: Chlorhexidine Gluconate 4% Topical Solution
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1 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product name. : Chlorhexidine Gluconate 4% Topical Solution 1.2. Relevant identified uses of the substance or mixture and uses advised against Use of the substance/mixture 1.3. Details of the supplier of the safety data sheet Xttrium Laboratories, Inc East Business Center Drive Mt. Prospect, IL : Pharmaceutical Agent 1.4. Emergency telephone number Emergency number : SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Classification (GHS-US) Skin Irrit. 2 H315 Eye Dam. 1 H318 Carc. 2 H Label elements GHS-US labeling Hazard pictograms (GHS-US) : Signal word (GHS-US) Hazard statements (GHS-US) Precautionary statements (GHS-US) GHS05 GHS08 : Danger : H315 - Causes skin irritation H318 - Causes serious eye damage H351 - Suspected of causing cancer : P201 - Obtain special instructions before use P202 - Do not handle until all safety precautions have been read and understood P264 - Wash... thoroughly after handling P280 - Wear protective gloves/protective clothing/eye protection/face protection P302 + P352 - If on skin: Wash with plenty of water/ P305 + P351 + P338 - If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing P308 + P313 - If exposed or concerned: Get medical advice/attention P310 - Immediately call a poison center/doctor/ P321 - Specific treatment (see... on this label) P332 + P313 - If skin irritation occurs: Get medical advice/attention P362 - Take off contaminated clothing and wash before reuse P405 - Store locked up P501 - Dispose of contents/container to Other hazards 2.4. Unknown acute toxicity (GHS US) No data available SECTION 3: Composition/information on ingredients 3.1. Substances Not applicable Full text of H-phrases: see section Mixture Name Product identifier % GHS-US classification Water (CAS No) Trade Secret Not classified Chlorhexidine digluconate (CAS No) Trade Secret Acute Tox. 4 (Oral), H302 Isopropyl alcohol (CAS No) Trade Secret Flam. Liq. 2, H225 06/03/2014 EN (English) Page 1
2 Name Product identifier % GHS-US classification Proprietary Component 1 (CAS No) Proprietary Trade Secret Not classified Proprietary Component 2 (CAS No) Proprietary Trade Secret Skin Corr. 1B, H314 Proprietary Component 3 (CAS No) Proprietary Trade Secret Carc. 2, H351 Proprietary Component 4 (CAS No) Proprietary Trade Secret Not classified Proprietary Component 5 (CAS No) Proprietary Trade Secret Not classified Proprietary Component 6 (CAS No) Proprietary Trade Secret Not classified SECTION 4: First aid measures 4.1. Description of first aid measures First-aid measures after inhalation First-aid measures after skin contact First-aid measures after eye contact First-aid measures after ingestion : No specific first aid necessary for this route of exposure. : Wash with soap and water. Seek medical advice if skin irritation develops or persists. : Immediately flush eyes with plenty of water for at least 15 minutes. If irritation persists get medical attention. : Do NOT induce vomiting. Seek medical attention Most important symptoms and effects, both acute and delayed Symptoms/injuries after inhalation : None under normal use. Symptoms/injuries after skin contact : Causes skin irritation. Symptoms/injuries after eye contact : Causes serious eye damage. Symptoms/injuries after ingestion : May be harmful if swallowed Indication of any immediate medical attention and special treatment needed SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media Unsuitable extinguishing media : Dry chemical powder, alcohol foam, carbon dioxide, water spray, fog. : None Special hazards arising from the substance or mixture Fire hazard Explosion hazard : Not flammable. Thermal decomposition may produce toxic fumes of ammonia, hydrogen chloride and oxides of carbon and nitrogen. : None known Advice for firefighters Protection during firefighting : Firefighters should wear full protective gear. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures For non-emergency personnel For emergency responders 6.2. Environmental precautions Avoid release to the environment Methods and material for containment and cleaning up For containment : Stop the flow of material, if this is without risk. Methods for cleaning up : Confine spill and soak up with absorbent. Place in an approved container and dispose in accordance with local, state and federal regulations Reference to other sections SECTION 7: Handling and storage 7.1. Precautions for safe handling Precautions for safe handling : Avoid contact with eyes. Wash thoroughly after handling Conditions for safe storage, including any incompatibilities Storage conditions : Keep away from open flames, hot surfaces and sources of ignition. Store at temperatures not exceeding 37 C Specific end use(s) Pharmaceutical Agent. 06/03/2014 EN (English) 2/6
3 SECTION 8: Exposure controls/personal protection 8.1. Control parameters USA ACGIH ACGIH TWA (ppm) 200 ppm USA ACGIH ACGIH STEL (ppm) 400 ppm USA OSHA OSHA PEL (TWA) (mg/m3) 980 mg/m³ USA OSHA OSHA PEL (TWA) (ppm) 400 ppm 8.2. Exposure controls Appropriate engineering controls Hand protection Eye protection Skin and body protection Respiratory protection : Provide adequate general and local exhaust ventilation. : Wear impervious gloves to minimize skin contact. : Chemical goggles or safety glasses. : Wear suitable working clothes. : None required under normal product handling conditions. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state : Liquid Colour : colorless. Odour Odour threshold ph Relative evaporation rate (butylacetate=1) Melting point Freezing point Boiling point : 97 C Flash point : >200 F Self ignition temperature Decomposition temperature Flammability (solid, gas) Vapour pressure Relative vapour density at 20 C Specific gravity : 1.06 Solubility : Water: Soluble Log Pow Log Kow Viscosity, kinematic Viscosity, dynamic Explosive properties Oxidising properties Explosive limits 9.2. Other information SECTION 10: Stability and reactivity Reactivity Chemical stability The product is stable at normal handling- and storage conditions Possibility of hazardous reactions Will not occur Conditions to avoid Storage in excess heat (104 F) over a long period of time Incompatible materials None. 06/03/2014 EN (English) 3/6
4 10.6. Hazardous decomposition products Thermal decomposition may produce toxic fumes of ammonia, hydrogen chloride and oxides of carbon and nitrogen. SECTION 11: Toxicological information Information on toxicological effects Acute toxicity Water ( ) Chlorhexidine digluconate ( ) ATE (oral) > 90 ml/kg 2 g/kg mg/kg 4396 mg/kg LD50 dermal rat mg/kg LD50 dermal rabbit mg/kg LC50 inhalation rat (mg/l) 72.6 mg/l (Exposure time: 4 h) Proprietary Component 6 (Proprietary) ATE (oral) Skin corrosion/irritation Serious eye damage/irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity 7930 mg/kg mg/kg bodyweight : Causes skin irritation. : Causes serious eye damage. : Suspected of causing cancer. IARC group 3 IARC group 2B National Toxicity Program (NTP) Status 1 Reproductive toxicity Specific target organ toxicity (single exposure) Specific target organ toxicity (repeated exposure) Aspiration hazard SECTION 12: Ecological information Toxicity LC50 fishes 1 EC50 Daphnia 1 EC50 other aquatic organisms 1 LC50 fish 2 EC50 other aquatic organisms 2 LC50 fishes 1 EC50 Daphnia mg/l (Exposure time: 96 h - Species: Pimephales promelas [flow-through]) mg/l (Exposure time: 48 h - Species: Daphnia magna) > 1000 mg/l (Exposure time: 96 h - Species: Desmodesmus subspicatus) mg/l (Exposure time: 96 h - Species: Pimephales promelas [static]) > 1000 mg/l (Exposure time: 72 h - Species: Desmodesmus subspicatus) 3.6 mg/l (Exposure time: 96 h - Species: Brachydanio rerio [semi-static]) 4.2 mg/l (Exposure time: 24 h - Species: Daphnia magna) Persistence and degradability Bioaccumulative potential Log Pow 0.05 (at 25 C) 06/03/2014 EN (English) 4/6
5 12.4. Mobility in soil Other adverse effects SECTION 13: Disposal considerations Waste treatment methods Waste disposal recommendations SECTION 14: Transport information In accordance with DOT / ADR / RID / ADNR / IMDG / ICAO / IATA UN number Not applicable UN proper shipping name DOT Proper Shipping Name SECTION 15: Regulatory information US Federal regulations Water ( ) Chlorhexidine digluconate ( ) : Dispose of contents/container in accordance with local/regional/national/international regulations. : Chlorhexidine Gluconate Aqueous Solutions of alcohol containing 24% or less alcohol by volume and no other hazardous material. Listed on SARA Section 313 (Specific toxic chemical listings) EPA TSCA Regulatory Flag T - T - indicates a substance that is the subject of a Section 4 test rule under TSCA. SARA Section Emission Reporting 1.0 % (only if manufactured by the strong acid process, no supplier notification) Proprietary Component 2 (Proprietary) Proprietary Component 5 (Proprietary) Proprietary Component 1 (Proprietary) Proprietary Component 4 (Proprietary) Proprietary Component 6 (Proprietary) US State regulations Carcinogens List Developmental Toxicity Reproductive Toxicity - Female Reproductive Toxicity - Male No significance risk level (NSRL) Yes U.S. - Massachusetts - Right To Know List U.S. - Minnesota - Hazardous Substance List U.S. - New Jersey - Right to Know Hazardous Substance List U.S. - Pennsylvania - RTK (Right to Know) List 06/03/2014 EN (English) 5/6
6 SECTION 16: Other information Full text of H-phrases: Acute Tox. 4 (Oral) Acute toxicity (oral) Category Carc. 2 Carcinogenicity Category Eye Dam. 1 Serious eye damage/eye irritation Category Flam. Liq. 2 Flammable liquids Category Flam. Liq. 3 Flammable liquids Category Skin Corr. 1B skin corrosion/irritation Category 1B Skin Irrit. 2 skin corrosion/irritation Category H225 Highly flammable liquid and vapour H226 Flammable liquid and vapour H302 Harmful if swallowed H314 Causes severe skin burns and eye damage H315 Causes skin irritation H318 Causes serious eye damage H351 Suspected of causing cancer This information is based on our current knowledge and is intended to describe the product for the purposes of health, safety and environmental requirements only. It should not therefore be construed as guaranteeing any specific property of the product. 06/03/2014 EN (English) 6/6
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Safety data sheet. May cause slight irritation to the skin and eyes.
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Date of issue: 28/12/2011 Revision date: Version: 1.0 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Chemical type Trade name Product code : Mixture
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