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: Clobetasol Propionate Scalp Solution 0.05%
Clobetasol Propionate Scalp Solution 0.05%
DESCRIPTION:
0168-0269-50
NDC #:
21-Chloro-9-fluoro-11,17-dihydroxy-16-methylpregna-
CHEMICAL NAME (for active ingredient):
1,4-diene-3,20-dione 17-Propionate
Steroid
CHEMICAL FAMILY (for active ingredient):
0.05% Topical Spray
HOW SUPPLIED:
C25H32ClFO5
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
EMERGENCY PHONE (OUTSIDE U.S.): 01-631-454-7677
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 colorless, slightly opalescent liquid with a rubbing
alcohol odor. Health Hazards: The chief health hazard associated with exposure during normal use and handling is
the potential for irritation of contaminated skin. Individuals who have had allergic reactions to products containing the
active ingredient, Clobetasol Propionate, other corticosteroids, or any other components of this product may
experience allergic reactions to this product. Repeated skin exposure of Clobetasol Propionate may cause adverse
reproductive effects, based on animal data. Flammability Hazards: This product is flammable. It is readily ignited
under ambient conditions. Vapors from the Isopropyl Alcohol component of this product are heavier than air and may
travel to a source of ignition and flashback to a leak or open container. Reactivity Hazards: This product is not
reactive. Environmental Hazards: This product has not been tested for environmental effects. 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
Clobetasol Propionate 25122-46-7 0.05%
Isopropyl Alcohol 67-63-0 Proprietary
Water and other components. Each of the other components The remaining components do not contribute any Balance
significant additional hazards.
is present in less 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.
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.
CLOBETASOL PROPIONATE SCALP SOLUTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 1 OF 10
Nycomed US Inc.
4 FIRST-AID MEASURES (Continued)
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 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. Consideration should be given to the high concentration of Isopropyl Alcohol in this product. If accidentally
swallowed, vomiting should be promptly induced or the stomach lavaged with 5% sodium bicarbonate solution. Artificial
respiration and atropine may be needed to counteract the symptoms of cholinesterase depletion. Repeat analyses of
serum and RBC cholinesterase may assist in establishing the diagnosis and formulating a long-range prognosis.
5. FIRE-FIGHTING MEASURES
FLASH POINT: 22.8癈 (73.0癋) Pensky-Martens Closed Cup
NFPA RATING
NOTE: The following values have not been determined for the product;
values given are for the main flammable component, Isopropyl Alcohol. FLAM MAB ILITY
AUTOIGNITION TEMPERATURE: 399癈 (750癋)
FLAMMABLE LIMITS (in air by volume, %):
3
Lower (LEL): 2.0% Upper (UEL): 12.7%
Use extinguishing media
FIRE EXTINGUISHING MATERIALS:
1 0
HEALTH INSTAB ILITY
appropriate for surrounding fire.
Water Spray: OK Carbon Dioxide: OK Foam: OK
Dry Chemical: OK Halon: OK Other: Any "ABC" Class
FIRE EXTINGUISHING MATERIALS NOT TO BE USED: None known. Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
3 = Serious 4 = Severe
UNUSUAL FIRE AND EXPLOSION HAZARDS: This product is OTHER
flammable; it can be readily ignited under ambient conditions. When
involved in a fire, this material may ignite and produce irritating vapors and toxic gases (e.g., carbon oxides, hydrogen
fluoride, and hydrogen chloride).
Explosion Sensitivity to Mechanical Impact: Not sensitive.
Explosion Sensitivity to Static Discharge: The vapors of this product may be ignited by static electrical energy.
SPECIAL FIRE-FIGHTING PROCEDURES: Incipient fire responders should wear eye protection. Structural
firefighters must wear Self-Contained Breathing Apparatus (SCBA) and full protective equipment. Chemical resistant
clothing may be necessary. 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. Move containers from fire area if it can be done without risk to personnel. Water
spray can be used to cool fire-exposed containers. Water fog or spray can also be used by trained firefighters to
disperse this product's vapors and to protect personnel. If possible, prevent runoff water from entering storm drains,
bodies of water, or other environmentally sensitive areas.
6. ACCIDENTAL RELEASE MEASURES
SPILL RESPONSE: Wipe up spilled product and wipe area with damp sponge or polypad. Trained personnel using
pre-planned procedures should respond to uncontrolled releases. Proper protective equipment should be used. In
case of a spill, clear the affected area, protect people, and respond with trained personnel. Eliminate all sources of
ignition before cleanup begins. Use non-sparking tools. Minimum Personal Protective Equipment should be double-
gloves (rubber over latex gloves) and rubber apron, splash goggles or safety glasses. Monitor area for combustible
vapor levels to determine level of combustible vapors before personnel are allowed into the spill area. The atmosphere
must have levels of components lower than those listed in Section 8, (Exposure Limits and Personal Protection) and at
least 19.5 percent oxygen before personnel can be allowed into the area without Self-Contained Breathing Apparatus
(SCBA). Wipe up spilled product. Decontaminate the area thoroughly. Place all spill residue in a suitable container
and seal. Dispose of in accordance with U.S. Federal, State, and local hazardous waste disposal regulations or waste
disposal regulations of Canada (see Section 13, Disposal Considerations).
CLOBETASOL PROPIONATE SCALP SOLUTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
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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. Keep away from
heat, sparks, and other sources of ignition. Use non-sparking tools. 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. Storage areas should be made of fire resistant
materials. Post warning and "NO SMOKING" signs in storage and use areas, as appropriate. Have appropriate
extinguishing equipment in the storage area (i.e., sprinkler system, portable fire extinguishers). Empty packages may
contain residual liquid or vapors that are flammable; therefore, empty packages should be handled with care. Refer to
NFPA 30, Flammable and Combustible Liquids Code, for additional information on storage.
PRODUCT PREPARATION INSTRUCTIONS FOR MEDICAL PERSONNEL: Handle this material following standard
medical practices and following the recommendations presented on the Package Insert.
PROTECTIVE PRACTICES DURING MAINTENANCE OF CONTAMINATED EQUIPMENT: When cleaning non-
disposable equipment, wear latex or butyl rubber (double gloving is recommended), goggles, and lab coat. Wash
equipment with soap and water. Wipe equipment down with damp sponge or polypad. Collect all rinsates and dispose
of according to applicable U.S. Federal, State, and local hazardous waste disposal regulations or waste disposal
regulations of Canada. All disposable items contaminated with this product should be disposed of properly.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION
VENTILATION AND ENGINEERING CONTROLS: Use with adequate ventilation. Follow standard medical product
handling procedures. During decontamination of work surfaces, workers should wear the same equipment
recommended in Section 6 (Accidental Release Measures) of this MSDS.
EXPOSURE LIMITS/GUIDELINES:
CAS # EXPOSURE LIMITS IN AIR
CHEMICAL
NAME ACGIH-TLVs OSHA-PELs NIOSH-RELs NIOSH OTHER
TWA STEL TWA STEL TWA STEL IDLH
mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3
Clobetasol 25122-46-7 NE NE NE NE NE NE NE NE
Propionate
DFG MAK:
Isopropyl Alcohol 67-63-0 492 984 980 1225 980 1225 4920
TWA = 500
(vacated
PEAK = 2稭AK 15 min., average value,
1989
1 hour interval, 4 per shift
PEL)
Pregnancy Risk Group 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 or appropriate standards of Canada.
CLOBETASOL PROPIONATE SCALP SOLUTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 3 OF 10
Nycomed US Inc.
9. PHYSICAL and CHEMICAL PROPERTIES
BOILING POINT: 50癈 (122癋) [Refluxes] FREEZING/MELTING POINT: Not established.
EVAPORATION RATE (Ether = 1): 0.23 SOLUBILITY IN WATER: Soluble.
VAPOR PRESSURE (air = 1): Not established. SPECIFIC GRAVITY @ 20?(water = 1): 0.94
ODOR THRESHOLD: Not established. pH: 5.5?.8
COEFFICIENT WATER/OIL DISTRIBUTION: Not established.
APPEARANCE AND COLOR: This product is a colorless, slightly opalescent liquid with a rubbing alcohol odor.
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, hydrogen fluoride, and hydrogen chloride).
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
(BLUE) 1
paragraphs describe the symptoms of exposure by route of exposure. HEALTH HAZARD
INHALATION: Inhalation of vapors of this product, especially in a
poorly ventilated space, may cause flushing, decreased pulse rate,
drop in blood pressure, numbness, narcosis, headache, dizziness,
mental depression, hallucinations, distorted perception, difficulty FLAMMABILITY HAZARD (RED) 3
breathing, respiratory depression, nausea, vomiting, and coma.
CONTACT WITH SKIN or EYES: Skin contact may cause mild
irritation, which is alleviated upon rinsing with soap and water.
Corticosteroids (such as Clobetasol Propionate) may cause allergic PHYSICAL HAZARD (YELLOW) 0
contact dermatitis. It is usually diagnosed by observing a failure to
heal rather than a clinical exacerbation. Eye contact can cause
irritation, stinging, redness, and tearing.
PROTECTIVE EQUIPMENT
The Isopropyl Alcohol and Clobetasol
SKIN ABSORPTION:
Propionate components of this product can be absorbed through
intact skin. Symptoms of acute overexposure by this route may EYES HANDS BODY
RESPIRATORY
include central nervous system depression as described under
"Inhalation". Symptoms of chronic overexposure by this route may S SE
EE CTION 8 SE SEC
E TION 8
include reversible hypothalamic-pituitaryadrenal (HPA) axis
suppression, abnormal accumulations of facial and trunk fat,
For Routine Industrial Use and Handling Applications
fatigue, high blood pressure, osteoporosis, abnormally high level of
glucose in the blood, and abnormally high levels of glucose in the
urine. Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
3 = Serious 4 = Severe * = Chronic hazard
INGESTION: Ingestion is not a significant route of occupational
overexposure. Acute ingestion of large quantities of this product or
chronic ingestion caused by poor hygiene practices may cause adverse symptoms. Symptoms of ingestion
overexposure may include nausea, vomiting, diarrhea, and respiratory distress. Ingestion can also cause symptoms as
described under "Inhalation".
INJECTION: Though not anticipated to be a significant route of overexposure for this product, injection (via punctures or
lacerations by contaminated objects) may cause redness at the site of injection. Symptoms may include those
described for "Other Potential Health Effects".
CLOBETASOL PROPIONATE SCALP SOLUTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 4 OF 10
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
OTHER POTENTIAL HEALTH EFFECTS-Therapeutic Doses: Employees administering the product should not
experience adverse effects if handled properly. Persons using the product in therapeutic doses have experienced
burning, stinging, scalp pustules, tingling, inflammation of hair follicles, tightness of the scalp, dermatitis, tenderness,
headache, hair loss, and eye 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 be harmful. Inhalation of vapors in a poorly ventilated
space can cause central nervous system effects. Eye contact will cause irritation.
Chronic: Corticosteroids (such as Clobetasol Propionate) may cause allergic contact dermatitis. Symptoms of chronic
skin absorption overexposure may include reversible hypothalamic-pituitaryadrenal (HPA) axis suppression,
abnormal accumulations of facial and trunk fat, fatigue, high blood pressure, osteoporosis, abnormally high level of
glucose in the blood, and abnormally high levels of glucose in the urine.
TARGET ORGANS:
Acute: Occupational Exposure: Skin, central nervous system. Therapeutic Doses: Skin.
Chronic: Occupational Exposure: Skin. Therapeutic Doses: Skin, endocrine system.
GENERAL TOXICITY INFORMATION: Individuals who have had allergic reactions to products containing the active
ingredient, Clobetasol Propionate, other corticosteroids, 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 may experience burning, stinging, scalp
pustules, tingling, inflammation of hair follicles, tightness of the scalp, dermatitis, tenderness, headache, hair loss, and
eye irritation.
IRRITANCY OF PRODUCT: This product may mildly to moderately irritate contaminated tissue.
SENSITIZATION OF PRODUCT: Corticosteroids (such as Clobetasol Propionate) may cause allergic contact
dermatitis.
TOXICITY DATA: The toxicity data available for the active component of this product, Clobetasol Propionate, 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.
CLOBETASOL PROPIONATE: CLOBETASOL PROPIONATE (continued): CLOBETASOL PROPIONATE (continued):
LD50 (Oral-Rat) > 3 g/kg TDLo (Skin-Rat) 3750 礸/kg/30 days-intermittent: TDLo (Subcutaneous-Rat) 2275 mg/kg/13 weeks-
LD50 (Oral-Mouse) > 3 g/kg Changes in bone marrow (not otherwise intermittent: Behavioral: somnolence (general
LD50 (Intraperitoneal-Rat) 351 mg/kg specified); Weight loss or decreased weight gain; depressed activity); Hair changes; Weight loss or
LD50 (Intraperitoneal-Mouse) 118 mg/kg Biochemical: Enzyme inhibition, induction, or decreased weight gain
LD50 (Subcutaneous-Rat) 366 mg/kg change in blood or tissue levels: transaminases TDLo (Subcutaneous-Rat) 2600 礸/kg: female 17-22
LD50 (Subcutaneous-Mouse) 81,700 礸/kg TDLo (Skin-Rat) 17,500 礸/kg/5 weeks-intermittent: day(s) after conception lactating female 21 days
Blood: changes in serum composition (e.g. TP, post-birth: Reproductive: Maternal Effects:
bilirubin, cholesterol), changes in leukocyte parturition; Effects on Newborn: live birth index
(WBC) count; Weight loss/decreased weight gain (measured after birth), other neonatal measures
or effects
CARCINOGENIC INFORMATION: Long-term animal studies have not been performed to evaluate the carcinogenic
potential of Clobetasol Propionate.
The incipient components of this product are listed by agencies tracking the carcinogenic potential of chemical
compounds, as follows:
ISOPROPYL ALCOHOL: IARC-3 (Not Classifiable as to Carcinogenicity to Humans); ACGIH-TLV-A4 C (Not Classifiable as a 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, Clobetasol Propionate, is rated as
Pregnancy Category C (RISK CANNOT BE RULED OUT; Human evidence is lacking, but animal evidence is
positive). Listed below is information concerning the effects of this compound on animal or human reproductive
systems.
Mutagenicity: Studies to determine mutagenicity with prednisolone have revealed negative results.
Embryotoxicity: This product has not been tested for embryotoxic effects.
Teratogenicity: Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at
relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory
animals. Clobetasol Propionate is absorbed percutaneously and when administered subcutaneously, it was a significant
teratogen in both the rabbit and the mouse. Clobetasol Propionate has greater teratogenic potential than steroids that are less
potent.
Reproductive Toxicity: Long-term animal studies have not been performed to evaluate the effect on fertility potential of Clobetasol
Propionate.
CLOBETASOL PROPIONATE SCALP SOLUTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 5 OF 10
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
REPRODUCTIVE TOXICITY INFORMATION (continued):
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.
CHEMICAL: SAMPLING TIME BEI
DETERMINANT
Isopropyl Alcohol
?Acetone in urine ?End of Shift End of Workweek ?40 mg/L
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:
ISOPROPYL ALCOHOL:
Octanol/Water Partition Coefficient: Log P = 0.34?.5
Persistence: If released to the soil, Isopropyl Alcohol will both rapidly evaporate and leach into the ground due to high vapor pressure and low adsorption to soil. If
released to water, Isopropyl Alcohol will volatilize, with an estimated half-life of 5.4 days. If released to the atmosphere, Isopropyl Alcohol will photo-degrade, with an
estimated half-life of one to several days. Due to the solubility of Isopropyl Alcohol in water, rainout may be significant.
Biodegradation: In soil, and water, degradation of Isopropyl Alcohol has not been determined. If soil degradation is not rapid, it will likely leach to groundwater.
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:
ISOPROPYL ALCOHOL: ISOPROPYL ALCOHOL (continued): ISOPROPYL ALCOHOL (continued):
EC0 (Microcystis aeruginosa) 8 days = 1,000 mg/L NOEC (Daphnia magna) 757-2,100 mg/L LC50 (goldfish) 24 hours = > 500 mg/L
EC0 (Scenedesmus quadricauda green algae) 7 days LC0 (creek chub) 24 hours = 900 mg/L LC50 (fathead minnow) 1 hour = 11,830 mg/L
= 1,800 mg/L LC50 (Artemia salina) 24 hours = 16,700 mg/L LC50 (fathead minnow) 24 hours = 11,160 mg/L
EC0 (Entosiphon sulcatum protozoa) 72 hr = 4,930 LC50 (Streptocephalus proboscideus) 24 hr = 11,600 LC50 (fathead minnow) 48 hours = 11,130 mg/L
mg/L mg/L LC50 (fathead minnow) 72 hours = 11,130 mg/L
EC0 (Uronema parduczi Chatton-Lwoff) = 3,425 mg/L LC50 (Daphnia magna) 24 hours = 9,500 mg/L LC50 (fathead minnow) 96 hours = 11,130 mg/L
EC50 (Photobacterium) 5 minutes = 22,800 mg/L LC50 (Brachionus calyciflorus) 24 hours = 28,600 mg/L LC50 (Poecilia reticulata guppy) 7 days = 7,060 mg/L
EC50 (Daphnia magna) 3,010 mg/L LC50 (Crangon crangon brown shrimp) 48 hr = 1,400 LC50 (Daphnia magna) 4,600 mg/L
EC50 (Pseudomonas putida) 16 hours = 1,050 mg/L mg/L LC100 (creek chub) 24 hours = 1,100 mg/L
Toxic (Chlorella pyrenoidosa algae) = 17,400 mg/L LC50 (Crangon crangon brown shrimp) 98 hr = 1,150
mg/L
13. DISPOSAL CONSIDERATIONS
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: Wastes of this product may need to be tested per the requirements of RCRA to determine
if such wastes meet the following characteristics: D001 (Ignitability).
14. TRANSPORTATION INFORMATION
U.S. DEPARTMENT OF TRANSPORTATION SHIPPING REGULATIONS: This product is classified as hazardous
under regulations of U.S. DOT 49 CFR 172.101. When the product meet requirements under 49 CFR ?173.144, and
requirements under 49 CFR ?173.150 (b), this product can be shipped as a Consumer Commodity, ORM-D material.
Inner packaging cannot exceed 5.0 liters (1.3 gallons), net capacity. Outer packaging cannot exceed 30 kg (66 lb gross
weight). See below (Limited Quantity Exceptions) for additional information.
Consumer Commodity
Proper Shipping Name:
ORM-D
Hazard Class Number and Description:
Not Applicable
UN Identification Number:
Not Applicable
Packing Group:
None
DOT Label(s) Required:
171
Emergency Response Guidebook Number (2008):
CLOBETASOL PROPIONATE SCALP SOLUTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
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Nycomed US Inc.
Marine Pollutant: No component of this product is classified by the U.S. DOT as a Marine Pollutant (as defined by 49 CFR 172.101,
Appendix B).
Limited Quantity Exceptions [49 CFR 173.150(b)]: Limited quantities for Class 3, Packing Group III materials have inner packagings not over
5.0 liters (1.3 gallons) net capacity each, packed in strong outer packaging. The gross weight of the outer package cannot exceed 30 kg (66
lb). Limited quantities are not subject to labeling (unless transported by air) or placarding requirements.
When the product does not meet the requirements for classification of Consumer Quantity and ORM-D, shipments of
this product must be classified as follows:
Flammable liquids, n.o.s. (Isopropyl Alcohol)
Proper Shipping Name:
3 (Flammable)
Hazard Class Number and Description:
UN 1993
UN Identification Number:
III
Packing Group:
Class 3 (Flammable)
DOT Label(s) Required:
128
Emergency Response Guidebook Number (2008):
Small Quantity Exception (49 CFR 173.4): Small quantities of Class 3 material are not subjected to other requirements of the Hazardous Materials
Regulations (Subchapter C) when the maximum quantity per inner receptacle is limited to 30 mL (1 oz). Refer to 49 CFR 173.4 for specific
information in packaging small quantity materials.
TRANSPORT CANADA TRANSPORTATION OF DANGEROUS GOODS REGULATIONS: This product is classified
as Dangerous Goods, per regulations of Transport Canada.
Flammable liquids, n.o.s. (Isopropyl Alcohol)
Proper Shipping Name:
Class 3 (Flammable)
Hazard Class Number and Description:
UN 1993
UN Identification Number:
III
Packing Group:
Class 3
Hazard Label(s) Required:
16
Special Provisions:
5
Explosive Limit & Limited Quantity Index:
None
ERAP Index:
None
Passenger Carrying Ship Index:
60
Passenger Carrying Road or Rail Vehicle Index:
Marine Pollutant: The components of this product are not listed as marine pollutants, per Part 2, Section 2.7 of the Consolidated
Transportation of Dangerous Goods Regulations.
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, as follows:
CHEMICAL NAME SARA 302 SARA 304 SARA 313
(40 CFR 355, Appendix A) (40 CFR Table 302.4) (40 CFR 372.65)
Isopropyl Alcohol (mfg-strong acid No No Yes
process)
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): The components
of this product are not on the California Proposition 65 lists.
OTHER U.S. FEDERAL REGULATIONS: Regulatory information is available for components of this product as
follows:
ISOPROPYL ALCOHOL:
FDA: Isopropyl Alcohol is a food additive permitted for direct addition to food for human consumption, as long as 1) the quantity added to food does not exceed the
amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food, and 2) when intended for use in or on food it is of
appropriate food grade and is prepared and handled as a food ingredient. Isopropyl Alcohol may safely used as a diluent in color additive mixtures for marking food
supplements in tablet form, gum, and confectionary as long as it leaves no residues.
FIFRA: Unless designated as an active ingredient (as determined by EPA), Isopropyl Alcohol, when used in antimicrobial products as a solvent (except in tinctures or
where sole or major active ingredient) is considered inert, having no independent pesticidal activity. The percentage of such an ingredient shall be included on the
label in the total percentage of inert ingredients. Residues of Isopropyl Alcohol are exempted from the requirement of a tolerance when used as a solvent, co-solvent,
stabilizer, or inhibitor in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops or to
raw agricultural commodities after harvest. Isopropyl Alcohol is exempted from the requirement of a tolerance when used as a solvent, co-solvent, stabilizer, or
inhibitor in accordance with good agricultural practice as inert (or occasionally active) ingredients in pesticide formulations applied to growing crops only. Isopropyl
Alcohol is exempted from the requirement of a tolerance when used as a solvent or co-solvent in accordance with good agricultural practice as inert (or occasionally
active) ingredients in pesticide formulations applied to animals.
ANSI LABELING (Based on 129.1, Provided to Summarize Occupational Exposure Hazards): WARNING!
FLAMMABLE LIQUID. MAY CAUSE ALLERGIC REACTION. CAUSES EYE AND RESPIRATORY TRACT
IRRITATION. MAY CAUSE SKIN IRRITATION. MAY CAUSE CENTRAL NERVOUS SYSTEM EFFECTS. Keep away
from heat, sparks, and flame. Avoid contact with skin or clothing. Do not breathe vapors. Do not taste or swallow. Keep
CLOBETASOL PROPIONATE SCALP SOLUTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 7 OF 10
Nycomed US Inc.
container closed. Use only with adequate ventilation. Wash thoroughly after handling. Wear gloves, goggles, and
appropriate body protection during handling or administration. FIRST-AID: In case of contact, flush eyes with plenty of
water. If vapors are inhaled, remove to fresh air. 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 is exempt from requirements of the DSL/NDSL Inventory.
CLOBETASOL PROPIONATE SCALP SOLUTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 8 OF 10
Nycomed US Inc.
15. REGULATORY INFORMATION (Continued)
CANADIAN REGULATIONS (continued):
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 B2 Flammable Liquid
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
September 21, 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. STEL: Short Term Exposure Limit, usually a 15-minute time-weighted average (TWA)
EXPOSURE LIMITS IN AIR: exposure that should not be exceeded at any time during a workday, even if the 8-hr
CEILING LEVEL: The concentration that shall not be exceeded during any part of the TWA is within the TLV-TWA, PEL-TWA or REL-TWA.
TLV: Threshold Limit Value. An airborne concentration of a substance that represents
working exposure.
DFG MAK Germ Cell Mutagen Categories: 1: Germ cell mutagens that have been conditions under which it is generally believed that nearly all workers may be repeatedly
shown to increase the mutant frequency in the progeny of exposed humans. 2: Germ exposed without adverse effect. The duration must be considered, including the 8-hour.
TWA: Time Weighted Average exposure concentration for a conventional 8-hr (TLV,
cell mutagens that have been shown to increase the mutant frequency in the progeny of
exposed mammals. 3A: Substances that have been shown to induce genetic damage in PEL) or up to a 10-hr (REL) workday and a 40-hr workweek.
germ cells of human of animals, or which produce mutagenic effects in somatic cells of HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
mammals in vivo and have been shown to reach the germ cells in an active form. 3B: RATINGS: This rating system was developed by the National Paint and Coating
Substances that are suspected of being germ cell mutagens because of their genotoxic
Association and has been adopted by industry to identify the degree of chemical
effects in mammalian somatic cell in vivo; in exceptional cases, substances for which
hazards.
there are no in vivo data, but that are clearly mutagenic in vitro and structurally related to
HEALTH HAZARD: 0 Minimal Hazard: No significant health risk, irritation of skin or eyes
known in vivo mutagens. 4: Not applicable (Category 4 carcinogenic substances are
not anticipated. Skin Irritation: Essentially non-irritating. Mechanical irritation may occur.
those with non-genotoxic mechanisms of action. By definition, germ cell mutagens are
PII or Draize = 0. Eye Irritation: Essentially non-irritating, minimal effects clearing in < 24
genotoxic. Therefore, a Category 4 for germ cell mutagens cannot apply. At some time in
hours. Mechanical irritation may occur. Draize = 0. Oral Toxicity LD50 Rat: > 5000 mg/kg.
the future, it is conceivable that a Category 4 could be established for genotoxic
Dermal Toxicity LD50 Rat or Rabbit: > 2000 mg/kg. Inhalation Toxicity 4-hrs LC50 Rat: >
substances with primary targets other than DNA [e.g. purely aneugenic substances] if
20 mg/L. 1) Slight Hazard: Minor reversible injury may occur; may irritate the stomach if
research results make this seem sensible.) 5: Germ cell mutagens, the potency of which
swallowed; may defat the skin and exacerbate existing dermatitis. Skin Irritation: Slightly
is considered to be so low that, provided the MAK value is observed, their contribution to
or mildly irritating. PII or Draize > 0 < 5. Eye Irritation: Slightly to mildly irritating, but
genetic risk for humans is expected not to be significant.
reversible within 7 days. Draize > 0 25. Oral Toxicity LD50 Rat: > 500?000 mg/kg.
DFG MAK Pregnancy Risk Group Classification: Group A: A risk of damage to the
Dermal Toxicity LD50 Rat or Rabbit: > 1000?000 mg/kg. Inhalation Toxicity LC50 4-hrs
developing embryo or fetus has been unequivocally demonstrated. Exposure of pregnant
Rat: > 2?0 mg/L. 2 Moderate Hazard: Temporary or transitory injury may occur;
women can lead to damage of the developing organism, even when MAK and BAT
prolonged exposure may affect the CNS. Skin Irritation: Moderately irritating; primary
(Biological Tolerance Value for Working Materials) values are observed. Group B:
irritant; sensitizer. PII or Draize 5, with no destruction of dermal tissue. Eye Irritation:
Currently available information indicates a risk of damage to the developing embryo or
Moderately to severely irritating; reversible corneal opacity; corneal involvement or
fetus must be considered to be probable. Damage to the developing organism cannot be
irritation clearing in 8?1 days. Draize = 26?00, with reversible effects. Oral Toxicity
excluded when pregnant women are exposed, even when MAK and BAT values are
LD50 Rat: > 50?00 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 200?000 mg/kg.
observed. Group C: There is no reason to fear a risk of damage to the developing
Inhalation Toxicity LC50 4-hrs Rat: > 0.5? mg/L. 3 Serious Hazard: Major injury likely
embryo or fetus when MAK and BAT values are observed. Group D: Classification in
unless prompt action is taken and medical treatment is given; high level of toxicity;
one of the groups A瑿 is not yet possible because, although the data available may
corrosive. Skin Irritation: Severely irritating and/or corrosive; may cause destruction of
indicate a trend, they are not sufficient for final evaluation.
dermal tissue, skin burns, and dermal necrosis. PII or Draize > 5?, with destruction of
IDLH: Immediately Dangerous to Life and Health. This level represents a concentration
tissue. Eye Irritation: Corrosive, irreversible destruction of ocular tissue; corneal
from which one can escape within 30-minutes without suffering escape-preventing or
involvement or irritation persisting for more than 21 days. Draize > 80 with effects
permanent injury.
irreversible in 21 days. Oral Toxicity LD50 Rat: > 1?0 mg/kg. Dermal Toxicity LD50 Rat or
LOQ: Limit of Quantitation.
Rabbit: > 20?00 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 0.05?.5 mg/L. 4 Severe
MAK: Federal Republic of Germany Maximum Concentration Values in the workplace.
Hazard: Life-threatening; major or permanent damage may result from single or
NE: Not Established. When no exposure guidelines are established, an entry of NE is
repeated exposures; extremely toxic; irreversible injury may result from brief contact.
made for reference.
Skin Irritation: Not appropriate. Do not rate as a 4, based on skin irritation alone. Eye
NIC: Notice of Intended Change.
Irritation: Not appropriate. Do not rate as a 4, based on eye irritation alone. Oral Toxicity
NIOSH CEILING: The exposure that shall not be exceeded during any part of the
LD50 Rat: 1 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: 20 mg/kg. Inhalation Toxicity
workday. If instantaneous monitoring is not feasible, the ceiling shall be assumed as a
LC50 4-hrs Rat: 0.05 mg/L.
15-minute TWA exposure (unless otherwise specified) that shall not be exceeded at any
FLAMMABILITY HAZARD: 0 Minimal Hazard: Materials that will not burn in air when
time during a workday.
exposure to a temperature of 815.5癈 (1500癋) for a period of 5 minutes. 1 Slight
NIOSH RELs: NIOSH's Recommended Exposure Limits.
Hazard: Materials that must be pre-heated before ignition can occur. Material requires
PEL: OSHA's Permissible Exposure Limits. This exposure value means exactly the
considerable pre-heating, under all ambient temperature conditions before ignition and
same as a TLV, except that it is enforceable by OSHA. The OSHA Permissible
combustion can occur. This usually includes the following: Materials that will burn in air
Exposure Limits are based in the 1989 PELs and the June, 1993 Air Contaminants Rule
when exposed to a temperature of 815.5癈 (1500癋) for a period of 5 minutes or less;
(Federal Register: 58: 35338-35351 and 58: 40191). Both the current PELs and the
Liquids, solids and semisolids having a flash point at or above 93.3癈 (200癋) (i.e.
vacated PELs are indicated. The phrase, "Vacated 1989 PEL" is placed next to the PEL
OSHA Class IIIB); and Most ordinary combustible materials (e.g. wood, paper, etc.). 2
that was vacated by Court Order.
Moderate Hazard: Materials that must be moderately heated or exposed to relatively
SKIN: Used when a there is a danger of cutaneous absorption.
high ambient temperatures before ignition can occur. Materials in this degree would not,
under normal conditions, form hazardous atmospheres in air, but under high ambient
temperatures or moderate heating may release vapor in sufficient quantities to produce
hazardous atmospheres with air.
CLOBETASOL PROPIONATE SCALP SOLUTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 9 OF 10
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS:
HEALTH HAZARD: 0 Materials that, under emergency conditions, would offer no hazard
RATINGS (continued):
beyond that of ordinary combustible materials. Gases and vapors with an LC50 for acute
FLAMMABILITY HAZARD (continued): This usually includes the following: Liquids
inhalation toxicity greater than 10,000 ppm. Dusts and mists with an LC50 for acute
having a flash-point at or above 37.8癈 (100癋); Solid materials in the form of course
inhalation toxicity greater than 200 mg/L. Materials with an LD50 for acute dermal toxicity
dusts that may burn rapidly but that generally do not form explosive atmospheres; Solid
greater than 2000 mg/kg. Materials with an LD50 for acute oral toxicity greater than 2000
materials in a fibrous or shredded form that may burn rapidly and create flash fire
mg/kg. Materials essentially non-irritating to the respiratory tract, eyes, and skin. 1
hazards (e.g. cotton, sisal, hemp); and Solids and semisolids (e.g. viscous and slow
Materials that, under emergency conditions, can cause significant irritation. Gases and
flowing as asphalt) that readily give off flammable vapors. 3 Serious Hazard: Liquids and
vapors with an LC50 for acute inhalation toxicity greater than 5,000 ppm but less than or
solids that can be ignited under almost all ambient temperature conditions. Materials in
equal to 10,000 ppm. Dusts and mists with an LC50 for acute inhalation toxicity greater
this degree produce hazardous atmospheres with air under almost all ambient
than 10 mg/L but less than or equal to 200 mg/L. Materials with an LD50 for acute dermal
temperatures, or, unaffected by ambient temperature, are readily ignited under almost all
toxicity greater than 1000 mg/kg but less than or equal to 2000 mg/kg. Materials that
conditions. This usually includes the following: Liquids having a flash point below 22.8癈
slightly to moderately irritate the respiratory tract, eyes and skin. Materials with an LD50
(73癋) and having a boiling point at or above 38癈 (100癋) and those liquids having a
for acute oral toxicity greater than 500 mg/kg but less than or equal to 2000 mg/kg. 2
flash point at or above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. OSHA Class IB and
Materials that, under emergency conditions, can cause temporary incapacitation or
IC); Materials that on account of their physical form or environmental conditions can form
residual injury. Gases with an LC50 for acute inhalation toxicity greater than 3,000 ppm
explosive mixtures with air and are readily dispersed in air (e.g., dusts of combustible
but less than or equal to 5,000 ppm. Any liquid whose saturated vapor concentration at
solids, mists or droplets of flammable liquids); and Materials that burn extremely rapidly,
20癈 (68癋) is equal to or greater than one-fifth its LC50 for acute inhalation toxicity, if its
usually by reason of self-contained oxygen (e.g. dry nitrocellulose and many organic
LC50 is less than or equal to 5000 ppm and that does not meet the criteria for either
peroxides). 4 Severe Hazard: Materials that will rapidly or completely vaporize at
degree of hazard 3 or degree of hazard 4. Dusts and mists with an LC50 for acute
atmospheric pressure and normal ambient temperature or that are readily dispersed in
inhalation toxicity greater than 2 mg/L but less than or equal to 10 mg/L. Materials with
air, and that will burn readily. This usually includes the following: Flammable gases;
an LD50 for acute dermal toxicity greater than 200 mg/kg but less than or equal to 1000
Flammable cryogenic materials; Any liquid or gaseous material that is liquid while under
mg/kg. Compressed liquefied gases with boiling points between -30癈 (-22癋) and -55癈
pressure and has a flash point below 22.8癈 (73癋) and a boiling point below 37.8癈
(-66.5癋) that cause severe tissue damage, depending on duration of exposure.
(100癋) (i.e. OSHA Class IA); and Materials that ignite spontaneously when exposed to
Materials that are respiratory irritants. Materials that cause severe, but reversible
air at a temperature of 54.4癈 (130癋) or below (pyrophoric).
irritation to the eyes or are lachrymators. Materials that are primary skin irritants or
PHYSICAL HAZARD: 0 Water Reactivity: Materials that do not react with water. Organic
sensitizers. Materials whose LD50 for acute oral toxicity is greater than 50 mg/kg but less
Peroxides: Materials that are normally stable, even under fire conditions and will not
than or equal to 500 mg/kg. 3 Materials that, under emergency conditions, can cause
react with water. Explosives: Substances that are Non-Explosive. Compressed Gases:
serious or permanent injury. Gases with an LC50 for acute inhalation toxicity greater than
No Rating. Pyrophorics: No Rating. Oxidizers: No 0 rating. Unstable Reactives:
1,000 ppm but less than or equal to 3,000 ppm. Any liquid whose saturated vapor
Substances that will not polymerize, decompose, condense, or self-react.). 1 Water
concentration at 20癈 (68癋) is equal to or greater its LC50 for acute inhalation toxicity, if
Reactivity: Materials that change or decompose upon exposure to moisture. Organic
its LC50 is less than or equal to 3000 ppm and that does not meet the criteria for degree
Peroxides: Materials that are normally stable, but can become unstable at high
of hazard 4. Dusts and mists with an LC50 for acute inhalation toxicity greater than 0.5
temperatures and pressures. These materials may react with water, but will not release
mg/L but less than or equal to 2 mg/L. Materials with an LD50 for acute dermal toxicity
energy violently. Explosives: Division 1.5 & 1.6 explosives. Substances that are very
greater than 40 mg/kg but less than or equal to 200 mg/kg. Materials that are corrosive
insensitive explosives or that do not have a mass explosion hazard. Compressed Gases:
to the respiratory tract. Materials that are corrosive to the eyes or cause irreversible
Pressure below OSHA definition. Pyrophorics: No Rating. Oxidizers: Packaging Group III
corneal opacity. Materials corrosive to the skin. Cryogenic gases that cause frostbite and
oxidizers; Solids: any material that in either concentration tested, exhibits a mean
irreversible tissue damage. Compressed liquefied gases with boiling points below -55癈
burning time less than or equal to the mean burning time of a 3:7 potassium
(-66.5癋) that cause frostbite and irreversible tissue damage. Materials with an LD50 for
bromate/cellulose mixture and the criteria for Packing Group I and II are not met. Liquids:
acute oral toxicity greater than 5 mg/kg but less than or equal to 50 mg/kg. 4 Materials
any material that exhibits a mean pressure rise time less than or equal to the pressure
that, under emergency conditions, can be lethal. Gases with an LC50 for acute inhalation
rise time of a 1:1 nitric acid (65%)/cellulose mixture and the criteria for Packing Group I
toxicity less than or equal to 1,000 ppm. Any liquid whose saturated vapor concentration
and II are not met. Unstable Reactives: Substances that may decompose condense, or
at 20癈 (68癋) is equal to or greater than ten times its LC50 for acute inhalation toxicity, if
self-react, but only under conditions of high temperature and/or pressure and have little
its LC50 is less than or equal to 1000 ppm. Dusts and mists whose LC50 for acute
or no potential to cause significant heat generation or explosion hazard. Substances that
inhalation toxicity is less than or equal to 0.5 mg/L. Materials whose LD50 for acute
readily undergo hazardous polymerization in the absence of inhibitors.Substances that
dermal toxicity is less than or equal to 40 mg/kg. Materials whose LD50 for acute oral
readily undergo hazardous polymerization in the absence of inhibitors. 2 Water
toxicity is less than or equal to 5 mg/kg.
Reactivity: Materials that may react violently with water. Organic Peroxides: Materials
FLAMMABILITY HAZARD: 0 Materials that will not burn under typical fire conditions,
that, in themselves, are normally unstable and will readily undergo violent chemical
including intrinsically noncombustible materials such as concrete, stone, and sand.
change, but will not detonate. These materials may also react violently with water.
Materials that will not burn in air when exposed to a temperature of 816癈 (1500癋) for a
Explosives: Division 1.4 explosives. Explosive substances where the explosive effects
period of 5 minutes in according with Annex D of NFPA 704. 1 Materials that must be
are largely confined to the package and no projection of fragments of appreciable size or
preheated before ignition can occur. Materials in this degree require considerable
range are expected. An external fire must not cause virtually instantaneous explosion of
preheating, under all ambient temperature conditions, before ignition and combustion
almost the entire contents of the package. Compressed Gases: Pressurized and meet
can occur: Materials that will burn in air when exposed to a temperature of 816癈
OSHA definition but < 514.7 psi absolute at 21.1癈 (70癋) [500 psig]. Pyrophorics: No
(1500癋) for a period of 5 minutes in according with Annex D of NFPA 704. Liquids,
Rating. Oxidizers: Packing Group II oxidizers. Solids: any material that, either in
solids, and semisolids having a flash point at or above 93.4癈 (200癋) (i.e. Class IIIB
concentration tested, exhibits a mean burning time of less than or equal to the mean
liquids). Liquids with a flash point greater than 35癈 (95癋) that do not sustain
burning time of a 2:3 potassium bromate/cellulose mixture and the criteria for Packing
combustion when tested using the Method of Testing for Sustained Combustibility, per
Group I are not met. Liquids: any material that exhibits a mean pressure rise time less
49 CFR 173, Appendix H or the UN Recommendations on the Transport of Dangerous
than or equal to the pressure rise of a 1:1 aqueous sodium chlorate solution
Goods, Model Regulations (current edition) and the related Manual of Tests and Criteria
(40%)/cellulose mixture and the criteria for Packing Group I are not met. Reactives:
(current edition). Liquids with a flash point greater than 35癈 (95癋) in a water-miscible
Substances that may polymerize, decompose, condense, or self-react at ambient
solution or dispersion with a water non-combustible liquid/solid content of more than
temperature and/or pressure, but have a low potential (or low risk) for significant heat
85% by weight. Liquids that have no fire point when tested by ASTM D 92, Standard
generation or explosion. Substances that readily form peroxides upon exposure to air or
Test Method for Flash and Fire Points by Cleveland Open Cup, up to the boiling point of
oxygen at room temperature. 3 Water Reactivity: Materials that may form explosive
the liquid or up to a temperature at which the sample being tested shows an obvious
reactions with water. Organic Peroxides: Materials that are capable of detonation or
physical change. Combustible pellets with a representative diameter of greater than 2
explosive reaction, but require a strong initiating source or must be heated under
mm (10 mesh). Most ordinary combustible materials. Solids containing greater than
confinement before initiation; or materials that react explosively with water. Explosives:
0.5% by weight of a flammable or combustible solvent are rated by the closed cup flash
Division 1.3 explosives. Explosive substances that have a fire hazard and either a minor
point of the solvent. 2 Materials that must be moderately heated or exposed to relatively
blast hazard or a minor projection hazard or both, but do not have a mass explosion
high ambient temperatures before ignition can occur. Materials in this degree would not
hazard. Compressed Gases: Pressure 514.7 psi absolute at 21.1癈 (70癋) [500 psig].
under normal conditions form hazardous atmospheres with air, but under high ambient
Pyrophorics: No Rating. Oxidizers: Packing Group I oxidizers. Solids: any material that,
temperatures or under moderate heating could release vapor in sufficient quantities to
in either concentration tested, exhibits a mean burning time less than the mean burning
produce hazardous atmospheres with air. Liquids having a flash point at or above 37.8癈
time of a 3:2 potassium bromate/cellulose mixture. Liquids: any material that
(100癋) and below 93.4癈 (200癋) (i.e. Class II and Class IIIA liquids.) Solid materials in
spontaneously ignites when mixed with cellulose in a 1:1 ratio, or which exhibits a mean
the form of powders or coarse dusts of representative diameter between 420 microns
pressure rise time less than the pressure rise time of a 1:1 perchloric acid
(40 mesh) and 2 mm (10 mesh) that burn rapidly but that generally do not form explosive
(50%)/cellulose mixture. Unstable Reactives: Substances that may polymerize,
mixtures with air. Solid materials in fibrous or shredded form that burn rapidly and create
decompose, condense, or self-react at ambient temperature and/or pressure and have a
flash fire hazards, such as cotton, sisal, and hemp. Solids and semisolids that readily
moderate potential (or moderate risk) to cause significant heat generation or explosion. 4
give off flammable vapors. Solids containing greater than 0.5% by weight of a flammable
Water Reactivity: Materials that react explosively with water without requiring heat or
or combustible solvent are rated by the closed cup flash point of the solvent. 3 Liquids
confinement. Organic Peroxides: Materials that are readily capable of detonation or
and solids that can be ignited under almost all ambient temperature conditions. Materials
explosive decomposition at normal temperature and pressures. Explosives: Division 1.1
in this degree produce hazardous atmospheres with air under almost all ambient
& 1.2 explosives. Explosive substances that have a mass explosion hazard or have a
temperatures or, though unaffected by ambient temperatures, are readily ignited under
projection hazard. A mass explosion is one that affects almost the entire load
almost all conditions. Liquids having a flash point below 22.8癈 (73癋) and having a
instantaneously. Compressed Gases: No Rating. Pyrophorics: Add to the definition of
boiling point at or above 37.8癈 (100癋) and those liquids having a flash point at or
Flammability 4. Oxidizers: No 4 rating. Unstable Reactives: Substances that may
above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. Class IB and IC liquids). Materials
polymerize, decompose, condense, or self-react at ambient temperature and/or pressure
that on account of their physical form or environmental conditions can form explosive
and have a high potential (or high risk) to cause significant heat generation or explosion.
mixtures with air and are readily dispersed in air.
CLOBETASOL PROPIONATE SCALP SOLUTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
PAGE 10 OF 10
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS TOXICOLOGICAL INFORMATION:
Human and Animal Toxicology: Possible health hazards as derived from human
(continued):
data, animal studies, or from the results of studies with similar compounds are
FLAMMABILITY HAZARD (continued): 3 (continued): Flammable or combustible dusts
presented. LD50: Lethal Dose (solids & liquids) that kills 50% of the exposed
with representative diameter less than 420 microns (40 mesh). Materials that burn with
animals. LC50: Lethal Concentration (gases) that kills 50% of the exposed animals.
extreme rapidity, usually by reason of self-contained oxygen (e.g. dry nitrocellulose and
many organic peroxides). Solids containing greater than 0.5% by weight of a flammable ppm: Concentration expressed in parts of material per million parts of air or water.
mg/m3: Concentration expressed in weight of substance per volume of air. mg/kg:
or combustible solvent are rated by the closed cup flash point of the solvent. 4 Materials
that will rapidly or completely vaporize at atmospheric pressure and normal ambient Quantity of material, by weight, administered to a test subject, based on their body
temperature or that are readily dispersed in air and will burn readily. Flammable gases. weight in kg. TDLo: Lowest dose to cause a symptom. TCLo: Lowest
Flammable cryogenic materials. Any liquid or gaseous materials that is liquid while under
concentration to cause a symptom. TDo, LDLo, and LDo, or TC, TCo, LCLo, and
pressure and has a flash point below 22.8癈 (73癋) and a boiling point below 37.8癈
LCo: Lowest dose (or concentration) to cause lethal or toxic effects. Cancer
(100癋) (i.e. Class IA liquids). Materials that ignite when exposed to air, Solids containing
Information: IARC: International Agency for Research on Cancer. NTP: National
greater than 0.5% by weight of a flammable or combustible solvent are rated by the
Toxicology Program. RTECS: Registry of Toxic Effects of Chemical Substances.
closed cup flash point of the solvent.
IARC and NTP rate chemicals on a scale of decreasing potential to cause human
INSTABILITY HAZARD: 0 Materials that in themselves are normally stable, even under
cancer with rankings from 1 to 4. Subrankings (2A, 2B, etc.) are also used. Other
fire conditions. Materials that have an instantaneous power density (product of heat of
Information: BEI: ACGIH Biological Exposure Indices, represent the levels of
reaction and reaction rate) at 250癈 (482癋) below 0.01 W/mL. Materials that do not
determinants which are most likely to be observed in specimens collected from a
exhibit an exotherm at temperatures less than or equal to 500癈 (932癋) when tested by
healthy worker who has been exposed to chemicals to the same extent as a
differential scanning calorimetry.
INSTABILITY HAZARD: 1 Materials that in themselves are normally stable, but that can worker with inhalation exposure to the TLV.
become unstable at elevated temperatures and pressures. Materials that have an ECOLOGICAL INFORMATION:
instantaneous power density (product of heat of reaction and reaction rate) at 250癈 EC: Effect concentration in water. BCF: Bioconcentration Factor, which is used to
(482癋) at or above 0.01 W/mL and below 10 W/mL. 2 Materials that readily undergo determine if a substance will concentrate in life forms that consume contaminated plant
violent chemical change at elevated temperatures and pressures. Materials that have an or animal matter. TLm: Median threshold limit. log KOW or log KOC: Coefficient of
instantaneous power density (product of heat of reaction and reaction rate) at 250癈 Oil/Water Distribution is used to assess a substance's behavior in the environment.
(482癋) at or above 10 W/mL and below 100W/mL. 3 Materials that in themselves are
REGULATORY INFORMATION:
capable of detonation or explosive decomposition or explosive reaction, but that require
U.S. and CANADA:
a strong initiating source or that must be heated under confinement before initiation.
This section explains the impact of various laws and regulations on the material. EPA:
Materials that have an estimated instantaneous power density (product of heat of
U.S. Environmental Protection Agency. ACGIH: American Conference of Governmental
reaction and reaction rate) at 250癈 (482癋) at or above 100 W/mL and below 1000
Industrial Hygienists, a professional association that establishes exposure limits. OSHA:
W/mL. Materials that are sensitive to thermal or mechanical shock at elevated
U.S. Occupational Safety and Health Administration. NIOSH: National Institute of
temperatures and pressures. 4 Materials that in themselves are readily capable of
Occupational Safety and Health, which is the research arm of OSHA. WHMIS: Canadian
detonation or explosive decomposition or explosive reaction at normal temperatures and
Workplace Hazardous Materials Information System. DOT: U.S. Department of
pressures. Materials that are sensitive to localized thermal or mechanical shock at
Transportation. TC: Transport Canada. SARA: Superfund Amendments and
normal temperatures and pressures. Materials that have an estimated instantaneous
Reauthorization Act. DSL/NDSL: Canadian Domestic/Non-Domestic Substances List.
power density (product of heat of reaction and reaction rate) at 250癈 (482癋) of 1000
TSCA: U.S. Toxic Substance Control Act. CERCLA: Comprehensive Environmental
W/mL or greater.
Response, Compensation, and Liability Act. Marine Pollutant status according to the
FLAMMABILITY LIMITS IN AIR: DOT; CERCLA or Superfund; and various state regulations. This section also includes
Much of the information related to fire and explosion is derived from the National Fire
information on the precautionary warnings that appear on the material's package label.
Protection Association (NFPA). Flash Point: Minimum temperature at which a liquid
gives off sufficient vapor to form an ignitable mixture with air near the surface of the
liquid or within the test vessel used. Autoignition Temperature: Minimum temperature of
a solid, liquid, or gas required to initiate or cause self-sustained combustion in air with no
other source of ignition. LEL: Lowest concentration of a flammable vapor or gas/air
mixture that will ignite and burn with a flame. UEL: Highest concentration of a flammable
vapor or gas/air mixture that will ignite and burn with a flame.
CLOBETASOL PROPIONATE SCALP SOLUTION 0.05% MSDS EFFECTIVE DATE: SEP 21, 2009
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