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Ketoconazole SDS Safety Data Sheet of Supplier Exporter Manufacturers' Representative |
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Ketoconazole
CAS Number: 65277-42-1
Molecular Formula: C26H28Cl2N4O4
Molecular Weight: 531.43
Ketoconazole
Ketoconazole SDS Safety Data Sheet
MSDS Sheet, Material Safety Data Sheet 05-Feb-25
1. Product Identification
Product Name & Other Names: Ketoconazole or (±)-cis-1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine.
CAS No.: 65277-42-1
EINECS EC Code: 265-667-4
Relevant uses and uses advised against (if any): Industrial Manufacturing.
Suppliers: As per letterhead.
2. Hazards Identification
GHS, Globally Harmonized System Classification in accordance with 29 CFR 1910
Classification according to Regulation (EC) No 1272/2008
Acute toxicity, Oral (Category 3), H301
Reproductive toxicity, (Category 1B), H360
Specific target organ toxicity - repeated exposure (Category 2) Blood, H373
Labeling according to GHS USA & Regulation (EC) No 1272/2008
GHS Label Elements  Toxic |
GHS Label Elements |
Signal Word: Danger
Hazard Statements:
H301 Toxic if swallowed.
H360F May damage fertility.
H373 May cause damage to organs through prolonged or repeated exposure.
Precautionary Statements
P202: Do not handle until all safety precautions have been read and understood.
P220: Keep/Store away from clothing/other combustible materials.
P260: Do not breathe dust/fume/gas/mist/vapors/spray.
P264: Wash ... thoroughly after handling.
P270: Do not eat, drink or smoke when using this product.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear protective gloves/protective clothing/eye protection/face protection.
P284 Wear respiratory protection.
P301+P310+330: IF SWALLOWED: Rinse mouth and immediately call a POISON CENTER or doctor/physician.
P302+P352: IF ON SKIN: Wash with soap and water.
P304+P340: IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.
P332+P313: If skin irritation occurs: Get medical advice/attention.
P337+P313: If eye irritation persists: Get medical advice/ attention.
3. Composition/Information on Ingredients
Product Name & Other Names: Ketoconazole or (±)-cis-1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine.
CAS No.: 65277-42-1
EINECS EC Code: 265-667-4
4. First Aid Measures
Always seek medical attention after first aid measures are provided.
Inhalation: If is inhaled, it will cause irritation and damage to the nose and throat. It can cause headaches, bleeding from nose coughing and chest discomfort. Remove the victim to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get medical attention.
Ingestion: It will cause irritation and burns to mouth, digestive tract and stomach. It may lead to pain, nausea, vomiting, and even collapse. Contact the medical center quickly. Never give anything by mouth to an unconscious person. Get medical attention.
Skin Contact: On contact, it can cause itching, pain, swelling and redness. Immediately flush skin with plenty of water for at least 15 minutes. Remove contaminated clothing and shoes. Get medical attention.
Eye Contact: It can cause severe damage to eyes. Check for and remove any contact lenses. Immediately flush your eyes with running water for at least 15 minutes, keeping eyelids open. Get medical attention.
5. Fire Fighting Measures
Toxic fumes, carbon dioxide, carbon monoxide, chlorine compounds, and nitrogen oxides may be formed in fire.
Fire Extinguishing Media: Dry chemical, foam or carbon dioxide and water spray jet. Avoid solid water jet.
Special Information: In the event of a fire, wear full protective clothing and NIOSH-approved self-contained breathing apparatus with full face piece operated in the pressure demand or other positive pressure mode.
6. Accidental Release Measures
Personal precautions, protective equipment, and emergency procedures: Avoid breathing dust/fumes/gas/mist/vapors/spray. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Environmental precautions: Do not let the product enter drains, soil, or water sources.
Methods and materials used for containment cleanup procedures and Storage:
Small Spill: Mop and pick up the material and place in an appropriate waste disposal container. Soak up with inert absorbent material and dispose of it as hazardous waste.
Large Spill: Contain spilled material. Cover with an inert, non-combustible absorbent material, (e.g., sand, earth, diatomaceous earth, vermiculite). Avoid mist formation. Wear full protective equipment and ensure proper ventilation. Keep away from heat. Keep away from sources of ignition. Provide ventilation. Vacuum or sweep up and remove to an approved disposal container. Contact Environment Agency.
7. Handling and Storage
Precautions for safe handling: Keep away from heat and source of fire, preferably in a ventilated area. Apply according to good manufacturing and industrial hygiene practices. Ensure proper ventilation. Do not drink, eat, or smoke while handling. Avoid contact with skin, eyes, and clothing. Minimize dust generation. Avoid breathing dust/fumes/gas/mist/vapors/spray. Keep container tightly closed. Avoid ingestion and inhalation. Use individual protective equipment (waterproof boots, suitable protective clothing, safety glasses, etc.).
Conditions for safe storage, including any incompatibilities: Store in cool, dry, and ventilated area away from heat sources and protected from sunlight in tightly closed original container. Keep air contact to a minimum. Keep locked up in tightly closed container. Do not leave the material container open. Store protected from heat, sparks and ignition sources and incompatible materials. Do not ingest. Avoid inhalation of dust/mist/vapor. Do not store with incompatible materials like oxidizing agents etc. Containers may be hazardous when empty since they retain product residues. Do not store near food items. Storage: Refrigerated (0-10C). Ok to freeze. Protected from light. Heat Sensitive.
8. Exposure Controls/Personal Protection
Airborne Exposure Limits: This product does not contain any hazardous materials with occupational exposure limits established by the region-specific regulatory bodies.
Ventilation System: A system of local and/or general exhaust is recommended to keep employee exposures as low as possible.
Personal Respirators (NIOSH Approved): For conditions of use where exposure to the substance is apparent and engineering controls are not feasible, consult an industrial hygienist.
Skin Protection: Wear impervious protective clothing, including boots, gloves, lab coat, apron or coveralls, as appropriate, to prevent skin contact.
Eye Protection: Use chemical safety goggles and/or a full-face shield where splashing is possible. Maintain eye wash fountain and quick-drench facilities in work area.
Other Control Measures: Maintain good housekeeping in work area. Handle in accordance with good industrial hygiene and safety practice.
9. Physical and Chemical Properties
Appearance: White to Almost white powder to crystal.
Odor: No information found.
Odor threshold: No information found.
pH: No information found.
Relative density: about 1.4
Melting point/freezing point: 148C to 152C literature.
Initial boiling point and boiling range: about 753C predicted.
Flash point: 88C.
Auto-ignition temperature: No information found.
Decomposition temperature: No information found.
Upper/lower flammability or explosive limits: No information found.
Vapor pressure: No information found.
Vapor density: No information found.
Evaporation rate: No information found.
Flammability (solid, gas): No information found.
Partition coefficient: n-octanol/water: No information found.
Solubility: Soluble in methanol.
Viscosity: No information found.
10. Stability and Reactivity
Stability: Stable under ordinary conditions of use and storage.
Hazardous Decomposition Products: Carbon dioxide, carbon monoxide, nitrogen oxides (NOx), chlorine compounds, and toxic fumes may form when heated to decomposition.
Hazardous Polymerization: Not reported.
Incompatibilities: Oxidizing agents.
Conditions to Avoid: Heat, flames, ignition sources and incompatibles.
11. Toxicological Information
4-HOUR EXPOSURE.
Acute oral toxicity (LD50): 166 mg/kg Rat.
Carcinogenicity: Not available.
Mutagenic Effects: Suspected of causing genetic defects.
Developmental Toxicity: No information found.
Reproductive Effects: May damage fertility. Presumed human reproductive toxicant.
12. Ecological Information
Toxicity to fish: No information found.
Persistence and Degradability: No information found.
Mobility: No information found.
Bioaccumulation/ Accumulation: No information found.
Results of PBT and vPvB assessment: No information found for assessment.
13. Disposal Considerations
Whatever cannot be saved for recovery or recycling should be managed in an appropriate and approved waste disposal facility. Follow all the pollution control rules.
14. Transport Information
DOT USA, TDG Canada & ADR/RID Europe
UN Number: 2811
Proper shipping name: Toxic solids, organic, n.o.s. (Ketoconazole).
Class: 6.1, Packing group: III.
IMDG & IATA
UN Number: 2811
Proper shipping name: Toxic solids, organic, n.o.s. (Ketoconazole).
Class: 6.1, Packing group: III.
15. Regulatory Information
USA:
SARA 311/312 Hazards: See section 2.
Section 16 - Additional Information
Disclaimer:
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Our company provides this MSDS sheet in good faith but makes no representation as to its comprehensiveness or accuracy. This SDS sheet is intended only as a guide to the appropriate precautionary handling of the material by a properly trained person using this product. The above information has been compiled from various sources and has the possibility of discrepancy and being out-dated information. Individuals receiving the information must exercise their independent judgment and do further search in determining its appropriateness for a particular purpose. In no case shall our company be liable to loss or damages by the product user.
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American Molecules, also known as ammol.org is a distributor, supplier and manufacturers' representative of all types of Pharmaceuticals, Functional Ingredients, Excipients and Specialty Chemicals in Texas USA. Our principals manufacture supply and export USP NF BP, Ph Eur, etc grades of chemicals pure and reagent grade, mineral fortifiers, FCC food grade. Tailor made particle size and customized specifications are offered. The principal's facility is having one or more of the certifications like FDA approval and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) for export to Europe is available. The manufacturers suppliers and exporters observe WHO Good Manufacturing Practices and Good Laboratory Practices.
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