cytogenetic Analysis (Oral-Mouse) 1200 mg/kg
day(s) pre-mating: Reproductive: Fertility: post- Mutation in Microorganisms (Bacteria-Escherichia Cytogenetic Analysis (Hamster-Lung) 10 mmol/L
implantation mortality (e.g. dead and/or resorbed coli) 100 祄ol/L Sister Chromatid Exchange (Oral-Hamster) 125
implants per total number of implants) Mutation in Microorganisms (Bacteria-Escherichia mg/kg
TDLo (Intraperitoneal-Mouse) 60 mg/kg: female 8- coli) 1 g/L Host-Mediated Assay (Mouse Bacteria-Salmonella
14 day(s) after conception: Reproductive: Effects Mutation in Microorganisms (Bacteria-Klebsiella typhimurium) 400 mg/kg/5 days
on Fetus: fetal death; Specific Developmental pneumoniae) 20 祄ol/L/20 hours Host-Mediated Assay (Mouse Bacteria-Escherichia
Abnormalities: other developmental abnormalities Mutation in Microorganisms (Bacteria-Salmonella coli) 4 mg/kg/2 hours
typhimurium) 156 礸/plate/20 minutes Host-Mediated Assay (Mouse Yeast-
Saccharomyces cerevisiae) 25 mmol/kg
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 incipient components of
this product are listed by agencies tracking the carcinogenic potential of chemical compounds, as follows:
GLYCERYL MONOSTEARATE (as a stearate compound): ACGIH TLV-A4 (Not Classifiable as Human Carcinogen);
MINERAL OIL: IARC-3 (Not Classifiable as to Carcinogenicity to Humans)
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: This product is not reported to cause human embryotoxic effects.
Teratogenicity: This product is 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.
METRONIDAZOLE LOTION 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 6 OF 11
Nycomed US Inc.
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.
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.
STEARYL ALCOHOL:
Persistence and Biodegradability: Based on a classification scheme, an estimated Koc value of 1.8X10+5, determined from a water solubility of 1.1X10-3 mg/L and a
regression-derived equation, indicates that Octadecanol is expected to be immobile in soil. Volatilization of Octadecanol from moist soil surfaces may be expected to
be an important fate process given an estimated Henry's Law constant of 8.41X10-4 atm-cu m/mole, derived from a vapor pressure of 2.7X10-6 mmHg at 25癈, and
its water solubility. However, adsorption to soil is expected to attenuate volatilization. Octadecanol is not expected to volatilize from dry soil surfaces based upon its
vapor pressure. Biodegradation of Octadecanol may be an important fate process in soil based on a mixed shake flask culture study. Based on a classification
scheme, an estimated Koc value of 1.8X10+5, determined from a water solubility of 1.1X10-3 mg/L and a regression-derived equation, indicates that Octadecanol is
expected to adsorb to suspended solids and sediments. Volatilization from water surfaces is expected based upon an estimated Henry's Law constant of 8.4X10-4
atm-cu m/mole, calculated from its water solubility and vapor pressure, 2.7X10-6 mmHg, values. Using this Henry's Law constant and an estimation method,
volatilization half-lives for a model river and model lake are 2.8 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. A percent theoretical oxygen demand value of 0.3 in 24-hrs using a Warburg test
suggests that biodegradation may not be an important fate process in water. According to a model of gas/particle partitioning of semi-volatile organic compounds in
the atmosphere, Octadecanol, which has a vapor pressure of 2.7X10-6 mm Hg at 25癈, will exist in both the vapor and particulate phases in the ambient
atmosphere. Vapor-phase Octadecanol is degraded in the atmosphere by reaction with photochemically-produced hydroxyl radicals; the half-life for this reaction in
air is estimated to be about 14 hours, calculated from its rate constant of 2.67X10-11 cu cm/molecule-sec at 25癈 that was derived using a structure estimation
method. Particulate-phase 1-Octadecanol may be removed from the air by wet or dry deposition. Using the Warburg test which employs activated sludge,
Octadecanol gave a theoretical oxygen demand of 0.3, 0.5, and 0.3 percent in 6, 12, and 24 hours. However, using an acclimated mixed shake flask culture with
incremental substrate addition of 1-octadecanol, biomass yield reached 54.5 percent after seven days. Given sufficient time in contact with adapted microbial
species under conditions otherwise non-limiting, the complete disappearance of 1-octadecanol as identifiable molecular species will occur.
Bioconcentration: An estimated BCF value of 2.8X10+4 was calculated for Octadecanol, using an experimental water solubility of 1.1X10-3 mg/L at 25癈 and a
recommended regression-derived equation. According to a classification scheme, this BCF suggests the potential for bioconcentration in aquatic organisms is very
high, provided the compound is not metabolized by the organism.
Soil Adsorption/Mobility: The Koc of Octadecanol is estimated as 1.8X10+5, using a water solubility of 1.1X10-3 mg/L at 25癈 and a regression-derived equation.
According to a classification scheme, this estimated Koc value suggests that 1-octadecanol is immobile 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 LC50 (Medina beryllina tidewater silverside fish) 96 hours = 15 ppm (static bioassay
LC0 (Lepomis macrochirus bluegill sunfish) 24 hours = >5 mg/L in synthetic seawater at 23癈, mild aeration after 24 hours)
LC0 (Leuciscus idus) 48 hours = 630 mg/L LC50,S (Lepomis macrochirus bluegill sunfish) 96 hours = 10 mg/L
LC0 (Salmo trutta) 24 hours = >5 mg/L LC50, S (Medina beryllina tidewater silverside fish) 96 hours = 15 mg/L
LC0 (Carassius auratus) 24 hours = > 5 mg/L LC50 (Daphnia) 24 hours = 55; 400 mg/L
LC0 (Daphnia) 48 hours = 369 ppm LC50 (Petromyzon marinus larvae) 24 hours = >5 mg/L
LC50 (Pimephales promelas fathead minnows) 24 hours = 770 mg/L LC100 (Daphnia) 24 hours = 100 mg/L
LC50 (Pimephales promelas fathead minnows) 48 hours = 770 mg/L (static bioassay EC0 (Daphnia) 24 hours = 26; 300 mg/L
in Lake Superior water at 18-22癈) EC0 (Anabaena inaequalis) 3 hours = 30 mg/L
LC50 (Pimephales promelas fathead minnows) 72 hours = 480 mg/L (static bioassay EC0 (E. coli) 48 hours = 1,000 mg/L
in Lake Superior water at 18-22癈) EC10 (Pseudomonas putida) 16 hours = 658 mg/L
LC50 (Pimephales promelas fathead minnows) 96 hours = 460 mg/L (static bioassay EC50 (Photobacterium phosphoreum) 30 minutes = 71 mg/L
in Lake Superior water at 18-22癈) EC50 (Photobacterium phosphoreum) 5 minutes = 50 mg/L
LC50 (Lepomis macrochirus bluegill sunfish) 96 hours = 10 ppm/L (static bioassay in EC50 (Scenedesmus quadricauda) 3 hours = 79 mg/L
fresh water at 23癈, mild aeration after 24 hours) EC50 (Haematococcus pluvialis) 4 hours = 2,600 mg/L
METRONIDAZOLE LOTION 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 7 OF 11
Nycomed US Inc.
12. ECOLOGICAL INFORMATION (Continued)
EFFECT OF CHEMICAL ON AQUATIC LIFE (continued):
BENZYL ALCOHOL (continued): GLYCERIN:
EC50 (Anabaena cylindrica) 3 hours = 90 mg/L EC0 (Pseudomonas putida bacteria) 16 hours = >10,000 mg/L
EC50 (Anabaena variabilis) 3 hours = 35 mg/L EC0 (Microcystis aeruginosa algae) 8 days = 2,900 mg/L
EC50 (Chlorella pyrenoidosa) 3 hours = 95 mg/L EC0 (Scenedesmus quadricauda green algae) 7 days = > 10,000 mg/L
(Lepomis macrochirus bluegill sunfish) static bioassay in fresh water at 23癈, mild EC0 (Entosiphon sulcatum protozoa) 72 hours = 3,200 mg/L
aeration applied after 24 hours: 100% survival after 5 ppm/96 hours, 20% survival EC0 (Uronema parduczi Chatton-Lwoff protozoa) = > 10,000 mg/L
after 18 ppm/96 hours, 20% survival after 32 ppm/48 hours LC50 (goldfish) 24 hours = > 5,000 mg/
(Menidia beryllina tidewater silverside fish) : static bioassay in synthetic seawater at STEARYL ALCOHOL:
23癈: mild aeration applied after 24 hours, 80% survival after 10 ppm/96 hours, NOEC (Streptococcus mutans bacteria) 24 hours = >3.3 mg/L
20% survival after 32 ppm/96 hours NOEC (Candida albicans fungi) 30 hours = 10 g/L
NOEC (Mucor mucedo fungi) 30 hours = 10 g/L
NOEC (Trichophyton mentagrophytes fungi) 5 days = 10 g/L
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.
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.
METRONIDAZOLE LOTION 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 8 OF 11
Nycomed US Inc.
15. REGULATORY INFORMATION (Continued)
UNITED STATES REGULATIONS (continued):
ANSI LABELING (continued): 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%)
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. IDLH: Immediately Dangerous to Life and Health. This level represents a
concentration from which one can escape within 30-minutes without suffering
EXPOSURE LIMITS IN AIR:
CEILING LEVEL: The concentration that shall not be exceeded during any part of escape-preventing or permanent injury.
the working exposure. LOQ: Limit of Quantitation.
DFG MAKs: Federal Republic of Germany Maximum Concentration Values in the NE: Not Established. When no exposure guidelines are established, an entry of
workplace. Exposure limits are given as TWA (Time-Weighted Average) or PEAK NE is made for reference.
(short-term exposure) values. NIC: Notice of Intended Change.
DFG MAK Germ Cell Mutagen Categories: 1: Germ cell mutagens that have NIOSH CEILING: The exposure that shall not be exceeded during any part of the
been shown to increase the mutant frequency in the progeny of exposed humans. workday. If instantaneous monitoring is not feasible, the ceiling shall be assumed
2: Germ cell mutagens that have been shown to increase the mutant frequency in as a 15-minute TWA exposure (unless otherwise specified) that shall not be
the progeny of exposed mammals. 3A: Substances that have been shown to exceeded at any time during a workday.
induce genetic damage in germ cells of human of animals, or which produce NIOSH RELs: NIOSH's Recommended Exposure Limits.
mutagenic effects in somatic cells of mammals in vivo and have been shown to PEL: OSHA's Permissible Exposure Limits. This exposure value means exactly
reach the germ cells in an active form. 3B: Substances that are suspected of the same as a TLV, except that it is enforceable by OSHA. The OSHA
being germ cell mutagens because of their genotoxic effects in mammalian Permissible Exposure Limits are based in the 1989 PELs and the June, 1993 Air
somatic cell in vivo; in exceptional cases, substances for which there are no in Contaminants Rule (Federal Register: 58: 35338-35351 and 58: 40191). Both the
vivo data, but that are clearly mutagenic in vitro and structurally related to known current PELs and the vacated PELs are indicated. The phrase, "Vacated 1989
in vivo mutagens. 4: Not applicable (Category 4 carcinogenic substances are PEL" is placed next to the PEL that was vacated by Court Order.
those with non-genotoxic mechanisms of action. By definition, germ cell mutagens SKIN: Used when a there is a danger of cutaneous absorption.
are genotoxic. Therefore, a Category 4 for germ cell mutagens cannot apply. At STEL: Short Term Exposure Limit, usually a 15-minute time-weighted average
some time in the future, it is conceivable that a Category 4 could be established (TWA) exposure that should not be exceeded at any time during a workday, even
for genotoxic substances with primary targets other than DNA [e.g. purely if the 8-hr TWA is within the TLV-TWA, PEL-TWA or REL-TWA.
aneugenic substances] if research results make this seem sensible.) 5: Germ cell TLV: Threshold Limit Value. An airborne concentration of a substance that
mutagens, the potency of which is considered to be so low that, provided the MAK represents conditions under which it is generally believed that nearly all workers
value is observed, their contribution to genetic risk for humans is expected not to may be repeatedly exposed without adverse effect. The duration must be
be significant. considered, including the 8-hour.
DFG MAK Pregnancy Risk Group Classification: Group A: A risk of damage to TWA: Time Weighted Average exposure concentration for a conventional 8-hr
the developing embryo or fetus has been unequivocally demonstrated. Exposure (TLV, PEL) or up to a 10-hr (REL) workday and a 40-hr workweek.
of pregnant women can lead to damage of the developing organism, even when WEEL: Workplace Environmental Exposure Limits from the AIHA.
MAK and BAT (Biological Tolerance Value for Working Materials) values are HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
observed. Group B: Currently available information indicates a risk of damage to RATINGS: This rating system was developed by the National Paint and Coating
the developing embryo or fetus must be considered to be probable. Damage to Association and has been adopted by industry to identify the degree of chemical
the developing organism cannot be excluded when pregnant women are exposed, hazards.
even when MAK and BAT values are observed. Group C: There is no reason to HEALTH HAZARD: 0 Minimal Hazard: No significant health risk, irritation of skin or
fear a risk of damage to the developing embryo or fetus when MAK and BAT eyes not anticipated. Skin Irritation: Essentially non-irritating. Mechanical irritation
values are observed. Group D: Classification in one of the groups A瑿 is not yet may occur. PII or Draize = 0. Eye Irritation: Essentially non-irritating, minimal
possible because, although the data available may indicate a trend, they are not effects clearing in < 24 hours. Mechanical irritation may occur. Draize = 0.
sufficient for final evaluation.
METRONIDAZOLE LOTION 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):
HEALTH HAZARD (continued): 0 (continued) Oral Toxicity LD50 Rat: > 5000 PHYSICAL HAZARD (continued): 1 (continued) Liquids: any material that exhibits
mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 2000 mg/kg. Inhalation Toxicity 4-hrs a mean pressure rise time less than or equal to the pressure rise time of a 1:1
LC50 Rat: > 20 mg/L. 1 Slight Hazard: Minor reversible injury may occur; may nitric acid (65%)/cellulose mixture and the criteria for Packing Group I and II are
irritate the stomach if swallowed; may defat the skin and exacerbate existing not met. Unstable Reactives: Substances that may decompose condense, or self-
dermatitis. Skin Irritation: Slightly or mildly irritating. PII or Draize > 0 < 5. Eye react, but only under conditions of high temperature and/or pressure and have
Irritation: Slightly to mildly irritating, but reversible within 7 days. Draize > 0 25. little or no potential to cause significant heat generation or explosion hazard.
Oral Toxicity LD50 Rat: > 500?000 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > Substances that readily undergo hazardous polymerization in the absence of
1000?000 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 2?0 mg/L. 2 Moderate inhibitors. 2 Water Reactivity: Materials that may react violently with water.
Hazard: Temporary or transitory injury may occur; prolonged exposure may affect Organic Peroxides: Materials that, in themselves, are normally unstable and will
the CNS. Skin Irritation: Moderately irritating; primary irritant; sensitizer. PII or readily undergo violent chemical change, but will not detonate. These materials
Draize 5, with no destruction of dermal tissue. Eye Irritation: Moderately to may also react violently with water. Explosives: Division 1.4 explosives. Explosive
severely irritating; reversible corneal opacity; corneal involvement or irritation substances where the explosive effects are largely confined to the package and
clearing in 8?1 days. Draize = 26?00, with reversible effects. Oral Toxicity LD50 no projection of fragments of appreciable size or range are expected. An external
Rat: > 50?00 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 200?000 mg/kg. fire must not cause virtually instantaneous explosion of almost the entire contents
Inhalation Toxicity LC50 4-hrs Rat: > 0.5? mg/L. 3 Serious Hazard: Major injury of the package. Compressed Gases: Pressurized and meet OSHA definition but <
likely unless prompt action is taken and medical treatment is given; high level of 514.7 psi absolute at 21.1癈 (70癋) [500 psig]. Pyrophorics: No Rating. Oxidizers:
toxicity; corrosive. Skin Irritation: Severely irritating and/or corrosive; may cause Packing Group II oxidizers. Solids: any material that, either in concentration
destruction of dermal tissue, skin burns, and dermal necrosis. PII or Draize > 5?, tested, exhibits a mean burning time of less than or equal to the mean burning
with destruction of tissue. Eye Irritation: Corrosive, irreversible destruction of time of a 2:3 potassium bromate/cellulose mixture and the criteria for Packing
ocular tissue; corneal involvement or irritation persisting for more than 21 days. Group I are not met. Liquids: any material that exhibits a mean pressure rise time
Draize > 80 with effects irreversible in 21 days. Oral Toxicity LD50 Rat: > 1?0 less than or equal to the pressure rise of a 1:1 aqueous sodium chlorate solution
mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 20?00 mg/kg. Inhalation Toxicity (40%)/cellulose mixture and the criteria for Packing Group I are not met.
LC50 4-hrs Rat: > 0.05?.5 mg/L. 4 Severe Hazard: Life-threatening; major or Reactives: Substances that may polymerize, decompose, condense, or self-react
permanent damage may result from single or repeated exposures; extremely at ambient temperature and/or pressure, but have a low potential (or low risk) for
toxic; irreversible injury may result from brief contact. Skin Irritation: Not significant heat generation or explosion. Substances that readily form peroxides
appropriate. Do not rate as a 4, based on skin irritation alone. Eye Irritation: Not upon exposure to air or oxygen at room temperature. 3 Water Reactivity: Materials
appropriate. Do not rate as a 4, based on eye irritation alone. Oral Toxicity LD50 that may form explosive reactions with water. Organic Peroxides: Materials that
Rat: 1 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: 20 mg/kg. Inhalation Toxicity are capable of detonation or explosive reaction, but require a strong initiating
LC50 4-hrs Rat: 0.05 mg/L. source or must be heated under confinement before initiation; or materials that
FLAMMABILITY HAZARD: 0 Minimal Hazard: Materials that will not burn in air react explosively with water. Explosives: Division 1.3 explosives. Explosive
when exposure to a temperature of 815.5癈 (1500癋) for a period of 5 minutes. 1 substances that have a fire hazard and either a minor blast hazard or a minor
Slight Hazard: Materials that must be pre-heated before ignition can occur. projection hazard or both, but do not have a mass explosion hazard. Compressed
Material requires considerable pre-heating, under all ambient temperature Gases: Pressure 514.7 psi absolute at 21.1癈 (70癋) [500 psig]. Pyrophorics: No
conditions before ignition and combustion can occur. This usually includes the Rating. Oxidizers: Packing Group I oxidizers. Solids: any material that, in either
following: Materials that will burn in air when exposed to a temperature of 815.5癈 concentration tested, exhibits a mean burning time less than the mean burning
(1500癋) for a period of 5 minutes or less; Liquids, solids and semisolids having a time of a 3:2 potassium bromate/cellulose mixture. Liquids: any material that
flash point at or above 93.3癈 (200癋) (i.e. OSHA Class IIIB); and Most ordinary spontaneously ignites when mixed with cellulose in a 1:1 ratio, or which exhibits a
combustible materials (e.g. wood, paper, etc.). 2 Moderate Hazard: Materials that mean pressure rise time less than the pressure rise time of a 1:1 perchloric acid
must be moderately heated or exposed to relatively high ambient temperatures (50%)/cellulose mixture. Unstable Reactives: Substances that may polymerize,
before ignition can occur. Materials in this degree would not, under normal decompose, condense, or self-react at ambient temperature and/or pressure and
conditions, form hazardous atmospheres in air, but under high ambient have a moderate potential (or moderate risk) to cause significant heat generation
temperatures or moderate heating may release vapor in sufficient quantities to or explosion. 4 Water Reactivity: Materials that react explosively with water
produce hazardous atmospheres with air. This usually includes the following: without requiring heat or confinement. Organic Peroxides: Materials that are
Liquids having a flash-point at or above 37.8癈 (100癋); Solid materials in the form readily capable of detonation or explosive decomposition at normal temperature
of course dusts that may burn rapidly but that generally do not form explosive and pressures. Explosives: Division 1.1 & 1.2 explosives. Explosive substances
atmospheres; Solid materials in a fibrous or shredded form that may burn rapidly that have a mass explosion hazard or have a projection hazard. A mass explosion
and create flash fire hazards (e.g. cotton, sisal, hemp); and Solids and semisolids is one that affects almost the entire load instantaneously. Compressed Gases: No
(e.g. viscous and slow flowing as asphalt) that readily give off flammable vapors. Rating. Pyrophorics: Add to the definition of Flammability 4. Oxidizers: No 4 rating.
3 Serious Hazard: Liquids and solids that can be ignited under almost all ambient Unstable Reactives: Substances that may polymerize, decompose, condense, or
temperature conditions. Materials in this degree produce hazardous atmospheres self-react at ambient temperature and/or pressure and have a high potential (or
with air under almost all ambient temperatures, or, unaffected by ambient high risk) to cause significant heat generation or explosion.
temperature, are readily ignited under almost all conditions. This usually includes NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS:
the following: Liquids having a flash point below 22.8癈 (73癋) and having a HEALTH HAZARD: 0 Materials that, under emergency conditions, would offer no
boiling point at or above 38癈 (100癋) and those liquids having a flash point at or hazard beyond that of ordinary combustible materials. Gases and vapors with an
above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. OSHA Class IB and IC); LC50 for acute inhalation toxicity greater than 10,000 ppm. Dusts and mists with an
Materials that on account of their physical form or environmental conditions can LC50 for acute inhalation toxicity greater than 200 mg/L. Materials with an LD50 for
form explosive mixtures with air and are readily dispersed in air (e.g., dusts of acute dermal toxicity greater than 2000 mg/kg. Materials with an LD50 for acute
combustible solids, mists or droplets of flammable liquids); and Materials that burn oral toxicity greater than 2000 mg/kg. Materials essentially non-irritating to the
extremely rapidly, usually by reason of self-contained oxygen (e.g. dry respiratory tract, eyes, and skin. 1 Materials that, under emergency conditions,
nitrocellulose and many organic peroxides). 4 Severe Hazard: Materials that will can cause significant irritation. Gases and vapors with an LC50 for acute inhalation
rapidly or completely vaporize at atmospheric pressure and normal ambient toxicity greater than 5,000 ppm but less than or equal to 10,000 ppm. Dusts and
temperature or that are readily dispersed in air, and that will burn readily. This mists with an LC50 for acute inhalation toxicity greater than 10 mg/L but less than
usually includes the following: Flammable gases; Flammable cryogenic materials; or equal to 200 mg/L. Materials with an LD50 for acute dermal toxicity greater than
Any liquid or gaseous material that is liquid while under pressure and has a flash 1000 mg/kg but less than or equal to 2000 mg/kg. Materials that slightly to
point below 22.8癈 (73癋) and a boiling point below 37.8癈 (100癋) (i.e. OSHA moderately irritate the respiratory tract, eyes and skin. Materials with an LD50 for
Class IA); and Materials that ignite spontaneously when exposed to air at a acute oral toxicity greater than 500 mg/kg but less than or equal to 2000 mg/kg. 2
temperature of 54.4癈 (130癋) or below (pyrophoric). Materials that, under emergency conditions, can cause temporary incapacitation
PHYSICAL HAZARD: 0 Water Reactivity: Materials that do not react with water. or residual injury. Gases with an LC50 for acute inhalation toxicity greater than
Organic Peroxides: Materials that are normally stable, even under fire conditions 3,000 ppm but less than or equal to 5,000 ppm. Any liquid whose saturated vapor
and will not react with water. Explosives: Substances that are Non-Explosive. concentration at 20癈 (68癋) is equal to or greater than one-fifth its LC50 for acute
Compressed Gases: No Rating. Pyrophorics: No Rating. Oxidizers: No 0 rating. inhalation toxicity, if its LC50 is less than or equal to 5000 ppm and that does not
Unstable Reactives: Substances that will not polymerize, decompose, condense, meet the criteria for either degree of hazard 3 or degree of hazard 4. Dusts and
or self-react.). 1 Water Reactivity: Materials that change or decompose upon mists with an LC50 for acute inhalation toxicity greater than 2 mg/L but less than or
exposure to moisture. Organic Peroxides: Materials that are normally stable, but equal to 10 mg/L. Materials with an LD50 for acute dermal toxicity greater than 200
can become unstable at high temperatures and pressures. These materials may mg/kg but less than or equal to 1000 mg/kg. Compressed liquefied gases with
react with water, but will not release energy violently. Explosives: Division 1.5 & boiling points between -30癈 (-22癋) and -55癈 (-66.5癋) that cause severe tissue
1.6 explosives. Substances that are very insensitive explosives or that do not have damage, depending on duration of exposure. Materials that are respiratory
a mass explosion hazard. Compressed Gases: Pressure below OSHA definition. irritants. Materials that cause severe, but reversible irritation to the eyes or are
Pyrophorics: No Rating. Oxidizers: Packaging Group III oxidizers; Solids: any lachrymators. Materials that are primary skin irritants or sensitizers. Materials
material that in either concentration tested, exhibits a mean burning time less than whose LD50 for acute oral toxicity is greater than 50 mg/kg but less than or equal
or equal to the mean burning time of a 3:7 potassium bromate/cellulose mixture to 500 mg/kg.
and the criteria for Packing Group I and II are not met.
METRONIDAZOLE LOTION 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 NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS
(continued): (continued):
HEALTH HAZARD (continued): 3 Materials that, under emergency conditions, can INSTABILITY HAZARD: 0 Materials that in themselves are normally stable, even
cause serious or permanent injury. Gases with an LC50 for acute inhalation toxicity under fire conditions. Materials that have an instantaneous power density (product
greater than 1,000 ppm but less than or equal to 3,000 ppm. Any liquid whose of heat of reaction and reaction rate) at 250癈 (482癋) below 0.01 W/mL.
saturated vapor concentration at 20癈 (68癋) is equal to or greater its LC50 for Materials that do not exhibit an exotherm at temperatures less than or equal to
acute inhalation toxicity, if its LC50 is less than or equal to 3000 ppm and that does 500癈 (932癋) when tested by differential scanning calorimetry. 1 Materials that in
not meet the criteria for degree of hazard 4. Dusts and mists with an LC50 for acute themselves are normally stable, but that can become unstable at elevated
inhalation toxicity greater than 0.5 mg/L but less than or equal to 2 mg/L. temperatures and pressures. Materials that have an instantaneous power density
Materials with an LD50 for acute dermal toxicity greater than 40 mg/kg but less (product of heat of reaction and reaction rate) at 250癈 (482癋) at or above 0.01
than or equal to 200 mg/kg. Materials that are corrosive to the respiratory tract. W/mL and below 10 W/mL. 2 Materials that readily undergo violent chemical
Materials that are corrosive to the eyes or cause irreversible corneal opacity. change at elevated temperatures and pressures. Materials that have an
Materials corrosive to the skin. Cryogenic gases that cause frostbite and instantaneous power density (product of heat of reaction and reaction rate) at
irreversible tissue damage. Compressed liquefied gases with boiling points below 250癈 (482癋) at or above 10 W/mL and below 100W/mL. 3 Materials that in
-55癈 (-66.5癋) that cause frostbite and irreversible tissue damage. Materials with themselves are capable of detonation or explosive decomposition or explosive
an LD50 for acute oral toxicity greater than 5 mg/kg but less than or equal to 50 reaction, but that require a strong initiating source or that must be heated under
mg/kg. 4 Materials that, under emergency conditions, can be lethal. Gases with an confinement before initiation. Materials that have an estimated instantaneous
LC50 for acute inhalation toxicity less than or equal to 1,000 ppm. Any liquid whose power density (product of heat of reaction and reaction rate) at 250癈 (482癋) at
saturated vapor concentration at 20癈 (68癋) is equal to or greater than ten times or above 100 W/mL and below 1000 W/mL. Materials that are sensitive to thermal
its LC50 for acute inhalation toxicity, if its LC50 is less than or equal to 1000 ppm. or mechanical shock at elevated temperatures and pressures. 4 Materials that in
Dusts and mists whose LC50 for acute inhalation toxicity is less than or equal to themselves are readily capable of detonation or explosive decomposition or
0.5 mg/L. Materials whose LD50 for acute dermal toxicity is less than or equal to 40 explosive reaction at normal temperatures and pressures. Materials that are
mg/kg. Materials whose LD50 for acute oral toxicity is less than or equal to 5 sensitive to localized thermal or mechanical shock at normal temperatures and
mg/kg. pressures. Materials that have an estimated instantaneous power density (product
FLAMMABILITY HAZARD: 0 Materials that will not burn under typical fire of heat of reaction and reaction rate) at 250癈 (482癋) of 1000 W/mL or greater.
conditions, including intrinsically noncombustible materials such as concrete, FLAMMABILITY LIMITS IN AIR:
stone, and sand. Materials that will not burn in air when exposed to a temperature Much of the information related to fire and explosion is derived from the National
of 816癈 (1500癋) for a period of 5 minutes in according with Annex D of NFPA Fire Protection Association (NFPA). Flash Point: Minimum temperature at which a
704. 1 Materials that must be preheated before ignition can occur. Materials in this liquid gives off sufficient vapor to form an ignitable mixture with air near the
degree require considerable preheating, under all ambient temperature conditions, surface of the liquid or within the test vessel used. Autoignition Temperature:
before ignition and combustion can occur: Materials that will burn in air when Minimum temperature of a solid, liquid, or gas required to initiate or cause self-
exposed to a temperature of 816癈 (1500癋) for a period of 5 minutes in according sustained combustion in air with no other source of ignition. LEL: Lowest
with Annex D of NFPA 704. Liquids, solids, and semisolids having a flash point at concentration of a flammable vapor or gas/air mixture that will ignite and burn with
or above 93.4癈 (200癋) (i.e. Class IIIB liquids). Liquids with a flash point greater a flame. UEL: Highest concentration of a flammable vapor or gas/air mixture that
than 35癈 (95癋) that do not sustain combustion when tested using the Method of will ignite and burn with a flame.
Testing for Sustained Combustibility, per 49 CFR 173, Appendix H or the UN
TOXICOLOGICAL INFORMATION:
Recommendations on the Transport of Dangerous Goods, Model Regulations
Human and Animal Toxicology: Possible health hazards as derived from human
(current edition) and the related Manual of Tests and Criteria (current edition).
data, animal studies, or from the results of studies with similar compounds are
Liquids with a flash point greater than 35癈 (95癋) in a water-miscible solution or
presented. LD50: Lethal Dose (solids & liquids) that kills 50% of the exposed
dispersion with a water non-combustible liquid/solid content of more than 85% by
animals. LC50: Lethal Concentration (gases) that kills 50% of the exposed animals.
weight. Liquids that have no fire point when tested by ASTM D 92, Standard Test
ppm: Concentration expressed in parts of material per million parts of air or water.
Method for Flash and Fire Points by Cleveland Open Cup, up to the boiling point
mg/m3: Concentration expressed in weight of substance per volume of air. mg/kg:
of the liquid or up to a temperature at which the sample being tested shows an
Quantity of material, by weight, administered to a test subject, based on their body
obvious physical change. Combustible pellets with a representative diameter of
weight in kg. TDLo: Lowest dose to cause a symptom. TCLo: Lowest
greater than 2 mm (10 mesh). Most ordinary combustible materials. Solids
concentration to cause a symptom. TDo, LDLo, and LDo, or TC, TCo, LCLo, and
containing greater than 0.5% by weight of a flammable or combustible solvent are
LCo: Lowest dose (or concentration) to cause lethal or toxic effects. Cancer
rated by the closed cup flash point of the solvent. 2 Materials that must be
Information: IARC: International Agency for Research on Cancer. NTP: National
moderately heated or exposed to relatively high ambient temperatures before
Toxicology Program. RTECS: Registry of Toxic Effects of Chemical Substances.
ignition can occur. Materials in this degree would not under normal conditions form
IARC and NTP rate chemicals on a scale of decreasing potential to cause human
hazardous atmospheres with air, but under high ambient temperatures or under
cancer with rankings from 1 to 4. Subrankings (2A, 2B, etc.) are also used. Other
moderate heating could release vapor in sufficient quantities to produce
Information: BEI: ACGIH Biological Exposure Indices, represent the levels of
hazardous atmospheres with air. Liquids having a flash point at or above 37.8癈
determinants which are most likely to be observed in specimens collected from a
(100癋) and below 93.4癈 (200癋) (i.e. Class II and Class IIIA liquids.) Solid
healthy worker who has been exposed to chemicals to the same extent as a
materials in the form of powders or coarse dusts of representative diameter
worker with inhalation exposure to the TLV.
between 420 microns (40 mesh) and 2 mm (10 mesh) that burn rapidly but that
ECOLOGICAL INFORMATION:
generally do not form explosive mixtures with air. Solid materials in fibrous or
EC: Effect concentration in water. BCF: Bioconcentration Factor, which is used to
shredded form that burn rapidly and create flash fire hazards, such as cotton,
determine if a substance will concentrate in life forms that consume contaminated
sisal, and hemp. Solids and semisolids that readily give off flammable vapors.
plant or animal matter. TLm: Median threshold limit. log KOW or log KOC: Coefficient
Solids containing greater than 0.5% by weight of a flammable or combustible
of Oil/Water Distribution is used to assess a substance's behavior in the
solvent are rated by the closed cup flash point of the solvent. 3 Liquids and solids
environment.
that can be ignited under almost all ambient temperature conditions. Materials in
REGULATORY INFORMATION:
this degree produce hazardous atmospheres with air under almost all ambient
U.S.:
temperatures or, though unaffected by ambient temperatures, are readily ignited
EPA: U.S. Environmental Protection Agency. ACGIH: American Conference of
under almost all conditions. Liquids having a flash point below 22.8癈 (73癋) and
Governmental Industrial Hygienists, a professional association that establishes
having a boiling point at or above 37.8癈 (100癋) and those liquids having a flash
exposure limits. OSHA: U.S. Occupational Safety and Health Administration.
point at or above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. Class IB and IC
NIOSH: National Institute of Occupational Safety and Health, which is the
liquids). Materials that on account of their physical form or environmental
research arm of OSHA. DOT: U.S. Department of Transportation. TC: Transport
conditions can form explosive mixtures with air and are readily dispersed in air.
Canada. SARA: Superfund Amendments and Reauthorization Act. TSCA: U.S.
Flammable or combustible dusts with representative diameter less than 420
Toxic Substance Control Act. CERCLA: Comprehensive Environmental
microns (40 mesh). Materials that burn with extreme rapidity, usually by reason of
Response, Compensation, and Liability Act. Marine Pollutant status according to
self-contained oxygen (e.g. dry nitrocellulose and many organic peroxides). Solids
the DOT; CERCLA or Superfund; and various state regulations. This section also
containing greater than 0.5% by weight of a flammable or combustible solvent are
includes information on the precautionary warnings that appear on the material's
rated by the closed cup flash point of the solvent. 4 Materials that will rapidly or
package label.
completely vaporize at atmospheric pressure and normal ambient temperature or
CANADA:
that are readily dispersed in air and will burn readily. Flammable gases.
WHMIS: Canadian Workplace Hazardous Materials Information System. TC:
Flammable cryogenic materials. Any liquid or gaseous materials that is liquid while
Transport Canada. DSL/NDSL: Canadian Domestic/Non-Domestic Substances
under pressure and has a flash point below 22.8癈 (73癋) and a boiling point
List.
below 37.8癈 (100癋) (i.e. Class IA liquids). Materials that ignite when exposed to
air, Solids containing greater than 0.5% by weight of a flammable or combustible
solvent are rated by the closed cup flash point of the solvent.
METRONIDAZOLE LOTION 0.75% MSDS EFFECTIVE DATE: JULY 22, 2008
PAGE 11 OF 11
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