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: Ciclopirox Cream 0.77%
Ciclopirox Cream
DESCRIPTION:
0168-0313-15; 0168-0313-30; 0168-0313-90
NDC #:
6-Cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, 2-
CHEMICAL NAME (for active ingredient):
Aminoethanol Salt
Substituted Pyridinone
CHEMICAL FAMILY (for active ingredient):
0.77% Cream
HOW SUPPLIED:
C12H17NO2稢2H7NO
FORMULA (for active ingredient):
Pharmaceutical for Human Use
PRODUCT USE:
SUPPLIER/MANUFACTURER'S NAME: NYCOMED US INC.
60 Baylis Road
ADDRESS:
Melville, NY 11747-0103
1-631-454-7677
BUSINESS PHONE/GENERAL MSDS INFORMATION:
EMERGENCY PHONE (U.S./Canada/Puerto Rico): 1-800-424-9300 (24-hrs)
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 white to off-white, smooth, odorless cream.
Health Hazards: The primary health hazard associated with occupational exposure to this product is the potential
for irritation of contaminated eyes and mild irritation of contaminated skin, especially if contamination is repeated.
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: Large quantities released to the 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
Ciclopirox Olamine 41621-49-2 0.77%
Benzyl Alcohol 100-51-6 Proprietary
Sorbitan Monostearate 1338-41-6 Proprietary
Myristyl Alcohol 112-72-1 Proprietary
Polysorbate 60 9005-67-8 Proprietary
Cocamide DEA 68155-06-6 Proprietary
Mineral Oil 8042-47-5 Proprietary
Cetyl Alcohol 124-29-8 Proprietary
Stearyl Alcohol 112-92-5 Proprietary
Octyldodecanol 5333-42-6 Proprietary
Water and other components. Each of the other components is present in less The remaining components do not contribute any significant Balance
additional hazards.
than 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.
SKIN EXPOSURE: If adverse skin effects occur, discontinue use. Seek medical attention.
CICLOPIROX CREAM 0.77% EFFECTIVE DATE: MAY 30, 2008
PAGE 1 OF 10
Nycomed US Inc.
4 FIRST-AID MEASURES (Continued)
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: Conditions including dermatitis and unusual or allergic
reaction to Ciclopirox may be aggravated by therapeutic use of this product. Regular visits to physician to check
progress during therapy should be scheduled.
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 flammable.
AUTOIGNITION TEMPERATURE: Not established. NFPA RATING
FLAMMABLE LIMITS (in air by volume, %):
FLAM MAB ILITY
Lower (LEL): Not applicable.
Upper (UEL): Not applicable.
Use extinguishing media 0
FIRE EXTINGUISHING MATERIALS:
appropriate for surrounding fire.
1 0
Water Spray: OK Carbon Dioxide: OK HEALTH INSTAB ILITY
Foam: OK Dry Chemical: OK
Halon: OK Other: Any "ABC" Class
FIRE EXTINGUISHING MATERIALS NOT TO BE USED: None known.
UNUSUAL FIRE AND EXPLOSION HAZARDS: When involved in a fire, OTHER
this material may ignite and produce irritating vapors and toxic gases
(e.g., carbon oxides and nitrogen oxides). Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
Explosion Sensitivity to Mechanical Impact: Not sensitive. 3 = Serious 4 = Severe
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.
The dispersal of mists or sprays into surrounding air and the possibility of inhalation 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.
Decontaminate the area of the spill thoroughly using detergent and water. Place all spill residue in an appropriate
container and seal. Dispose of in accordance with applicable Federal, State, and local procedures (see Section 13,
Disposal Considerations).
CICLOPIROX CREAM 0.77% EFFECTIVE DATE: MAY 30, 2008
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Nycomed US Inc.
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. Avoid breathing vapors or mists
generated by this product. Use in a well-ventilated location. 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
Ciclopirox Olamine 41621-49-2 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
Sorbitan Monostearate 1338-41-6 10 NE NE NE NE NE NE NE
(Exposure limits are for Stearates)
Myristyl Alcohol 112-72-1 NE NE NE NE NE NE NE NE
Polysorbate 60 9005-67-8 NE NE NE NE NE NE NE NE
Cocamide DEA 68155-06-6 NE NE NE NE NE NE NE NE
Mineral Oil 8042-47-5 NE NE NE NE NE NE NE NE
Cetyl Alcohol 124-29-8 NE NE NE NE NE NE NE NE
Stearyl Alcohol 112-92-5 NE NE NE NE NE NE NE NE
Octyldodecanol 5333-42-6 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.
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.
CICLOPIROX CREAM 0.77% EFFECTIVE DATE: MAY 30, 2008
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Nycomed US Inc.
9. PHYSICAL and CHEMICAL PROPERTIES
BOILING POINT: Not established. FREEZING/MELTING POINT: Not established.
EVAPORATION RATE (nBuAc = 1): Not established. SOLUBILITY IN WATER: Soluble.
VAPOR PRESSURE (air = 1): Not established. SPECIFIC GRAVITY @ 50癈 (water = 1): Approx. 0.94
ODOR THRESHOLD: Not established. pH: 5?
COEFFICIENT WATER/OIL DISTRIBUTION: Not established.
APPEARANCE AND COLOR: This product is a white to off-white, smooth, odorless cream.
HOW TO DETECT THIS SUBSTANCE (warning properties): The appearance and odor of this product are
distinguishing characteristics to identify the product in event of accidental release.
10. STABILITY and REACTIVITY
STABILITY: This product is stable.
DECOMPOSITION PRODUCTS: If exposed to extremely high temperatures, thermal decomposition may generate
irritating fumes and toxic gases (e.g., carbon oxides and nitrogen oxides).
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 HAZARDOUS MATERIAL IDENTIFICATION SYSTEM
employees handling this product in an occupational setting. This product is
designed for application on the skin. The following paragraphs describe
(BLUE) 1
HEALTH HAZARD
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.
FLAMMABILITY HAZARD (RED) 0
CONTACT WITH SKIN or EYES: Skin contact may cause mild irritation,
which is alleviated upon rinsing with soap and water. Sensitive
individuals may have a localized allergic skin contact reaction to
Ciclopirox. Prolonged or repeated skin overexposures can cause PHYSICAL HAZARD (YELLOW) 0
dermatitis (dry red skin). Eye contact can cause irritation, stinging,
redness, and tearing.
SKIN ABSORPTION: The Benzyl Alcohol component of this product may PROTECTIVE EQUIPMENT
be absorbed through the skin. Skin absorption is not expected to
contribute significantly to overall exposure. EYES HANDS BODY
RE SPIRATORY
INGESTION: Ingestion is not a significant route of occupational
overexposure. Acute ingestion of large quantities of this product or S SE
EE CTION 8 SE SEC
E TION 8
chronic ingestion caused by poor hygiene practices may cause adverse
symptoms. Symptoms of ingestion overexposure may include nausea, For Routine Industrial Use and Handling Applications
vomiting, diarrhea, and respiratory distress.
Though not anticipated to be a significant route of
INJECTION: Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
overexposure for this product, injection (via punctures or lacerations by 3 = Serious 4 = Severe * = Chronic hazard
contaminated objects) may cause redness at the site of injection.
Symptoms may include those described for "General Toxicity Information".
GENERAL TOXICITY INFORMATION: Individuals who have had allergic reactions to products containing the
Ciclopirox component of this product or any other components of this product may experience allergic reactions to
this product. Symptoms described in patients given therapeutic doses of this substance include the following.
For Males and Females: Persons using the product in therapeutic doses have experienced burning sensation,
contact dermatitis, itching, dry skin, acne, rash, hair loss, pain, and facial swelling.
IRRITANCY OF PRODUCT: This product may mildly to moderately irritate contaminated tissue.
SENSITIZATION OF PRODUCT: Sensitive individuals may have a localized allergic skin contact reaction to
Ciclopirox. 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 redness, itching, welts, and irritation.
CICLOPIROX CREAM 0.77% EFFECTIVE DATE: MAY 30, 2008
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Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
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 be harmful. Inhalation of vapors in a poorly ventilated
space can cause central nervous system effects. Eye contact will cause irritation.
Chronic: Prolonged or repeated skin exposures can cause dermatitis (dry, red skin).
TARGET ORGANS:
Acute: Occupational Exposure: Skin, central nervous system. Therapeutic Doses: Skin.
Chronic: Occupational Exposure: Skin. Therapeutic Doses: Skin, endocrine system.
TOXICITY DATA: The toxicity data available for the active component of this product, Ciclopirox, are 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.
CICLOPIROX OLAMINE: CICLOPIROX OLAMINE (continued): CICLOPIROX OLAMINE (continued):
LD50 (Oral-Rat) 2350 mg/kg LD50 (Intraperitoneal-Rat) 146 mg/kg; Behavioral: LD50 (Intravenous-Mouse) 71 mg/kg; Behavioral:
LD50 (Oral-Mouse) 1740 mg/kg changes in motor activity (specific assay); Lungs, changes in motor activity (specific assay); Lungs,
LD50 (Oral-Rabbit) > 3065 mg/kg Thorax, or Respiration: dyspnea; Nutritional and Thorax, or Respiration: dyspnea; Nutritional and
LD50 (Subcutaneous-Rat) > 2500 mg/kg Gross Metabolic: body temperature decrease Gross Metabolic: body temperature decrease
LD50 (Subcutaneous-Mouse) 1730 mg/kg LD50 (Intraperitoneal-Mouse) 83 mg/kg; Behavioral: TDLo (Oral-Rat) 2800 mg/kg/4 weeks/continuous;
LD50 (Intravenous-Rat) 72 mg/kg changes in motor activity (specific assay); Lungs, Liver: other changes; Gastrointestinal: other
Thorax, or Respiration: dyspnea; Nutritional and changes; Related to Chronic Data: death
Gross Metabolic: body temperature decrease TDLo (Skin-Dog) 1456 mg/kg/26 weeks/intermittent;
Skin and Appendages: dermatitis, other (after
systemic exposure
CARCINOGENIC INFORMATION: A carcinogenicity study of Ciclopirox (1% and 5% solutions in polyethylene glycol
400) in female mice dosed topically twice per week for 50 weeks followed by a 6-month drug-free observation period
prior to necropsy revealed no evidence of tumors at the application sites. The incipient components of this product
are listed by agencies tracking the carcinogenic potential of chemical compounds, as follows:
SORBITAN MONOSTEARATE (as a stearate compound): ACGIH TLV-A4 (Not Classifiable as Human Carcinogen);
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, Ciclopirox, 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 Ciclopirox on human and animal reproductive systems.
Mutagenicity: The following in vitro genotoxicity tests have been conducted with Ciclopirox: evaluation of gene mutation in Ames
Salmonella and E. coli assays (negative); chromosome aberration assays in V79 Chinese hamster lung fibroblasts, with and
without metabolic activation (positive); gene mutation assay in the HGPRT-test with V79 Chinese hamster lung fibroblasts
(negative); unscheduled DNA synthesis in human A549 cells (negative); and BALB/c3T3 cell transformation assay (negative). In
an in vivo Chinese hamster bone marrow cytogenetic assay, Ciclopirox was negative for chromosome aberrations at 5,000
mg/kg. In addition, in vitro genotoxicity tests were conducted with Ciclopirox Topical Solution, 8%: Ames Salmonella test
(negative); unscheduled DNA synthesis in the rat hepatocytes (negative); cell transformation assay in BALB/c3T3 cell assay
(positive). The positive response of the lacquer formulation in the BALB/c3T3 test was attributed to its butyl monoester of
poly[methylvinyl ether/maleic acid] resin component, which also tested positive in this test. The cell transformation assay may
have been confounded because of the film-forming nature of the resin. The butyl monoester of poly[methylvinyl ether/maleic
acid] resin component tested non-mutagenic in both the in vitro mouse lymphoma forward mutation assay with or without
activation and unscheduled DNA synthesis assay in rat hepatocytes.
Embryotoxicity: This product is not reported to cause human embryotoxic effects.
Teratogenicity: Teratology studies in mice, rats, rabbits, and monkeys at oral doses of up to 77, 23, 23, or 38.5 mg, respectively,
of Ciclopirox as ciclopirox olamine/kg/day (14, 8, 17, and 28 times MRHTD), or in rats and rabbits receiving topical doses of up
to 92.4 and 77 mg/kg/day, respectively (33 and 55 times MRHTD), did not indicate any significant fetal malformations.
Reproductive Toxicity: Oral reproduction studies in rats at doses up to 3.85 mg Ciclopirox (as ciclopirox olamine)/kg/day
[equivalent to approximately 1.4 times the potential exposure at the maximum recommended human topical dose (MRHTD)] did
not reveal any specific effects on fertility or other reproductive parameters. MRHTD (mg/m2) is based on the assumption of
100% systemic absorption of 27.12 mg Ciclopirox (~340 mg Ciclopirox Topical Solution, 8%) that will cover all the fingernails
and toenails including 5 mm proximal and lateral fold area plus onycholysis to a maximal extent of 50%.
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 been
determined for components of this product.
CICLOPIROX CREAM 0.77% EFFECTIVE DATE: MAY 30, 2008
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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. The following environmental data are available for the components of this product:
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.
CETYL ALCOHOL:
Persistence and Biodegradability: If released to air, a vapor pressure of 6X10-6 mm Hg at 25癈 indicates Cetyl Alcohol will exist in both the vapor and particulate
phases in the atmosphere. Vapor-phase Cetyl 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 16 hours. Particulate-phase Cetyl Alcohol will be removed from the atmosphere by wet or dry deposition. If released to soil,
Cetyl Alcohol is expected to have no mobility based upon an estimated Koc of 25,000. Volatilization from moist soil surfaces is expected to be an important fate
process based upon an estimated Henry's Law constant of 4.6X10-2 atm-cu m/mole. However, adsorption to soil is expected to attenuate volatilization. Various
biological screening studies have demonstrated that Cetyl Alcohol biodegrades both aerobically and anaerobically. If released into water, Cetyl Alcohol is expected to
adsorb to suspended solids and sediment based upon the estimated Koc. 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 23 hours and 12 days, respectively.
However, volatilization from water surfaces is expected to be attenuated by adsorption to suspended solids and sediment in the water column. The estimated
volatilization half-life from a model pond is 1.8 years if adsorption is considered. An observed BCF of 56 suggests bioconcentration in aquatic organisms is
moderate. Hydrolysis is not expected to be an important environmental fate process since this compound lacks functional groups that hydrolyze under environmental
conditions.
Bioconcentration: In a 3-day static exposure study using golden orfe fish (Leuciscus idus melanotus), a Cetyl Alcohol bioconcentration factor (BCF) of 56 was
observed. According to a classification scheme, this BCF suggests the potential for bioconcentration in aquatic organisms is moderate, provided the compound is
not metabolized by the organism. A 24-hr BCF of 17000 was observed in algae (Chlorella fusca)
Soil Adsorption/Mobility: The Koc of Cetyl Alcohol is estimated as 25,000(SRC), using a water solubility of 4.122X10-2(1) and a regression-derived equation.
According to a classification scheme(3), this estimated Koc value suggests that Cetyl Alcohol is expected to be immobile 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: 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. The following aquatic
toxicity data are available for the components of this product:
BENZYL ALCOHOL: BENZYL ALCOHOL (continued):
LC0 (Scenedesmus quadricauda) 96 hours = 640 ppm LC50 (Lepomis macrochirus bluegill sunfish) 96 hours = 10 ppm/L (static bioassay in fresh
LC0 (Lepomis macrochirus bluegill sunfish) 24 hours = >5 mg/L water at 23癈, mild aeration after 24 hours)
LC0 (Leuciscus idus) 48 hours = 630 mg/L LC50 (Medina beryllina tidewater silverside fish) 96 hours = 15 ppm (static bioassay in
LC0 (Salmo trutta) 24 hours = >5 mg/L synthetic seawater at 23癈, mild aeration after 24 hours)
LC0 (Carassius auratus) 24 hours = > 5 mg/L LC50,S (Lepomis macrochirus bluegill sunfish) 96 hours = 10 mg/L
LC0 (Daphnia) 48 hours = 369 ppm LC50, S (Medina beryllina tidewater silverside fish) 96 hours = 15 mg/L
LC50 (Pimephales promelas fathead minnows) 24 hours = 770 mg/L LC50 (Daphnia) 24 hours = 55; 400 mg/L
LC50 (Pimephales promelas fathead minnows) 48 hours = 770 mg/L (static bioassay in LC50 (Petromyzon marinus larvae) 24 hours = >5 mg/L
Lake Superior water at 18-22癈) LC100 (Daphnia) 24 hours = 100 mg/L
LC50 (Pimephales promelas fathead minnows) 72 hours = 480 mg/L (static bioassay in EC0 (Daphnia) 24 hours = 26; 300 mg/L
Lake Superior water at 18-22癈) EC0 (Anabaena inaequalis) 3 hours = 30 mg/L
LC50 (Pimephales promelas fathead minnows) 96 hours = 460 mg/L (static bioassay in EC0 (E. coli) 48 hours = 1,000 mg/L
Lake Superior water at 18-22癈) EC10 (Pseudomonas putida) 16 hours = 658 mg/L
CICLOPIROX CREAM 0.77% EFFECTIVE DATE: MAY 30, 2008
PAGE 6 OF 10
Nycomed US Inc.
12. ECOLOGICAL INFORMATION (Continued)
EFFECT OF CHEMICAL ON AQUATIC LIFE (continued):
BENZYL ALCOHOL (continued): BENZYL ALCOHOL (continued):
EC50 (Photobacterium phosphoreum) 30 minutes = 71 mg/L (Menidia beryllina tidewater silverside fish) : static bioassay in synthetic seawater at
EC50 (Photobacterium phosphoreum) 5 minutes = 50 mg/L 23癈: mild aeration applied after 24 hours, 80% survival after 10 ppm/96 hours,
EC50 (Scenedesmus quadricauda) 3 hours = 79 mg/L 20% survival after 32 ppm/96 hours
EC50 (Haematococcus pluvialis) 4 hours = 2,600 mg/L CETYL ALCOHOL:
EC50 (Anabaena cylindrica) 3 hours = 90 mg/L EC50 (Scenedesmus subspicatus Algae) 72 hours = 676 mg/L; Effect: cell
EC50 (Anabaena variabilis) 3 hours = 35 mg/L multiplication inhibition test
EC50 (Chlorella pyrenoidosa) 3 hours = 95 mg/L STEARYL ALCOHOL:
(Lepomis macrochirus bluegill sunfish) static bioassay in fresh water at 23癈, mild NOEC (Streptococcus mutans bacteria) 24 hours = >3.3 mg/L
aeration applied after 24 hours: 100% survival after 5 ppm/96 hours, 20% survival NOEC (Candida albicans fungi) 30 hours = 10 g/L
after 18 ppm/96 hours, 20% survival after 32 ppm/48 hours 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 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.
OTHER U.S. FEDERAL REGULATIONS: Regulatory information is available for components of this product as
follows:
CALIFORNIA SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT (PROPOSITION 65): The components
of this product are not on the California Proposition 65 lists.
CICLOPIROX CREAM 0.77% EFFECTIVE DATE: MAY 30, 2008
PAGE 7 OF 10
Nycomed US Inc.
15. REGULATORY INFORMATION (Continued)
UNITED STATES REGULATIONS (continued):
ANSI LABELING (Based on 129.1, Provided to Summarize Occupational Exposure Hazards): WARNING! MAY
CAUSE ALLERGIC SKIN REACTION. MAY CAUSE SKIN AND EYE IRRITATION. Avoid prolonged or repeated
contact with skin and clothing. Avoid contact with eyes. Wash thoroughly after handling. Wear gloves, safety glasses,
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, 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 is regulated by the Therapeutic Products Programme
(TPP) of Health Canada and so it is 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 D2B (Materials Causing Other Toxic Effects--
Contains a D2B Material in 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. DFG MAK Pregnancy Risk Group Classification (continued): Group D:
Classification in one of the groups A瑿 is not yet possible because, although the
EXPOSURE LIMITS IN AIR:
CEILING LEVEL: The concentration that shall not be exceeded during any part of data available may indicate a trend, they are not sufficient for final evaluation.
the working exposure. IDLH: Immediately Dangerous to Life and Health. This level represents a
DFG MAKs: Federal Republic of Germany Maximum Concentration Values in the concentration from which one can escape within 30-minutes without suffering
workplace. Exposure limits are given as TWA (Time-Weighted Average) or PEAK escape-preventing or permanent injury.
(short-term exposure) values. LOQ: Limit of Quantitation.
DFG MAK Germ Cell Mutagen Categories: 1: Germ cell mutagens that have NE: Not Established. When no exposure guidelines are established, an entry of NE
been shown to increase the mutant frequency in the progeny of exposed humans. is made for reference.
2: Germ cell mutagens that have been shown to increase the mutant frequency in NIC: Notice of Intended Change.
the progeny of exposed mammals. 3A: Substances that have been shown to NIOSH CEILING: The exposure that shall not be exceeded during any part of the
induce genetic damage in germ cells of human of animals, or which produce workday. If instantaneous monitoring is not feasible, the ceiling shall be assumed
mutagenic effects in somatic cells of mammals in vivo and have been shown to as a 15-minute TWA exposure (unless otherwise specified) that shall not be
reach the germ cells in an active form. 3B: Substances that are suspected of being exceeded at any time during a workday.
germ cell mutagens because of their genotoxic effects in mammalian somatic cell in NIOSH RELs: NIOSH's Recommended Exposure Limits.
vivo; in exceptional cases, substances for which there are no in vivo data, but that PEL: OSHA's Permissible Exposure Limits. This exposure value means exactly the
are clearly mutagenic in vitro and structurally related to known in vivo mutagens. 4: same as a TLV, except that it is enforceable by OSHA. The OSHA Permissible
Not applicable (Category 4 carcinogenic substances are those with non-genotoxic Exposure Limits are based in the 1989 PELs and the June, 1993 Air Contaminants
mechanisms of action. By definition, germ cell mutagens are genotoxic. Therefore, Rule (Federal Register: 58: 35338-35351 and 58: 40191). Both the current PELs
a Category 4 for germ cell mutagens cannot apply. At some time in the future, it is and the vacated PELs are indicated. The phrase, "Vacated 1989 PEL" is placed
conceivable that a Category 4 could be established for genotoxic substances with next to the PEL that was vacated by Court Order.
primary targets other than DNA [e.g. purely aneugenic substances] if research SKIN: Used when a there is a danger of cutaneous absorption.
results make this seem sensible.) 5: Germ cell mutagens, the potency of which is STEL: Short Term Exposure Limit, usually a 15-minute time-weighted average
considered to be so low that, provided the MAK value is observed, their contribution (TWA) exposure that should not be exceeded at any time during a workday, even if
to genetic risk for humans is expected not to be significant. the 8-hr TWA is within the TLV-TWA, PEL-TWA or REL-TWA.
DFG MAK Pregnancy Risk Group Classification: Group A: A risk of damage to TLV: Threshold Limit Value. An airborne concentration of a substance that
the developing embryo or fetus has been unequivocally demonstrated. Exposure of represents conditions under which it is generally believed that nearly all workers
pregnant women can lead to damage of the developing organism, even when MAK may be repeatedly exposed without adverse effect. The duration must be
and BAT (Biological Tolerance Value for Working Materials) values are observed. considered, including the 8-hour.
Group B: Currently available information indicates a risk of damage to the TWA: Time Weighted Average exposure concentration for a conventional 8-hr
developing embryo or fetus must be considered to be probable. Damage to the (TLV, PEL) or up to a 10-hr (REL) workday and a 40-hr workweek.
developing organism cannot be excluded when pregnant women are exposed, WEEL: Workplace Environmental Exposure Limits from the AIHA.
even when MAK and BAT values are observed. Group C: There is no reason to
fear a risk of damage to the developing embryo or fetus when MAK and BAT values
are observed.
CICLOPIROX CREAM 0.77% EFFECTIVE DATE: MAY 30, 2008
PAGE 8 OF 10
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
RATINGS: This rating system was developed by the National Paint and Coating RATINGS (continued):
Association and has been adopted by industry to identify the degree of chemical PHYSICAL HAZARD (continued): 1 (continued) Oxidizers: Packaging Group III
hazards. oxidizers; Solids: any material that in either concentration tested, exhibits a mean
HEALTH HAZARD: 0 Minimal Hazard: No significant health risk, irritation of skin or burning time less than or equal to the mean burning time of a 3:7 potassium
eyes not anticipated. Skin Irritation: Essentially non-irritating. Mechanical irritation bromate/cellulose mixture and the criteria for Packing Group I and II are not met.
may occur. PII or Draize = 0. Eye Irritation: Essentially non-irritating, minimal effects Liquids: any material that exhibits a mean pressure rise time less than or equal to
clearing in < 24 hours. Mechanical irritation may occur. Draize = 0. Oral Toxicity the pressure rise time of a 1:1 nitric acid (65%)/cellulose mixture and the criteria for
LD50 Rat: > 5000 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 2000 mg/kg. Packing Group I and II are not met. Unstable Reactives: Substances that may
Inhalation Toxicity 4-hrs LC50 Rat: > 20 mg/L. 1 Slight Hazard: Minor reversible decompose condense, or self-react, but only under conditions of high temperature
injury may occur; may irritate the stomach if swallowed; may defat the skin and and/or pressure and have little or no potential to cause significant heat generation
exacerbate existing dermatitis. Skin Irritation: Slightly or mildly irritating. PII or or explosion hazard. Substances that readily undergo hazardous polymerization in
Draize > 0 < 5. Eye Irritation: Slightly to mildly irritating, but reversible within 7 days. the absence of inhibitors. 2 Water Reactivity: Materials that may react violently with
Draize > 0 25. Oral Toxicity LD50 Rat: > 500?000 mg/kg. Dermal Toxicity LD50 water. Organic Peroxides: Materials that, in themselves, are normally unstable and
Rat or Rabbit: > 1000?000 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 2?0 mg/L. will readily undergo violent chemical change, but will not detonate. These materials
2 Moderate Hazard: Temporary or transitory injury may occur; prolonged exposure may also react violently with water. Explosives: Division 1.4 explosives. Explosive
may affect the CNS. Skin Irritation: Moderately irritating; primary irritant; sensitizer. substances where the explosive effects are largely confined to the package and no
PII or Draize 5, with no destruction of dermal tissue. Eye Irritation: Moderately to projection of fragments of appreciable size or range are expected. An external fire
severely irritating; reversible corneal opacity; corneal involvement or irritation must not cause virtually instantaneous explosion of almost the entire contents of
clearing in 8?1 days. Draize = 26?00, with reversible effects. Oral Toxicity LD50 the package. Compressed Gases: Pressurized and meet OSHA definition but <
Rat: > 50?00 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 200?000 mg/kg. 514.7 psi absolute at 21.1癈 (70癋) [500 psig]. Pyrophorics: No Rating. Oxidizers:
Inhalation Toxicity LC50 4-hrs Rat: > 0.5? mg/L. 3 Serious Hazard: Major injury Packing Group II oxidizers. Solids: any material that, either in concentration tested,
likely unless prompt action is taken and medical treatment is given; high level of exhibits a mean burning time of less than or equal to the mean burning time of a 2:3
toxicity; corrosive. Skin Irritation: Severely irritating and/or corrosive; may cause potassium bromate/cellulose mixture and the criteria for Packing Group I are not
destruction of dermal tissue, skin burns, and dermal necrosis. PII or Draize > 5?, met. Liquids: any material that exhibits a mean pressure rise time less than or
with destruction of tissue. Eye Irritation: Corrosive, irreversible destruction of ocular equal to the pressure rise of a 1:1 aqueous sodium chlorate solution
tissue; corneal involvement or irritation persisting for more than 21 days. Draize > (40%)/cellulose mixture and the criteria for Packing Group I are not met. Reactives:
80 with effects irreversible in 21 days. Oral Toxicity LD50 Rat: > 1?0 mg/kg. Substances that may polymerize, decompose, condense, or self-react at ambient
Dermal Toxicity LD50 Rat or Rabbit: > 20?00 mg/kg. Inhalation Toxicity LC50 4-hrs temperature and/or pressure, but have a low potential (or low risk) for significant
Rat: > 0.05?.5 mg/L. 4 Severe Hazard: Life-threatening; major or permanent heat generation or explosion. Substances that readily form peroxides upon
damage may result from single or repeated exposures; extremely toxic; irreversible exposure to air or oxygen at room temperature. 3 Water Reactivity: Materials that
injury may result from brief contact. Skin Irritation: Not appropriate. Do not rate as a may form explosive reactions with water. Organic Peroxides: Materials that are
4, based on skin irritation alone. Eye Irritation: Not appropriate. Do not rate as a 4, capable of detonation or explosive reaction, but require a strong initiating source or
based on eye irritation alone. Oral Toxicity LD50 Rat: 1 mg/kg. Dermal Toxicity must be heated under confinement before initiation; or materials that react
LD50 Rat or Rabbit: 20 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: 0.05 mg/L. explosively with water. Explosives: Division 1.3 explosives. Explosive substances
FLAMMABILITY HAZARD: 0 Minimal Hazard: Materials that will not burn in air that have a fire hazard and either a minor blast hazard or a minor projection hazard
when exposure to a temperature of 815.5癈 (1500癋) for a period of 5 minutes. 1 or both, but do not have a mass explosion hazard. Compressed Gases: Pressure
Slight Hazard: Materials that must be pre-heated before ignition can occur. Material 514.7 psi absolute at 21.1癈 (70癋) [500 psig]. Pyrophorics: No Rating. Oxidizers:
requires considerable pre-heating, under all ambient temperature conditions before Packing Group I oxidizers. Solids: any material that, in either concentration tested,
ignition and combustion can occur. This usually includes the following: Materials exhibits a mean burning time less than the mean burning time of a 3:2 potassium
that will burn in air when exposed to a temperature of 815.5癈 (1500癋) for a period bromate/cellulose mixture. Liquids: any material that spontaneously ignites when
of 5 minutes or less; Liquids, solids and semisolids having a flash point at or above mixed with cellulose in a 1:1 ratio, or which exhibits a mean pressure rise time less
93.3癈 (200癋) (i.e. OSHA Class IIIB); and Most ordinary combustible materials than the pressure rise time of a 1:1 perchloric acid (50%)/cellulose mixture.
(e.g. wood, paper, etc.). 2 Moderate Hazard: Materials that must be moderately Unstable Reactives: Substances that may polymerize, decompose, condense, or
heated or exposed to relatively high ambient temperatures before ignition can self-react at ambient temperature and/or pressure and have a moderate potential
occur. Materials in this degree would not, under normal conditions, form hazardous (or moderate risk) to cause significant heat generation or explosion. 4 Water
atmospheres in air, but under high ambient temperatures or moderate heating may Reactivity: Materials that react explosively with water without requiring heat or
release vapor in sufficient quantities to produce hazardous atmospheres with air. confinement. Organic Peroxides: Materials that are readily capable of detonation or
This usually includes the following: Liquids having a flash-point at or above 37.8癈 explosive decomposition at normal temperature and pressures. Explosives: Division
(100癋); Solid materials in the form of course dusts that may burn rapidly but that 1.1 & 1.2 explosives. Explosive substances that have a mass explosion hazard or
generally do not form explosive atmospheres; Solid materials in a fibrous or have a projection hazard. A mass explosion is one that affects almost the entire
shredded form that may burn rapidly and create flash fire hazards (e.g. cotton, load instantaneously. Compressed Gases: No Rating. Pyrophorics: Add to the
sisal, hemp); and Solids and semisolids (e.g. viscous and slow flowing as asphalt) definition of Flammability 4. Oxidizers: No 4 rating. Unstable Reactives: Substances
that readily give off flammable vapors. 3 Serious Hazard: Liquids and solids that that may polymerize, decompose, condense, or self-react at ambient temperature
can be ignited under almost all ambient temperature conditions. Materials in this and/or pressure and have a high potential (or high risk) to cause significant heat
degree produce hazardous atmospheres with air under almost all ambient generation or explosion.
temperatures, or, unaffected by ambient temperature, are readily ignited under NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS
almost all conditions. This usually includes the following: Liquids having a flash HEALTH HAZARD: 0 Materials that, under emergency conditions, would offer no
point below 22.8癈 (73癋) and having a boiling point at or above 38癈 (100癋) and hazard beyond that of ordinary combustible materials. Gases and vapors with an
those liquids having a flash point at or above 22.8癈 (73癋) and below 37.8癈 LC50 for acute inhalation toxicity greater than 10,000 ppm. Dusts and mists with an
(100癋) (i.e. OSHA Class IB and IC); Materials that on account of their physical LC50 for acute inhalation toxicity greater than 200 mg/L. Materials with an LD50 for
form or environmental conditions can form explosive mixtures with air and are acute dermal toxicity greater than 2000 mg/kg. Materials with an LD50 for acute oral
readily dispersed in air (e.g., dusts of combustible solids, mists or droplets of toxicity greater than 2000 mg/kg. Materials essentially non-irritating to the
flammable liquids); and Materials that burn extremely rapidly, usually by reason of respiratory tract, eyes, and skin. 1 Materials that, under emergency conditions, can
self-contained oxygen (e.g. dry nitrocellulose and many organic peroxides). 4 cause significant irritation. Gases and vapors with an LC50 for acute inhalation
Severe Hazard: Materials that will rapidly or completely vaporize at atmospheric toxicity greater than 5,000 ppm but less than or equal to 10,000 ppm. Dusts and
pressure and normal ambient temperature or that are readily dispersed in air, and mists with an LC50 for acute inhalation toxicity greater than 10 mg/L but less than or
that will burn readily. This usually includes the following: Flammable gases; equal to 200 mg/L. Materials with an LD50 for acute dermal toxicity greater than
Flammable cryogenic materials; Any liquid or gaseous material that is liquid while 1000 mg/kg but less than or equal to 2000 mg/kg. Materials that slightly to
under pressure and has a flash point below 22.8癈 (73癋) and a boiling point below moderately irritate the respiratory tract, eyes and skin. Materials with an LD50 for
37.8癈 (100癋) (i.e. OSHA Class IA); and Materials that ignite spontaneously when acute oral toxicity greater than 500 mg/kg but less than or equal to 2000 mg/kg. 2
exposed to air at a temperature of 54.4癈 (130癋) or below (pyrophoric). Materials that, under emergency conditions, can cause temporary incapacitation or
PHYSICAL HAZARD: 0 Water Reactivity: Materials that do not react with water. residual injury. Gases with an LC50 for acute inhalation toxicity greater than 3,000
Organic Peroxides: Materials that are normally stable, even under fire conditions 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, or meet the criteria for either degree of hazard 3 or degree of hazard 4. Dusts and
self-react.). 1 Water Reactivity: Materials that change or decompose upon exposure mists with an LC50 for acute inhalation toxicity greater than 2 mg/L but less than or
to moisture. Organic Peroxides: Materials that are normally stable, but can become equal to 10 mg/L. Materials with an LD50 for acute dermal toxicity greater than 200
unstable at high temperatures and pressures. These materials may react with mg/kg but less than or equal to 1000 mg/kg. Compressed liquefied gases with
water, but will not release energy violently. Explosives: Division 1.5 & 1.6 boiling points between -30癈 (-22癋) and -55癈 (-66.5癋) that cause severe tissue
explosives. Substances that are very insensitive explosives or that do not have a damage, depending on duration of exposure. Materials that are respiratory irritants.
mass explosion hazard. Compressed Gases: Pressure below OSHA definition. Materials that cause severe, but reversible irritation to the eyes or are lachrymators.
Pyrophorics: No Rating. Materials that are primary skin irritants or sensitizers. Materials whose LD50 for
acute oral toxicity is greater than 50 mg/kg but less than or equal to 500 mg/kg.
CICLOPIROX CREAM 0.77% EFFECTIVE DATE: MAY 30, 2008
PAGE 9 OF 10
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. Materials
saturated vapor concentration at 20癈 (68癋) is equal to or greater its LC50 for that do not exhibit an exotherm at temperatures less than or equal to 500癈 (932癋)
acute inhalation toxicity, if its LC50 is less than or equal to 3000 ppm and that does when tested by differential scanning calorimetry. 1 Materials that in themselves are
not meet the criteria for degree of hazard 4. Dusts and mists with an LC50 for acute normally stable, but that can become unstable at elevated temperatures and
inhalation toxicity greater than 0.5 mg/L but less than or equal to 2 mg/L. Materials pressures. Materials that have an instantaneous power density (product of heat of
with an LD50 for acute dermal toxicity greater than 40 mg/kg but less than or equal reaction and reaction rate) at 250癈 (482癋) at or above 0.01 W/mL and below 10
to 200 mg/kg. Materials that are corrosive to the respiratory tract. Materials that are W/mL. 2 Materials that readily undergo violent chemical change at elevated
corrosive to the eyes or cause irreversible corneal opacity. Materials corrosive to temperatures and pressures. Materials that have an instantaneous power density
the skin. Cryogenic gases that cause frostbite and irreversible tissue damage. (product of heat of reaction and reaction rate) at 250癈 (482癋) at or above 10
Compressed liquefied gases with boiling points below -55癈 (-66.5癋) that cause W/mL and below 100W/mL. 3 Materials that in themselves are capable of
frostbite and irreversible tissue damage. Materials with an LD50 for acute oral detonation or explosive decomposition or explosive reaction, but that require a
toxicity greater than 5 mg/kg but less than or equal to 50 mg/kg. 4 Materials that, strong initiating source or that must be heated under confinement before initiation.
under emergency conditions, can be lethal. Gases with an LC50 for acute inhalation Materials that have an estimated instantaneous power density (product of heat of
toxicity less than or equal to 1,000 ppm. Any liquid whose saturated vapor reaction and reaction rate) at 250癈 (482癋) at or above 100 W/mL and below 1000
concentration at 20癈 (68癋) is equal to or greater than ten times its LC50 for acute W/mL. Materials that are sensitive to thermal or mechanical shock at elevated
inhalation toxicity, if its LC50 is less than or equal to 1000 ppm. Dusts and mists temperatures and pressures. 4 Materials that in themselves are readily capable of
whose LC50 for acute inhalation toxicity is less than or equal to 0.5 mg/L. Materials detonation or explosive decomposition or explosive reaction at normal
whose LD50 for acute dermal toxicity is less than or equal to 40 mg/kg. Materials temperatures and pressures. Materials that are sensitive to localized thermal or
whose LD50 for acute oral toxicity is less than or equal to 5 mg/kg. mechanical shock at normal temperatures and pressures. Materials that have an
FLAMMABILITY HAZARD: 0 Materials that will not burn under typical fire estimated instantaneous power density (product of heat of reaction and reaction
conditions, including intrinsically noncombustible materials such as concrete, stone, rate) at 250癈 (482癋) of 1000 W/mL or greater.
and sand. Materials that will not burn in air when exposed to a temperature of FLAMMABILITY LIMITS IN AIR:
816癈 (1500癋) for a period of 5 minutes in according with Annex D of NFPA 704. 1 Much of the information related to fire and explosion is derived from the National
Materials that must be preheated before ignition can occur. Materials in this degree Fire Protection Association (NFPA). Flash Point: Minimum temperature at which a
require considerable preheating, under all ambient temperature conditions, before liquid gives off sufficient vapor to form an ignitable mixture with air near the surface
ignition and combustion can occur: Materials that will burn in air when exposed to a of the liquid or within the test vessel used. Autoignition Temperature: Minimum
temperature of 816癈 (1500癋) for a period of 5 minutes in according with Annex D temperature of a solid, liquid, or gas required to initiate or cause self-sustained
of NFPA 704. Liquids, solids, and semisolids having a flash point at or above combustion in air with no other source of ignition. LEL: Lowest concentration of a
93.4癈 (200癋) (i.e. Class IIIB liquids). Liquids with a flash point greater than 35癈 flammable vapor or gas/air mixture that will ignite and burn with a flame. UEL:
(95癋) that do not sustain combustion when tested using the Method of Testing for Highest concentration of a flammable vapor or gas/air mixture that will ignite and
Sustained Combustibility, per 49 CFR 173, Appendix H or the UN burn with a flame.
Recommendations on the Transport of Dangerous Goods, Model Regulations TOXICOLOGICAL INFORMATION:
(current edition) and the related Manual of Tests and Criteria (current edition). Human and Animal Toxicology: Possible health hazards as derived from human
Liquids with a flash point greater than 35癈 (95癋) in a water-miscible solution or data, animal studies, or from the results of studies with similar compounds are
dispersion with a water non-combustible liquid/solid content of more than 85% by presented. LD50: Lethal Dose (solids & liquids) that kills 50% of the exposed
weight. Liquids that have no fire point when tested by ASTM D 92, Standard Test animals. LC50: Lethal Concentration (gases) that kills 50% of the exposed animals.
Method for Flash and Fire Points by Cleveland Open Cup, up to the boiling point of ppm: Concentration expressed in parts of material per million parts of air or water.
the liquid or up to a temperature at which the sample being tested shows an mg/m3: Concentration expressed in weight of substance per volume of air. mg/kg:
obvious physical change. Combustible pellets with a representative diameter of Quantity of material, by weight, administered to a test subject, based on their body
greater than 2 mm (10 mesh). Most ordinary combustible materials. Solids weight in kg. TDLo: Lowest dose to cause a symptom. TCLo: Lowest concentration
containing greater than 0.5% by weight of a flammable or combustible solvent are to cause a symptom. TDo, LDLo, and LDo, or TC, TCo, LCLo, and LCo: Lowest
rated by the closed cup flash point of the solvent. 2 Materials that must be dose (or concentration) to cause lethal or toxic effects. Cancer Information: IARC:
moderately heated or exposed to relatively high ambient temperatures before International Agency for Research on Cancer. NTP: National Toxicology Program.
ignition can occur. Materials in this degree would not under normal conditions form RTECS: Registry of Toxic Effects of Chemical Substances. IARC and NTP rate
hazardous atmospheres with air, but under high ambient temperatures or under chemicals on a scale of decreasing potential to cause human cancer with rankings
moderate heating could release vapor in sufficient quantities to produce hazardous from 1 to 4. Subrankings (2A, 2B, etc.) are also used. Other Information: BEI:
atmospheres with air. Liquids having a flash point at or above 37.8癈 (100癋) and ACGIH Biological Exposure Indices, represent the levels of determinants which are
below 93.4癈 (200癋) (i.e. Class II and Class IIIA liquids.) Solid materials in the most likely to be observed in specimens collected from a healthy worker who has
form of powders or coarse dusts of representative diameter between 420 microns been exposed to chemicals to the same extent as a worker with inhalation
(40 mesh) and 2 mm (10 mesh) that burn rapidly but that generally do not form exposure to the TLV.
explosive mixtures with air. Solid materials in fibrous or shredded form that burn ECOLOGICAL INFORMATION:
rapidly and create flash fire hazards, such as cotton, sisal, and hemp. Solids and EC: Effect concentration in water. BCF: Bioconcentration Factor, which is used to
semisolids that readily give off flammable vapors. Solids containing greater than determine if a substance will concentrate in life forms that consume contaminated
0.5% by weight of a flammable or combustible solvent are rated by the closed cup plant or animal matter. TLm: Median threshold limit. log KOW or log KOC: Coefficient
flash point of the solvent. 3 Liquids and solids that can be ignited under almost all of Oil/Water Distribution is used to assess a substance's behavior in the
ambient temperature conditions. Materials in this degree produce hazardous environment.
atmospheres with air under almost all ambient temperatures or, though unaffected
REGULATORY INFORMATION: This section explains the impact of various
by ambient temperatures, are readily ignited under almost all conditions. Liquids
laws and regulations on the material.
having a flash point below 22.8癈 (73癋) and having a boiling point at or above
U.S.:
37.8癈 (100癋) and those liquids having a flash point at or above 22.8癈 (73癋) and
EPA: U.S. Environmental Protection Agency. ACGIH: American Conference of
below 37.8癈 (100癋) (i.e. Class IB and IC liquids). Materials that on account of
Governmental Industrial Hygienists, a professional association that establishes
their physical form or environmental conditions can form explosive mixtures with air
exposure limits. OSHA: U.S. Occupational Safety and Health Administration.
and are readily dispersed in air. Flammable or combustible dusts with
NIOSH: National Institute of Occupational Safety and Health, which is the research
representative diameter less than 420 microns (40 mesh). Materials that burn with
arm of OSHA. DOT: U.S. Department of Transportation. TC: Transport Canada.
extreme rapidity, usually by reason of self-contained oxygen (e.g. dry nitrocellulose
SARA: Superfund Amendments and Reauthorization Act. TSCA: U.S. Toxic
and many organic peroxides). Solids containing greater than 0.5% by weight of a
Substance Control Act. CERCLA: Comprehensive Environmental Response,
flammable or combustible solvent are rated by the closed cup flash point of the
Compensation, and Liability Act. Marine Pollutant status according to the DOT;
solvent. 4 Materials that will rapidly or completely vaporize at atmospheric pressure
CERCLA or Superfund; and various state regulations. This section also includes
and normal ambient temperature or that are readily dispersed in air and will burn
information on the precautionary warnings that appear on the material's package
readily. Flammable gases. Flammable cryogenic materials. Any liquid or gaseous
label.
materials that is liquid while under pressure and has a flash point below 22.8癈
CANADA:
(73癋) and a boiling point below 37.8癈 (100癋) (i.e. Class IA liquids). Materials that
WHMIS: Canadian Workplace Hazardous Materials Information System. TC:
ignite when exposed to air, Solids containing greater than 0.5% by weight of a
Transport Canada. DSL/NDSL: Canadian Domestic/Non-Domestic Substances List.
flammable or combustible solvent are rated by the closed cup flash point of the
solvent.
CICLOPIROX CREAM 0.77% EFFECTIVE DATE: MAY 30, 2008
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