ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION/PHARMADERM DIVISION
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: Mometasone / Mometasone Furoate Topical
Solution 0.1%
Mometasone Furoate Topical Solution
DESCRIPTION:
0168-0272-30; 0168-0272-60
NDC #:
9α,21-Dichloro-11β,17dihydroxy-16α-methylpregna-1,4-
CHEMICAL NAME (for active ingredient):
diene-3,20-dione 17-(2-Furoate)
Steroid
CHEMICAL FAMILY (for active ingredient):
0.1% Topical Solution
HOW SUPPLIED:
C27H30Cl2O6
FORMULA (for active ingredient):
Pharmaceutical for Human Use
PRODUCT USE:
SUPPLIER/MANUFACTURER'S NAME: ALTANA 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
2. HAZARD IDENTIFICATION
EMERGENCY OVERVIEW: Product Description: This product is a white liquid with a slight 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,
Mometasone Furoate, or any other components of this product may experience allergic reactions to this product.
Repeated skin exposure of Mometasone Furoate 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
Isopropanol 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.
SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: The health hazard information provided below is
pertinent to medical employees handling this product in an occupational setting. This product is designed for application
on the skin. The following paragraphs describe the symptoms of exposure by route of exposure.
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 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 Mometasone Furoate) may cause allergic 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.
SKIN ABSORPTION: The Isopropanol and Mometasone Furoate components of this product can be absorbed through
intact skin. Symptoms of acute overexposure by this route may include central nervous system depression as
described under “Inhalation�. Symptoms of chronic overexposure by this route 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.
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�.
MOMETASONE FUROATE TOPICAL SOLUTION 0.1% MSDS EFFECTIVE DATE: AUGUST 30, 2007
PAGE 1 OF 11
ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION/PHARMADERM DIVISION
2. HAZARD IDENTIFICATION (Continued)
INJECTION: Though not anticipated to be a significant route of
overexposure for this product, injection (via punctures or lacerations HAZARDOUS MATERIAL IDENTIFICATION SYSTEM
by contaminated objects) may cause redness at the site of injection.
Symptoms may include those described for “Other Potential Health
(BLUE) 1
Effects�. HEALTH HAZARD
OTHER POTENTIAL HEALTH EFFECTS-Therapeutic Doses:
Employees administering the product should not experience adverse
effects if handled properly. Persons using the product in therapeutic
FLAMMABILITY HAZARD (RED) 3
doses have experienced an acne-like reaction; inflammation of hair
follicles; decreased glucocortoid levels; burning, prickling, itching, or
tingling of the skin; dry mouth; unspecified endocrine disorder; skin
shininess, raised dark red blotches on the skin; loss of skin
elasticity, and loss of normal skin markings. PHYSICAL HAZARD (YELLOW) 0
HEALTH EFFECTS OR RISKS FROM EXPOSURE: An Explanation
in Lay Terms. Overexposure to this product may cause the following
health effects: PROTECTIVE EQUIPMENT
Acute: The primary health effects that may be experienced by
medical personnel exposed to this product is mild irritation of
EYES HANDS BODY
RESPIRATORY
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. SEE SECTION 8 SEE SECTION 8
Chronic: Corticosteroids (such as Mometasone Furoate) may cause
allergic contact dermatitis. Symptoms of chronic skin absorption For Routine Industrial Use and Handling Applications
overexposure may include reversible hypothalamic-
pituitaryadrenal (HPA) axis suppression, abnormal accumulations Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
of facial and trunk fat, fatigue, high blood pressure, osteoporosis, 3 = Serious 4 = Severe * = Chronic hazard
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.
3. COMPOSITION and INFORMATION ON INGREDIENTS
CHEMICAL NAME CAS # % w/w
Mometasone Furoate 83919-23-7 0.1%
Propylene Glycol 57-55-6 Proprietary
Isopropyl Alcohol 67-63-0 40.0%
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).
NOTE: ALL Canadian WHMIS U.S. Federal Occupational Safety and Health Administration Standard (29 CFR 1910.1200), and U.S. State equivalent Standard required
information is included in appropriate sections based on the ANSI Z400.1-2004 format. This product has been classified in accordance with the hazard criteria of the
CPR and the MSDS contains all the information required by the CPR.
PART II What should I do if a hazardous situation occurs?
4 FIRST-AID MEASURES
Persons developing hypersensitivity reactions should receive medical attention. If breathing is difficult, give oxygen. If
not breathing, give artificial respiration. Take a copy of label and MSDS to physician or health professional with the
contaminated individual.
SKIN EXPOSURE: If adverse skin effects occur, discontinue use. Seek medical attention.
EYE EXPOSURE: If this product contaminates the eyes, rinse eyes under gently running water. Use sufficient force to
open eyelids and then "roll" eyes while flushing. Minimum flushing is for 15 minutes. The contaminated individual must
seek medical attention if any adverse effect continues after rinsing.
INHALATION: If vapors of this product are inhaled, causing irritation, remove victim to fresh air. If necessary, use
artificial respiration to support vital functions.
MOMETASONE FUROATE TOPICAL SOLUTION 0.1% MSDS EFFECTIVE DATE: AUGUST 30, 2007
PAGE 2 OF 11
ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION/PHARMADERM DIVISION
4 FIRST-AID MEASURES (Continued)
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 Isopropanol 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: 24°C (75°F)
AUTOIGNITION TEMPERATURE: Not established. NFPA RATING
FLAMMABLE LIMITS (in air by volume, %): FLAM MAB ILITY
Lower (LEL): Not applicable.
Upper (UEL): Not applicable.
3
Use extinguishing media
FIRE EXTINGUISHING MATERIALS:
appropriate for surrounding fire. 1 0
HEALTH INSTAB ILITY
Water Spray: OK Carbon Dioxide: OK
Foam: OK Dry Chemical: OK
Halon: OK Other: Any "ABC" Class
UNUSUAL FIRE AND EXPLOSION HAZARDS: This product is
flammable; it can be readily ignited under ambient conditions. When OTHER
involved in a fire, this material may ignite and produce irritating vapors Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
3 = Serious 4 = Severe
and toxic gases (e.g., carbon oxides, phosphorus oxides, 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).
MOMETASONE FUROATE TOPICAL SOLUTION 0.1% MSDS EFFECTIVE DATE: AUGUST 30, 2007
PAGE 3 OF 11
ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION/PHARMADERM DIVISION
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
83919-23-7
Mometasone NE NE NE NE NE NE NE NE
Furoate
AIHA WEEL:
Propylene Glycol 57-55-6 NE NE NE NE NE NE NE
TWA = 10
DFG MAK:
Isopropanol 67-63-0 492 984 980 1225 980 1225 4920
TWA = 500
(vacated
PEAK = 2•MAK 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 Z94.3-02). 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 OSHAs 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 Z94.3-02.
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.
MOMETASONE FUROATE TOPICAL SOLUTION 0.1% MSDS EFFECTIVE DATE: AUGUST 30, 2007
PAGE 4 OF 11
ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION/PHARMADERM DIVISION
8. EXPOSURE CONTROLS - PERSONAL PROTECTION (Continued)
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.
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 (water = 1): Not established.
ODOR THRESHOLD: Not established. pH: Not established.
COEFFICIENT WATER/OIL DISTRIBUTION: Not established.
APPEARANCE AND COLOR: This product is a white liquid with a slight 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, phosphorus oxides, 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
GENERAL TOXICITY INFORMATION: Individuals who have had allergic reactions to products containing the
Mometasone Furoate 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 may experience an acne-like reaction;
inflammation of hair follicles; decreased glucocortoid levels; burning, prickling, itching, or tingling of the skin; dry
mouth; unspecified endocrine disorder; skin shininess, raised dark red blotches on the skin; loss of skin elasticity,
and loss of normal skin markings.
IRRITANCY OF PRODUCT: This product may mildly to moderately irritate contaminated tissue.
SENSITIZATION OF PRODUCT: Corticosteroids (such as Mometasone Furoate) may cause allergic contact
dermatitis.
TOXICITY DATA: The toxicity data available for the active component of this product, Mometasone Furoate, is
presented in this MSDS. Additional data are available for the excipient components of this product, but are not
presented in this MSDS; Contact Altana Inc. for more information.
MOMETASONE FUROATE: MOMETASONE FUROATE (continued): MOMETASONE FUROATE (continued):
LD50 (Subcutaneous-Rat) 300 mg/kg: Lungs, TDLo (Subcutaneous-Rat) 210 µg/kg: female 14 TDLo (Subcutaneous-Rat) 13 mg/kg: female 6-18
Thorax, or Respiration: respiratory days pre-mating: 7 days after conception: days after conception: Reproductive: Effects on
depression; Nutritional and Gross Metabolic: Reproductive: Fertility: post-implantation mortality Embryo or Fetus: fetotoxicity (except death, e.g.,
body temperature decrease (e.g. dead and/or resorbed implants per total stunted fetus), other effects to embryo; Specific
LDLo (Subcutaneous-Mouse) 1 g/kg number of implants); Effects on Fetus: fetotoxicity Developmental Abnormalities: craniofacial
TDLo (Skin-Rat) 10,920 µg/kg/52 weeks- (except death, e.g., stunted fetus), fetal death (including nose and tongue)
continuous: Lungs, Thorax, or Respiration: TDLo (Subcutaneous-Rat) 66 µg/kg: female 7-17 TDLo (Skin-Rabbit) 2600 µg/kg: female 6-18 days
other changes; Endocrine: adrenal cortex days after conception: Reproductive: Effects on after conception: Reproductive: Musculoskeletal
hypoplasia; Blood: changes in spleen Embryo or Fetus: fetotoxicity (except death, e.g., Developmental Abnormalities
TDLo (Skin-Dog) 36,400 µg/kg/52 weeks- stunted fetus); Specific Developmental TDLo (Skin-Rabbit) 13 mg/kg: female 6-18 days after
continuous: Liver: other changes; Endocrine: Abnormalities: musculoskeletal system conception: Reproductive: Specific Developmental
adrenal cortex hypoplasia; Blood: other TDLo (Subcutaneous-Rat) 330 µg/kg: female 7-17 Abnormalities: cardiovascular (circulatory) system
changes days after conception: Effects on Newborn: growth Reproductive: Specific Developmental
statistics (e.g.%, reduced weight gain), physical Abnormalities: cardiovascular (circulatory) system
TDLo (Subcutaneous-Rat) 13 µg/kg: female 7-17
days after conception: Reproductive: Effects on
Newborn: behavioral
MOMETASONE FUROATE TOPICAL SOLUTION 0.1% MSDS EFFECTIVE DATE: AUGUST 30, 2007
PAGE 5 OF 11
ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION/PHARMADERM DIVISION
11. TOXICOLOGICAL INFORMATION (Continued)
CARCINOGENIC INFORMATION: The following information is available from carcinogenic studies performed with the
active ingredient of this product, Mometasone Furoate:
Long-term carcinogenicity studies of Mometasone Furoate were conducted by the inhalation route in rats and mice.
In a 2-year carcinogenicity study in Sprague-Dawley rats, Mometasone Furoate demonstrated no statistically
significant increase of tumors at inhalation doses up to 67 mcg/kg (approximately 0.04 times the estimated
maximum clinical topical dose from Mometasone Furoate Topical Solution 0.1% on a mcg/m2 basis). In a 19-month
carcinogenicity study in Swiss CD-1 mice, Mometasone Furoate demonstrated no statistically significant increase
in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 0.05 times the estimated maximum
clinical topical dose from Mometasone Furoate Topical Solution 0.1% on a mcg/m2 basis).
The incipient components of this product are listed by agencies tracking the carcinogenic potential of chemical
compounds, as follows:
ISOPROPANOL: 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, Mometasone Furoate, 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: Mometasone Furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary cell assay, but did
no increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone Furoate was not mutagenic
in the Ames test or mouse lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay, a rat bone
marrow chromosomal aberration assay, or a mouse male germ-cell chromosomal aberration assay. Mometasone Furoate also
did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.
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. When administered to pregnant rats, rabbits, and mice, Mometasone Furoate increased fetal malformations. The
doses that produced malformations also decreased fetal growth, as measured by lower fetal weights and/or delayed
ossification. Mometasone Furoate also caused dystocia and related complications when administered to rats during the end of
pregnancy. In mice, Mometasone Furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above. Fetal survival
was reduced at 180 mcg/kg. No toxicity was observed at 20 mcg/kg. (Doses of 20, 60, and 180 mcg/kg in the mouse are
approximately 0.01, 0.02, and 0.05 times the estimated maximum clinical topical dose from Mometasone Furoate Topical
2
Solution 0.1% on a mcg/m basis). In rats, Mometasone Furoate produced umbilical hernias at topical doses of 600 mcg/kg
and above. A dose of 300 mcg/kg produced delays in ossification, but no malformations. (Doses of 300 and 600 mcg/kg in the
rat are approximately 0.2 and 0.4 times the estimated maximum clinical topical dose from Mometasone Furoate Topical
Solution 0.1% on a mcg/m2 basis). In rabbits, Mometasone Furoate caused multiple malformations (e.g., flexed front paws,
gallbladder agenesis, umbilical hernia, hydrocephaly) at topical doses of 150 mcg/kg and above (approximately 0.2 times the
estimated maximum clinical topical dose from Mometasone Furoate Topical Solution 0.1% on a mcg/m2 basis). In an oral
study, Mometasone Furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly and
domed head) at 700 mcg/kg. At 2800 mcg/kg most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg.
(Doses at 140, 700, and 2800 mcg/kg in the rabbit are approximately 0.2, 0.9, and 3.6 times the estimated maximum clinical
2
topical dose from Mometasone Furoate Topical Solution 0.1% on a mcg/m basis). When rats received subcutaneous doses of
Mometasone Furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg caused prolonged and difficult
labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5
mcg/kg. (Doses of 7.5 and 15 mcg/kg in the rat are approximately 0.005 and 0.01 times the estimated maximum clinical topical
2
dose from Mometasone Furoate Topical Solution 0.1% on a mcg/m basis).
Reproductive Toxicity: In reproductive studies in rats, impairment of fertility was not produced in male or female rats by
subcutaneous doses up to 15 mcg/kg (approximately 0.01 times the estimated maximum clinical topical dose from
Mometasone Furoate Topical Solution 0.1% on a mcg/m2 basis).
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
Isopropanol
� Acetone in urine � End of Shift End of Workweek � 40 mg/L
MOMETASONE FUROATE TOPICAL SOLUTION 0.1% MSDS EFFECTIVE DATE: AUGUST 30, 2007
PAGE 6 OF 11
ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION/PHARMADERM DIVISION
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:
ISOPROPANOL:
Octanol/Water Partition Coefficient: Log P = 0.34�0.5
Persistence: If released to the soil, Isopropanol will both rapidly evaporate and leach into the ground due to high vapor pressure and low adsorption to soil. If released
to water, Isopropanol will volatilize, with an estimated half-life of 5.4 days. If released to the atmosphere, Isopropanol will photo-degrade, with an estimated half-life
of one to several days. Due to the solubility of Isopropanol in water, rainout may be significant.
Biodegradation: In soil, and water, degradation of Isopropanol 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:
ISOPROPANOL: ISOPROPANOL (continued): ISOPROPANOL (continued):
EC0 (Microcystis aeruginosa) 8 days = 1,000 mg/L Toxic (Chlorella pyrenoidosa algae) = 17,400 mg/L LC50 (Crangon crangon brown shrimp) 98 hours =
EC0 (Scenedesmus quadricauda green algae) 7 NOEC (Daphnia magna) 757-2,100 mg/L 1,150 mg/L
days = 1,800 mg/L LC0 (creek chub) 24 hours = 900 mg/L LC50 (goldfish) 24 hours = > 500 mg/L
EC0 (Entosiphon sulcatum protozoa) 72 hours = LC50 (Artemia salina) 24 hours = 16,700 mg/L LC50 (fathead minnow) 1 hour = 11,830 mg/L
4,930 mg/L LC50 (Streptocephalus proboscideus) 24 hours = LC50 (fathead minnow) 24 hours = 11,160 mg/L
EC0 (Uronema parduczi Chatton-Lwoff) = 3,425 11,600 mg/L LC50 (fathead minnow) 48 hours = 11,130 mg/L
mg/L LC50 (Daphnia magna) 24 hours = 9,500 mg/L LC50 (fathead minnow) 72 hours = 11,130 mg/L
EC50 (Photobacterium) 5 minutes = 22,800 mg/L LC50 (Brachionus calyciflorus) 24 hours = 28,600 LC50 (fathead minnow) 96 hours = 11,130 mg/L
EC50 (Daphnia magna) 3,010 mg/L mg/L LC50 (Poecilia reticulata guppy) 7 days = 7,060
EC50 (Pseudomonas putida) 16 hours = 1,050 mg/L LC50 (Crangon crangon brown shrimp) 48 hours = mg/L
1,400 mg/L LC50 (Daphnia magna) 4,600 mg/L
LC100 (creek chub) 24 hours = 1,100 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.
Flammable liquids, n.o.s. (Isopropanol)
Proper Shipping Name:
Class 3 (Flammable)
Hazard Class Number and Description:
UN 1993
UN Identification Number:
III
Packing Group:
Flammable
DOT Label(s) Required:
128
Emergency Response Guidebook Number (2004):
Marine Pollutant: The Mometasone Furoate component of this product is classified by the U.S. DOT as a Marine Pollutant (as
defined by 49 CFR 172.101, Appendix B).
TRANSPORT CANADA TRANSPORTATION OF DANGEROUS GOODS REGULATIONS: This product is classified
as Dangerous Goods, per regulations of Transport Canada.
Flammable liquids, n.o.s. (Isopropanol)
Proper Shipping Name:
Class 2 (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 Mometasone Furoate component of this product is listed as a marine pollutant, per Part 2, Section 2.7 of the
Consolidated Transportation of Dangerous Goods Regulations.
15. REGULATORY INFORMATION
MOMETASONE FUROATE TOPICAL SOLUTION 0.1% MSDS EFFECTIVE DATE: AUGUST 30, 2007
PAGE 7 OF 11
ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION/PHARMADERM DIVISION
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)
Isopropanol (mfg-strong acid process) No No Yes
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:
ISOPROPANOL:
FDA: Isopropanol 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. Isopropanol 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), Isopropanol, 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 Isopropanol 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. Isopropanol 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.
Isopropanol 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
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.
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 Altana, 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
800/441-3365619/670-0609
July 20, 2007
DATE OF PRINTING:
MOMETASONE FUROATE TOPICAL SOLUTION 0.1% MSDS EFFECTIVE DATE: AUGUST 30, 2007
PAGE 8 OF 11
ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION/PHARMADERM DIVISION
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 HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
each constituent. RATINGS (continued):
EXPOSURE LIMITS IN AIR: HEALTH HAZARD (continued): 2 Moderate Hazard: Temporary or transitory injury
CEILING LEVEL: The concentration that shall not be exceeded during any part of may occur; prolonged exposure may affect the CNS. Skin Irritation: Moderately
the working exposure. irritating; primary irritant; sensitizer. PII or Draize � 5, with no destruction of dermal
DFG MAK Germ Cell Mutagen Categories: 1: Germ cell mutagens that have tissue. Eye Irritation: Moderately to severely irritating; reversible corneal opacity;
been shown to increase the mutant frequency in the progeny of exposed humans. corneal involvement or irritation clearing in 8�21 days. Draize = 26�100, with
2: Germ cell mutagens that have been shown to increase the mutant frequency in reversible effects. Oral Toxicity LD50 Rat: > 50�500 mg/kg. Dermal Toxicity LD50
the progeny of exposed mammals. 3A: Substances that have been shown to Rat or Rabbit: > 200�1000 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 0.5�2
induce genetic damage in germ cells of human of animals, or which produce mg/L. 3 Serious Hazard: Major injury likely unless prompt action is taken and
mutagenic effects in somatic cells of mammals in vivo and have been shown to medical treatment is given; high level of toxicity; corrosive. Skin Irritation: Severely
reach the germ cells in an active form. 3B: Substances that are suspected of irritating and/or corrosive; may cause destruction of dermal tissue, skin burns, and
being germ cell mutagens because of their genotoxic effects in mammalian dermal necrosis. PII or Draize > 5�8, with destruction of tissue. Eye Irritation:
somatic cell in vivo; in exceptional cases, substances for which there are no in Corrosive, irreversible destruction of ocular tissue; corneal involvement or irritation
vivo data, but that are clearly mutagenic in vitro and structurally related to known persisting for more than 21 days. Draize > 80 with effects irreversible in 21 days.
in vivo mutagens. 4: Not applicable (Category 4 carcinogenic substances are Oral Toxicity LD50 Rat: > 1�50 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 20�
those with non-genotoxic mechanisms of action. By definition, germ cell mutagens 200 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 0.05�0.5 mg/L. 4 Severe Hazard:
are genotoxic. Therefore, a Category 4 for germ cell mutagens cannot apply. At Life-threatening; major or permanent damage may result from single or repeated
some time in the future, it is conceivable that a Category 4 could be established exposures; extremely toxic; irreversible injury may result from brief contact. Skin
for genotoxic substances with primary targets other than DNA [e.g. purely Irritation: Not appropriate. Do not rate as a 4, based on skin irritation alone. Eye
aneugenic substances] if research results make this seem sensible.) 5: Germ cell Irritation: Not appropriate. Do not rate as a 4, based on eye irritation alone. Oral
mutagens, the potency of which is considered to be so low that, provided the MAK Toxicity LD50 Rat: � 1 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: � 20 mg/kg.
value is observed, their contribution to genetic risk for humans is expected not to Inhalation Toxicity LC50 4-hrs Rat: � 0.05 mg/L.
be significant. FLAMMABILITY HAZARD: 0 Minimal Hazard: Materials that will not burn in air
DFG MAK Pregnancy Risk Group Classification: Group A: A risk of damage to when exposure to a temperature of 815.5°C (1500°F) for a period of 5 minutes. 1
the developing embryo or fetus has been unequivocally demonstrated. Exposure Slight Hazard: Materials that must be pre-heated before ignition can occur.
of pregnant women can lead to damage of the developing organism, even when Material requires considerable pre-heating, under all ambient temperature
MAK and BAT (Biological Tolerance Value for Working Materials) values are conditions before ignition and combustion can occur. This usually includes the
observed. Group B: Currently available information indicates a risk of damage to following: Materials that will burn in air when exposed to a temperature of 815.5°C
the developing embryo or fetus must be considered to be probable. Damage to (1500°F) for a period of 5 minutes or less; Liquids, solids and semisolids having a
the developing organism cannot be excluded when pregnant women are exposed, flash point at or above 93.3°C (200°F) (i.e. OSHA Class IIIB); and Most ordinary
even when MAK and BAT values are observed. Group C: There is no reason to combustible materials (e.g. wood, paper, etc.). 2 Moderate Hazard: Materials that
fear a risk of damage to the developing embryo or fetus when MAK and BAT must be moderately heated or exposed to relatively high ambient temperatures
values are observed. Group D: Classification in one of the groups A–C is not yet before ignition can occur. Materials in this degree would not, under normal
possible because, although the data available may indicate a trend, they are not conditions, form hazardous atmospheres in air, but under high ambient
sufficient for final evaluation. temperatures or moderate heating may release vapor in sufficient quantities to
IDLH: Immediately Dangerous to Life and Health. This level represents a produce hazardous atmospheres with air. This usually includes the following:
concentration from which one can escape within 30-minutes without suffering Liquids having a flash-point at or above 37.8°C (100°F); Solid materials in the form
escape-preventing or permanent injury. of course dusts that may burn rapidly but that generally do not form explosive
LOQ: Limit of Quantitation. atmospheres; Solid materials in a fibrous or shredded form that may burn rapidly
MAK: Federal Republic of Germany Maximum Concentration Values in the and create flash fire hazards (e.g. cotton, sisal, hemp); and Solids and semisolids
workplace. (e.g. viscous and slow flowing as asphalt) that readily give off flammable vapors. 3
NE: Not Established. When no exposure guidelines are established, an entry of Serious Hazard: Liquids and solids that can be ignited under almost all ambient
NE is made for reference. temperature conditions. Materials in this degree produce hazardous atmospheres
NIC: Notice of Intended Change. with air under almost all ambient temperatures, or, unaffected by ambient
NIOSH CEILING: The exposure that shall not be exceeded during any part of the temperature, are readily ignited under almost all conditions. This usually includes
workday. If instantaneous monitoring is not feasible, the ceiling shall be assumed the following: Liquids having a flash point below 22.8°C (73°F) and having a
as a 15-minute TWA exposure (unless otherwise specified) that shall not be boiling point at or above 38°C (100°F) and those liquids having a flash point at or
exceeded at any time during a workday. above 22.8°C (73°F) and below 37.8°C (100°F) (i.e. OSHA Class IB and IC);
NIOSH RELs: NIOSH’s Recommended Exposure Limits. Materials that on account of their physical form or environmental conditions can
PEL: OSHA's Permissible Exposure Limits. This exposure value means exactly form explosive mixtures with air and are readily dispersed in air (e.g., dusts of
the same as a TLV, except that it is enforceable by OSHA. The OSHA combustible solids, mists or droplets of flammable liquids); and Materials that burn
Permissible Exposure Limits are based in the 1989 PELs and the June, 1993 Air extremely rapidly, usually by reason of self-contained oxygen (e.g. dry
Contaminants Rule (Federal Register: 58: 35338-35351 and 58: 40191). Both the nitrocellulose and many organic peroxides). 4 Severe Hazard: Materials that will
current PELs and the vacated PELs are indicated. The phrase, “Vacated 1989 rapidly or completely vaporize at atmospheric pressure and normal ambient
PEL� is placed next to the PEL that was vacated by Court Order. temperature or that are readily dispersed in air, and that will burn readily. This
SKIN: Used when a there is a danger of cutaneous absorption. usually includes the following: Flammable gases; Flammable cryogenic materials;
STEL: Short Term Exposure Limit, usually a 15-minute time-weighted average Any liquid or gaseous material that is liquid while under pressure and has a flash
(TWA) exposure that should not be exceeded at any time during a workday, even point below 22.8°C (73°F) and a boiling point below 37.8°C (100°F) (i.e. OSHA
if the 8-hr TWA is within the TLV-TWA, PEL-TWA or REL-TWA. Class IA); and Materials that ignite spontaneously when exposed to air at a
TLV: Threshold Limit Value. An airborne concentration of a substance that temperature of 54.4°C (130°F) or below (pyrophoric).
represents conditions under which it is generally believed that nearly all workers PHYSICAL HAZARD: 0 Water Reactivity: Materials that do not react with water.
may be repeatedly exposed without adverse effect. The duration must be Organic Peroxides: Materials that are normally stable, even under fire conditions
considered, including the 8-hour. and will not react with water. Explosives: Substances that are Non-Explosive.
TWA: Time Weighted Average exposure concentration for a conventional 8-hr Compressed Gases: No Rating. Pyrophorics: No Rating. Oxidizers: No 0 rating.
(TLV, PEL) or up to a 10-hr (REL) workday and a 40-hr workweek. Unstable Reactives: Substances that will not polymerize, decompose, condense,
or self-react.). 1 Water Reactivity: Materials that change or decompose upon
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
exposure to moisture. Organic Peroxides: Materials that are normally stable, but
RATINGS: This rating system was developed by the National Paint and Coating
can become unstable at high temperatures and pressures. These materials may
Association and has been adopted by industry to identify the degree of chemical
react with water, but will not release energy violently. Explosives: Division 1.5 &
hazards.
1.6 explosives. Substances that are very insensitive explosives or that do not have
HEALTH HAZARD: 0 Minimal Hazard: No significant health risk, irritation of skin or
a mass explosion hazard. Compressed Gases: Pressure below OSHA definition.
eyes not anticipated. Skin Irritation: Essentially non-irritating. Mechanical irritation
Pyrophorics: No Rating. Oxidizers: Packaging Group III oxidizers; Solids: any
may occur. PII or Draize = 0. Eye Irritation: Essentially non-irritating, minimal
material that in either concentration tested, exhibits a mean burning time less than
effects clearing in < 24 hours. Mechanical irritation may occur. Draize = 0. Oral
or equal to the mean burning time of a 3:7 potassium bromate/cellulose mixture
Toxicity LD50 Rat: > 5000 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 2000
and the criteria for Packing Group I and II are not met. Liquids: any material that
mg/kg. Inhalation Toxicity 4-hrs LC50 Rat: > 20 mg/L. 1) Slight Hazard: Minor
exhibits a mean pressure rise time less than or equal to the pressure rise time of a
reversible injury may occur; may irritate the stomach if swallowed; may defat the
1:1 nitric acid (65%)/cellulose mixture and the criteria for Packing Group I and II
skin and exacerbate existing dermatitis. Skin Irritation: Slightly or mildly irritating.
are not met. Unstable Reactives: Substances that may decompose condense, or
PII or Draize > 0 < 5. Eye Irritation: Slightly to mildly irritating, but reversible within
self-react, but only under conditions of high temperature and/or pressure and have
7 days. Draize > 0 � 25. Oral Toxicity LD50 Rat: > 500�5000 mg/kg. Dermal
little or no potential to cause significant heat generation or explosion hazard.
Toxicity LD50 Rat or Rabbit: > 1000�2000 mg/kg. Inhalation Toxicity LC50 4-hrs
Substances that readily undergo hazardous polymerization in the absence of
Rat: > 2�20 mg/L.
inhibitors.
MOMETASONE FUROATE TOPICAL SOLUTION 0.1% MSDS EFFECTIVE DATE: AUGUST 30, 2007
PAGE 9 OF 11
ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION/PHARMADERM DIVISION
DEFINITION OF TERMS (Continued)
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS
RATINGS (continued): (continued):
PHYSICAL HAZARD (continued): 1 (continued) Substances that readily undergo HEALTH HAZARD (continued): 3 (continued) Any liquid whose saturated vapor
hazardous polymerization in the absence of inhibitors. 2 Water Reactivity: concentration at 20°C (68°F) is equal to or greater its LC50 for acute inhalation
Materials that may react violently with water. Organic Peroxides: Materials that, in toxicity, if its LC50 is less than or equal to 3000 ppm and that does not meet the
themselves, are normally unstable and will readily undergo violent chemical criteria for degree of hazard 4. Dusts and mists with an LC50 for acute inhalation
change, but will not detonate. These materials may also react violently with water. toxicity greater than 0.5 mg/L but less than or equal to 2 mg/L. Materials with an
Explosives: Division 1.4 explosives. Explosive substances where the explosive LD50 for acute dermal toxicity greater than 40 mg/kg but less than or equal to 200
effects are largely confined to the package and no projection of fragments of mg/kg. Materials that are corrosive to the respiratory tract. Materials that are
appreciable size or range are expected. An external fire must not cause virtually corrosive to the eyes or cause irreversible corneal opacity. Materials corrosive to
instantaneous explosion of almost the entire contents of the package. the skin. Cryogenic gases that cause frostbite and irreversible tissue damage.
Compressed Gases: Pressurized and meet OSHA definition but < 514.7 psi Compressed liquefied gases with boiling points below -55°C (-66.5°F) that cause
absolute at 21.1°C (70°F) [500 psig]. Pyrophorics: No Rating. Oxidizers: Packing frostbite and irreversible tissue damage. Materials with an LD50 for acute oral
Group II oxidizers. Solids: any material that, either in concentration tested, exhibits toxicity greater than 5 mg/kg but less than or equal to 50 mg/kg. 4 Materials that,
a mean burning time of less than or equal to the mean burning time of a 2:3 under emergency conditions, can be lethal. Gases with an LC50 for acute
potassium bromate/cellulose mixture and the criteria for Packing Group I are not inhalation toxicity less than or equal to 1,000 ppm. Any liquid whose saturated
met. Liquids: any material that exhibits a mean pressure rise time less than or vapor concentration at 20°C (68°F) is equal to or greater than ten times its LC50 for
equal to the pressure rise of a 1:1 aqueous sodium chlorate solution acute inhalation toxicity, if its LC50 is less than or equal to 1000 ppm. Dusts and
(40%)/cellulose mixture and the criteria for Packing Group I are not met. mists whose LC50 for acute inhalation toxicity is less than or equal to 0.5 mg/L.
Reactives: Substances that may polymerize, decompose, condense, or self-react Materials whose LD50 for acute dermal toxicity is less than or equal to 40 mg/kg.
at ambient temperature and/or pressure, but have a low potential (or low risk) for Materials whose LD50 for acute oral toxicity is less than or equal to 5 mg/kg.
significant heat generation or explosion. Substances that readily form peroxides FLAMMABILITY HAZARD: 0 Materials that will not burn under typical fire
upon exposure to air or oxygen at room temperature. 3 Water Reactivity: Materials conditions, including intrinsically noncombustible materials such as concrete,
that may form explosive reactions with water. Organic Peroxides: Materials that stone, and sand. Materials that will not burn in air when exposed to a temperature
are capable of detonation or explosive reaction, but require a strong initiating of 816°C (1500°F) for a period of 5 minutes in according with Annex D of NFPA
source or must be heated under confinement before initiation; or materials that 704. 1 Materials that must be preheated before ignition can occur. Materials in this
react explosively with water. Explosives: Division 1.3 explosives. Explosive degree require considerable preheating, under all ambient temperature conditions,
substances that have a fire hazard and either a minor blast hazard or a minor before ignition and combustion can occur: Materials that will burn in air when
projection hazard or both, but do not have a mass explosion hazard. Compressed exposed to a temperature of 816°C (1500°F) for a period of 5 minutes in according
Gases: Pressure � 514.7 psi absolute at 21.1°C (70°F) [500 psig]. Pyrophorics: No with Annex D of NFPA 704. Liquids, solids, and semisolids having a flash point at
Rating. Oxidizers: Packing Group I oxidizers. Solids: any material that, in either or above 93.4°C (200°F) (i.e. Class IIIB liquids). Liquids with a flash point greater
concentration tested, exhibits a mean burning time less than the mean burning than 35°C (95°F) that do not sustain combustion when tested using the Method of
time of a 3:2 potassium bromate/cellulose mixture. Liquids: any material that Testing for Sustained Combustibility, per 49 CFR 173, Appendix H or the UN
spontaneously ignites when mixed with cellulose in a 1:1 ratio, or which exhibits a Recommendations on the Transport of Dangerous Goods, Model Regulations
mean pressure rise time less than the pressure rise time of a 1:1 perchloric acid (current edition) and the related Manual of Tests and Criteria (current edition).
(50%)/cellulose mixture. Unstable Reactives: Substances that may polymerize, Liquids with a flash point greater than 35°C (95°F) in a water-miscible solution or
decompose, condense, or self-react at ambient temperature and/or pressure and dispersion with a water non-combustible liquid/solid content of more than 85% by
have a moderate potential (or moderate risk) to cause significant heat generation weight. Liquids that have no fire point when tested by ASTM D 92, Standard Test
or explosion. 4 Water Reactivity: Materials that react explosively with water Method for Flash and Fire Points by Cleveland Open Cup, up to the boiling point
without requiring heat or confinement. Organic Peroxides: Materials that are of the liquid or up to a temperature at which the sample being tested shows an
readily capable of detonation or explosive decomposition at normal temperature obvious physical change. Combustible pellets with a representative diameter of
and pressures. Explosives: Division 1.1 & 1.2 explosives. Explosive substances greater than 2 mm (10 mesh). Most ordinary combustible materials. Solids
that have a mass explosion hazard or have a projection hazard. A mass explosion containing greater than 0.5% by weight of a flammable or combustible solvent are
is one that affects almost the entire load instantaneously. Compressed Gases: No rated by the closed cup flash point of the solvent. 2 Materials that must be
Rating. Pyrophorics: Add to the definition of Flammability 4. Oxidizers: No 4 rating. moderately heated or exposed to relatively high ambient temperatures before
Unstable Reactives: Substances that may polymerize, decompose, condense, or ignition can occur. Materials in this degree would not under normal conditions form
self-react at ambient temperature and/or pressure and have a high potential (or hazardous atmospheres with air, but under high ambient temperatures or under
high risk) to cause significant heat generation or explosion. moderate heating could release vapor in sufficient quantities to produce
hazardous atmospheres with air. Liquids having a flash point at or above 37.8°C
NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS:
(100°F) and below 93.4°C (200°F) (i.e. Class II and Class IIIA liquids.) Solid
HEALTH HAZARD: 0 Materials that, under emergency conditions, would offer no
materials in the form of powders or coarse dusts of representative diameter
hazard beyond that of ordinary combustible materials. Gases and vapors with an
between 420 microns (40 mesh) and 2 mm (10 mesh) that burn rapidly but that
LC50 for acute inhalation toxicity greater than 10,000 ppm. Dusts and mists with an
generally do not form explosive mixtures with air. Solid materials in fibrous or
LC50 for acute inhalation toxicity greater than 200 mg/L. Materials with an LD50 for
shredded form that burn rapidly and create flash fire hazards, such as cotton,
acute dermal toxicity greater than 2000 mg/kg. Materials with an LD50 for acute
sisal, and hemp. Solids and semisolids that readily give off flammable vapors.
oral toxicity greater than 2000 mg/kg. Materials essentially non-irritating to the
Solids containing greater than 0.5% by weight of a flammable or combustible
respiratory tract, eyes, and skin. 1 Materials that, under emergency conditions,
solvent are rated by the closed cup flash point of the solvent. 3 Liquids and solids
can cause significant irritation. Gases and vapors with an LC50 for acute inhalation
that can be ignited under almost all ambient temperature conditions. Materials in
toxicity greater than 5,000 ppm but less than or equal to 10,000 ppm. Dusts and
this degree produce hazardous atmospheres with air under almost all ambient
mists with an LC50 for acute inhalation toxicity greater than 10 mg/L but less than
temperatures or, though unaffected by ambient temperatures, are readily ignited
or equal to 200 mg/L. Materials with an LD50 for acute dermal toxicity greater than
under almost all conditions. Liquids having a flash point below 22.8°C (73°F) and
1000 mg/kg but less than or equal to 2000 mg/kg. Materials that slightly to
having a boiling point at or above 37.8°C (100°F) and those liquids having a flash
moderately irritate the respiratory tract, eyes and skin. Materials with an LD50 for
point at or above 22.8°C (73°F) and below 37.8°C (100°F) (i.e. Class IB and IC
acute oral toxicity greater than 500 mg/kg but less than or equal to 2000 mg/kg. 2
liquids). Materials that on account of their physical form or environmental
Materials that, under emergency conditions, can cause temporary incapacitation
conditions can form explosive mixtures with air and are readily dispersed in air.
or residual injury. Gases with an LC50 for acute inhalation toxicity greater than
Flammable or combustible dusts with representative diameter less than 420
3,000 ppm but less than or equal to 5,000 ppm. Any liquid whose saturated vapor
microns (40 mesh). Materials that burn with extreme rapidity, usually by reason of
concentration at 20°C (68°F) is equal to or greater than one-fifth its LC50 for acute
self-contained oxygen (e.g. dry nitrocellulose and many organic peroxides). Solids
inhalation toxicity, if its LC50 is less than or equal to 5000 ppm and that does not
containing greater than 0.5% by weight of a flammable or combustible solvent are
meet the criteria for either degree of hazard 3 or degree of hazard 4. Dusts and
rated by the closed cup flash point of the solvent. 4 Materials that will rapidly or
mists with an LC50 for acute inhalation toxicity greater than 2 mg/L but less than or
completely vaporize at atmospheric pressure and normal ambient temperature or
equal to 10 mg/L. Materials with an LD50 for acute dermal toxicity greater than 200
that are readily dispersed in air and will burn readily. Flammable gases.
mg/kg but less than or equal to 1000 mg/kg. Compressed liquefied gases with
Flammable cryogenic materials. Any liquid or gaseous materials that is liquid while
boiling points between -30°C (-22°F) and -55°C (-66.5°F) that cause severe tissue
under pressure and has a flash point below 22.8°C (73°F) and a boiling point
damage, depending on duration of exposure. Materials that are respiratory
below 37.8°C (100°F) (i.e. Class IA liquids). Materials that ignite when exposed to
irritants. Materials that cause severe, but reversible irritation to the eyes or are
air, Solids containing greater than 0.5% by weight of a flammable or combustible
lachrymators. Materials that are primary skin irritants or sensitizers. Materials
solvent are rated by the closed cup flash point of the solvent.
whose LD50 for acute oral toxicity is greater than 50 mg/kg but less than or equal
INSTABILITY HAZARD: 0 Materials that in themselves are normally stable, even
to 500 mg/kg. 3 Materials that, under emergency conditions, can cause serious or
under fire conditions. Materials that have an instantaneous power density (product
permanent injury. Gases with an LC50 for acute inhalation toxicity greater than
of heat of reaction and reaction rate) at 250°C (482°F) below 0.01 W/mL.
1,000 ppm but less than or equal to 3,000 ppm.
Materials that do not exhibit an exotherm at temperatures less than or equal to
500°C (932°F) when tested by differential scanning calorimetry.
MOMETASONE FUROATE TOPICAL SOLUTION 0.1% MSDS EFFECTIVE DATE: AUGUST 30, 2007
PAGE 10 OF 11
ALTANA INC.
Divisions: E. FOUGERA & COMPANY DIVISION/PHARMADERM DIVISION
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
INSTABILITY HAZARD: 1 Materials that in themselves are normally stable, but
presented. LD50: Lethal Dose (solids & liquids) that kills 50% of the exposed
that can become unstable at elevated temperatures and pressures. Materials that
animals. LC50: Lethal Concentration (gases) that kills 50% of the exposed animals.
have an instantaneous power density (product of heat of reaction and reaction
ppm: Concentration expressed in parts of material per million parts of air or water.
rate) at 250°C (482°F) at or above 0.01 W/mL and below 10 W/mL. 2 Materials
mg/m3: Concentration expressed in weight of substance per volume of air. mg/kg:
that readily undergo violent chemical change at elevated temperatures and
Quantity of material, by weight, administered to a test subject, based on their body
pressures. Materials that have an instantaneous power density (product of heat of
weight in kg. TDLo: Lowest dose to cause a symptom. TCLo: Lowest
reaction and reaction rate) at 250°C (482°F) at or above 10 W/mL and below
concentration to cause a symptom. TDo, LDLo, and LDo, or TC, TCo, LCLo, and
100W/mL. 3 Materials that in themselves are capable of detonation or explosive
LCo: Lowest dose (or concentration) to cause lethal or toxic effects. Cancer
decomposition or explosive reaction, but that require a strong initiating source or
Information: IARC: International Agency for Research on Cancer. NTP: National
that must be heated under confinement before initiation. Materials that have an
Toxicology Program. RTECS: Registry of Toxic Effects of Chemical Substances.
estimated instantaneous power density (product of heat of reaction and reaction
IARC and NTP rate chemicals on a scale of decreasing potential to cause human
rate) at 250°C (482°F) at or above 100 W/mL and below 1000 W/mL. Materials
cancer with rankings from 1 to 4. Subrankings (2A, 2B, etc.) are also used. Other
that are sensitive to thermal or mechanical shock at elevated temperatures and
Information: BEI: ACGIH Biological Exposure Indices, represent the levels of
pressures. 4 Materials that in themselves are readily capable of detonation or
determinants which are most likely to be observed in specimens collected from a
explosive decomposition or explosive reaction at normal temperatures and
healthy worker who has been exposed to chemicals to the same extent as a
pressures. Materials that are sensitive to localized thermal or mechanical shock at
worker with inhalation exposure to the TLV.
normal temperatures and pressures. Materials that have an estimated
instantaneous power density (product of heat of reaction and reaction rate) at ECOLOGICAL INFORMATION:
250°C (482°F) of 1000 W/mL or greater. EC: Effect concentration in water. BCF: Bioconcentration Factor, which is used to
determine if a substance will concentrate in life forms that consume contaminated
FLAMMABILITY LIMITS IN AIR:
plant or animal matter. TLm: Median threshold limit. log KOW or log KOC: Coefficient
Much of the information related to fire and explosion is derived from the National
of Oil/Water Distribution is used to assess a substance’s behavior in the
Fire Protection Association (NFPA). Flash Point: Minimum temperature at which a
environment.
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: REGULATORY INFORMATION:
Minimum temperature of a solid, liquid, or gas required to initiate or cause self- U.S. and CANADA:
sustained combustion in air with no other source of ignition. LEL: Lowest This section explains the impact of various laws and regulations on the material.
concentration of a flammable vapor or gas/air mixture that will ignite and burn with EPA: U.S. Environmental Protection Agency. ACGIH: American Conference of
a flame. UEL: Highest concentration of a flammable vapor or gas/air mixture that Governmental Industrial Hygienists, a professional association that establishes
will ignite and burn with a flame. exposure limits. OSHA: U.S. Occupational Safety and Health Administration.
NIOSH: National Institute of Occupational Safety and Health, which is the
research arm of OSHA. WHMIS: Canadian Workplace Hazardous Materials
Information System. DOT: U.S. Department of Transportation. TC: Transport
Canada. SARA: Superfund Amendments and Reauthorization Act. DSL/NDSL:
Canadian Domestic/Non-Domestic Substances List. TSCA: U.S. Toxic Substance
Control Act. CERCLA: Comprehensive Environmental Response, Compensation,
and Liability Act. Marine Pollutant status according to the DOT; CERCLA or
Superfund; and various state regulations. This section also includes information
on the precautionary warnings that appear on the material’s package label.
MOMETASONE FUROATE TOPICAL SOLUTION 0.1% MSDS EFFECTIVE DATE: AUGUST 30, 2007
PAGE 11 OF 11
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