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: Hydrocortisone Lotion 1.0% and 2.5%
Hydrocortisone Lotion
DESCRIPTION:
0168-0287-04; 0168-0288-02
NDC #:
Hydrocortisone [pregn-4-ene-3,20-dione, 11,17,21-
CHEMICAL NAME (for active ingredient):
trihydroxy-, (11,)]
Corticosteroid
CHEMICAL FAMILY (for active ingredient):
1.0% and 2.5% Lotion
HOW SUPPLIED:
C21H30O5
FORMULA (for active ingredient):
Pharmaceutical for Human Use
PRODUCT USE:
SUPPLIER/MANUFACTURER'S NAME: NYCOMED US INC.
60 Baylis Road
ADDRESS:
Melville, NY 11747
1-631-454-7677
BUSINESS PHONE/GENERAL MSDS INFORMATION:
EMERGENCY PHONE (U.S./Canada/Puerto Rico): 1-800-424-9300 (24-hrs)
EMERGENCY PHONE (OUTSIDE U.S.): +1-631-454-7677
NOTE: ALL United States Occupational Safety and Health Administration Standard (29 CFR 1910.1200), U.S. State equivalent Standards, and Canadian WHMIS [Controlled
Products Regulations] required information is included in appropriate sections based on the U.S. ANSI Z400.1-2004 format. This product has been classified in accordance
with the hazard criteria of the countries listed above.
2. HAZARD IDENTIFICATION
EMERGENCY OVERVIEW: Product Description: This product is a translucent, white to off-white, odorless lotion.
Health Hazards: The chief health hazard associated with exposure during normal use and handling is the potential for
irritation of contaminated skin. Individuals who have had allergic reactions to products containing the active ingredient,
Hydrocortisone, or any other components of this product may experience allergic reactions to this product. Repeated
skin exposure to Corticosteroids (such as Hydrocortisone) may cause adverse reproductive effects, based on animal
data. Flammability Hazards: If heated to high temperatures for a prolonged period, the water in this product can
evaporate off and the residue may ignite. When involved in a fire, this material may decompose and produce irritating
vapors and toxic compounds (including carbon oxides). Reactivity Hazards: This product is not reactive.
Environmental Hazards: This product has not been tested for environmental effects. Emergency Considerations:
Emergency responders should wear appropriate protection for situation to which they respond.
3. COMPOSITION and INFORMATION ON INGREDIENTS
CHEMICAL NAME CAS # % w/w
Hydrocortisone 50-23-7 1.0% and 2.5%
Sorbic Acid 110-44-1 Proprietary
Triethanolamine 102-71-6 Proprietary
Cholesterol 57-88-5 Proprietary
Isopropyl Myristate 110-27-0 Proprietary
Polysorbate 40 9005-66-7 Proprietary
Propylene Glycol Stearate 1323-39-3 Proprietary
Propylene Glycol 57-55-6 Proprietary
Water and other components. Each of the other components is present in less The remaining components do not contribute any Balance
significant additional hazards.
than 1 percent concentration (0.1% concentration for potential carcinogens,
reproductive toxins, respiratory tract sensitizers, and mutagens).
HYDROCORTISONE LOTION 1.0% AND 2.5% MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 1 OF 11
Nycomed US Inc.
PART II What should I do if a hazardous situation occurs?
4 FIRST-AID MEASURES
Persons developing hypersensitivity reactions should receive medical attention. If breathing is difficult, give oxygen. If
not breathing, give artificial respiration. Take a copy of label and MSDS to physician or health professional with the
contaminated individual.
SKIN EXPOSURE: If adverse skin effects occur, discontinue use. Seek medical attention.
EYE EXPOSURE: If this product contaminates the eyes, rinse eyes under gently running water. Use sufficient force to
open eyelids and then "roll" eyes while flushing. Minimum flushing is for 15 minutes. The contaminated individual must
seek medical attention if any adverse effect continues after rinsing.
INHALATION: If vapors of this product are inhaled, causing irritation, remove victim to fresh air. If necessary, use
artificial respiration to support vital functions. Seek medical attention if adverse effect continues after removal to fresh
air.
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.
5. FIRE-FIGHTING MEASURES
FLASH POINT: Not established.
NFPA RATING
AUTOIGNITION TEMPERATURE: Not established.
FLAMMABLE LIMITS (in air by volume, %): FLAM MAB ILITY
Lower (LEL): Not applicable. Upper (UEL): Not applicable.
Use extinguishing media
FIRE EXTINGUISHING MATERIALS: 0
appropriate for surrounding fire.
1 0
Water Spray: OK Carbon Dioxide: OK HEALTH INSTAB ILITY
Foam: OK Dry Chemical: OK
Halon: OK Other: Any "ABC" Class
FIRE EXTINGUISHING MATERIALS NOT TO BE USED: None known.
UNUSUAL FIRE AND EXPLOSION HAZARDS: The Triethanolamine OTHER
component of this product is a skin sensitizer; subsequent exposure to Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
small amount may cause allergic reaction and so poses a contact 3 = Serious 4 = Severe
hazard to firefighters. If heated to high temperatures for a prolonged
period, the water in this product can evaporate off and the residue may ignite. When involved in a fire, this material
may decompose and produce irritating vapors and toxic compounds (including carbon oxides).
Explosion Sensitivity to Mechanical Impact: Not sensitive.
Explosion Sensitivity to Static Discharge: Not sensitive.
SPECIAL FIRE-FIGHTING PROCEDURES: Incipient fire responders should wear eye protection. Structural
firefighters must wear Self-Contained Breathing Apparatus (SCBA) and full protective equipment. If protective
equipment is contaminated by this product, it should be thoroughly washed with running water prior to removal of
SCBA respiratory protection. Firefighters whose protective equipment becomes contaminated should thoroughly
shower with warm, soapy water and should receive medical evaluation if they experience any adverse effects.
6. ACCIDENTAL RELEASE MEASURES
SPILL AND LEAK RESPONSE: Proper protective equipment should be used. In the event of a spill, clear the area
and protect people. The atmosphere must have levels of components lower than those listed in Section 8, (Exposure
Controls and Personal Protective Equipment) if applicable, and have at least 19.5 percent oxygen before personnel can
be allowed into the area without Self-Contained Breathing Apparatus (SCBA).
Small Spills: Wear goggles and gloves while wiping up small spills of this product with polypad or sponge.
HYDROCORTISONE LOTION 1.0% AND 2.5% MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 2 OF 11
Nycomed US Inc.
6. ACCIDENTAL RELEASE MEASURES (Continued)
SPILL AND LEAK RESPONSE (continued):
Large Spills: Trained personnel following pre-planned procedures should handle non-incidental releases. Access to the spill
areas should be restricted. Protective apparel should be used with a respirator when there is any danger of mists or sprays
being generated. Minimum Personal Protective Equipment should be rubber gloves, rubber boots, face shield, and Tyvek suit.
The dispersal of mists or sprays into surrounding air and the possibility of inhalation is a serious matter and should be treated as
such. Minimum level of personal protective equipment for releases in which the level of oxygen is less than 19.5% or is
unknown must be Level B: triple-gloves (rubber gloves and nitrile gloves over latex gloves), chemical resistant suit and
boots, hard hat, and Self-Contained Breathing Apparatus. Absorb spilled liquid using polypads or other suitable absorbent
material. Prevent material from entering sewer or confined spaces, waterways, soil or public waters. Monitor area and confirm
levels are bellow exposure limits given in Section 8 (Exposure Controls-Personal Protection), if applicable, before non-response
personnel are allowed into the spill area.
Decontaminate the area of the spill thoroughly using detergent and water. Place all spill residue in an appropriate
container and seal. Dispose of in accordance with applicable Federal, State, and local procedures (see Section 13,
Disposal Considerations).
PART III How can I prevent hazardous situations from occurring?
7. HANDLING and USE
WORK PRACTICES AND HYGIENE PRACTICES: As with all chemicals, avoid getting this product ON YOU or IN
YOU. Do not eat, drink, smoke, or apply cosmetics while handling this product. Wash hands thoroughly after
handling this product or equipment and containers that contain this product. Follow SPECIFIC USE INSTRUCTIONS
supplied with this product. Particular care in working with this product must be practiced in pharmacies and other
preparation areas, during manufacture of this product, and during patient administration.
STORAGE AND HANDLING PRACTICES: Employees must be trained to properly use this product. Use of this
product should be performed in a designated area for working with drugs. Ensure product is properly labeled. Store
this product away from incompatible materials. Store this product in original container.
PRODUCT PREPARATION INSTRUCTIONS FOR MEDICAL PERSONNEL: Handle this material following standard
medical practices and following the recommendations presented on the Package Insert.
SPECIFIC USE(S): This product is a human pharmaceutical. Follow all industry standards for use of this product.
PROTECTIVE PRACTICES DURING MAINTENANCE OF CONTAMINATED EQUIPMENT: When cleaning non-
disposable equipment, wear latex or butyl rubber (double gloving is recommended), goggles, and lab coat. Wash
equipment with soap and water. Wipe equipment down with damp sponge or polypad. Collect all rinsates and dispose
of according to applicable U.S. Federal, State, and local hazardous waste disposal regulations or waste disposal
regulations of Canada. All disposable items contaminated with this product should be disposed of properly.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION
VENTILATION AND ENGINEERING CONTROLS: Use with adequate ventilation. Follow standard medical product
handling procedures. During decontamination of work surfaces, workers should wear the same equipment
recommended in Section 6 (Accidental Release Measures) of this MSDS.
EXPOSURE LIMITS/GUIDELINES:
CHEMICAL NAME CAS # EXPOSURE LIMITS IN AIR
ACGIH-TLVs OSHA-PELs NIOSH-RELs NIOSH OTHER
TWA STEL TWA STEL TWA STEL IDLH
mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3
Hydrocortisone 50-23-7 NE NE NE NE NE NE NE NE
Sorbic Acid 110-44-1 NE NE NE NE NE NE NE NE
Triethanolamine 102-71-6 5 NE NE NE NE NE NE NE
Cholesterol 57-88-5 NE NE NE NE NE NE NE NE
Isopropyl Myristate 110-27-0 NE NE NE NE NE NE NE NE
Polysorbate 40 9005-66-7 NE NE NE NE NE NE NE NE
Propylene Glycol Stearate 1323-39-3 10 NE NE NE NE NE NE NE
(Exposure limits are for Stearates)
Propylene Glycol 57-55-6 NE NE NE NE NE NE NE AIHA WEEL:
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.
HYDROCORTISONE LOTION 1.0% AND 2.5% MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 3 OF 11
Nycomed US Inc.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION (Continued)
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.
BODY PROTECTION: During patient administration, use of lightweight cotton gown or other medical attire is
recommended. If a hazard of injury to the feet exists due to falling objects, rolling objects, where objects may pierce the
soles of the feet or where employee's feet may be exposed to electrical hazards, use foot protection, as described in
U.S. OSHA 29 CFR 1910.136 and the Canadian CSA Standard Z195-02, Protective Footwear.
9. PHYSICAL and CHEMICAL PROPERTIES
BOILING POINT: Approximately 107癈 (224癋) FREEZING/MELTING POINT: 36癈 (97癋)
EVAPORATION RATE (nBuAc = 1): 0.1 SOLUBILITY IN WATER: Insoluble.
VAPOR PRESSURE (air = 1): Not established. SPECIFIC GRAVITY @ 25癈 (water = 1): 1.27
ODOR THRESHOLD: Not established. pH: 4.0?.5
COEFFICIENT WATER/OIL DISTRIBUTION: Not established.
APPEARANCE AND COLOR: This product is a translucent, white to off-white, odorless lotion.
HOW TO DETECT THIS SUBSTANCE (warning properties): The appearance of this product can be a distinguishing
characteristic to identify it 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. Acids, caustics, and other chemicals that could affect its performance should
be avoided.
HAZARDOUS POLYMERIZATION: Will not occur.
CONDITIONS TO AVOID: Avoid heat, light, and contact with incompatible chemicals.
PART IV Is there any other useful information about this material?
11. TOXICOLOGICAL INFORMATION
SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: The health hazard information provided below is
pertinent to medical employees handling this product in an occupational setting. This product is designed for application
on the skin. The following paragraphs describe the symptoms of exposure by route of exposure.
INHALATION: Inhalation of mists or sprays may slightly irritate the nose, throat, and lungs. Symptoms are generally
alleviated upon breathing fresh air.
CONTACT WITH SKIN or EYES: Skin contact may cause burning sensation, stinging, prickling, itching, and tingling.
The Sorbic Acid component of this product can cause redness, swelling, and itching (non-allergic hives).
Corticosteroids (such as Hydrocortisone) may cause allergic contact dermatitis. This 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 Triethanolamine component of this product can be absorbed through intact skin. If a large
area of the skin is involved, adverse effect may occur by this route of exposure. The Hydrocortisone component of this
product can be absorbed through intact skin. 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.
HYDROCORTISONE LOTION 1.0% AND 2.5% MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 4 OF 11
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
INGESTION: Ingestion is not a significant route of occupational
HAZARDOUS MATERIAL IDENTIFICAT IONSYSTEM
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
(BLUE) 1
HEALTH HAZARD
nausea, vomiting, and diarrhea.
INJECTION: Though not anticipated to be a significant route of
exposure for this product, injection (via punctures or lacerations by
contaminated objects) may cause redness at the site of injection.
FLAMMABI ITY HAZARD (RED) 0
L
Symptoms may include those described for "General Toxicity
Information".
GENERAL TOXICITY INFORMATION: Individuals who have had
allergic reactions to products containing the Hydrocortisone
PHYSICAL HAZARD (YELLOW) 0
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. PROTECTIVE E QUIP MENT
For Males and Females: Persons using the product in therapeutic
doses may experience burning, itching, irritation, dryness,
EYES RESPIRATORY HANDS BODY
inflammation of hair follicles, excessive growth of hair, acne-form
eruptions, diminished pigmentation, dermatitis around the mouth,
allergic contact dermatitis, softening of the skin, secondary SEE SECTION 8 SEE SECTION 8
infections, skin atrophy, striae, and prickly heat.
IRRITANCY OF PRODUCT: This product may mildly to moderately For Routine In al Use and Han
dustri dling App lications
irritate contaminated tissue.
Corticosteroids (such as
SENSITIZATION OF PRODUCT: Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
Hydrocortisone) may cause allergic contact dermatitis. The 3 = Serious 4 = Severe * = Chronic hazard
Triethanolamine component of this product is a skin sensitizer
(capable of producing rashes, increased skin sensitivity, and other allergic skin reactions); subsequent exposure to very
small amounts may cause allergic reaction in susceptible individuals.
HEALTH EFFECTS OR RISKS FROM EXPOSURE: An Explanation in Lay Terms. Overexposure to this product may
cause the following health effects:
Acute: The primary health effects that may be experienced by medical personnel exposed to this product is mild
irritation of contaminated skin. Accidental ingestion may be harmful. Although unlikely, inhalation can irritate the
respiratory system. Eye contact will cause irritation.
Chronic: Corticosteroids (such as Hydrocortisone) may cause allergic contact dermatitis. Symptoms of chronic skin
absorption exposure may include reversible hypothalamic-pituitaryadrenal (HPA) axis suppression, abnormal
accumulations of facial and trunk fat, fatigue, high blood pressure, osteoporosis, abnormally high level of glucose in
the blood, and abnormally high levels of glucose in the urine.
TARGET ORGANS:
Acute: Occupational Exposure: Skin, eyes. Therapeutic Doses: Skin.
Chronic: Occupational Exposure: Skin. Therapeutic Doses: Skin, endocrine system, blood system, bones,
pituitaryadrenal system, urinary system, cardio-vascular system.
TOXICITY DATA: The toxicity data available for the active component of this product, Hydrocortisone, 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.
HYDROCORTISONE: HYDROCORTISONE (continued): HYDROCORTISONE (continued):
Standard Draize Test (Skin-Rabbit) 1000 ppm: Mild LD50 (Subcutaneous-Rat) 3260 mg/kg: Eye: ptosis; TDLo (Skin-Rat) 82,500 礸/kg: female 7-17 days
LD50 (Oral-Rat) 5120 mg/kg: Eye: ptosis; Behavioral: Behavioral: changes in motor activity (specific after conception: Effects on Newborn: growth
changes in motor activity (specific assay); Lungs, assay); Lungs, Thorax, or Respiration: respiratory statistics (e.g.%, reduced weight gain)
Thorax, or Respiration: respiratory depression depression TDLo (Skin-Dog) 18,200 礸/kg/91 days-intermittent:
LD50 (Oral-Mouse) 6720 mg/kg: Sense Organs and LD50 (Subcutaneous-Mouse) 1980 mg/kg: Eye: Endocrine: changes in adrenal weight; Blood:
Special Senses (Eye): ptosis; Behavioral: ptosis; Behavioral: changes in motor activity pigmented or nucleated red blood cells, changes
changes in motor activity (specific assay); Lungs, (specific assay); Lungs, Thorax, or Respiration: in leukocyte (WBC) count
Thorax, or Respiration: respiratory depression respiratory depression TDLo (Subcutaneous-Rat) 60 mg/kg/30 days-
LD50 (Intraperitoneal-Rat) 1420 mg/kg: Eye: ptosis; LD50 (Subcutaneous-Dog) > 1 gm/kg intermittent: Endocrine: changes in spleen weight;
Behavioral: changes in motor activity (specific TDLo (Skin-Rat) 82,500 礸/kg: female 7-17 days Blood: changes in leukocyte (WBC) count;
assay); Lungs, Thorax, or Respiration: respiratory after conception: Reproductive: Effects on Fetus: Biochemical: Enzyme inhibition, induction, or
depression fetotoxicity (except death, e.g., stunted fetus); change in blood or tissue levels: transaminases
LD50 (Intraperitoneal-Mouse) 1660 mg/kg: Eye: Specific Developmental Abnormalities: TDLo (Subcutaneous-Rat) 15,600 礸/kg/26 weeks-
ptosis; Behavioral: changes in motor activity musculoskeletal system; Effects on Newborn: live intermittent: Cardiac: changes in heart weight;
(specific assay); Lungs, Thorax, or Respiration: birth index (measured after birth) Liver: changes in liver weight; Blood: changes in
respiratory depression platelet count
HYDROCORTISONE LOTION 1.0% AND 2.5% MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 5 OF 11
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
TOXICITY DATA (continued):
HYDROCORTISONE (continued): HYDROCORTISONE (continued): HYDROCORTISONE (continued):
TDLo (Subcutaneous-Rat) 5 mg/kg: female 7 days TDLo (Subcutaneous-Rat) 440 礸/kg: female 7-17 TDLo (Subcutaneous-Rabbit) 1300 礸/kg: female 6-
after conception: Reproductive: Effects on Fetus: days after conception: Reproductive: Effects on 18 days after conception: Reproductive: Effects
fetotoxicity (except death, e.g., stunted fetus) Newborn: physical on Newborn: growth statistics (e.g.%, reduced
TDLo (Subcutaneous-Rat) 1100 礸/kg: female 7-17 TDLo (Subcutaneous-Rabbit) 6500 礸/kg: female 6- weight gain)
days after conception: Reproductive: 18 days after conception: Reproductive: Fertility: TDLo (Subcutaneous-Rabbit) 6500 礸/kg: female 6-
Musculoskeletal Developmental Abnormalities post-implantation mortality (e.g. dead and/or 18 days after conception: Reproductive:
TDLo (Subcutaneous-Rat) 1296 礸/kg: male 9 resorbed implants per total number of implants), Musculoskeletal Developmental Abnormalities
weeks pre-mating female 2 weeks pre-mating: 7 litter size (e.g. # fetuses per litter; measured
days after conception: Reproductive: Fertility: pre- before birth); Effects on Fetus: fetal death
implantation mortality (e.g. reduction in number of
implants per female; total number of implants per
corpora lutea)
CARCINOGENIC INFORMATION: Long-term animal studies have not been performed to evaluate the carcinogenic
potential of topical corticosteroids. The incipient components of this product are listed by agencies tracking the
carcinogenic potential of chemical compounds, as follows:
CHOLESTEROL: IARC-3 (Unclassifiable as to Carcinogenicity in Humans)
PROPYLENE GLYCOL STEARATE (as a stearate compound): ACGIH TLV-A4 (Not Classifiable as Human Carcinogen);
TRIETHANOLAMINE: IARC-3 (Unclassifiable as to Carcinogenicity in Humans)
The remaining components of this product are not found on the following lists: U.S. EPA, U.S. NTP, U.S. OSHA, U.S.
NIOSH, GERMAN MAK, IARC, or ACGIH and therefore are neither considered to be nor suspected to be cancer-
causing agents by these agencies.
REPRODUCTIVE TOXICITY INFORMATION: The active component of this product, Hydrocortisone, 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: The components of this product are not reported to cause mutagenic effects in humans.
Embryotoxicity: Studies have not been performed to evaluate the embryotoxic effects of this product.
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.
Reproductive Toxicity: Long-term animal studies have not been performed to evaluate the effect on fertility of topical
corticosteroids.
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, there are no ACGIH Biological Exposure Indices (BEIs)
determined for components of this product.
12. ECOLOGICAL INFORMATION
ALL WORK PRACTICES MUST BE AIMED AT ELIMINATING ENVIRONMENTAL CONTAMINATION.
ENVIRONMENTAL STABILITY: This product has not been tested for persistence, biodegradability, bioconcentration,
soil absorption or mobility. The following environmental data are available for the components of this product:
CHOLESTEROL:
Terrestrial Fate: Based on a classification scheme, an estimated Koc value of 99, determined from a log Kow of 1.14 and a regression-derived equation, indicates that
Chloramphenicol is expected to have high mobility in soil. Volatilization of Chloramphenicol from moist soil surfaces is not expected to be an important fate process
given an estimated Henry's Law constant of 1.3X10-18 atm-cu m/mole, using a fragment constant estimation method. Chloramphenicol is not expected to volatilize
from dry soil surfaces based upon an estimated vapor pressure of 1.7X10-12 mmHg, determined from a fragment constant method. Half-lives in marine and
freshwater sediment of 2.4 to 18.4 days and < 12 days, respectively, indicate that biodegradation may occur in terrestrial environments
Aquatic Fate: Based on a classification scheme, an estimated Koc value of 99, determined from a log Kow of 1.14 and a regression-derived equation, indicates that
Chloramphenicol 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 2.3X10-18 atm-cu m/mole, developed using a fragment constant estimation method. According to a classification scheme, an estimated BCF of < 1,
from its log Kow and a regression-derived equation, suggests the potential for bioconcentration in aquatic organisms is low. Half-lives in marine and freshwater
sediment of 2.4 to 18.4 days and < 12 days, respectively, indicate that biodegradation may occur in aquatic environments.
Atmospheric Fate: According to a model of gas/particle partitioning of semi-volatile organic compounds in the atmosphere, Chloramphenicol, which has an estimated
vapor pressure of 1.7X10-12 mm Hg at 25癈, determined from a fragment constant method, is expected to exist solely in the particulate phase in the ambient
atmosphere. Particulate-phase Chloramphenicol may be removed from the air by wet and dry deposition. Chloramphenicol solutions, when exposed to a UV source
(sunlight) or to high temperatures, decompose with the formation of hydrochloric and dichloric acid.
Bioconcentration: An estimated BCF of < 1 was calculated for Chloramphenicol, using a log Kow of 1.14 and a regression-derived equation. According to a
classification scheme, this BCF suggests the potential for bioconcentration in aquatic organisms is low.
ISOPROPYL MYRISTATE:
Persistence and Biodegradability: If released to air, a vapor pressure of 9.35X10-5 mm Hg at 25癈 indicates Isopropyl Myristate will exist in both the vapor and
particulate phases in the ambient atmosphere. Vapor-phase Isopropyl Myristate will be degraded in the atmosphere by reaction with photochemically-produced
hydroxyl radicals; the half-life for this reaction in air is estimated to be 20 hours. Particulate-phase Isopropyl Myristate will be removed from the atmosphere by both
wet and dry deposition. If released to soil, Isopropyl Myristate is expected to have no mobility based upon an estimated Koc of 15,000. Volatilization from moist soil
surfaces is expected to be an important fate process based upon an estimated Henry's Law constant of 0.009 atm-cu m/mole. However, adsorption to soil is
expected to attenuate volatilization. Isopropyl Myristate is expected to rapidly biodegrade in aerobic soils as suggested by the rapid biodegradation of structurally
similar long-chain fatty acid esters. If released into water, Isopropyl Myristate is expected to adsorb to suspended solids and sediment in the water column based
upon the estimated Koc.
HYDROCORTISONE LOTION 1.0% AND 2.5% MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 6 OF 11
Nycomed US Inc.
12. ECOLOGICAL INFORMATION (Continued)
ENVIRONMENTAL STABILITY (continued):
ISOPROPYL MYRISTATE (continued):
Persistence and Biodegradability (continued): Isopropyl Myristate is expected to rapidly biodegrade in aerobic waters as suggested by the rapid biodegradation of
structurally similar long-chain fatty acid esters. Volatilization from water surfaces is expected to be an important fate process based upon this compound's estimated
Henry's Law constant. Estimated volatilization half-lives for a model river and model lake are 5 hours and 6.5 days, respectively. However, volatilization from water
surfaces is expected to be attenuated by adsorption to suspended solids and sediment in the water column. The volatilization half-life from a model pond is estimated
to be about 60 hours ignoring adsorption; when considering maximum adsorption the volatilization half-life increases to 130 days. An estimated BCF of 1200
suggests the potential for bioconcentration in aquatic organisms is very high. An estimated base-catalyzed second-order hydrolysis rate constant of 0.021 L/mole-sec
corresponds to half-lives of 10.2 years and 1 year at pH values of 7 and 8, respectively.
Bioconcentration: An estimated BCF of 1200 was calculated for Isopropyl Myristate using an estimated log Kow of 7.17 and a regression-derived equation. According
to a classification scheme, the estimated BCF suggests the potential for bioconcentration in aquatic organisms is very high.
Soil Adsorption/Mobility: Using a structure estimation method based on molecular connectivity indices, the Koc for Isopropyl Myristate can be estimated to be about
15,000. According to a classification scheme, this estimated Koc value suggests that Isopropyl Myristate is expected to be immobile in soil.
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癈, 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癈
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.
PROPYLENE GLYCOL: PROPYLENE GLYCOL (continued):
EC50 (Photobacterium phosphoreum, bacteria) 30 minutes = 26,800 mg/L LC50 (Lebistes reticulatus, guppy) 48 hours > 10,000 mg/L
TD (Chlorella pyrenoidosa, algae) = 92,000 mg/L LC50 (Carassius auratus) 24 hours = > 5,000 mg/L
EC0 (Daphnia magna, crustacean) 48 hours= < 4,295 mg/L LC50 (Salmo gairdneri) 24 hours = 50,000 mg/L
EC50 (Daphnia magna, crustacean) 48 hours = 34,400 mg/L LC50 (Pimephales promelas) 96 hours = 54,900 mg/L
EC100 (Daphnia magna, crustacean) 48 hours = 50,000 mg/L LC50 (Artemia salina) 24 hours = >10,000 mg/L
EC50 (Daphnia magna, crustacean) 24 hours = > 10,000 mg/L LC100 (Pimephales promelas) 96 hours = 65,610 mg/L
EC100 (Daphnia magna, crustacean) 24 hours = > 10,000 mg/L NOEC (Pimephales promelas) 96 hours < 47,829 mg/L
EC50 (Nitocra spinipes, crustacean) 96 hours = > 10,000 mg/L Fingerling trout: at 50,000 mg/l at 10癈: no mortality or apparent signs of stress
were produced during a 25-hr exposure period (static bioassay)
ENVIRONMENTAL EXPOSURE CONTROLS: Controls should be engineered to prevent release to the environment,
including procedures to prevent spills, atmospheric release and release to waterways.
OTHER ADVERSE EFFECTS: No component of this product is known to have ozone depletion potential.
13. DISPOSAL CONSIDERATIONS
DISPOSAL METHODS: It is the responsibility of the generator to determine at the time of disposal whether the product
meets the criteria of a hazardous waste per regulations of the area in which the waste is generated and/or disposed of.
Waste disposal must be in accordance with appropriate Federal, State, and local regulations. This product, if unaltered
by use, may be disposed of by treatment at a permitted facility or as advised by your local hazardous waste regulatory
authority. Shipment of wastes must be done with appropriately permitted and registered transporters.
DISPOSAL CONTAINERS: Waste materials must be placed in and shipped in appropriate 5-gallon or 55-gallon poly or
metal waste pails or drums. Permeable cardboard containers are not appropriate and should not be used. Ensure that
any required marking or labeling of the containers be done to all applicable regulations.
PRECAUTIONS TO BE FOLLOWED DURING WASTE HANDLING: Wear proper protective equipment when handling
waste materials.
PREPARING WASTES FOR DISPOSAL: Waste disposal must be in accordance with appropriate U.S. Federal, State,
and local regulations or with regulations of Canada. This product, if unaltered by handling, may be disposed of by
treatment at a permitted facility or as advised by your local hazardous waste regulatory authority. All gowns, gloves,
and disposable materials used in the preparation or handling of this drug should be disposed of in accordance with
established hazardous waste disposal procedures. Handle as if capable of transmitting infectious agents.
Incineration is recommended. Reusable equipment should be cleaned with soap and water.
U.S. EPA WASTE NUMBER: Not applicable to wastes consisting only of this product.
HYDROCORTISONE LOTION 1.0% AND 2.5% MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 7 OF 11
Nycomed US Inc.
14. TRANSPORTATION INFORMATION
U.S. DEPARTMENT OF TRANSPORTATION SHIPPING REGULATIONS: This product is not classified as hazardous
under regulations of U.S. DOT 49 CFR 172.101.
TRANSPORT CANADA TRANSPORTATION OF DANGEROUS GOODS REGULATIONS: This product is not
classified as Dangerous Goods, per regulations of Transport Canada.
15. REGULATORY INFORMATION
UNITED STATES REGULATIONS:
U.S. SARA REPORTING REQUIREMENTS: The components of this product are not subject to the reporting
requirements of Sections 302, 304, and 313 of Title III of the Superfund Amendments and Reauthorization Act.
U.S. SARA THRESHOLD PLANNING QUANTITY: There are no specific Threshold Planning Quantities for any
component of this product. The default Federal MSDS submission and inventory requirement filing threshold of 10,000
lb (4,540 kg) therefore applies, per 40 CFR 370.20.
U.S. CERCLA REPORTABLE QUANTITIES (RQ): Not applicable.
U.S. TSCA INVENTORY STATUS: This product is regulated by the Food and Drug Administration; it is not subject to
requirements under TSCA.
CALIFORNIA SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT (PROPOSITION 65): The components
of this product are not on the California Proposition 65 lists.
OTHER U.S. FEDERAL REGULATIONS: Not applicable.
ANSI LABELING (Based on 129.1, Provided to Summarize Occupational Exposure Hazards): CAUTION! MAY
CAUSE ALLERGIC REACTION. MAY CAUSE SKIN AND EYE IRRITATION. Avoid contact with skin, eyes, and
clothing. Wash thoroughly after handling. Wear gloves, goggles, and appropriate body protection during handling or
administration. FIRST-AID: In case of contact, flush skin or eyes with plenty of water. 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: Not applicable.
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
800/441-3365 ?619/670-0609
May 14, 2009
DATE OF PRINTING:
DEFINITION OF TERMS
A large number of abbreviations and acronyms appear on a MSDS. Some of these, which are commonly used, include the following:
CAS #: This is the Chemical Abstract Service Number that uniquely identifies EXPOSURE LIMITS IN AIR (continued):
each constituent. DFG MAK Germ Cell Mutagen Categories (continued): 3B: Substances that
are suspected of being germ cell mutagens because of their genotoxic effects in
EXPOSURE LIMITS IN AIR:
CEILING LEVEL: The concentration that shall not be exceeded during any part of mammalian somatic cell in vivo; in exceptional cases, substances for which there
the working exposure. are no in vivo data, but that are clearly mutagenic in vitro and structurally related
DFG MAK Germ Cell Mutagen Categories: 1: Germ cell mutagens that have to known in vivo mutagens. 4: Not applicable (Category 4 carcinogenic
been shown to increase the mutant frequency in the progeny of exposed humans. substances are those with non-genotoxic mechanisms of action. By definition,
2: Germ cell mutagens that have been shown to increase the mutant frequency in germ cell mutagens are genotoxic. Therefore, a Category 4 for germ cell
the progeny of exposed mammals. 3A: Substances that have been shown to mutagens cannot apply. At some time in the future, it is conceivable that a
induce genetic damage in germ cells of human of animals, or which produce Category 4 could be established for genotoxic substances with primary targets
mutagenic effects in somatic cells of mammals in vivo and have been shown to other than DNA [e.g. purely aneugenic substances] if research results make this
reach the germ cells in an active form. seem sensible.)
HYDROCORTISONE LOTION 1.0% AND 2.5% MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 8 OF 11
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
EXPOSURE LIMITS IN AIR (continued): HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
DFG MAK Germ Cell Mutagen Categories (continued): 5: Germ cell mutagens, RATINGS (continued):
the potency of which is considered to be so low that, provided the MAK value is FLAMMABILITY HAZARD: 0 Minimal Hazard: Materials that will not burn in air
observed, their contribution to genetic risk for humans is expected not to be when exposure to a temperature of 815.5癈 (1500癋) for a period of 5 minutes. 1
significant. Slight Hazard: Materials that must be pre-heated before ignition can occur.
DFG MAK Pregnancy Risk Group Classification: Group A: A risk of damage to Material requires considerable pre-heating, under all ambient temperature
the developing embryo or fetus has been unequivocally demonstrated. Exposure conditions before ignition and combustion can occur. This usually includes the
of pregnant women can lead to damage of the developing organism, even when following: Materials that will burn in air when exposed to a temperature of 815.5癈
MAK and BAT (Biological Tolerance Value for Working Materials) values are (1500癋) for a period of 5 minutes or less; Liquids, solids and semisolids having a
observed. Group B: Currently available information indicates a risk of damage to flash point at or above 93.3癈 (200癋) (i.e. OSHA Class IIIB); and Most ordinary
the developing embryo or fetus must be considered to be probable. Damage to combustible materials (e.g. wood, paper, etc.). 2 Moderate Hazard: Materials that
the developing organism cannot be excluded when pregnant women are exposed, must be moderately heated or exposed to relatively high ambient temperatures
even when MAK and BAT values are observed. Group C: There is no reason to before ignition can occur. Materials in this degree would not, under normal
fear a risk of damage to the developing embryo or fetus when MAK and BAT conditions, form hazardous atmospheres in air, but under high ambient
values are observed. Group D: Classification in one of the groups A瑿 is not yet temperatures or moderate heating may release vapor in sufficient quantities to
possible because, although the data available may indicate a trend, they are not produce hazardous atmospheres with air. This usually includes the following:
sufficient for final evaluation. Liquids having a flash-point at or above 37.8癈 (100癋); Solid materials in the form
IDLH: Immediately Dangerous to Life and Health. This level represents a of course dusts that may burn rapidly but that generally do not form explosive
concentration from which one can escape within 30-minutes without suffering atmospheres; Solid materials in a fibrous or shredded form that may burn rapidly
escape-preventing or permanent injury. and create flash fire hazards (e.g. cotton, sisal, hemp); and Solids and semisolids
LOQ: Limit of Quantitation. (e.g. viscous and slow flowing as asphalt) that readily give off flammable vapors. 3
MAK: Federal Republic of Germany Maximum Concentration Values in the Serious Hazard: Liquids and solids that can be ignited under almost all ambient
workplace. temperature conditions. Materials in this degree produce hazardous atmospheres
NE: Not Established. When no exposure guidelines are established, an entry of with air under almost all ambient temperatures, or, unaffected by ambient
NE is made for reference. temperature, are readily ignited under almost all conditions. This usually includes
NIC: Notice of Intended Change. the following: Liquids having a flash point below 22.8癈 (73癋) and having a
NIOSH CEILING: The exposure that shall not be exceeded during any part of the boiling point at or above 38癈 (100癋) and those liquids having a flash point at or
workday. If instantaneous monitoring is not feasible, the ceiling shall be assumed above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. OSHA Class IB and IC);
as a 15-minute TWA exposure (unless otherwise specified) that shall not be Materials that on account of their physical form or environmental conditions can
exceeded at any time during a workday. form explosive mixtures with air and are readily dispersed in air (e.g., dusts of
NIOSH RELs: NIOSH's Recommended Exposure Limits. combustible solids, mists or droplets of flammable liquids); and Materials that burn
PEL: OSHA's Permissible Exposure Limits. This exposure value means exactly extremely rapidly, usually by reason of self-contained oxygen (e.g. dry
the same as a TLV, except that it is enforceable by OSHA. The OSHA nitrocellulose and many organic peroxides). 4 Severe Hazard: Materials that will
Permissible Exposure Limits are based in the 1989 PELs and the June, 1993 Air rapidly or completely vaporize at atmospheric pressure and normal ambient
Contaminants Rule (Federal Register: 58: 35338-35351 and 58: 40191). Both the temperature or that are readily dispersed in air, and that will burn readily. This
current PELs and the vacated PELs are indicated. The phrase, "Vacated 1989 usually includes the following: Flammable gases; Flammable cryogenic materials;
PEL" is placed next to the PEL that was vacated by Court Order. Any liquid or gaseous material that is liquid while under pressure and has a flash
SKIN: Used when a there is a danger of cutaneous absorption. point below 22.8癈 (73癋) and a boiling point below 37.8癈 (100癋) (i.e. OSHA
STEL: Short Term Exposure Limit, usually a 15-minute time-weighted average Class IA); and Materials that ignite spontaneously when exposed to air at a
(TWA) exposure that should not be exceeded at any time during a workday, even temperature of 54.4癈 (130癋) or below (pyrophoric).
if the 8-hr TWA is within the TLV-TWA, PEL-TWA or REL-TWA. PHYSICAL HAZARD: 0 Water Reactivity: Materials that do not react with water.
TLV: Threshold Limit Value. An airborne concentration of a substance that Organic Peroxides: Materials that are normally stable, even under fire conditions
represents conditions under which it is generally believed that nearly all workers and will not react with water. Explosives: Substances that are Non-Explosive.
may be repeatedly exposed without adverse effect. The duration must be Compressed Gases: No Rating. Pyrophorics: No Rating. Oxidizers: No 0 rating.
considered, including the 8-hour. Unstable Reactives: Substances that will not polymerize, decompose, condense,
TWA: Time Weighted Average exposure concentration for a conventional 8-hr or self-react.). 1 Water Reactivity: Materials that change or decompose upon
(TLV, PEL) or up to a 10-hr (REL) workday and a 40-hr workweek. exposure to moisture. Organic Peroxides: Materials that are normally stable, but
WEEL: Workplace Environmental Exposure Limits from the AIHA. can become unstable at high temperatures and pressures. These materials may
react with water, but will not release energy violently. Explosives: Division 1.5 &
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
1.6 explosives. Substances that are very insensitive explosives or that do not have
RATINGS: This rating system was developed by the National Paint and Coating
a mass explosion hazard. Compressed Gases: Pressure below OSHA definition.
Association and has been adopted by industry to identify the degree of chemical
Pyrophorics: No Rating. Oxidizers: Packaging Group III oxidizers; Solids: any
hazards.
material that in either concentration tested, exhibits a mean burning time less than
HEALTH HAZARD: 0 Minimal Hazard: No significant health risk, irritation of skin or
or equal to the mean burning time of a 3:7 potassium bromate/cellulose mixture
eyes not anticipated. Skin Irritation: Essentially non-irritating. Mechanical irritation
and the criteria for Packing Group I and II are not met. Liquids: any material that
may occur. PII or Draize = 0. Eye Irritation: Essentially non-irritating, minimal
exhibits a mean pressure rise time less than or equal to the pressure rise time of a
effects clearing in < 24 hours. Mechanical irritation may occur. Draize = 0. Oral
1:1 nitric acid (65%)/cellulose mixture and the criteria for Packing Group I and II
Toxicity LD50 Rat: > 5000 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 2000
are not met. Unstable Reactives: Substances that may decompose condense, or
mg/kg. Inhalation Toxicity 4-hrs LC50 Rat: > 20 mg/L. 1 Slight Hazard: Minor
self-react, but only under conditions of high temperature and/or pressure and have
reversible injury may occur; may irritate the stomach if swallowed; may defat the
little or no potential to cause significant heat generation or explosion hazard.
skin and exacerbate existing dermatitis. Skin Irritation: Slightly or mildly irritating.
Substances that readily undergo hazardous polymerization in the absence of
PII or Draize > 0 < 5. Eye Irritation: Slightly to mildly irritating, but reversible within
inhibitors. Substances that readily undergo hazardous polymerization in the
7 days. Draize > 0 25. Oral Toxicity LD50 Rat: > 500?000 mg/kg. Dermal
absence of inhibitors. 2 Water Reactivity: Materials that may react violently with
Toxicity LD50 Rat or Rabbit: > 1000?000 mg/kg. Inhalation Toxicity LC50 4-hrs
water. Organic Peroxides: Materials that, in themselves, are normally unstable
Rat: > 2?0 mg/L. 2 Moderate Hazard: Temporary or transitory injury may occur;
and will readily undergo violent chemical change, but will not detonate. These
prolonged exposure may affect the CNS. Skin Irritation: Moderately irritating;
materials may also react violently with water. Explosives: Division 1.4 explosives.
primary irritant; sensitizer. PII or Draize 5, with no destruction of dermal tissue.
Explosive substances where the explosive effects are largely confined to the
Eye Irritation: Moderately to severely irritating; reversible corneal opacity; corneal
package and no projection of fragments of appreciable size or range are
involvement or irritation clearing in 8?1 days. Draize = 26?00, with reversible
expected. An external fire must not cause virtually instantaneous explosion of
effects. Oral Toxicity LD50 Rat: > 50?00 mg/kg. Dermal Toxicity LD50 Rat or
almost the entire contents of the package. Compressed Gases: Pressurized and
Rabbit: > 200?000 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 0.5? mg/L. 3
meet OSHA definition but < 514.7 psi absolute at 21.1癈 (70癋) [500 psig].
Serious Hazard: Major injury likely unless prompt action is taken and medical
Pyrophorics: No Rating. Oxidizers: Packing Group II oxidizers. Solids: any
treatment is given; high level of toxicity; corrosive. Skin Irritation: Severely irritating
material that, either in concentration tested, exhibits a mean burning time of less
and/or corrosive; may cause destruction of dermal tissue, skin burns, and dermal
than or equal to the mean burning time of a 2:3 potassium bromate/cellulose
necrosis. PII or Draize > 5?, with destruction of tissue. Eye Irritation: Corrosive,
mixture and the criteria for Packing Group I are not met. Liquids: any material that
irreversible destruction of ocular tissue; corneal involvement or irritation persisting
exhibits a mean pressure rise time less than or equal to the pressure rise of a 1:1
for more than 21 days. Draize > 80 with effects irreversible in 21 days. Oral
aqueous sodium chlorate solution (40%)/cellulose mixture and the criteria for
Toxicity LD50 Rat: > 1?0 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 20?00
Packing Group I are not met. Reactives: Substances that may polymerize,
mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 0.05?.5 mg/L. 4 Severe Hazard: Life-
decompose, condense, or self-react at ambient temperature and/or pressure, but
threatening; major or permanent damage may result from single or repeated
have a low potential (or low risk) for significant heat generation or explosion.
exposures; extremely toxic; irreversible injury may result from brief contact. Skin
Substances that readily form peroxides upon exposure to air or oxygen at room
Irritation: Not appropriate. Do not rate as a 4, based on skin irritation alone. Eye
temperature.
Irritation: Not appropriate. Do not rate as a 4, based on eye irritation alone. Oral
Toxicity LD50 Rat: 1 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: 20 mg/kg.
Inhalation Toxicity LC50 4-hrs Rat: 0.05 mg/L.
HYDROCORTISONE LOTION 1.0% AND 2.5% MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 9 OF 11
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS
RATINGS (continued): (continued):
PHYSICAL HAZARD (continued): 3 Water Reactivity: Materials that may form FLAMMABILITY HAZARD (continued): 1 Materials that must be preheated before
explosive reactions with water. Organic Peroxides: Materials that are capable of ignition can occur. Materials in this degree require considerable preheating, under
detonation or explosive reaction, but require a strong initiating source or must be all ambient temperature conditions, before ignition and combustion can occur:
heated under confinement before initiation; or materials that react explosively with Materials that will burn in air when exposed to a temperature of 816癈 (1500癋)
water. Explosives: Division 1.3 explosives. Explosive substances that have a fire for a period of 5 minutes in according with Annex D of NFPA 704. Liquids, solids,
hazard and either a minor blast hazard or a minor projection hazard or both, but and semisolids having a flash point at or above 93.4癈 (200癋) (i.e. Class IIIB
do not have a mass explosion hazard. Compressed Gases: Pressure 514.7 psi liquids). Liquids with a flash point greater than 35癈 (95癋) that do not sustain
absolute at 21.1癈 (70癋) [500 psig]. Pyrophorics: No Rating. Oxidizers: Packing combustion when tested using the Method of Testing for Sustained Combustibility,
Group I oxidizers. Solids: any material that, in either concentration tested, exhibits per 49 CFR 173, Appendix H or the UN Recommendations on the Transport of
a mean burning time less than the mean burning time of a 3:2 potassium Dangerous Goods, Model Regulations (current edition) and the related Manual of
bromate/cellulose mixture. Liquids: any material that spontaneously ignites when Tests and Criteria (current edition). Liquids with a flash point greater than 35癈
mixed with cellulose in a 1:1 ratio, or which exhibits a mean pressure rise time (95癋) in a water-miscible solution or dispersion with a water non-combustible
less than the pressure rise time of a 1:1 perchloric acid (50%)/cellulose mixture. liquid/solid content of more than 85% by weight. Liquids that have no fire point
Unstable Reactives: Substances that may polymerize, decompose, condense, or when tested by ASTM D 92, Standard Test Method for Flash and Fire Points by
self-react at ambient temperature and/or pressure and have a moderate potential Cleveland Open Cup, up to the boiling point of the liquid or up to a temperature at
(or moderate risk) to cause significant heat generation or explosion. 4 Water which the sample being tested shows an obvious physical change. Combustible
Reactivity: Materials that react explosively with water without requiring heat or pellets with a representative diameter of greater than 2 mm (10 mesh). Most
confinement. Organic Peroxides: Materials that are readily capable of detonation ordinary combustible materials. Solids containing greater than 0.5% by weight of a
or explosive decomposition at normal temperature and pressures. Explosives: flammable or combustible solvent are rated by the closed cup flash point of the
Division 1.1 & 1.2 explosives. Explosive substances that have a mass explosion solvent. 2 Materials that must be moderately heated or exposed to relatively high
hazard or have a projection hazard. A mass explosion is one that affects almost ambient temperatures before ignition can occur. Materials in this degree would not
the entire load instantaneously. Compressed Gases: No Rating. Pyrophorics: Add under normal conditions form hazardous atmospheres with air, but under high
to the definition of Flammability 4. Oxidizers: No 4 rating. Unstable Reactives: ambient temperatures or under moderate heating could release vapor in sufficient
Substances that may polymerize, decompose, condense, or self-react at ambient quantities to produce hazardous atmospheres with air. Liquids having a flash point
temperature and/or pressure and have a high potential (or high risk) to cause at or above 37.8癈 (100癋) and below 93.4癈 (200癋) (i.e. Class II and Class IIIA
significant heat generation or explosion. liquids.) Solid materials in the form of powders or coarse dusts of representative
diameter between 420 microns (40 mesh) and 2 mm (10 mesh) that burn rapidly
NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS:
but that generally do not form explosive mixtures with air. Solid materials in fibrous
HEALTH HAZARD: 0 Materials that, under emergency conditions, would offer no
or shredded form that burn rapidly and create flash fire hazards, such as cotton,
hazard beyond that of ordinary combustible materials. Gases and vapors with an
sisal, and hemp. Solids and semisolids that readily give off flammable vapors.
LC50 for acute inhalation toxicity greater than 10,000 ppm. Dusts and mists with an
Solids containing greater than 0.5% by weight of a flammable or combustible
LC50 for acute inhalation toxicity greater than 200 mg/L. Materials with an LD50 for
solvent are rated by the closed cup flash point of the solvent. 3 Liquids and solids
acute dermal toxicity greater than 2000 mg/kg. Materials with an LD50 for acute
that can be ignited under almost all ambient temperature conditions. Materials in
oral toxicity greater than 2000 mg/kg. Materials essentially non-irritating to the
this degree produce hazardous atmospheres with air under almost all ambient
respiratory tract, eyes, and skin. 1 Materials that, under emergency conditions,
temperatures or, though unaffected by ambient temperatures, are readily ignited
can cause significant irritation. Gases and vapors with an LC50 for acute inhalation
under almost all conditions. Liquids having a flash point below 22.8癈 (73癋) and
toxicity greater than 5,000 ppm but less than or equal to 10,000 ppm. Dusts and
having a boiling point at or above 37.8癈 (100癋) and those liquids having a flash
mists with an LC50 for acute inhalation toxicity greater than 10 mg/L but less than
point at or above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. Class IB and IC
or equal to 200 mg/L. Materials with an LD50 for acute dermal toxicity greater than
liquids). Materials that on account of their physical form or environmental
1000 mg/kg but less than or equal to 2000 mg/kg. Materials that slightly to
conditions can form explosive mixtures with air and are readily dispersed in air.
moderately irritate the respiratory tract, eyes and skin. Materials with an LD50 for
Flammable or combustible dusts with representative diameter less than 420
acute oral toxicity greater than 500 mg/kg but less than or equal to 2000 mg/kg. 2
microns (40 mesh). Materials that burn with extreme rapidity, usually by reason of
Materials that, under emergency conditions, can cause temporary incapacitation
self-contained oxygen (e.g. dry nitrocellulose and many organic peroxides). Solids
or residual injury. Gases with an LC50 for acute inhalation toxicity greater than
containing greater than 0.5% by weight of a flammable or combustible solvent are
3,000 ppm but less than or equal to 5,000 ppm. Any liquid whose saturated vapor
rated by the closed cup flash point of the solvent. 4 Materials that will rapidly or
concentration at 20癈 (68癋) is equal to or greater than one-fifth its LC50 for acute
completely vaporize at atmospheric pressure and normal ambient temperature or
inhalation toxicity, if its LC50 is less than or equal to 5000 ppm and that does not
that are readily dispersed in air and will burn readily. Flammable gases.
meet the criteria for either degree of hazard 3 or degree of hazard 4. Dusts and
Flammable cryogenic materials. Any liquid or gaseous materials that is liquid while
mists with an LC50 for acute inhalation toxicity greater than 2 mg/L but less than or
under pressure and has a flash point below 22.8癈 (73癋) and a boiling point
equal to 10 mg/L. Materials with an LD50 for acute dermal toxicity greater than 200
below 37.8癈 (100癋) (i.e. Class IA liquids). Materials that ignite when exposed to
mg/kg but less than or equal to 1000 mg/kg. Compressed liquefied gases with
air, Solids containing greater than 0.5% by weight of a flammable or combustible
boiling points between -30癈 (-22癋) and -55癈 (-66.5癋) that cause severe tissue
solvent are rated by the closed cup flash point of the solvent.
damage, depending on duration of exposure. Materials that are respiratory
INSTABILITY HAZARD: 0 Materials that in themselves are normally stable, even
irritants. Materials that cause severe, but reversible irritation to the eyes or are
under fire conditions. Materials that have an instantaneous power density (product
lachrymators. Materials that are primary skin irritants or sensitizers. Materials
of heat of reaction and reaction rate) at 250癈 (482癋) below 0.01 W/mL.
whose LD50 for acute oral toxicity is greater than 50 mg/kg but less than or equal
Materials that do not exhibit an exotherm at temperatures less than or equal to
to 500 mg/kg. 3 Materials that, under emergency conditions, can cause serious or
500癈 (932癋) when tested by differential scanning calorimetry. 1 Materials that in
permanent injury. Gases with an LC50 for acute inhalation toxicity greater than
themselves are normally stable, but that can become unstable at elevated
1,000 ppm but less than or equal to 3,000 ppm. Any liquid whose saturated vapor
temperatures and pressures. Materials that have an instantaneous power density
concentration at 20癈 (68癋) is equal to or greater its LC50 for acute inhalation
(product of heat of reaction and reaction rate) at 250癈 (482癋) at or above 0.01
toxicity, if its LC50 is less than or equal to 3000 ppm and that does not meet the
W/mL and below 10 W/mL. 2 Materials that readily undergo violent chemical
criteria for degree of hazard 4. Dusts and mists with an LC50 for acute inhalation
change at elevated temperatures and pressures. Materials that have an
toxicity greater than 0.5 mg/L but less than or equal to 2 mg/L. Materials with an
instantaneous power density (product of heat of reaction and reaction rate) at
LD50 for acute dermal toxicity greater than 40 mg/kg but less than or equal to 200
250癈 (482癋) at or above 10 W/mL and below 100W/mL. 3 Materials that in
mg/kg. Materials that are corrosive to the respiratory tract. Materials that are
themselves are capable of detonation or explosive decomposition or explosive
corrosive to the eyes or cause irreversible corneal opacity. Materials corrosive to
reaction, but that require a strong initiating source or that must be heated under
the skin. Cryogenic gases that cause frostbite and irreversible tissue damage.
confinement before initiation. Materials that have an estimated instantaneous
Compressed liquefied gases with boiling points below -55癈 (-66.5癋) that cause
power density (product of heat of reaction and reaction rate) at 250癈 (482癋) at
frostbite and irreversible tissue damage. Materials with an LD50 for acute oral
or above 100 W/mL and below 1000 W/mL. Materials that are sensitive to thermal
toxicity greater than 5 mg/kg but less than or equal to 50 mg/kg. 4 Materials that,
or mechanical shock at elevated temperatures and pressures. 4 Materials that in
under emergency conditions, can be lethal. Gases with an LC50 for acute
themselves are readily capable of detonation or explosive decomposition or
inhalation toxicity less than or equal to 1,000 ppm. Any liquid whose saturated
explosive reaction at normal temperatures and pressures. Materials that are
vapor concentration at 20癈 (68癋) is equal to or greater than ten times its LC50 for
sensitive to localized thermal or mechanical shock at normal temperatures and
acute inhalation toxicity, if its LC50 is less than or equal to 1000 ppm. Dusts and
pressures. Materials that have an estimated instantaneous power density (product
mists whose LC50 for acute inhalation toxicity is less than or equal to 0.5 mg/L.
of heat of reaction and reaction rate) at 250癈 (482癋) of 1000 W/mL or greater.
Materials whose LD50 for acute dermal toxicity is less than or equal to 40 mg/kg.
Materials whose LD50 for acute oral toxicity is less than or equal to 5 mg/kg.
FLAMMABILITY HAZARD: 0 Materials that will not burn under typical fire
conditions, including intrinsically noncombustible materials such as concrete,
stone, and sand. Materials that will not burn in air when exposed to a temperature
of 816癈 (1500癋) for a period of 5 minutes in according with Annex D of NFPA
704.
HYDROCORTISONE LOTION 1.0% AND 2.5% MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 10 OF 11
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
FLAMMABILITY LIMITS IN AIR:
Much of the information related to fire and explosion is derived from the National Fire Protection Association (NFPA). Flash Point: Minimum temperature at which a liquid
gives off sufficient vapor to form an ignitable mixture with air near the surface of the liquid or within the test vessel used. Autoignition Temperature: Minimum temperature
of a solid, liquid, or gas required to initiate or cause self-sustained combustion in air with no other source of ignition. LEL: Lowest concentration of a flammable vapor or
gas/air mixture that will ignite and burn with a flame. UEL: Highest concentration of a flammable vapor or gas/air mixture that will ignite and burn with a flame.
TOXICOLOGICAL INFORMATION:
Human and Animal Toxicology: Possible health hazards as derived from human data, animal studies, or from the results of studies with similar compounds are
presented. LD50: Lethal Dose (solids & liquids) that kills 50% of the exposed animals. LC50: Lethal Concentration (gases) that kills 50% of the exposed animals. ppm:
Concentration expressed in parts of material per million parts of air or water. mg/m3: Concentration expressed in weight of substance per volume of air. mg/kg: Quantity of
material, by weight, administered to a test subject, based on their body weight in kg. TDLo: Lowest dose to cause a symptom. TCLo: Lowest concentration to cause a
symptom. TDo, LDLo, and LDo, or TC, TCo, LCLo, and LCo: Lowest dose (or concentration) to cause lethal or toxic effects. Cancer Information: IARC: International
Agency for Research on Cancer. NTP: National Toxicology Program. RTECS: Registry of Toxic Effects of Chemical Substances. IARC and NTP rate chemicals on a
scale of decreasing potential to cause human cancer with rankings from 1 to 4. Subrankings (2A, 2B, etc.) are also used. Other Information: BEI: ACGIH Biological
Exposure Indices, represent the levels of determinants which are most likely to be observed in specimens collected from a healthy worker who has been exposed to
chemicals to the same extent as a worker with inhalation exposure to the TLV.
ECOLOGICAL INFORMATION:
EC: Effect concentration in water. BCF: Bioconcentration Factor, which is used to determine if a substance will concentrate in life forms that consume contaminated plant
or animal matter. TLm: Median threshold limit. log KOW or log KOC: Coefficient of Oil/Water Distribution is used to assess a substance's behavior in the environment.
REGULATORY INFORMATION:
U.S.:
EPA: U.S. Environmental Protection Agency. ACGIH: American Conference of Governmental Industrial Hygienists, a professional association that establishes 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.
DOT: U.S. Department of Transportation. TC: Transport Canada. SARA: Superfund Amendments and Reauthorization Act. 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.
CANADA:
WHMIS: Canadian Workplace Hazardous Materials Information System. TC: Transport Canada. DSL/NDSL: Canadian Domestic/Non-Domestic Substances List.
HYDROCORTISONE LOTION 1.0% AND 2.5% MSDS EFFECTIVE DATE: MAY 04, 2009
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