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: Calcipotriene Topical Solution 0.005%
Calcipotriene Topical Solution
DESCRIPTION:
0168-400-03; 0168-400-60
NDC #:
(5Z,7E,22E,24S)-24-Cyclopropyl-9,10-secochola-
CHEMICAL NAME (for active ingredient):
5,7,10(19),22-tetraene-1α,3β,24-triol
Vitamin D3 Derivative
CHEMICAL FAMILY (for active ingredient):
0.005% Topical Solution
HOW SUPPLIED:
C27H40O3
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
2. HAZARD IDENTIFICATION
EMERGENCY OVERVIEW: Product Description: This product is a colorless 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,
Calcipotriene (or any other components of this product) may experience allergic reactions to this product. Oral
exposure to Calcipotriene can cause adverse reproductive effects and skin exposure 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.
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 can cause mild irritation, which is alleviated upon rinsing with soap and
water. Prolonged or repeated skin contact may cause redness, swelling, burning, and stinging. Eye contact can
cause irritation, stinging, redness, and tearing.
SKIN ABSORPTION: The Isopropyl Alcohol and Calcipotriene components of this product can be absorbed through
intact skin. If a large area of the skin is involved, symptoms of acute overexposure by this route may include central
nervous system depression as described under “Inhalation�. Acute and chronic skin absorption of Calcipotriene can
cause reversible elevation of serum calcium with symptoms such as bone pain, loss of height, bowing of the
shoulders, spinal column curvature, pathological fractures, kidney pain, frequent urination, frequent thirst, abdominal
pain, nausea, vomiting, poor appetite, constipation, irritability, memory loss, apathy, depression, dementia, coma,
muscular weakness, muscle twitches, and muscle atrophy.
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 reversible elevation of serum calcium with
symptoms such as described under “Skin Absorption�.
CALCIPOTRIENE TOPICAL SOLUTION 0.005% MSDS EFFECTIVE DATE: DECEMBER 12, 2007
PAGE 1 OF 11
Nycomed US Inc.
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 “Skin Absorption�.
(BLUE) 1
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
doses have experienced burning, itching, irritation, inflammation, dry
(RED) 3
skin, peeling, rash, dermatitis, worsening of psoriasis, skin atrophy, FLAMMABILITY HAZARD
hyper-pigmentation, reversible elevation of serum calcium, and
inflamed hair follicles.
HEALTH EFFECTS OR RISKS FROM EXPOSURE: An Explanation
PHYSICAL HAZARD (YELLOW) 0
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 irritation of PROTECTIVE EQUIPMENT
contaminated skin. Skin absorption, ingestion, and injection
overexposure may cause reversible elevation of serum calcium.
EYES HANDS BODY
RESPIRATORY
Inhalation of vapors in a poorly ventilated space can cause central
nervous system effects. Eye contact will cause irritation.
Chronic skin absorption overexposure may cause SEE SECTION 8
Chronic: SEE SECTION 8
reversible elevation of serum calcium.
TARGET ORGANS: For Routine Industrial Use and Handling Applications
Occupational Exposure: Skin, central nervous system.
Acute:
Therapeutic Doses: Skin. Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
3 = Serious 4 = Severe * = Chronic hazard
Chronic: Occupational Exposure: Skin. Therapeutic Doses: Skin,
kidneys.
3. COMPOSITION and INFORMATION ON INGREDIENTS
CHEMICAL NAME CAS # % w/w
Calcipotriene 112965-21-6 0.005%
Isopropyl Alcohol 67-63-0 Proprietary
Propylene Glycol 57-55-6 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).
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.
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.
CALCIPOTRIENE TOPICAL SOLUTION 0.005% MSDS EFFECTIVE DATE: DECEMBER 12, 2007
PAGE 2 OF 11
Nycomed US Inc.
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, elevated of serum calcium,
and impaired renal functions 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 should be 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: 18°C (65°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
FIRE EXTINGUISHING MATERIALS NOT TO BE USED: None known.
OTHER
UNUSUAL FIRE AND EXPLOSION HAZARDS: This product is
flammable; it can be readily ignited under ambient conditions. When Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
involved in a fire, this material may ignite and produce irritating vapors 3 = Serious 4 = Severe
and toxic gases (e.g., carbon oxides).
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).
CALCIPOTRIENE TOPICAL SOLUTION 0.005% MSDS EFFECTIVE DATE: DECEMBER 12, 2007
PAGE 3 OF 11
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
Calcipotriene 112965-21-6 NE NE NE NE NE NE NE NE
DFG MAK:
Isopropyl Alcohol 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
AIHA WEEL:
Propylene Glycol 57-55-6 NE NE NE NE NE NE NE
TWA = 10
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 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 Z94.3-07.
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.
CALCIPOTRIENE TOPICAL SOLUTION 0.005% MSDS EFFECTIVE DATE: DECEMBER 12, 2007
PAGE 4 OF 11
Nycomed US Inc.
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: -21°C (-5°F) [Estimated]
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 colorless 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).
MATERIALS WITH WHICH SUBSTANCE IS INCOMPATIBLE: This product is generally compatible with other
common materials in a medical facility. Oxidizers, strong acids, alkalis, 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
Calcipotriene 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 burning, itching, irritation,
inflammation, dry skin, peeling, rash, dermatitis, worsening of psoriasis, skin atrophy, hyper-pigmentation, reversible
elevation of serum calcium, and inflamed hair follicles.
IRRITANCY OF PRODUCT: This product may irritate contaminated tissue.
SENSITIZATION OF PRODUCT: Individuals who have had allergic reactions to products containing the Calcipotriene
component of this product or any other components of this product may experience allergic reactions to this product.
TOXICITY DATA: The toxicity data available for the active component of this product, Calcipotriene, 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.
CALCIPOTRIENE: CALCIPOTRIENE (continued): CALCIPOTRIENE (continued):
Standard Draize Test (Skin-Human) 40 ppm: Mild TDLo (Skin-Woman) 5428.6 mg/kg/19 days-cont.: LD50 (Skin-Rat) > 15 mg/kg: Behavioral: somnolence
Standard Draize Test (Skin-Human) 0.0025%/8 weeks- Nutritional & Metabolic: changes in Calcium (general depressed activity), ataxia; Weight loss or
intermittent: Mild TDLo (Skin-Woman) 1142.9 mg/kg/5 days-cont.: decreased weight gain
TDLo (Skin-Human) 0.005 pph/8 weeks-intermittent: Nutritional & Gross Metabolic: changes in calcium LD50 (Skin-Dog) > 1500 µg/kg: Behavioral: somnolence
Skin and Appendages: primary irritation (after topical TDLo (Skin-Man) 11 gm/kg/11 weeks-intermittent: (general depressed activity); Gastrointestinal: nausea
exposure) Nutritional & Gross Metabolic: changes in calcium or vomiting; Musculoskeletal: other changes
TDLo (Skin-Woman) 10 g/kg/6 weeks-intermittent: TDLo (Skin-Man) 10,780 mg/kg/11 weeks-intermittent: LD50 (Subcutaneous-Rat) 2190 µg/kg: Behavioral:
Nutritional & Gross Metabolic: changes in calcium Blood: changes in serum composition (e.g. TP, convulsions or effect on seizure threshold; Lungs,
TDLo (Skin-Woman) 28,000 mg/kg/7 days-intermittent: bilirubin, cholesterol); Nutritional and Gross Metabolic: Thorax, or Respiration: dyspnea; Gastrointestinal:
Blood: changes in serum composition (e.g. TP, changes in calcium hypermotility, diarrhea
bilirubin, cholesterol); Nutritional and Gross Metabolic: TDLo (Skin-Man) 11,000 mg/kg/11 weeks-cont.: TDLo (Skin-Rat) 560 µg/kg/4 weeks-intermittent: Sense
changes in calcium Nutritional & Gross Metabolic: changes in calcium Organs and Special Senses (Eye): corneal damage;
TDLo (Skin-Woman) 1000 mg/kg/5 days-intermittent: TDLo (Oral-Woman) 420,000 mg/kg/6 weeks- Kidney/Ureter/Bladder: other changes in urine
Blood: changes in serum composition (e.g. TP, intermittent: Blood: changes in serum composition composition; Nutritional and Gross Metabolic:
bilirubin, cholesterol); Nutritional and Gross Metabolic: (e.g. TP, bilirubin, cholesterol); Nutritional and Gross changes in calcium
changes in calcium Metabolic: changes in calcium TDLo (Skin-Dog) 728 µg/kg /26 weeks-intermittent:
TDLo (Skin-Woman) 10,000 mg/kg/6 weeks-continuous: TDLo (Oral-Man) 847,000 mg/kg/11 weeks-intermittent: Kidney/Ureter/Bladder: other changes in urine
Nutritional and Gross Metabolic: changes in calcium Blood: changes in serum composition (e.g. TP, composition; Skin and Appendages: dermatitis, other
TDLo (Skin-Woman) 4000 mg/kg/7 days-continuous: bilirubin, cholesterol); Nutritional and Gross Metabolic: (after systemic exposure); Nutritional and Gross
Nutritional & Gross Metabolic: changes in calcium changes in calcium Metabolic: changes in calcium
CALCIPOTRIENE TOPICAL SOLUTION 0.005% MSDS EFFECTIVE DATE: DECEMBER 12, 2007
PAGE 5 OF 11
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
TOXICITY DATA (continued):
CALCIPOTRIENE (continued): CALCIPOTRIENE (continued): CALCIPOTRIENE (continued):
TDLo (Subcutaneous-Rat) 364 µg/kg/26 weeks- TDLo (Subcutaneous-Rat) 13 µg/kg: female 6-18 TDLo (Subcutaneous-Rat) 275 µg/kg: female 7-17
intermittent: Changes in bladder weight; Changes day(s) after conception: Reproductive: Maternal days after conception: Maternal reproductive
in serum composition (e.g. TP, bilirubin, Effects: other effects; Specific Developmental effects; Other effects to embryo
cholesterol); Nutritional & Gross Metabolic: Abnormalities: cardiovascular (circulatory) system TDLo (Subcutaneous-Rat) 925 µg/kg: female 7-22
changes in calcium TDLo (Subcutaneous-Rat) 32.5 µg/kg: female 6-18 days after conception lactating female 21 days
TDLo (Subcutaneous-Rat) 1575 µg/kg/9 weeks- day(s) after conception: Reproductive: Maternal post-birth: Maternal reproductive effects; Effects
intermittent: Sense Organs and Special Senses Effects: other effects; Specific Developmental on Newborn: growth statistics (e.g.%, reduced
(Eye): corneal damage; Kidney/Ureter/Bladder: Abnormalities: urogenital system weight gain)
changes in kidney weight; Nutritional and Gross TDLo (Subcutaneous-Rat) 675 µg/kg: female 17-22 TDLo (Subcutaneous-Rabbit) 13 µg/kg: female 6-18
Metabolic: weight loss or decreased weight gain day(s) after conception lactating female 21 day(s) day(s) after conception: Reproductive: Specific
TDLo (Subcutaneous-Rat) 275 µg/kg: female 7-17 post-birth: Reproductive: Maternal Effects: other Developmental Abnormalities: cardiovascular
days after conception: Maternal reproductive effects; Effects on Newborn: growth statistics (circulatory) system; Effects on Newborn: growth
effects; Specific Developmental Abnormalities: (e.g.%, reduced weight gain) statistics (e.g.%, reduced weight gain)
musculoskeletal system TDLo (Subcutaneous-Rat) 525 µg/kg: female 14 TDLo (Subcutaneous-Rabbit) 32.5 µg/kg: female 6�
TDLo (Subcutaneous-Rat) 650 µg/kg: female 17-21 day(s) pre-mating 0-7 day(s) after conception: 18 days after conception: Specific Developmental
day(s) after conception lactating female 21 day(s) Reproductive: Maternal Effects: other effects Abnormalities: cardiovascular (circulatory) system,
post-birth: Reproductive: Effects on Newborn: TDLo (Subcutaneous-Rat) 1575 µg/kg: male 63 urogenital system; Effects on Newborn: growth
growth statistics (e.g.%, reduced weight gain) day(s) pre-mating: Reproductive: Paternal Effects: statistics (e.g., reduced weight gain)
TDLo (Subcutaneous-Rat) 13 µg/kg: female 6-18 other effects on male TDLo (Subcutaneous-Rabbit) 65 µg/kg: female 6-18
day(s) after conception: Reproductive: Maternal days after conception: Reproductive: Specific
Effects: other effects; Fertility: post-implantation Developmental Abnormalities: cardiovascular
mortality (e.g. dead and/or resorbed implants per (circulatory) system, urogenital system; Effects on
total number of implants), litter size (e.g. # fetuses Newborn: behavioral
per litter; measured before birth)
CARCINOGENIC INFORMATION: The following information is available from carcinogenic studies performed with the
active ingredient of this product, Calcipotriene:
The potential of Calcipotriene to induce carcinogenesis in standard long-term animal studies [in the absence of ultra-
violet radiation (UVR)] has not been evaluated. In a study in which albino hairless mice were exposed to both UVR
and topically applied Calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors
was observed (statistically significant in males only), suggesting that Calcipotriene may enhance the effect of UVR to
induce skin tumors.
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, Calcipotriene, 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: Calcipotriene did not elicit any mutagenic effects in an Ames mutagenicity assay, a mouse lymphoma TK locus
assay, a human lymphocyte chromosome aberration assay, or in a micronucleus assay conducted in mice.
Embryotoxicity: This product has not been tested for embryotoxic effects.
Teratogenicity: Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40�60%
of the administered dose. In rabbits, increased maternal and fetal toxicity were noted at a dosage of 12 µg/kg/day (132
2 2
µg/m /day); a dosage of 36 µg/kg/day (396 µg/m /day) resulted in a significant increase in the incidence of incomplete
ossification of the pubic bones and forelimb phalanges of fetuses. In a rat study, a dosage of 54 µg/kg/day (318 µg/m2/day)
resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanels and extra ribs). The enlarged
fontanels are most likely due to the effect of Calcipotriene upon calcium metabolism. The estimated maternal and fetal no-effect
2 2
exposure levels in the rat (43.2 µg/m /day) and rabbit (17.6 µg/m /day) studies are approximately equal to the expected human
systemic exposure level 18.5 µg/m2/day) from dermal application.
Reproductive Toxicity: Studies in rats at doses up to 54 mg/kg/day (318 mï€ g/m2/day) of Calcipotriene indicated no impairment of
fertility or general reproductive performance.
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
CALCIPOTRIENE TOPICAL SOLUTION 0.005% MSDS EFFECTIVE DATE: DECEMBER 12, 2007
PAGE 6 OF 11
Nycomed US Inc.
12. ECOLOGICAL INFORMATION
ALL WORK PRACTICES MUST BE AIMED AT ELIMINATING ENVIRONMENTAL CONTAMINATION.
ENVIRONMENTAL STABILITY: The components of this product will slowly degrade in the environment and form a
variety of organic materials. The following environmental data are available for the components of this product:
ISOPROPYL ALCOHOL: Octanol/Water Partition Coefficient: Log P = 0.34�0.5
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.
PROPYLENE GLYCOL:
Persistence and Biodegradability: Based on a classification scheme, an estimated Koc value of 8, determined from a log Kow of -0.92 and a regression-derived equation, indicates
that Propylene Glycol is expected to have very high mobility in soil. Volatilization of Propylene Glycol from moist soil surfaces is not expected to be an important fate process
given an estimated Henry's Law constant of 1.3X10-8 atm-cu m/mole, derived from its vapor pressure, 0.13 mmHg, and water solubility, 1X10+6 mg/liter. Propylene Glycol is not
expected to volatilize from dry soil surfaces based upon its vapor pressure. Laboratory experiments using agricultural soils from South Carolina conducted at 22 deg C and a
fortification of 1,000 ppm Propylene Glycol, yielded 73-78% mineralization during a 51 day incubation period, suggesting that biodegradation will be an important fate process in
soils. Based on a classification scheme, an estimated Koc value of 8, determined from a log Kow of -0.92 and a regression-derived equation, indicates that Propylene Glycol is
not expected to adsorb to suspended solids and sediment. Volatilization from water surfaces is not expected based upon an estimated Henry's Law constant of 1.3X10-8 atm-cu
m/mole, derived from its vapor pressure, 0.13 mmHg, and water solubility, 1X10+6 mg/L. Numerous screening studies using wastewater or sewage inoculum as seed, suggests
that Propylene Glycol will be degraded readily under aqueous environments. According to a model of gas/particle partitioning of semi-volatile organic compounds in the
atmosphere, Propylene Glycol, which has a vapor pressure of 0.13 mmHg at 25°C, is expected to exist solely as a vapor in the ambient atmosphere. Vapor-phase Propylene
Glycol is degraded in the atmosphere by reaction with photochemically-produced hydroxyl radicals; the half-life for this reaction in air is estimated to be 32 hours, calculated from
its rate constant of 1.2X10-11 cu cm/molecule-sec at 25°C
Bioconcentration: An estimated BCF of 3 was calculated for Propylene Glycol, using a log Kow of -0.92 and a regression-derived equation. According to a classification scheme,
this BCF suggests the potential for bioconcentration in aquatic organisms is low.
Soil Adsorption/Mobility: The Koc of Propylene Glycol is estimated as 8, using a log Kow of -0.92 and a regression-derived equation. According to a classification scheme, this
estimated Koc value suggests that Propylene Glycol is expected to have very high mobility in soil.
EFFECT OF MATERIAL ON PLANTS or ANIMALS: No specific information is currently available on the effect of this
product on plants or animals in the environment. This product may be harmful to contaminated plant and animal life,
especially in large quantities.
EFFECT OF CHEMICAL ON AQUATIC LIFE: 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): PROPYLENE GLYCOL (continued):
EC0 (Microcystis aeruginosa) 8 days = 1,000 mg/L LC50 (Crangon crangon brown shrimp) 98 hr = 1,150 mg/L EC100 (Daphnia magna, crustacean) 48 hr = 50,000 mg/L
EC0 (Scenedesmus quadricauda green algae) 7 days = LC50 (goldfish) 24 hours = > 500 mg/L EC50 (Daphnia magna, crustacean) 24 hr > 10,000 mg/L
1,800 mg/L LC50 (fathead minnow) 1 hour = 11,830 mg/L EC100 (Daphnia magna, crustacean) 24 hr > 10,000 mg/L
EC0 (Entosiphon sulcatum protozoa) 72 hr = 4,930 mg/L LC50 (fathead minnow) 24 hours = 11,160 mg/L EC50 (Nitocra spinipes, crustacean) 96 hr > 10,000 mg/L
EC0 (Uronema parduczi Chatton-Lwoff) = 3,425 mg/L LC50 (fathead minnow) 48 hours = 11,130 mg/L LC50 (Lebistes reticulatus, guppy) 48 hr > 10,000 mg/L
EC50 (Photobacterium) 5 minutes = 22,800 mg/L LC50 (fathead minnow) 72 hours = 11,130 mg/L LC50 (Carassius auratus) 24 hours = > 5,000 mg/L
EC50 (Daphnia magna) 3,010 mg/L LC50 (fathead minnow) 96 hours = 11,130 mg/L LC50 (Salmo gairdneri) 24 hours = 50,000 mg/L
EC50 (Pseudomonas putida) 16 hours = 1,050 mg/L LC50 (Poecilia reticulata guppy) 7 days = 7,060 mg/L LC50 (Pimephales promelas) 96 hours = 54,900 mg/L
Toxic (Chlorella pyrenoidosa algae) = 17,400 mg/L LC50 (Daphnia magna) 4,600 mg/L LC50 (Artemia salina) 24 hours = >10,000 mg/L
NOEC (Daphnia magna) 757-2,100 mg/L LC100 (creek chub) 24 hours = 1,100 mg/L LC100 (Pimephales promelas) 96 hours = 65,610 mg/L
LC0 (creek chub) 24 hours = 900 mg/L NOEC (Pimephales promelas) 96 hr < 47,829 mg/L
PROPYLENE GLYCOL:
LC50 (Artemia salina) 24 hours = 16,700 mg/L EC50 (Photobacterium phosphoreum, bacteria) 30 minutes fingerling trout: at 50,000 mg/l at 10°C: no mortality or
LC50 (Streptocephalus proboscideus) 24 hr = 11,600 mg/L = 26,800 mg/L apparent signs of stress were produced during a 25-hr
LC50 (Daphnia magna) 24 hours = 9,500 mg/L TD (Chlorella pyrenoidosa, algae) = 92,000 mg/L exposure period (static bioassay)
LC50 (Brachionus calyciflorus) 24 hours = 28,600 mg/L EC0 (Daphnia magna, crustacean) 48 hr < 4,295 mg/L
LC50 (Crangon crangon brown shrimp) 48 hr = 1,400 mg/L EC50 (Daphnia magna, crustacean) 48 hr = 34,400 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. (Isopropyl Alcohol)
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 component of this product are not classified by the U.S. DOT as Marine Pollutants (as defined by 49 CFR
172.101, Appendix B).
CALCIPOTRIENE TOPICAL SOLUTION 0.005% MSDS EFFECTIVE DATE: DECEMBER 12, 2007
PAGE 7 OF 11
Nycomed US Inc.
14. TRANSPORTATION INFORMATION (Continued)
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 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 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 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:
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 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.
CALCIPOTRIENE TOPICAL SOLUTION 0.005% MSDS EFFECTIVE DATE: DECEMBER 12, 2007
PAGE 8 OF 11
Nycomed US Inc.
15. REGULATORY INFORMATION (Continued)
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 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
800/441-3365619/670-0609
February 11, 2008
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 EXPOSURE LIMITS IN AIR (continued):
each constituent. NIC: Notice of Intended Change.
NIOSH CEILING: The exposure that shall not be exceeded during any part of the
EXPOSURE LIMITS IN AIR:
CEILING LEVEL: The concentration that shall not be exceeded during any part of workday. If instantaneous monitoring is not feasible, the ceiling shall be assumed
the working exposure. as a 15-minute TWA exposure (unless otherwise specified) that shall not be
DFG MAK: Federal Republic of Germany Maximum Concentration Values in the exceeded at any time during a workday.
workplace. NIOSH RELs: NIOSH’s Recommended Exposure Limits.
DFG MAK Germ Cell Mutagen Categories: 1: Germ cell mutagens that have PEL: OSHA's Permissible Exposure Limits. This exposure value means exactly
been shown to increase the mutant frequency in the progeny of exposed humans. the same as a TLV, except that it is enforceable by OSHA. The OSHA
2: Germ cell mutagens that have been shown to increase the mutant frequency in Permissible Exposure Limits are based in the 1989 PELs and the June, 1993 Air
the progeny of exposed mammals. 3A: Substances that have been shown to Contaminants Rule (Federal Register: 58: 35338-35351 and 58: 40191). Both the
induce genetic damage in germ cells of human of animals, or which produce current PELs and the vacated PELs are indicated. The phrase, “Vacated 1989
mutagenic effects in somatic cells of mammals in vivo and have been shown to PEL� is placed next to the PEL that was vacated by Court Order.
reach the germ cells in an active form. 3B: Substances that are suspected of SKIN: Used when a there is a danger of cutaneous absorption.
being germ cell mutagens because of their genotoxic effects in mammalian STEL: Short Term Exposure Limit, usually a 15-minute time-weighted average
somatic cell in vivo; in exceptional cases, substances for which there are no in (TWA) exposure that should not be exceeded at any time during a workday, even
vivo data, but that are clearly mutagenic in vitro and structurally related to known if the 8-hr TWA is within the TLV-TWA, PEL-TWA or REL-TWA.
in vivo mutagens. 4: Not applicable (Category 4 carcinogenic substances are TLV: Threshold Limit Value. An airborne concentration of a substance that
those with non-genotoxic mechanisms of action. By definition, germ cell mutagens represents conditions under which it is generally believed that nearly all workers
are genotoxic. Therefore, a Category 4 for germ cell mutagens cannot apply. At may be repeatedly exposed without adverse effect. The duration must be
some time in the future, it is conceivable that a Category 4 could be established considered, including the 8-hour.
for genotoxic substances with primary targets other than DNA [e.g. purely TWA: Time Weighted Average exposure concentration for a conventional 8-hr
aneugenic substances] if research results make this seem sensible.) 5: Germ cell (TLV, PEL) or up to a 10-hr (REL) workday and a 40-hr workweek.
mutagens, the potency of which is considered to be so low that, provided the MAK HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
value is observed, their contribution to genetic risk for humans is expected not to RATINGS: This rating system was developed by the National Paint and Coating
be significant. Association and has been adopted by industry to identify the degree of chemical
DFG MAK Pregnancy Risk Group Classification: Group A: A risk of damage to hazards.
the developing embryo or fetus has been unequivocally demonstrated. Exposure HEALTH HAZARD: 0 Minimal Hazard: No significant health risk, irritation of skin or
of pregnant women can lead to damage of the developing organism, even when eyes not anticipated. Skin Irritation: Essentially non-irritating. Mechanical irritation
MAK and BAT (Biological Tolerance Value for Working Materials) values are may occur. PII or Draize = 0. Eye Irritation: Essentially non-irritating, minimal
observed. Group B: Currently available information indicates a risk of damage to effects clearing in < 24 hours. Mechanical irritation may occur. Draize = 0. Oral
the developing embryo or fetus must be considered to be probable. Damage to Toxicity LD50 Rat: > 5000 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 2000
the developing organism cannot be excluded when pregnant women are exposed, mg/kg. Inhalation Toxicity 4-hrs LC50 Rat: > 20 mg/L. 1) Slight Hazard: Minor
even when MAK and BAT values are observed. Group C: There is no reason to reversible injury may occur; may irritate the stomach if swallowed; may defat the
fear a risk of damage to the developing embryo or fetus when MAK and BAT skin and exacerbate existing dermatitis. Skin Irritation: Slightly or mildly irritating.
values are observed. Group D: Classification in one of the groups A–C is not yet PII or Draize > 0 < 5. Eye Irritation: Slightly to mildly irritating, but reversible within
possible because, although the data available may indicate a trend, they are not 7 days. Draize > 0 � 25. Oral Toxicity LD50 Rat: > 500�5000 mg/kg. Dermal
sufficient for final evaluation. Toxicity LD50 Rat or Rabbit: > 1000�2000 mg/kg. Inhalation Toxicity LC50 4-hrs
IDLH: Immediately Dangerous to Life and Health. This level represents a Rat: > 2�20 mg/L. 2 Moderate Hazard: Temporary or transitory injury may occur;
concentration from which one can escape within 30-minutes without suffering prolonged exposure may affect the CNS. Skin Irritation: Moderately irritating;
escape-preventing or permanent injury. primary irritant; sensitizer. PII or Draize � 5, with no destruction of dermal tissue.
LOQ: Limit of Quantitation. Eye Irritation: Moderately to severely irritating; reversible corneal opacity; corneal
NE: Not Established. When no exposure guidelines are established, an entry of involvement or irritation clearing in 8�21 days. Draize = 26�100, with reversible
NE is made for reference. effects. Oral Toxicity LD50 Rat: > 50�500 mg/kg. Dermal Toxicity LD50 Rat or
Rabbit: > 200�1000 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 0.5�2 mg/L.
CALCIPOTRIENE TOPICAL SOLUTION 0.005% MSDS EFFECTIVE DATE: DECEMBER 12, 2007
PAGE 9 OF 11
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
RATINGS (continued): RATINGS (continued):
HEALTH HAZARD (continued): 3 Serious Hazard: Major injury likely unless PHYSICAL HAZARD (continued): 2 (continued) Explosives: Division 1.4
prompt action is taken and medical treatment is given; high level of toxicity; explosives. Explosive substances where the explosive effects are largely confined
corrosive. Skin Irritation: Severely irritating and/or corrosive; may cause to the package and no projection of fragments of appreciable size or range are
destruction of dermal tissue, skin burns, and dermal necrosis. PII or Draize > 5�8, expected. An external fire must not cause virtually instantaneous explosion of
with destruction of tissue. Eye Irritation: Corrosive, irreversible destruction of almost the entire contents of the package. Compressed Gases: Pressurized and
ocular tissue; corneal involvement or irritation persisting for more than 21 days. meet OSHA definition but < 514.7 psi absolute at 21.1°C (70°F) [500 psig].
Draize > 80 with effects irreversible in 21 days. Oral Toxicity LD50 Rat: > 1�50 Pyrophorics: No Rating. Oxidizers: Packing Group II oxidizers. Solids: any
mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 20�200 mg/kg. Inhalation Toxicity material that, either in concentration tested, exhibits a mean burning time of less
LC50 4-hrs Rat: > 0.05�0.5 mg/L. 4 Severe Hazard: Life-threatening; major or than or equal to the mean burning time of a 2:3 potassium bromate/cellulose
permanent damage may result from single or repeated exposures; extremely mixture and the criteria for Packing Group I are not met. Liquids: any material that
toxic; irreversible injury may result from brief contact. Skin Irritation: Not exhibits a mean pressure rise time less than or equal to the pressure rise of a 1:1
appropriate. Do not rate as a 4, based on skin irritation alone. Eye Irritation: Not aqueous sodium chlorate solution (40%)/cellulose mixture and the criteria for
appropriate. Do not rate as a 4, based on eye irritation alone. Oral Toxicity LD50 Packing Group I are not met. Reactives: Substances that may polymerize,
Rat: � 1 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: � 20 mg/kg. Inhalation Toxicity decompose, condense, or self-react at ambient temperature and/or pressure, but
LC50 4-hrs Rat: � 0.05 mg/L. have a low potential (or low risk) for significant heat generation or explosion.
FLAMMABILITY HAZARD: 0 Minimal Hazard: Materials that will not burn in air Substances that readily form peroxides upon exposure to air or oxygen at room
when exposure to a temperature of 815.5°C (1500°F) for a period of 5 minutes. 1 temperature. 3 Water Reactivity: Materials that may form explosive reactions with
Slight Hazard: Materials that must be pre-heated before ignition can occur. water. Organic Peroxides: Materials that are capable of detonation or explosive
Material requires considerable pre-heating, under all ambient temperature reaction, but require a strong initiating source or must be heated under
conditions before ignition and combustion can occur. This usually includes the confinement before initiation; or materials that react explosively with water.
following: Materials that will burn in air when exposed to a temperature of 815.5°C Explosives: Division 1.3 explosives. Explosive substances that have a fire hazard
(1500°F) for a period of 5 minutes or less; Liquids, solids and semisolids having a and either a minor blast hazard or a minor projection hazard or both, but do not
flash point at or above 93.3°C (200°F) (i.e. OSHA Class IIIB); and Most ordinary have a mass explosion hazard. Compressed Gases: Pressure � 514.7 psi
combustible materials (e.g. wood, paper, etc.). 2 Moderate Hazard: Materials that absolute at 21.1°C (70°F) [500 psig]. Pyrophorics: No Rating. Oxidizers: Packing
must be moderately heated or exposed to relatively high ambient temperatures Group I oxidizers. Solids: any material that, in either concentration tested, exhibits
before ignition can occur. Materials in this degree would not, under normal a mean burning time less than the mean burning time of a 3:2 potassium
conditions, form hazardous atmospheres in air, but under high ambient bromate/cellulose mixture. Liquids: any material that spontaneously ignites when
temperatures or moderate heating may release vapor in sufficient quantities to mixed with cellulose in a 1:1 ratio, or which exhibits a mean pressure rise time
produce hazardous atmospheres with air. This usually includes the following: less than the pressure rise time of a 1:1 perchloric acid (50%)/cellulose mixture.
Liquids having a flash-point at or above 37.8°C (100°F); Solid materials in the form Unstable Reactives: Substances that may polymerize, decompose, condense, or
of course dusts that may burn rapidly but that generally do not form explosive self-react at ambient temperature and/or pressure and have a moderate potential
atmospheres; Solid materials in a fibrous or shredded form that may burn rapidly (or moderate risk) to cause significant heat generation or explosion. 4 Water
and create flash fire hazards (e.g. cotton, sisal, hemp); and Solids and semisolids Reactivity: Materials that react explosively with water without requiring heat or
(e.g. viscous and slow flowing as asphalt) that readily give off flammable vapors. 3 confinement. Organic Peroxides: Materials that are readily capable of detonation
Serious Hazard: Liquids and solids that can be ignited under almost all ambient or explosive decomposition at normal temperature and pressures. Explosives:
temperature conditions. Materials in this degree produce hazardous atmospheres Division 1.1 & 1.2 explosives. Explosive substances that have a mass explosion
with air under almost all ambient temperatures, or, unaffected by ambient hazard or have a projection hazard. A mass explosion is one that affects almost
temperature, are readily ignited under almost all conditions. This usually includes the entire load instantaneously. Compressed Gases: No Rating. Pyrophorics: Add
the following: Liquids having a flash point below 22.8°C (73°F) and having a to the definition of Flammability 4. Oxidizers: No 4 rating. Unstable Reactives:
boiling point at or above 38°C (100°F) and those liquids having a flash point at or Substances that may polymerize, decompose, condense, or self-react at ambient
above 22.8°C (73°F) and below 37.8°C (100°F) (i.e. OSHA Class IB and IC); temperature and/or pressure and have a high potential (or high risk) to cause
Materials that on account of their physical form or environmental conditions can significant heat generation or explosion.
form explosive mixtures with air and are readily dispersed in air (e.g., dusts of NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS:
combustible solids, mists or droplets of flammable liquids); and Materials that burn HEALTH HAZARD: 0 Materials that, under emergency conditions, would offer no
extremely rapidly, usually by reason of self-contained oxygen (e.g. dry hazard beyond that of ordinary combustible materials. Gases and vapors with an
nitrocellulose and many organic peroxides). 4 Severe Hazard: Materials that will LC50 for acute inhalation toxicity greater than 10,000 ppm. Dusts and mists with an
rapidly or completely vaporize at atmospheric pressure and normal ambient LC50 for acute inhalation toxicity greater than 200 mg/L. Materials with an LD50 for
temperature or that are readily dispersed in air, and that will burn readily. This acute dermal toxicity greater than 2000 mg/kg. Materials with an LD50 for acute
usually includes the following: Flammable gases; Flammable cryogenic materials; oral toxicity greater than 2000 mg/kg. Materials essentially non-irritating to the
Any liquid or gaseous material that is liquid while under pressure and has a flash respiratory tract, eyes, and skin. 1 Materials that, under emergency conditions,
point below 22.8°C (73°F) and a boiling point below 37.8°C (100°F) (i.e. OSHA can cause significant irritation. Gases and vapors with an LC50 for acute inhalation
Class IA); and Materials that ignite spontaneously when exposed to air at a toxicity greater than 5,000 ppm but less than or equal to 10,000 ppm. Dusts and
temperature of 54.4°C (130°F) or below (pyrophoric). mists with an LC50 for acute inhalation toxicity greater than 10 mg/L but less than
PHYSICAL HAZARD: 0 Water Reactivity: Materials that do not react with water. or equal to 200 mg/L. Materials with an LD50 for acute dermal toxicity greater than
Organic Peroxides: Materials that are normally stable, even under fire conditions 1000 mg/kg but less than or equal to 2000 mg/kg. Materials that slightly to
and will not react with water. Explosives: Substances that are Non-Explosive. moderately irritate the respiratory tract, eyes and skin. Materials with an LD50 for
Compressed Gases: No Rating. Pyrophorics: No Rating. Oxidizers: No 0 rating. acute oral toxicity greater than 500 mg/kg but less than or equal to 2000 mg/kg. 2
Unstable Reactives: Substances that will not polymerize, decompose, condense, Materials that, under emergency conditions, can cause temporary incapacitation
or self-react.). 1 Water Reactivity: Materials that change or decompose upon or residual injury. Gases with an LC50 for acute inhalation toxicity greater than
exposure to moisture. Organic Peroxides: Materials that are normally stable, but 3,000 ppm but less than or equal to 5,000 ppm. Any liquid whose saturated vapor
can become unstable at high temperatures and pressures. These materials may concentration at 20°C (68°F) is equal to or greater than one-fifth its LC50 for acute
react with water, but will not release energy violently. Explosives: Division 1.5 & inhalation toxicity, if its LC50 is less than or equal to 5000 ppm and that does not
1.6 explosives. Substances that are very insensitive explosives or that do not have meet the criteria for either degree of hazard 3 or degree of hazard 4. Dusts and
a mass explosion hazard. Compressed Gases: Pressure below OSHA definition. mists with an LC50 for acute inhalation toxicity greater than 2 mg/L but less than or
Pyrophorics: No Rating. Oxidizers: Packaging Group III oxidizers; Solids: any equal to 10 mg/L. Materials with an LD50 for acute dermal toxicity greater than 200
material that in either concentration tested, exhibits a mean burning time less than mg/kg but less than or equal to 1000 mg/kg. Compressed liquefied gases with
or equal to the mean burning time of a 3:7 potassium bromate/cellulose mixture boiling points between -30°C (-22°F) and -55°C (-66.5°F) that cause severe tissue
and the criteria for Packing Group I and II are not met. Liquids: any material that damage, depending on duration of exposure. Materials that are respiratory
exhibits a mean pressure rise time less than or equal to the pressure rise time of a irritants. Materials that cause severe, but reversible irritation to the eyes or are
1:1 nitric acid (65%)/cellulose mixture and the criteria for Packing Group I and II lachrymators. Materials that are primary skin irritants or sensitizers. Materials
are not met. Unstable Reactives: Substances that may decompose condense, or whose LD50 for acute oral toxicity is greater than 50 mg/kg but less than or equal
self-react, but only under conditions of high temperature and/or pressure and have to 500 mg/kg. 3 Materials that, under emergency conditions, can cause serious or
little or no potential to cause significant heat generation or explosion hazard. permanent injury. Gases with an LC50 for acute inhalation toxicity greater than
Substances that readily undergo hazardous polymerization in the absence of 1,000 ppm but less than or equal to 3,000 ppm. Any liquid whose saturated vapor
inhibitors. Substances that readily undergo hazardous polymerization in the concentration at 20°C (68°F) is equal to or greater its LC50 for acute inhalation
absence of inhibitors. 2 Water Reactivity: Materials that may react violently with toxicity, if its LC50 is less than or equal to 3000 ppm and that does not meet the
water. Organic Peroxides: Materials that, in themselves, are normally unstable criteria for degree of hazard 4. Dusts and mists with an LC50 for acute inhalation
and will readily undergo violent chemical change, but will not detonate. These toxicity greater than 0.5 mg/L but less than or equal to 2 mg/L. Materials with an
materials may also react violently with water. LD50 for acute dermal toxicity greater than 40 mg/kg but less than or equal to 200
mg/kg.
CALCIPOTRIENE TOPICAL SOLUTION 0.005% MSDS EFFECTIVE DATE: DECEMBER 12, 2007
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Nycomed US Inc.
DEFINITION OF TERMS (Continued)
NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS
(continued): (continued):
HEALTH HAZARD (continued): 3 (continued) Materials that are corrosive to the INSTABILITY HAZARD: 1 Materials that in themselves are normally stable, but
respiratory tract. Materials that are corrosive to the eyes or cause irreversible that can become unstable at elevated temperatures and pressures. Materials that
corneal opacity. Materials corrosive to the skin. Cryogenic gases that cause have an instantaneous power density (product of heat of reaction and reaction
frostbite and irreversible tissue damage. Compressed liquefied gases with boiling rate) at 250°C (482°F) at or above 0.01 W/mL and below 10 W/mL. 2 Materials
points below -55°C (-66.5°F) that cause frostbite and irreversible tissue damage. that readily undergo violent chemical change at elevated temperatures and
Materials with an LD50 for acute oral toxicity greater than 5 mg/kg but less than or pressures. Materials that have an instantaneous power density (product of heat of
equal to 50 mg/kg. 4 Materials that, under emergency conditions, can be lethal. reaction and reaction rate) at 250°C (482°F) at or above 10 W/mL and below
Gases with an LC50 for acute inhalation toxicity less than or equal to 1,000 ppm. 100W/mL. 3 Materials that in themselves are capable of detonation or explosive
Any liquid whose saturated vapor concentration at 20°C (68°F) is equal to or decomposition or explosive reaction, but that require a strong initiating source or
greater than ten times its LC50 for acute inhalation toxicity, if its LC50 is less than or that must be heated under confinement before initiation. Materials that have an
equal to 1000 ppm. Dusts and mists whose LC50 for acute inhalation toxicity is less estimated instantaneous power density (product of heat of reaction and reaction
than or equal to 0.5 mg/L. Materials whose LD50 for acute dermal toxicity is less rate) at 250°C (482°F) at or above 100 W/mL and below 1000 W/mL. Materials
than or equal to 40 mg/kg. Materials whose LD50 for acute oral toxicity is less than that are sensitive to thermal or mechanical shock at elevated temperatures and
or equal to 5 mg/kg. pressures. 4 Materials that in themselves are readily capable of detonation or
FLAMMABILITY HAZARD: 0 Materials that will not burn under typical fire explosive decomposition or explosive reaction at normal temperatures and
conditions, including intrinsically noncombustible materials such as concrete, pressures. Materials that are sensitive to localized thermal or mechanical shock at
stone, and sand. Materials that will not burn in air when exposed to a temperature normal temperatures and pressures. Materials that have an estimated
of 816°C (1500°F) for a period of 5 minutes in according with Annex D of NFPA instantaneous power density (product of heat of reaction and reaction rate) at
704. 1 Materials that must be preheated before ignition can occur. Materials in this 250°C (482°F) of 1000 W/mL or greater.
degree require considerable preheating, under all ambient temperature conditions, FLAMMABILITY LIMITS IN AIR:
before ignition and combustion can occur: Materials that will burn in air when Much of the information related to fire and explosion is derived from the National
exposed to a temperature of 816°C (1500°F) for a period of 5 minutes in according Fire Protection Association (NFPA). Flash Point: Minimum temperature at which a
with Annex D of NFPA 704. Liquids, solids, and semisolids having a flash point at liquid gives off sufficient vapor to form an ignitable mixture with air near the
or above 93.4°C (200°F) (i.e. Class IIIB liquids). Liquids with a flash point greater surface of the liquid or within the test vessel used. Autoignition Temperature:
than 35°C (95°F) that do not sustain combustion when tested using the Method of Minimum temperature of a solid, liquid, or gas required to initiate or cause self-
Testing for Sustained Combustibility, per 49 CFR 173, Appendix H or the UN 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
Recommendations on the Transport of Dangerous Goods, Model Regulations
(current edition) and the related Manual of Tests and Criteria (current edition). a flame. UEL: Highest concentration of a flammable vapor or gas/air mixture that
Liquids with a flash point greater than 35°C (95°F) in a water-miscible solution or will ignite and burn with a flame.
dispersion with a water non-combustible liquid/solid content of more than 85% by TOXICOLOGICAL INFORMATION:
weight. Liquids that have no fire point when tested by ASTM D 92, Standard Test Human and Animal Toxicology: Possible health hazards as derived from human
Method for Flash and Fire Points by Cleveland Open Cup, up to the boiling point data, animal studies, or from the results of studies with similar compounds are
of the liquid or up to a temperature at which the sample being tested shows an presented. LD50: Lethal Dose (solids & liquids) that kills 50% of the exposed
obvious physical change. Combustible pellets with a representative diameter of animals. LC50: Lethal Concentration (gases) that kills 50% of the exposed animals.
greater than 2 mm (10 mesh). Most ordinary combustible materials. Solids ppm: Concentration expressed in parts of material per million parts of air or water.
containing greater than 0.5% by weight of a flammable or combustible solvent are mg/m3: Concentration expressed in weight of substance per volume of air. mg/kg:
rated by the closed cup flash point of the solvent. 2 Materials that must be Quantity of material, by weight, administered to a test subject, based on their body
moderately heated or exposed to relatively high ambient temperatures before weight in kg. TDLo: Lowest dose to cause a symptom. TCLo: Lowest
ignition can occur. Materials in this degree would not under normal conditions form concentration to cause a symptom. TDo, LDLo, and LDo, or TC, TCo, LCLo, and
hazardous atmospheres with air, but under high ambient temperatures or under LCo: Lowest dose (or concentration) to cause lethal or toxic effects. Cancer
moderate heating could release vapor in sufficient quantities to produce Information: IARC: International Agency for Research on Cancer. NTP: National
hazardous atmospheres with air. Liquids having a flash point at or above 37.8°C Toxicology Program. RTECS: Registry of Toxic Effects of Chemical Substances.
(100°F) and below 93.4°C (200°F) (i.e. Class II and Class IIIA liquids.) Solid IARC and NTP rate chemicals on a scale of decreasing potential to cause human
materials in the form of powders or coarse dusts of representative diameter cancer with rankings from 1 to 4. Subrankings (2A, 2B, etc.) are also used. Other
between 420 microns (40 mesh) and 2 mm (10 mesh) that burn rapidly but that Information: BEI: ACGIH Biological Exposure Indices, represent the levels of
generally do not form explosive mixtures with air. Solid materials in fibrous or determinants which are most likely to be observed in specimens collected from a
shredded form that burn rapidly and create flash fire hazards, such as cotton, healthy worker who has been exposed to chemicals to the same extent as a
sisal, and hemp. Solids and semisolids that readily give off flammable vapors. worker with inhalation exposure to the TLV.
Solids containing greater than 0.5% by weight of a flammable or combustible ECOLOGICAL INFORMATION:
solvent are rated by the closed cup flash point of the solvent. 3 Liquids and solids EC: Effect concentration in water. BCF: Bioconcentration Factor, which is used to
that can be ignited under almost all ambient temperature conditions. Materials in determine if a substance will concentrate in life forms that consume contaminated
this degree produce hazardous atmospheres with air under almost all ambient plant or animal matter. TLm: Median threshold limit. log KOW or log KOC: Coefficient
temperatures or, though unaffected by ambient temperatures, are readily ignited of Oil/Water Distribution is used to assess a substance’s behavior in the
under almost all conditions. Liquids having a flash point below 22.8°C (73°F) and environment.
having a boiling point at or above 37.8°C (100°F) and those liquids having a flash
REGULATORY INFORMATION:
point at or above 22.8°C (73°F) and below 37.8°C (100°F) (i.e. Class IB and IC
U.S. and CANADA:
liquids). Materials that on account of their physical form or environmental
This section explains the impact of various laws and regulations on the material.
conditions can form explosive mixtures with air and are readily dispersed in air.
EPA: U.S. Environmental Protection Agency. ACGIH: American Conference of
Flammable or combustible dusts with representative diameter less than 420
Governmental Industrial Hygienists, a professional association that establishes
microns (40 mesh). Materials that burn with extreme rapidity, usually by reason of
exposure limits. OSHA: U.S. Occupational Safety and Health Administration.
self-contained oxygen (e.g. dry nitrocellulose and many organic peroxides). Solids
NIOSH: National Institute of Occupational Safety and Health, which is the
containing greater than 0.5% by weight of a flammable or combustible solvent are
research arm of OSHA. WHMIS: Canadian Workplace Hazardous Materials
rated by the closed cup flash point of the solvent. 4 Materials that will rapidly or
Information System. DOT: U.S. Department of Transportation. TC: Transport
completely vaporize at atmospheric pressure and normal ambient temperature or
Canada. SARA: Superfund Amendments and Reauthorization Act. DSL/NDSL:
that are readily dispersed in air and will burn readily. Flammable gases.
Canadian Domestic/Non-Domestic Substances List. TSCA: U.S. Toxic Substance
Flammable cryogenic materials. Any liquid or gaseous materials that is liquid while
Control Act. CERCLA: Comprehensive Environmental Response, Compensation,
under pressure and has a flash point below 22.8°C (73°F) and a boiling point
and Liability Act. Marine Pollutant status according to the DOT; CERCLA or
below 37.8°C (100°F) (i.e. Class IA liquids). Materials that ignite when exposed to
Superfund; and various state regulations. This section also includes information
air, Solids containing greater than 0.5% by weight of a flammable or combustible
on the precautionary warnings that appear on the material’s package label.
solvent are rated by the closed cup flash point of the solvent.
INSTABILITY HAZARD: 0 Materials that in themselves are normally stable, even
under fire conditions. Materials that have an instantaneous power density (product
of heat of reaction and reaction rate) at 250°C (482°F) below 0.01 W/mL.
Materials that do not exhibit an exotherm at temperatures less than or equal to
500°C (932°F) when tested by differential scanning calorimetry.
CALCIPOTRIENE TOPICAL SOLUTION 0.005% MSDS EFFECTIVE DATE: DECEMBER 12, 2007
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