Nizoral Cream

Material Safety Data Sheet
Ketoconazole

ACC# 91529

Section 1 - Chemical Product and Company Identification

MSDS Name: Ketoconazole
Catalog Numbers: BP2734-1, BP2734-100, BP2734-50, BP2734-500
Synonyms:
Company Identification:
Fisher Scientific
1 Reagent Lane
Fair Lawn, NJ 07410
For information, call: 201-796-7100
Emergency Number: 201-796-7100
For CHEMTREC assistance, call: 800-424-9300
For International CHEMTREC assistance, call: 703-527-3887

Section 2 - Composition, Information on Ingredients

CAS#	Chemical Name	Percent	EINECS/ELINCS
65277-42-1	Ketoconazole	100	265-667-4

Section 3 - Hazards Identification

EMERGENCY OVERVIEW

Appearance: white powder.
Warning! Toxic. Harmful if swallowed. May cause eye and skin irritation. May cause respiratory and digestive tract irritation. May cause liver damage. May cause adverse reproductive effects.
Target Organs: Liver, endocrine.

Potential Health Effects
Eye: May cause eye irritation.
Skin: May cause skin irritation.
Ingestion: Harmful if swallowed. May cause irritation of the digestive tract. May cause liver damage. May cause thyroid abnormalities. Human fatalities have been reported from acute poisoning.
Inhalation: May cause respiratory tract irritation. May cause thryoid effects. May cause liver damage.
Chronic: Chronic exposure may cause liver damage. Chronic exposure may cause thyroid damage: thyroid enlargement, decrease in metabolic rate, and hypothyroidism. Adverse reproductive effects have been reported in humans.

Section 4 - First Aid Measures

Eyes: Flush eyes with plenty of water for at least 15 minutes, occasionally lifting the upper and lower eyelids. Get medical aid.
Skin: Get medical aid. Flush skin with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. Wash clothing before reuse.
Ingestion: Never give anything by mouth to an unconscious person. Get medical aid. Do NOT induce vomiting. If conscious and alert, rinse mouth and drink 2-4 cupfuls of milk or water.
Inhalation: Remove from exposure and move to fresh air immediately. If breathing is difficult, give oxygen. Get medical aid. Do NOT use mouth-to-mouth resuscitation. If breathing has ceased apply artificial respiration using oxygen and a suitable mechanical device such as a bag and a mask.
Notes to Physician: Treat symptomatically and supportively.

Section 5 - Fire Fighting Measures

General Information: As in any fire, wear a self-contained breathing apparatus in pressure-demand, MSHA/NIOSH (approved or equivalent), and full protective gear. During a fire, irritating and highly toxic gases may be generated by thermal decomposition or combustion.
Extinguishing Media: Use water spray, dry chemical, carbon dioxide, or appropriate foam.
Flash Point: Not applicable.
Autoignition Temperature: Not applicable.
Explosion Limits, Lower:Not available.
Upper: Not available.
NFPA Rating: (estimated) Health: 2; Flammability: 0; Instability: 0

Section 6 - Accidental Release Measures

General Information: Use proper personal protective equipment as indicated in Section 8.
Spills/Leaks: Vacuum or sweep up material and place into a suitable disposal container. Clean up spills immediately, observing precautions in the Protective Equipment section. Avoid generating dusty conditions. Provide ventilation.

Section 7 - Handling and Storage

Handling: Wash thoroughly after handling. Use with adequate ventilation. Minimize dust generation and accumulation. Avoid contact with eyes, skin, and clothing. Keep container tightly closed. Avoid ingestion and inhalation.
Storage: Store in a tightly closed container. Store in a cool, dry, well-ventilated area away from incompatible substances.

Section 8 - Exposure Controls, Personal Protection

Engineering Controls: Facilities storing or utilizing this material should be equipped with an eyewash facility and a safety shower. Use adequate ventilation to keep airborne concentrations low.
Exposure Limits

Chemical Name	ACGIH	NIOSH	OSHA - Final PELs
Ketoconazole	none listed	none listed	none listed

OSHA Vacated PELs: Ketoconazole: No OSHA Vacated PELs are listed for this chemical.
Personal Protective Equipment
Eyes: Wear appropriate protective eyeglasses or chemical safety goggles as described by OSHA's eye and face protection regulations in 29 CFR 1910.133 or European Standard EN166.
Skin: Wear appropriate protective gloves to prevent skin exposure.
Clothing: Wear appropriate protective clothing to prevent skin exposure.
Respirators: Follow the OSHA respirator regulations found in 29 CFR 1910.134 or European Standard EN 149. Use a NIOSH/MSHA or European Standard EN 149 approved respirator if exposure limits are exceeded or if irritation or other symptoms are experienced.

Section 9 - Physical and Chemical Properties

Physical State: Powder
Appearance: white
Odor: Not available.
pH: Not available.
Vapor Pressure: Not available.
Vapor Density: Not available.
Evaporation Rate:Not available.
Viscosity: Not available.
Boiling Point: Not available.
Freezing/Melting Point:148-150C
Decomposition Temperature:Not available.
Solubility: Not available.
Specific Gravity/Density:Not available.
Molecular Formula:C26H28N4O4Cl2
Molecular Weight:531.1264

Section 10 - Stability and Reactivity

Chemical Stability: Stable at room temperature in closed containers under normal storage and handling conditions.
Conditions to Avoid: Incompatible materials, dust generation, excess heat, strong oxidants.
Incompatibilities with Other Materials: Oxidizing agents.
Hazardous Decomposition Products: Hydrogen chloride, nitrogen oxides, carbon monoxide, irritating and toxic fumes and gases, carbon dioxide.
Hazardous Polymerization: Has not been reported

Section 11 - Toxicological Information

RTECS#:
CAS# 65277-42-1: TK7912300
LD50/LC50:
CAS# 65277-42-1:
     Oral, mouse: LD50 = 618 mg/kg;
     Oral, rat: LD50 = 166 mg/kg;
.

Carcinogenicity:
CAS# 65277-42-1: Not listed by ACGIH, IARC, NTP, or CA Prop 65.

Epidemiology: No information available.
Teratogenicity: Teratogenic effects have occurred in experimental animals.
Reproductive Effects: Adverse reproductive effects have occurred in humans.
Mutagenicity: Mutagenic effects have occurred in humans.
Neurotoxicity: No information found
Other Studies:

Section 12 - Ecological Information

No information available.

Section 13 - Disposal Considerations

Chemical waste generators must determine whether a discarded chemical is classified as a hazardous waste. US EPA guidelines for the classification determination are listed in 40 CFR Parts 261.3. Additionally, waste generators must consult state and local hazardous waste regulations to ensure complete and accurate classification.
RCRA P-Series: None listed.
RCRA U-Series: None listed.

Section 14 - Transport Information

	US DOT	Canada TDG
Shipping Name:	DOT regulated - small quantity provisions apply (see 49CFR173.4)	No information available.
Hazard Class:
UN Number:
Packing Group:

Section 15 - Regulatory Information

US FEDERAL

TSCA
     CAS# 65277-42-1 is not listed on the TSCA inventory. It is for research and development use only.
Health & Safety Reporting List
     None of the chemicals are on the Health & Safety Reporting List.
Chemical Test Rules
     None of the chemicals in this product are under a Chemical Test Rule.
Section 12b
     None of the chemicals are listed under TSCA Section 12b.
TSCA Significant New Use Rule
     None of the chemicals in this material have a SNUR under TSCA.
CERCLA Hazardous Substances and corresponding RQs
     None of the chemicals in this material have an RQ.
SARA Section 302 Extremely Hazardous Substances
     None of the chemicals in this product have a TPQ.
Section 313      No chemicals are reportable under Section 313.
Clean Air Act:
     This material does not contain any hazardous air pollutants.
     This material does not contain any Class 1 Ozone depletors.
     This material does not contain any Class 2 Ozone depletors.
Clean Water Act:
     None of the chemicals in this product are listed as Hazardous Substances under the CWA.
     None of the chemicals in this product are listed as Priority Pollutants under the CWA.
     None of the chemicals in this product are listed as Toxic Pollutants under the CWA.
OSHA:
     None of the chemicals in this product are considered highly hazardous by OSHA.
STATE
     CAS# 65277-42-1 is not present on state lists from CA, PA, MN, MA, FL, or NJ.

California Prop 65

California No Significant Risk Level: None of the chemicals in this product are listed.

European/International Regulations
European Labeling in Accordance with EC Directives
Hazard Symbols:
     T
Risk Phrases:
     R 25 Toxic if swallowed.

Safety Phrases:
     S 37 Wear suitable gloves.
     S 45 In case of accident or if you feel unwell, seek medical advice
     immediately (show the label where possible).
     S 28A After contact with skin, wash immediately with plenty of water
     .

WGK (Water Danger/Protection)
     CAS# 65277-42-1: No information available.
Canada - DSL/NDSL
     CAS# 65277-42-1 is listed on Canada's DSL List.
Canada - WHMIS
     WHMIS: Not available.
This product has been classified in accordance with the hazard criteria of the Controlled Products Regulations and the MSDS contains all of the information required by those regulations.
Canadian Ingredient Disclosure List

Section 16 - Additional Information

MSDS Creation Date: 4/25/2000
Revision #7 Date: 10/05/2005

The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no event shall Fisher be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if Fisher has been advised of the possibility of such damages.