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: Nystatin Oral Suspension
Nystatin Oral Suspension
DESCRIPTION:
0168-0037-60
NDC #:
Nystatin
CHEMICAL NAME (for active ingredient):
Antifungal Antibiotic
CHEMICAL FAMILY (for active ingredient):
Liquid
HOW SUPPLIED:
C47H75NO17
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-hr)
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 an opaque, light yellow liquid suspension with a
mint 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, Nystatin, or any of the other components may experience allergic reactions to this product. Nystatin may
cause adverse reproductive effects, based on experimental 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 and nitrogen 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
Nystatin 1400-61-9 100,000 Units
Methylparaben 99-76-3 Proprietary
Alcohol 64-17-5 Proprietary
Glycerin 56-81-5 Proprietary
Sucrose 57-50-1 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).
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.
NYSTATIN ORAL SUSPENSION MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 1 OF 10
Nycomed US Inc.
4 FIRST-AID MEASURES (Continued)
EYE EXPOSURE: If this product contaminates the eyes, rinse eyes under gently running water. Use sufficient force to
open eyelids and then "roll" eyes while flushing. Minimum flushing is for 15 minutes. The contaminated individual must
seek medical attention if any adverse effect continues after rinsing.
INHALATION: If vapors of this product are inhaled, causing irritation, remove victim to fresh air. If necessary, use
artificial respiration to support vital functions. Seek medical attention if adverse effect continues after removal to fresh
air.
INGESTION: If amounts of this product exceeding the prescribed dose are 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.
Water Spray: OK Carbon Dioxide: OK Foam: OK
1 0
HEALTH INSTAB ILITY
Dry Chemical: OK Halon: OK Other: Any "ABC" Class
FIRE EXTINGUISHING MATERIALS NOT TO BE USED: None known.
UNUSUAL FIRE AND EXPLOSION HAZARDS: This product contains a
potential skin and respiratory sensitizer and so presents a contact
hazard to firefighters. If heated to high temperatures for a prolonged OTHER
period, the water in this product can evaporate off and the residue may Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
ignite. When involved in a fire, this material may decompose and 3 = Serious 4 = Severe
produce irritating vapors and toxic compounds (including carbon oxides
and nitrogen 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.
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).
NYSTATIN ORAL SUSPENSION MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 2 OF 10
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. 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:
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
Nystatin 1400-61-9 NE NE NE NE NE NE NE NE
Methylparaben 99-76-3 NE NE NE NE NE NE NE NE
Alcohol 64-17-5 1880 NE 1900 NE 1900 NE 3300 DFG MAK:
(based on TWA = 960
LEL) P
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Pregnancy Risk Group: C
Carcinogen: MAK-5, TLV-A4
NYSTATIN ORAL SUSPENSION MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 3 OF 10
Nycomed US Inc.
Glycerin 56-81-5 10 NE 15 (Total dust) 5 NE NE NE NE DFG MAKs:
(mist) (Resp. fraction) TWA = 50 (Inhalable fraction)
PEAK = 2稭AK 15 min, average
10 (Total) 5
value, 1-hr interval
(Resp. fraction)
DFG MAK Pregnancy Risk
[vacated 1989
Classification: C
PEL]
Sucrose 57-50-1 10 NE 15 (Total dust) 5 NE 10 (Total NE NE NE
(Resp. fraction) dust) 5
(Resp.
fraction)
NE = Not Established. See Section 16 for Definitions of Terms Used.
The following information on appropriate Personal Protective Equipment is provided to assist employers in complying with OSHA
regulations found in 29 CFR Subpart I (beginning at 1910.132) or equivalent standards of Canada (including CSA Standard Z94.4-
02 and CSA Standard Z94.3-07). Please reference applicable regulations and standards for relevant details.
RESPIRATORY PROTECTION: A respirator is not required for routine conditions of use of this product. If respiratory
protection is needed, use only respiratory protection authorized in the U.S. Federal OSHA Respiratory Protection
Standard (29 CFR 1910.134), equivalent U.S. State standards, or Canadian CSA Standard Z94.4-02. Oxygen levels
below 19.5% are considered IDLH by OSHA. In such atmospheres, use of a full-facepiece pressure/demand SCBA or
a full facepiece, supplied air respirator with auxiliary self-contained air supply is required under OSHA's Respiratory
Protection Standard (1910.134-1998).
EYE PROTECTION: Not normally needed during normal use. If necessary, refer to U.S. OSHA 29 CFR 1910.133 or
Canadian CSA Standard Z94.3-07.
NYSTATIN ORAL SUSPENSION MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 4 OF 10
Nycomed US Inc.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION (Continued)
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 100癈 (212癋). FREEZING/MELTING POINT: Not established.
EVAPORATION RATE (nBuAc = 1): 0.03 SOLUBILITY IN WATER: Soluble.
VAPOR PRESSURE (air = 1): Not established. SPECIFIC GRAVITY @ 25癈 (water = 1): 1.23
ODOR THRESHOLD: Not established. pH: 6.0?.5
COEFFICIENT WATER/OIL DISTRIBUTION: Not established.
APPEARANCE AND COLOR: This product is an opaque, light yellow liquid suspension with a mint odor.
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 and nitrogen oxides).
MATERIALS WITH WHICH SUBSTANCE IS INCOMPATIBLE: This product is generally compatible with other
common materials in a medical facility. Acids, caustics, and other chemicals that could affect its performance should
be avoided.
HAZARDOUS POLYMERIZATION: Will not occur.
CONDITIONS TO AVOID: Avoid heat, light, and contact with incompatible chemicals.
PART IV Is there any other useful information about this material?
11. TOXICOLOGICAL INFORMATION
SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: The
HAZARDOUS MATERIAL IDENTIFICATION SYSTEM
health hazard information provided below is pertinent to medical
employees handling this product in an occupational setting. This
product is designed for ingestion. The following paragraphs describe the
(BLUE) 1
HEALTH HAZARD
symptoms of exposure by route of exposure.
INHALATION: Although unlikely due to form of product, inhalation of
vapors may slightly irritate the nose, throat, and lungs. Symptoms
are generally alleviated upon breathing fresh air. Due to the presence
(RED) 0
FLAMMABILITY HAZARD
of Methylparaben, this product may cause respiratory sensitization in
susceptible individuals; subsequent exposure to very small amounts
may cause an asthma-like reaction in persons who have been
sensitized.
PHYSICAL HAZARD (YELLOW) 0
CONTACT WITH SKIN or EYES: Skin contact may cause mild
irritation in sensitive individuals. Due the presence of Methylparaben,
skin contact may cause an allergic reaction in sensitive individuals;
PROTECTIVE EQUIPMENT
subsequent exposure to very small amounts may cause an allergic
reaction once sensitized, with symptoms of redness, itching, welts and
irritation. Eye contact may cause irritation and tearing. EYES HANDS BODY
R IRATORY
ESP
SKIN ABSORPTION: The Ethanol component of this product can be
absorbed through intact skin. Due to the low concentration of Ethanol
SS
EE ECTION 8 SS
EE ECTION 8
in this product, adverse effects form skin absorption are not expected.
INGESTION: Ingestion is not a significant route of occupational
For Routine Industrial Use and Handling Applications
overexposure. Acute ingestion of large quantities of this product or
chronic ingestion caused by poor hygiene practices may cause Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
3 = Serious 4 = Severe * = Chronic hazard
adverse symptoms. Symptoms of ingestion overexposure may include
nausea, vomiting, and diarrhea.
NYSTATIN ORAL SUSPENSION MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 5 OF 10
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
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. Symptoms may include those
described for "General Toxicity Information".
GENERAL TOXICITY INFORMATION: Individuals who have had allergic reactions to products containing the Nystatin
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 mild irritation.
IRRITANCY OF PRODUCT: This product may mildly to moderately irritate contaminated tissue.
SENSITIZATION OF PRODUCT: Due to the presence of Methylparaben, susceptible persons may experience skin and
respiratory allergic reaction.
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: None currently known.
TARGET ORGANS:
Acute: Occupational Exposure: Skin, eyes. Therapeutic Doses: Skin.
Chronic: Occupational Exposure: Skin. Therapeutic Doses: Skin.
TOXICITY DATA: The toxicity data available for the active component of this product, Nystatin, 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.
NYSTATIN: NYSTATIN (continued): NYSTATIN (continued):
LD50 (Oral-Rat) 10 gm/kg TDLo (Intravenous-Rat) 82.5 mg/kg/55 days- TDLo (Intravenous-Rat) 39 mg/kg: female 6-18
LD50 (Oral-Mouse) 8 gm/kg intermittent: Behavioral: food intake (animal); day(s) after conception: Reproductive: Maternal
LD50 (Intraperitoneal-Rat) 24,305 礸/kg Nutritional and Gross Metabolic :weight loss or Effects: other effects
LD50 (Intraperitoneal-Mouse) 4400 礸/kg decreased weight gain TDLo (Intravenous-Rat) 18.5 mg/kg: female 6-22
LD50 (Subcutaneous-Mouse) 120 mg/kg TDLo (Intravenous-Rat) 61.5 mg/kg/41 days- day(s) after conception lactating female 20 day(s)
LD50 (Intravenous-Mouse) 3 mg/kg intermittent: Nutritional and Gross Metabolic: post-birth: Reproductive: Specific Developmental
TCLo (Inhalation-Rat) 5 mg/m3/4 hours/17 weeks- weight loss or decreased weight gain Abnormalities: eye/ear, other developmental
intermittent: Immunological Including Allergic: TDLo (Intravenous-Rat) 90 mg/kg/41 days- abnormalities; Effects on Newborn: growth
hypersensitivity delayed intermittent: Behavioral: food intake (animal) statistics (e.g.%, reduced weight gain)
TCLo (Inhalation-Rat) 40 H mg/m3/24 hours/10 TDLo (Intravenous-Rat) 55.5 mg/kg/37 days- TDLo (Intravenous-Rat) 55.5 mg/kg: female 6-22
days-continuous: Immunological Including intermittent: Behavioral: food intake (animal); day(s) after conception lactating female 20 day(s)
Allergic: decrease in humoral immune response; Nutritional and Gross Metabolic: weight loss or post-birth: Reproductive: Specific Developmental
Biochemical: Metabolism (Intermediary): Plasma decreased weight gain Abnormalities: urogenital system
proteins not involving coagulation TDLo (Intravenous-Rat) 87 mg/kg/37 days- TDLo (Intravenous-Rat) 30 mg/kg: female 6-15
TCLo (Inhalation-Guinea Pig) 5 mg/m3/4 hours/17 intermittent: Related to Chronic Data: death day(s) after conception: Reproductive: Effects on
weeks-intermittent: Immunological Including TDLo (Intravenous-Rat) 30 mg/kg/10 days- Embryo or Fetus: fetotoxicity (except death, e.g.,
Allergic: hypersensitivity delayed intermittent: Behavioral: food intake (animal) stunted fetus)
TDLo (Oral-Rat) 100 mg/kg: female 9 day(s) after TDLo (Intravenous-Rat) 18,500 礸/kg: female 6-22 TDLo (Intravenous-Dog) 180 mg/kg/90 days-
conception: Reproductive: Effects on Embryo or day(s) after conception lactating female 20 day(s) intermittent: Kidney/Ureter/Bladder: changes in
Fetus: fetal death post-birth: Reproductive: Maternal Effects: other tubules (including acute renal failure, acute
TDLo (Oral-Rat) 11 gm/kg: female 1-22 day(s) after effects; Effects on Newborn: growth statistics tubular necrosis); Blood: changes in serum
conception: Reproductive: Fertility: abortion (e.g.%, reduced weight gain), physical composition (e.g. TP, bilirubin, cholesterol)
TDLo (Intravenous-Rat) 42 mg/kg/4 weeks- TDLo (Intravenous-Rat) 30 mg/kg: female 6-15 TDLo (Intravenous-Rabbit) 39 mg/kg/13 days-
intermittent: Behavioral: food intake (animal); Skin day(s) after conception: Reproductive: Maternal intermittent: Behavioral: food intake (animal);
and Appendages: hair; Nutritional and Gross Effects: other effects Liver: changes in liver weight
Metabolic: weight loss or decreased weight gain Cytogenetic Analysis (Parenteral-Mouse) 50 mg/kg
CARCINOGENIC POTENTIAL OF COMPONENTS: 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:
ALCOHOL: MAK-5 (Substances with carcinogenic and genotoxic effects, the potency of which is considered to be so low that, provided the MAK and BAT values are
observed, no significant contribution to human cancer risk is to be expected); TLV-A4 (Not Classifiable as a Human Carcinogen)
SUCROSE: ACGIH TLV-A4 (Not Classifiable as Human Carcinogen);
The remaining components of this product are not found on the following lists: U.S. EPA, U.S. NTP, U.S. OSHA, U.S.
NIOSH, GERMAN MAK, IARC, or ACGIH and therefore are neither considered to be nor suspected to be cancer-
causing agents by these agencies.
REPRODUCTIVE TOXICITY INFORMATION: The active component of this product, Nystatin, is rated as Pregnancy
Category C (RISK CANNOT BE RULED OUT; Human evidence is lacking, but animal evidence is positive). Listed
below is information concerning the effects of this compound on animal or human reproductive systems.
Mutagenicity: Studies have not been performed to evaluate the mutagenic effects of this product.
Embryotoxicity: Studies have not been performed to evaluate the embryotoxic effects of this product.
Teratogenicity: Nystatin may cause adverse reproductive effects, based on experimental data.
Reproductive Toxicity: Studies have not been performed to evaluate the reproductive toxicity of this product.
NYSTATIN ORAL SUSPENSION MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 6 OF 10
Nycomed US Inc.
11. TOXICOLOGICAL INFORMATION (Continued)
REPRODUCTIVE TOXICITY INFORMATION (continued):
A mutagen is a chemical that causes permanent changes to genetic material (DNA) such that the changes will propagate through generation lines. An
embryo toxin is a chemical that causes damage to a developing embryo (i.e. within the first eight weeks of pregnancy in humans), but the damage
does not propagate across generational lines. A teratogen is a chemical that causes damage to a developing fetus, but the damage does not
propagate across generational lines. A reproductive toxin is any substance that interferes in any way with the reproductive process.
ACGIH BIOLOGICAL EXPOSURE INDICES (BEIs): Currently, 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:
GLYCERIN:
Persistence and Biodegradability: If released to soil, glycerin is expected to undergo rapid biodegradation under aerobic conditions. It is expected to display very high
mobility in soil and it is not expected to significantly volatilize to the atmosphere. If released to water, glycerin is expected to rapidly degrade under aerobic
conditions. Biodegradation in seawater and under anaerobic conditions is also expected. Glycerin is not expected to bioconcentrate is fish and aquatic organisms nor
is it expected to adsorb to sediment and suspended organic matter. Volatilization to the atmosphere is expected to be slower then for water itself. If released to the
atmosphere, Glycerin may undergo a gas-phase oxidation with photochemically produced hydroxyl radicals with a half-life of 33 hrs. It may also undergo
atmospheric removal by wet deposition processes.
Bioconcentration: Based on an experimental log octanol/water partition coefficient of -1.76 and its water solubility, 1,220,000 mg/L at 5癈, bioconcentration factors for
Glycerin can be estimated at 3 and 0.2, respectively, using regression-derived equations. The magnitude of these values indicate that bioconcentration of Glycerin in
fish and aquatic organisms will not be significant. Log KOW = -1.76.
Soil Adsorption/Mobility: Based on an experimental log octanol/water partition coefficient of -1.76 and its water solubility, 1,220,000 mg/L at 5癈, soil adsorption
coefficients for Glycerin can be estimated at 3 and 2, respectively, using regression-derived equations. The magnitude of these values indicate that glycerin will
display very high mobility in soil.
NYSTATIN:
Bioconcentration: An estimated BCF of 22 was calculated for Nystatin, using a water solubility of 3.60X10+2 mg/L and a regression-derived equation. According to a
classification scheme, this BCF suggests the potential for bioconcentration in aquatic organisms is low provided the compound is not metabolized by the organism.
Soil Adsorption/Mobility: The Koc of Nystatin is estimated as 170, using a water solubility of 3.60X10+2 mg/L at 25癈and a regression-derived equation. According to a
classification scheme, this estimated Koc value suggests that Nystatin is expected to have moderate mobility in soil.
Persistence and Biodegradability: If released to air, an estimated vapor pressure of 8.7X10-7 mm Hg at 25癈 indicates Nystatin will exist in both the vapor and
particulate phases in the atmosphere. Vapor-phase Nystatin 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 1.5 hours. Reaction with ozone is also expected to occur; the half-life for this reaction is estimated to be 2.6 hours.
Particulate-phase Nystatin will be removed from the atmosphere by wet or dry deposition. Nystatin may be susceptible to direct photolysis by sunlight. If released to
soil, Nystatin is expected to have moderate mobility based upon an estimated Koc of 170. Volatilization from moist soil surfaces is not expected to be an important
fate process based upon an estimated Henry's Law constant of 2.0X10-7 atm-cu m/mole. Nystatin is not expected to volatilize from dry soil surfaces based upon its
vapor pressure. A 4% degradation in 28 days using the Closed Bottle test indicates that biodegradation is not an important environmental fate process. If released
into water, Nystatin is expected to adsorb slightly to suspended solids and sediment based upon the estimated Koc. Volatilization from water surfaces is not
expected to be an important fate process based upon this compound's estimated Henry's Law constant. Hydrolysis is not expected to be an important environmental
fate process since this compound lacks functional groups that hydrolyze under environmental conditions..
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.
GLYCERIN: GLYCERIN (continued):
EC0 (Pseudomonas putida bacteria) 16 hours = >10,000 mg/L EC0 (Entosiphon sulcatum protozoa) 72 hours = 3,200 mg/L
EC0 (Microcystis aeruginosa algae) 8 days = 2,900 mg/L EC0 (Uronema parduczi Chatton-Lwoff protozoa) = > 10,000 mg/L
EC0 (Scenedesmus quadricauda green algae) 7 days = > 10,000 mg/L LC50 (goldfish) 24 hours = > 5,000 mg/
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.
NYSTATIN ORAL SUSPENSION MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 7 OF 10
Nycomed US Inc.
13. DISPOSAL CONSIDERATIONS (Continued)
PREPARING WASTES FOR DISPOSAL: Waste disposal must be in accordance with appropriate U.S. Federal, State,
and local regulations or with regulations of Canada. This product, if unaltered by handling, may be disposed of by
treatment at a permitted facility or as advised by your local hazardous waste regulatory authority. All gowns, gloves,
and disposable materials used in the preparation or handling of this drug should be disposed of in accordance with
established hazardous waste disposal procedures. Handle as if capable of transmitting infectious agents.
Incineration is recommended. Reusable equipment should be cleaned with soap and water.
U.S. EPA WASTE NUMBER: Not applicable to wastes consisting only of this product.
14. TRANSPORTATION INFORMATION
U.S. DEPARTMENT OF TRANSPORTATION SHIPPING REGULATIONS: This product is not classified as hazardous
under regulations of U.S. DOT 49 CFR 172.101.
TRANSPORT CANADA TRANSPORTATION OF DANGEROUS GOODS REGULATIONS: This product is not
classified as Dangerous Goods, per regulations of Transport Canada.
15. REGULATORY INFORMATION
UNITED STATES REGULATIONS:
U.S. SARA REPORTING REQUIREMENTS: 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): In the form of
alcoholic beverages to be consumed, the Ethanol component of this product is on the California Proposition 65 lists as
a compound that is known to cause developmental harm. This does not apply to Ethanol that is not consumed as a
beverage.
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:
NYSTATIN ORAL SUSPENSION MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 8 OF 10
Nycomed US Inc.
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 Rat: > 2?0 mg/L.
each constituent. HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
EXPOSURE LIMITS IN AIR: RATINGS (continued):
CEILING LEVEL: The concentration that shall not be exceeded during any part of HEALTH HAZARD (continued): 2 Moderate Hazard: Temporary or transitory injury
the working exposure. may occur; prolonged exposure may affect the CNS. Skin Irritation: Moderately
DFG MAK Germ Cell Mutagen Categories: 1: Germ cell mutagens that have irritating; primary irritant; sensitizer. PII or Draize 5, with no destruction of dermal
been shown to increase the mutant frequency in the progeny of exposed humans. tissue. Eye Irritation: Moderately to severely irritating; reversible corneal opacity;
2: Germ cell mutagens that have been shown to increase the mutant frequency in corneal involvement or irritation clearing in 8?1 days. Draize = 26?00, with
the progeny of exposed mammals. 3A: Substances that have been shown to reversible effects. Oral Toxicity LD50 Rat: > 50?00 mg/kg. Dermal Toxicity LD50
induce genetic damage in germ cells of human of animals, or which produce Rat or Rabbit: > 200?000 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 0.5?
mutagenic effects in somatic cells of mammals in vivo and have been shown to mg/L. 3 Serious Hazard: Major injury likely unless prompt action is taken and
reach the germ cells in an active form. 3B: Substances that are suspected of medical treatment is given; high level of toxicity; corrosive. Skin Irritation: Severely
being germ cell mutagens because of their genotoxic effects in mammalian irritating and/or corrosive; may cause destruction of dermal tissue, skin burns, and
somatic cell in vivo; in exceptional cases, substances for which there are no in dermal necrosis. PII or Draize > 5?, with destruction of tissue. Eye Irritation:
vivo data, but that are clearly mutagenic in vitro and structurally related to known Corrosive, irreversible destruction of ocular tissue; corneal involvement or irritation
in vivo mutagens. 4: Not applicable (Category 4 carcinogenic substances are persisting for more than 21 days. Draize > 80 with effects irreversible in 21 days.
those with non-genotoxic mechanisms of action. By definition, germ cell mutagens Oral Toxicity LD50 Rat: > 1?0 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 20?br>
are genotoxic. Therefore, a Category 4 for germ cell mutagens cannot apply. At 200 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 0.05?.5 mg/L. 4 Severe Hazard:
some time in the future, it is conceivable that a Category 4 could be established Life-threatening; major or permanent damage may result from single or repeated
for genotoxic substances with primary targets other than DNA [e.g. purely exposures; extremely toxic; irreversible injury may result from brief contact. Skin
aneugenic substances] if research results make this seem sensible.) 5: Germ cell Irritation: Not appropriate. Do not rate as a 4, based on skin irritation alone. Eye
mutagens, the potency of which is considered to be so low that, provided the MAK Irritation: Not appropriate. Do not rate as a 4, based on eye irritation alone. Oral
value is observed, their contribution to genetic risk for humans is expected not to Toxicity LD50 Rat: 1 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: 20 mg/kg.
be significant. Inhalation Toxicity LC50 4-hrs Rat: 0.05 mg/L.
DFG MAK Pregnancy Risk Group Classification: Group A: A risk of damage to FLAMMABILITY HAZARD: 0 Minimal Hazard: Materials that will not burn in air
the developing embryo or fetus has been unequivocally demonstrated. Exposure when exposure to a temperature of 815.5癈 (1500癋) for a period of 5 minutes. 1
of pregnant women can lead to damage of the developing organism, even when Slight Hazard: Materials that must be pre-heated before ignition can occur.
MAK and BAT (Biological Tolerance Value for Working Materials) values are Material requires considerable pre-heating, under all ambient temperature
observed. Group B: Currently available information indicates a risk of damage to conditions before ignition and combustion can occur. This usually includes the
the developing embryo or fetus must be considered to be probable. Damage to following: Materials that will burn in air when exposed to a temperature of 815.5癈
the developing organism cannot be excluded when pregnant women are exposed, (1500癋) for a period of 5 minutes or less; Liquids, solids and semisolids having a
even when MAK and BAT values are observed. Group C: There is no reason to flash point at or above 93.3癈 (200癋) (i.e. OSHA Class IIIB); and Most ordinary
fear a risk of damage to the developing embryo or fetus when MAK and BAT combustible materials (e.g. wood, paper, etc.). 2 Moderate Hazard: Materials that
values are observed. Group D: Classification in one of the groups A瑿 is not yet must be moderately heated or exposed to relatively high ambient temperatures
possible because, although the data available may indicate a trend, they are not before ignition can occur. Materials in this degree would not, under normal
sufficient for final evaluation. conditions, form hazardous atmospheres in air, but under high ambient
IDLH: Immediately Dangerous to Life and Health. This level represents a temperatures or moderate heating may release vapor in sufficient quantities to
concentration from which one can escape within 30-minutes without suffering produce hazardous atmospheres with air. This usually includes the following:
escape-preventing or permanent injury. Liquids having a flash-point at or above 37.8癈 (100癋); Solid materials in the form
LOQ: Limit of Quantitation. of course dusts that may burn rapidly but that generally do not form explosive
MAK: Federal Republic of Germany Maximum Concentration Values in the atmospheres; Solid materials in a fibrous or shredded form that may burn rapidly
workplace. and create flash fire hazards (e.g. cotton, sisal, hemp); and Solids and semisolids
NE: Not Established. When no exposure guidelines are established, an entry of (e.g. viscous and slow flowing as asphalt) that readily give off flammable vapors. 3
NE is made for reference. Serious Hazard: Liquids and solids that can be ignited under almost all ambient
NIC: Notice of Intended Change. temperature conditions. Materials in this degree produce hazardous atmospheres
NIOSH CEILING: The exposure that shall not be exceeded during any part of the with air under almost all ambient temperatures, or, unaffected by ambient
workday. If instantaneous monitoring is not feasible, the ceiling shall be assumed temperature, are readily ignited under almost all conditions. This usually includes
as a 15-minute TWA exposure (unless otherwise specified) that shall not be the following: Liquids having a flash point below 22.8癈 (73癋) and having a
exceeded at any time during a workday. boiling point at or above 38癈 (100癋) and those liquids having a flash point at or
NIOSH RELs: NIOSH's Recommended Exposure Limits. above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. OSHA Class IB and IC);
PEL: OSHA's Permissible Exposure Limits. This exposure value means exactly Materials that on account of their physical form or environmental conditions can
the same as a TLV, except that it is enforceable by OSHA. The OSHA form explosive mixtures with air and are readily dispersed in air (e.g., dusts of
Permissible Exposure Limits are based in the 1989 PELs and the June, 1993 Air combustible solids, mists or droplets of flammable liquids); and Materials that burn
Contaminants Rule (Federal Register: 58: 35338-35351 and 58: 40191). Both the extremely rapidly, usually by reason of self-contained oxygen (e.g. dry
current PELs and the vacated PELs are indicated. The phrase, "Vacated 1989 nitrocellulose and many organic peroxides). 4 Severe Hazard: Materials that will
PEL" is placed next to the PEL that was vacated by Court Order. rapidly or completely vaporize at atmospheric pressure and normal ambient
SKIN: Used when a there is a danger of cutaneous absorption. temperature or that are readily dispersed in air, and that will burn readily. This
STEL: Short Term Exposure Limit, usually a 15-minute time-weighted average usually includes the following: Flammable gases; Flammable cryogenic materials;
(TWA) exposure that should not be exceeded at any time during a workday, even Any liquid or gaseous material that is liquid while under pressure and has a flash
if the 8-hr TWA is within the TLV-TWA, PEL-TWA or REL-TWA. point below 22.8癈 (73癋) and a boiling point below 37.8癈 (100癋) (i.e. OSHA
TLV: Threshold Limit Value. An airborne concentration of a substance that Class IA); and Materials that ignite spontaneously when exposed to air at a
represents conditions under which it is generally believed that nearly all workers temperature of 54.4癈 (130癋) or below (pyrophoric).
may be repeatedly exposed without adverse effect. The duration must be PHYSICAL HAZARD: 0 Water Reactivity: Materials that do not react with water.
considered, including the 8-hour. Organic Peroxides: Materials that are normally stable, even under fire conditions
TWA: Time Weighted Average exposure concentration for a conventional 8-hr and will not react with water. Explosives: Substances that are Non-Explosive.
(TLV, PEL) or up to a 10-hr (REL) workday and a 40-hr workweek. Compressed Gases: No Rating. Pyrophorics: No Rating. Oxidizers: No 0 rating.
WEEL: Workplace Environmental Exposure Limits from the AIHA. Unstable Reactives: Substances that will not polymerize, decompose, condense,
or self-react.). 1 Water Reactivity: Materials that change or decompose upon
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
exposure to moisture. Organic Peroxides: Materials that are normally stable, but
RATINGS: This rating system was developed by the National Paint and Coating
can become unstable at high temperatures and pressures. These materials may
Association and has been adopted by industry to identify the degree of chemical
react with water, but will not release energy violently. Explosives: Division 1.5 &
hazards.
1.6 explosives. Substances that are very insensitive explosives or that do not have
HEALTH HAZARD: 0 Minimal Hazard: No significant health risk, irritation of skin or
a mass explosion hazard. Compressed Gases: Pressure below OSHA definition.
eyes not anticipated. Skin Irritation: Essentially non-irritating. Mechanical irritation
Pyrophorics: No Rating. Oxidizers: Packaging Group III oxidizers; Solids: any
may occur. PII or Draize = 0. Eye Irritation: Essentially non-irritating, minimal
material that in either concentration tested, exhibits a mean burning time less than
effects clearing in < 24 hours. Mechanical irritation may occur. Draize = 0. Oral
or equal to the mean burning time of a 3:7 potassium bromate/cellulose mixture
Toxicity LD50 Rat: > 5000 mg/kg. Dermal Toxicity LD50 Rat or Rabbit: > 2000
and the criteria for Packing Group I and II are not met. Liquids: any material that
mg/kg. Inhalation Toxicity 4-hrs LC50 Rat: > 20 mg/L. 1 Slight Hazard: Minor
exhibits a mean pressure rise time less than or equal to the pressure rise time of a
reversible injury may occur; may irritate the stomach if swallowed; may defat the
1:1 nitric acid (65%)/cellulose mixture and the criteria for Packing Group I and II
skin and exacerbate existing dermatitis. Skin Irritation: Slightly or mildly irritating.
are not met. Unstable Reactives: Substances that may decompose condense, or
PII or Draize > 0 < 5. Eye Irritation: Slightly to mildly irritating, but reversible within
self-react, but only under conditions of high temperature and/or pressure and have
7 days. Draize > 0 25. Oral Toxicity LD50 Rat: > 500?000 mg/kg. Dermal
little or no potential to cause significant heat generation or explosion hazard.
Toxicity LD50 Rat or Rabbit: > 1000?000 mg/kg. Inhalation Toxicity LC50 4-hrs
NYSTATIN ORAL SUSPENSION MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 9 OF 10
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS
RATINGS (continued): (continued):
PHYSICAL HAZARD (continued): 1 (continued) Substances that readily undergo HEALTH HAZARD (continued): 3 (continued) Any liquid whose saturated vapor
hazardous polymerization in the absence of inhibitors. Substances that readily concentration at 20癈 (68癋) is equal to or greater its LC50 for acute inhalation
undergo hazardous polymerization in the absence of inhibitors. 2 Water Reactivity: toxicity, if its LC50 is less than or equal to 3000 ppm and that does not meet the
Materials that may react violently with water. Organic Peroxides: Materials that, in criteria for degree of hazard 4. Dusts and mists with an LC50 for acute inhalation
themselves, are normally unstable and will readily undergo violent chemical toxicity greater than 0.5 mg/L but less than or equal to 2 mg/L. Materials with an
change, but will not detonate. These materials may also react violently with water. LD50 for acute dermal toxicity greater than 40 mg/kg but less than or equal to 200
Explosives: Division 1.4 explosives. Explosive substances where the explosive mg/kg. Materials that are corrosive to the respiratory tract. Materials that are
effects are largely confined to the package and no projection of fragments of corrosive to the eyes or cause irreversible corneal opacity. Materials corrosive to
appreciable size or range are expected. An external fire must not cause virtually the skin. Cryogenic gases that cause frostbite and irreversible tissue damage.
instantaneous explosion of almost the entire contents of the package. Compressed liquefied gases with boiling points below -55癈 (-66.5癋) that cause
Compressed Gases: Pressurized and meet OSHA definition but < 514.7 psi frostbite and irreversible tissue damage. Materials with an LD50 for acute oral
absolute at 21.1癈 (70癋) [500 psig]. Pyrophorics: No Rating. Oxidizers: Packing toxicity greater than 5 mg/kg but less than or equal to 50 mg/kg. 4 Materials that,
Group II oxidizers. Solids: any material that, either in concentration tested, exhibits under emergency conditions, can be lethal. Gases with an LC50 for acute
a mean burning time of less than or equal to the mean burning time of a 2:3 inhalation toxicity less than or equal to 1,000 ppm. Any liquid whose saturated
potassium bromate/cellulose mixture and the criteria for Packing Group I are not vapor concentration at 20癈 (68癋) is equal to or greater than ten times its LC50 for
met. Liquids: any material that exhibits a mean pressure rise time less than or acute inhalation toxicity, if its LC50 is less than or equal to 1000 ppm. Dusts and
equal to the pressure rise of a 1:1 aqueous sodium chlorate solution mists whose LC50 for acute inhalation toxicity is less than or equal to 0.5 mg/L.
(40%)/cellulose mixture and the criteria for Packing Group I are not met. Materials whose LD50 for acute dermal toxicity is less than or equal to 40 mg/kg.
Reactives: Substances that may polymerize, decompose, condense, or self-react Materials whose LD50 for acute oral toxicity is less than or equal to 5 mg/kg.
at ambient temperature and/or pressure, but have a low potential (or low risk) for FLAMMABILITY HAZARD: 0 Materials that will not burn under typical fire
significant heat generation or explosion. Substances that readily form peroxides conditions, including intrinsically noncombustible materials such as concrete,
upon exposure to air or oxygen at room temperature. 3 Water Reactivity: Materials stone, and sand. Materials that will not burn in air when exposed to a temperature
that may form explosive reactions with water. Organic Peroxides: Materials that of 816癈 (1500癋) for a period of 5 minutes in according with Annex D of NFPA
are capable of detonation or explosive reaction, but require a strong initiating 704. 1 Materials that must be preheated before ignition can occur. Materials in this
source or must be heated under confinement before initiation; or materials that degree require considerable preheating, under all ambient temperature conditions,
react explosively with water. Explosives: Division 1.3 explosives. Explosive before ignition and combustion can occur: Materials that will burn in air when
substances that have a fire hazard and either a minor blast hazard or a minor exposed to a temperature of 816癈 (1500癋) for a period of 5 minutes in according
projection hazard or both, but do not have a mass explosion hazard. Compressed with Annex D of NFPA 704. Liquids, solids, and semisolids having a flash point at
Gases: Pressure 514.7 psi absolute at 21.1癈 (70癋) [500 psig]. Pyrophorics: No or above 93.4癈 (200癋) (i.e. Class IIIB liquids). Liquids with a flash point greater
Rating. Oxidizers: Packing Group I oxidizers. Solids: any material that, in either than 35癈 (95癋) that do not sustain combustion when tested using the Method of
concentration tested, exhibits a mean burning time less than the mean burning Testing for Sustained Combustibility, per 49 CFR 173, Appendix H or the UN
time of a 3:2 potassium bromate/cellulose mixture. Liquids: any material that Recommendations on the Transport of Dangerous Goods, Model Regulations
spontaneously ignites when mixed with cellulose in a 1:1 ratio, or which exhibits a (current edition) and the related Manual of Tests and Criteria (current edition).
mean pressure rise time less than the pressure rise time of a 1:1 perchloric acid Liquids with a flash point greater than 35癈 (95癋) in a water-miscible solution or
(50%)/cellulose mixture. Unstable Reactives: Substances that may polymerize, dispersion with a water non-combustible liquid/solid content of more than 85% by
decompose, condense, or self-react at ambient temperature and/or pressure and weight. Liquids that have no fire point when tested by ASTM D 92, Standard Test
have a moderate potential (or moderate risk) to cause significant heat generation Method for Flash and Fire Points by Cleveland Open Cup, up to the boiling point
or explosion. 4 Water Reactivity: Materials that react explosively with water of the liquid or up to a temperature at which the sample being tested shows an
without requiring heat or confinement. Organic Peroxides: Materials that are obvious physical change. Combustible pellets with a representative diameter of
readily capable of detonation or explosive decomposition at normal temperature greater than 2 mm (10 mesh). Most ordinary combustible materials. Solids
and pressures. Explosives: Division 1.1 & 1.2 explosives. Explosive substances containing greater than 0.5% by weight of a flammable or combustible solvent are
that have a mass explosion hazard or have a projection hazard. A mass explosion rated by the closed cup flash point of the solvent. 2 Materials that must be
is one that affects almost the entire load instantaneously. Compressed Gases: No moderately heated or exposed to relatively high ambient temperatures before
Rating. Pyrophorics: Add to the definition of Flammability 4. Oxidizers: No 4 rating. ignition can occur. Materials in this degree would not under normal conditions form
Unstable Reactives: Substances that may polymerize, decompose, condense, or hazardous atmospheres with air, but under high ambient temperatures or under
self-react at ambient temperature and/or pressure and have a high potential (or moderate heating could release vapor in sufficient quantities to produce
high risk) to cause significant heat generation or explosion. hazardous atmospheres with air. Liquids having a flash point at or above 37.8癈
(100癋) and below 93.4癈 (200癋) (i.e. Class II and Class IIIA liquids.) Solid
NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS:
materials in the form of powders or coarse dusts of representative diameter
HEALTH HAZARD: 0 Materials that, under emergency conditions, would offer no
between 420 microns (40 mesh) and 2 mm (10 mesh) that burn rapidly but that
hazard beyond that of ordinary combustible materials. Gases and vapors with an
generally do not form explosive mixtures with air. Solid materials in fibrous or
LC50 for acute inhalation toxicity greater than 10,000 ppm. Dusts and mists with an
shredded form that burn rapidly and create flash fire hazards, such as cotton,
LC50 for acute inhalation toxicity greater than 200 mg/L. Materials with an LD50 for
sisal, and hemp. Solids and semisolids that readily give off flammable vapors.
acute dermal toxicity greater than 2000 mg/kg. Materials with an LD50 for acute
Solids containing greater than 0.5% by weight of a flammable or combustible
oral toxicity greater than 2000 mg/kg. Materials essentially non-irritating to the
solvent are rated by the closed cup flash point of the solvent. 3 Liquids and solids
respiratory tract, eyes, and skin. 1 Materials that, under emergency conditions,
that can be ignited under almost all ambient temperature conditions. Materials in
can cause significant irritation. Gases and vapors with an LC50 for acute inhalation
this degree produce hazardous atmospheres with air under almost all ambient
toxicity greater than 5,000 ppm but less than or equal to 10,000 ppm. Dusts and
temperatures or, though unaffected by ambient temperatures, are readily ignited
mists with an LC50 for acute inhalation toxicity greater than 10 mg/L but less than
under almost all conditions. Liquids having a flash point below 22.8癈 (73癋) and
or equal to 200 mg/L. Materials with an LD50 for acute dermal toxicity greater than
having a boiling point at or above 37.8癈 (100癋) and those liquids having a flash
1000 mg/kg but less than or equal to 2000 mg/kg. Materials that slightly to
point at or above 22.8癈 (73癋) and below 37.8癈 (100癋) (i.e. Class IB and IC
moderately irritate the respiratory tract, eyes and skin. Materials with an LD50 for
liquids). Materials that on account of their physical form or environmental
acute oral toxicity greater than 500 mg/kg but less than or equal to 2000 mg/kg. 2
conditions can form explosive mixtures with air and are readily dispersed in air.
Materials that, under emergency conditions, can cause temporary incapacitation
Flammable or combustible dusts with representative diameter less than 420
or residual injury. Gases with an LC50 for acute inhalation toxicity greater than
microns (40 mesh). Materials that burn with extreme rapidity, usually by reason of
3,000 ppm but less than or equal to 5,000 ppm. Any liquid whose saturated vapor
self-contained oxygen (e.g. dry nitrocellulose and many organic peroxides). Solids
concentration at 20癈 (68癋) is equal to or greater than one-fifth its LC50 for acute
containing greater than 0.5% by weight of a flammable or combustible solvent are
inhalation toxicity, if its LC50 is less than or equal to 5000 ppm and that does not
rated by the closed cup flash point of the solvent. 4 Materials that will rapidly or
meet the criteria for either degree of hazard 3 or degree of hazard 4. Dusts and
completely vaporize at atmospheric pressure and normal ambient temperature or
mists with an LC50 for acute inhalation toxicity greater than 2 mg/L but less than or
that are readily dispersed in air and will burn readily. Flammable gases.
equal to 10 mg/L. Materials with an LD50 for acute dermal toxicity greater than 200
Flammable cryogenic materials. Any liquid or gaseous materials that is liquid while
mg/kg but less than or equal to 1000 mg/kg. Compressed liquefied gases with
under pressure and has a flash point below 22.8癈 (73癋) and a boiling point
boiling points between -30癈 (-22癋) and -55癈 (-66.5癋) that cause severe tissue
below 37.8癈 (100癋) (i.e. Class IA liquids). Materials that ignite when exposed to
damage, depending on duration of exposure. Materials that are respiratory
air, Solids containing greater than 0.5% by weight of a flammable or combustible
irritants. Materials that cause severe, but reversible irritation to the eyes or are
solvent are rated by the closed cup flash point of the solvent.
lachrymators. Materials that are primary skin irritants or sensitizers. Materials
whose LD50 for acute oral toxicity is greater than 50 mg/kg but less than or equal
to 500 mg/kg. 3 Materials that, under emergency conditions, can cause serious or
permanent injury. Gases with an LC50 for acute inhalation toxicity greater than
1,000 ppm but less than or equal to 3,000 ppm.
NYSTATIN ORAL SUSPENSION MSDS EFFECTIVE DATE: MAY 04, 2009
PAGE 10 OF 10
Nycomed US Inc.
DEFINITION OF TERMS (Continued)
NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS TOXICOLOGICAL INFORMATION:
Human and Animal Toxicology: Possible health hazards as derived from human
(continued):
data, animal studies, or from the results of studies with similar compounds are
INSTABILITY HAZARD: 0 Materials that in themselves are normally stable, even
presented. LD50: Lethal Dose (solids & liquids) that kills 50% of the exposed
under fire conditions. Materials that have an instantaneous power density (product
animals. LC50: Lethal Concentration (gases) that kills 50% of the exposed animals.
of heat of reaction and reaction rate) at 250癈 (482癋) below 0.01 W/mL.
ppm: Concentration expressed in parts of material per million parts of air or water.
Materials that do not exhibit an exotherm at temperatures less than or equal to
mg/m3: Concentration expressed in weight of substance per volume of air. mg/kg:
500癈 (932癋) when tested by differential scanning calorimetry. 1 Materials that in
Quantity of material, by weight, administered to a test subject, based on their body
themselves are normally stable, but that can become unstable at elevated
weight in kg. TDLo: Lowest dose to cause a symptom. TCLo: Lowest
temperatures and pressures. Materials that have an instantaneous power density
concentration to cause a symptom. TDo, LDLo, and LDo, or TC, TCo, LCLo, and
(product of heat of reaction and reaction rate) at 250癈 (482癋) at or above 0.01
LCo: Lowest dose (or concentration) to cause lethal or toxic effects. Cancer
W/mL and below 10 W/mL. 2 Materials that readily undergo violent chemical
Information: IARC: International Agency for Research on Cancer. NTP: National
change at elevated temperatures and pressures. Materials that have an
Toxicology Program. RTECS: Registry of Toxic Effects of Chemical Substances.
instantaneous power density (product of heat of reaction and reaction rate) at
IARC and NTP rate chemicals on a scale of decreasing potential to cause human
250癈 (482癋) at or above 10 W/mL and below 100W/mL. 3 Materials that in
cancer with rankings from 1 to 4. Subrankings (2A, 2B, etc.) are also used. Other
themselves are capable of detonation or explosive decomposition or explosive
Information: BEI: ACGIH Biological Exposure Indices, represent the levels of
reaction, but that require a strong initiating source or that must be heated under
determinants which are most likely to be observed in specimens collected from a
confinement before initiation. Materials that have an estimated instantaneous
healthy worker who has been exposed to chemicals to the same extent as a
power density (product of heat of reaction and reaction rate) at 250癈 (482癋) at
worker with inhalation exposure to the TLV.
or above 100 W/mL and below 1000 W/mL. Materials that are sensitive to thermal
or mechanical shock at elevated temperatures and pressures. 4 Materials that in ECOLOGICAL INFORMATION:
themselves are readily capable of detonation or explosive decomposition or EC: Effect concentration in water. BCF: Bioconcentration Factor, which is used to
explosive reaction at normal temperatures and pressures. Materials that are determine if a substance will concentrate in life forms that consume contaminated
sensitive to localized thermal or mechanical shock at normal temperatures and plant or animal matter. TLm: Median threshold limit. log KOW or log KOC: Coefficient
pressures. Materials that have an estimated instantaneous power density (product of Oil/Water Distribution is used to assess a substance's behavior in the
of heat of reaction and reaction rate) at 250癈 (482癋) of 1000 W/mL or greater. environment.
FLAMMABILITY LIMITS IN AIR: REGULATORY INFORMATION:
Much of the information related to fire and explosion is derived from the National U.S.:
EPA: U.S. Environmental Protection Agency. ACGIH: American Conference of
Fire Protection Association (NFPA). Flash Point: Minimum temperature at which a
Governmental Industrial Hygienists, a professional association that establishes
liquid gives off sufficient vapor to form an ignitable mixture with air near the
exposure limits. OSHA: U.S. Occupational Safety and Health Administration.
surface of the liquid or within the test vessel used. Autoignition Temperature:
NIOSH: National Institute of Occupational Safety and Health, which is the
Minimum temperature of a solid, liquid, or gas required to initiate or cause self-
research arm of OSHA. DOT: U.S. Department of Transportation. TC: Transport
sustained combustion in air with no other source of ignition. LEL: Lowest
Canada. SARA: Superfund Amendments and Reauthorization Act. TSCA: U.S.
concentration of a flammable vapor or gas/air mixture that will ignite and burn with
Toxic Substance Control Act. CERCLA: Comprehensive Environmental
a flame. UEL: Highest concentration of a flammable vapor or gas/air mixture that
Response, Compensation, and Liability Act. Marine Pollutant status according to
will ignite and burn with a flame.
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.
NYSTATIN ORAL SUSPENSION MSDS EFFECTIVE DATE: MAY 04, 2009
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