Purpose Gentle Cleansing Wash. Relevant identified uses of the substance or mixture and uses advised against

Transcription

1 Safety Data Sheet Section 1: Identification Product identifier Product Name Product Code Purpose Gentle Cleansing Wash ; ; MS9707 Relevant identified uses of the substance or mixture and uses advised against Recommended use Restrictions on use Skin care product. Use in accordance with product literature. Details of the supplier of the safety data sheet Manufacturer Valeant Pharmaceuticals North America, LLC 400 Somerset Corporate Blvd. Bridgewater, NJ United States valeant.com Telephone (General) Emergency telephone number Manufacturer Manufacturer US - Infotrac International - Infotrac Consumer product: This safety data sheet is written to provide health, safety and environmental information for people handling this formulated product in the workplace. It is not intended to provide information relevant to consumer use of the product. Section 2: Hazard Identification According to: UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS): Third Revised Edition Classification of the substance or mixture UN GHS Classification criteria not met Label elements UN GHS Precautionary statements Other hazards UN GHS Section 3 - Composition/Information on Ingredients Substances Page 1 of 11

2 Mixtures Material does not meet the criteria of a substance according to United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Composition Chemical Name Identifiers % Classifications According to Regulation/Directive Citric acid CAS: : Skin Irrit. 2; Eye Irrit. 2; Acute Tox. Oral 5; STOT SE EINECS: N/A 3: Resp. Irrit. 1 Cocamidopropyl betaine CAS: EINECS: N/A : NDA 8 Ethylhexylglycerin CAS: N/A : Eye Dam. 1 Fragrance NDA N/A : NDA Glycerin CAS: EINECS: N/A : Skin Irrit. 3; Eye Irrit. 2 5 Lauryl glucoside CAS: N/A : Skin Irrit. 2; Eye Irrit. 2A PEG-150 Distearate CAS: N/A : NDA PEG-80 sorbitan laurate CAS: N/A : Skin Irrit. 3 Phenoxyethanol CAS: EINECS: N/A : Eye Irrit. 2A; Acute Tox. Oral 4 7 Sodium cocoamphoacetate CAS: EINECS: N/A : NDA 4 Sodium cocoyl glutamate CAS: EINECS: N/A : NDA Sodium lauroampho PG-acetate phosphate Sodium lauryl glucose carboxylate Tetrasodium EDTA Water CAS: CAS: CAS: EINECS: CAS: EINECS: N/A N/A : NDA : NDA N/A : Skin Irrit. 2; Eye Irrit. 2; Acute Tox. Oral 4 N/A : Classification criteria not met N/A - Designates that the chemical percentage of composition is not available as it is considered proprietary information. Section 4: First-Aid Measures Description of first aid measures Inhalation Skin Eye No adverse effects anticipated by breathing small amounts. If large amounts are inhaled, remove to fresh air. No specific treatment is necessary since this material is not likely to be hazardous by contact with the skin or mucous membranes. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. Page 2 of 11

3 Ingestion Call a physician or poison control center. Most important symptoms and effects, both acute and delayed Indication of any immediate medical attention and special treatment needed Other information Have the product container or label with you when calling a poison control center or doctor, or going for treatment. Section 5: Fire-Fighting Measures Extinguishing media Suitable Extinguishing Media Carbon dioxide, dry chemical powder, appropriate foam or water fog. Unsuitable Extinguishing Media Firefighting Procedures As in any fire, wear self-contained breathing apparatus and full protective gear. Special hazards arising from the substance or mixture Unusual Fire and Explosion Hazards Hazardous Combustion Products Advice for firefighters Section 6 - Accidental Release Measures Personal precautions, protective equipment and emergency procedures Personal Precautions No special controls or personal protection required under conditions of intended use. In the event of bulk spills, wear suitable protective eyewear, clothing, protective boots and protective gloves. Evacuate immediate area. Ensure adequate ventilation. Refer to Section 8. Emergency Procedures Pick up spilled material. Dispose of in accordance with Section 13. Environmental precautions No environmental impact if this product is spilled. Methods and material for containment and cleaning up Containment/Clean-up Measures Section 7 - Handling and Storage Precautions for safe handling Handling No special handling is required. Refer to Section 8. Use only in accordance with product literature. Conditions for safe storage, including any incompatibilities Storage Store at room temperature 15-30C (59-86F). Section 8 - Exposure Controls/Personal Protection Page 3 of 11

4 Control parameters Exposure Limits/Guidelines Glycerin ( ) Refer to the occupational exposure limits / guidelines for the individual product components. Exposure Limits/Guidelines Result Canada Quebec OSHA TWAs Exposure controls 10 mg/m3 TWAEV (mist) 15 mg/m3 TWA (mist, total particulate); 5 mg/m3 TWA (mist, respirable fraction) Engineering No special controls are required under conditions of intended use. Local exhaust Measures/Controls ventilation should be provided when handling bulk product. Personal Protective Equipment Respiratory In the event of a bulk spill, and where risk assessment shows that air-purifying respirators are appropriate, a NIOSH (US) or CEN (EU) -certified air-purifying respirator equipped with organic vapor cartridges may be permissible under certain circumstances where airborne concentrations are expected to exceed exposure limits, when adequate oxygen is present and as a backup to engineering controls. Use a positive pressure air-supplied respirator if there is any potential for an uncontrolled release or any other circumstances where air purifying respirators may not provide adequate protection. Eye/Face No special personal protection required under conditions of intended use. In the event of a bulk spill, appropriate eye/face protection should be worn. Hands No special personal protection required under conditions of intended use. In the event of a bulk spill, wear rubber or nitrile gloves. Skin/Body No special personal protection required under conditions of intended use. In the event of a bulk spill, wear appropriate protective clothing. General Industrial Hygiene Handle in accordance with good industrial hygiene and safety practice. Considerations Environmental Exposure Controls Section 9 - Physical and Chemical Properties Information on Physical and Chemical Properties Material Description Physical Form Liquid Appearance/Description Color Clear to amber. Odor Mild odor. Odor Threshold Not relevant General Properties Clear, colorless liquid on a white wipe. Boiling Point No data available Melting Point/Freezing Point No data available Decomposition Temperature No data available ph 6.3 to 7.1 Specific Gravity/Relative Density Viscosity Volatility = 1.19 Water=1 estimated 1400 to 4000 Centipoise (cps, cp) or mpas Water Solubility Soluble Vapor Pressure Not relevant Vapor Density Not relevant Evaporation Rate Not relevant Flammability Flash Point Not relevant UEL Not relevant LEL Not relevant Autoignition Not relevant Page 4 of 11

5 Environmental Octanol/Water Partition coefficient No data available Section 10: Stability and Reactivity Reactivity Chemical stability No dangerous reactions known. Stable under normal temperatures and pressures. Possibility of hazardous reactions Conditions to avoid Extreme heat or cold. Do not freeze. Incompatible materials Hazardous decomposition products Section 11 - Toxicological Information Information on toxicological effects Components PEG-150 Distearate (N/A) Cocamidopropyl betaine (N/A) PEG-80 sorbitan laurate (N/A) Acute Toxicity: Intravenous-Mouse LD mg/kg Acute Toxicity: Skin-Human TDLo mg/kg 24 Hour(s); Skin and Appendages:After topical exposure:primary irritation; Irritation: Eye-Rabbit 100 µl 24 Hour(s) Severe irritation Acute Toxicity: Ingestion/Oral-Rat LD µl/kg GHS Properties Acute toxicity Skin corrosion/irritation Classification Serious eye damage/irritation Skin sensitization Respiratory sensitization Aspiration Hazard Carcinogenicity Germ Cell Mutagenicity Toxicity for Reproduction STOT-SE STOT-RE Page 5 of 11

6 Potential Health Effects Inhalation Acute (Immediate) Chronic (Delayed) Skin Acute (Immediate) Chronic (Delayed) Eye Acute (Immediate) Chronic (Delayed) Ingestion Acute (Immediate) Chronic (Delayed) Not expected to cause skin irritation. Not expected to cause skin irritation. Not expected to cause sensitization. May cause mild irritation. Repeated and prolonged exposure may cause irritation. May be harmful if swallowed. Section 12 - Ecological Information Toxicity This material has not been tested for environmental effects. Persistence and degradability Bioaccumulative potential Mobility in Soil Other adverse effects Section 13 - Disposal Considerations Waste treatment methods Product waste Packaging waste Section 14 - Transport Information Waste characterizations and compliance with applicable laws are the responsibility solely of the waste generator. Dispose of content and/or container in accordance with local, regional, national, and/or international regulations. UN number UN proper shipping name Transport hazard class (es) Packing group DOT Not Applicable Not Regulated Not Applicable Not Applicable TDG Not Applicable Not Regulated Not Applicable Not Applicable IMO/IMDG Not Applicable Not Regulated Not Applicable Not Applicable IATA/ICAO Not Applicable Not Regulated Not Applicable Not Applicable Environmental hazards Special precautions for user Page 6 of 11

7 Transport in bulk according to Annex II of MARPOL 73/78 and the IBC Code Section 15 - Regulatory Information Safety, health and environmental regulations/legislation specific for the substance or mixture SARA Hazard Classifications Inventory Component CAS Canada DSL Canada NDSL EU EINECS EU ELNICS TSCA Phenoxyethanol Yes No Yes No Yes Ethylhexylglycerin Yes No No Yes No Lauryl glucoside Yes No No No Yes Citric acid Yes No Yes No Yes Tetrasodium EDTA Yes No Yes No Yes Glycerin Yes No Yes No Yes PEG-150 Distearate Yes No No No Yes PEG-80 sorbitan laurate Cocamidopropyl betaine Sodium cocoamphoacetate Sodium cocoyl glutamate Yes No No No Yes Yes No Yes No Yes Yes No Yes No Yes No Yes Yes No Yes Sodium lauroampho PG-acetate phosphate No No No No No Sodium lauryl glucose carboxylate No Yes No No Yes Canada Labor Canada - List of Prohibited and Restricted Cosmetic Ingredients (The Cosmetic Ingredient Hotlist) Phenoxyethanol Not Listed Restricted (Manufacturers of oral and leave-on products containing Glycerin must ensure the raw material used is within the specifications of Glycerin an accepted pharmacopoeia with respect to Diethylene glycol (DEG) impurities (e.g. Glycerin Official Monograph in the most current edition of the Page 7 of 11

8 USP)) Restricted (Permitted at total concentrations <=10%, with a ph >=3.5. Preparations containing concentrations of AHAs between 10% and 30% or a ph between 3.0 and 3.5 may be permitted for professional use if the manufacturer provides Health Canada with evidence of their safety including: ph levels, AHA concentrations, directions for use and clinical studies demonstrating minimal skin irritation. All skin products containing AHAs at concentrations >=3% shall Citric acid carry cautionary statements to the effect: ''Use only as directed'', ''Avoid contact with the eyes'', ''If irritation persists, discontinue use and consult a physician'', ''It is recommended that prior to exposure to the sun, users cover areas where AHAs have been applied, with sunscreen'', ''Contact of the product with the skin must be of limited frequency and duration.'' Preparations intended to be diluted in bath water may contain levels of Citric acid >10%., listed under.alpha.-hydroxy acids) Canada - WHMIS - Classifications of Substances Phenoxyethanol D2B Uncontrolled product PEG-80 sorbitan laurate according to WHMIS classification criteria Tetrasodium EDTA D2B (including 39%, 50%) Uncontrolled product PEG-150 Distearate according to WHMIS classification criteria Uncontrolled product Glycerin according to WHMIS classification criteria Citric acid E (including 40%) Page 8 of 11

9 Canada - WHMIS - Ingredient Disclosure List Phenoxyethanol % Citric acid % Europe Other EU - CLP (1272/2008) - Annex VI - Table Classification Phenoxyethanol Xn; R22 Xi; R36 Tetrasodium EDTA Xn; R22 Xi; R41 Ethylhexylglycerin Xi; R41 R52-53 EU - CLP (1272/2008) - Annex VI - Table Labelling Phenoxyethanol Xn R:22-36 S:(2)-26 Tetrasodium EDTA Xn R:22-41 S:(2) Ethylhexylglycerin Xi R:41-52/53 S:(2) EU - CLP (1272/2008) - Annex VI - Table Safety Phrases Phenoxyethanol S:(2)-26 Page 9 of 11

10 Tetrasodium EDTA S:(2) Ethylhexylglycerin S:(2) United States Environment U.S. - EPA - Designated Generic Categories - Certain Glycol Ethers Phenoxyethanol United States - California Environment U.S. - California - Proposition 65 - Carcinogens List Phenoxyethanol Not Listed U.S. - California - Proposition 65 - Developmental Toxicity Phenoxyethanol Not Listed Page 10 of 11

11 U.S. - California - Proposition 65 - Reproductive Toxicity - Female Phenoxyethanol Not Listed U.S. - California - Proposition 65 - Reproductive Toxicity - Male Phenoxyethanol Not Listed Section 16 - Other Information Revision Date Last Revision Date Preparation Date Disclaimer/Statement of Liability 21/April/ /April/ /November/2014 To the best of our knowledge, the information contained herein is accurate. However, neither Valeant Pharmaceuticals International, Inc. nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the information contained herein. Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist. NO WARRANTY, EXPRESS OR IMPLIED, OF MERCHANTABILITY, FITNESS OR OTHERWISE IS MADE. In no event shall Valeant Pharmaceuticals International, Inc. or any of its subsidiaries be liable for any special, incidental or consequential damages. Page 11 of 11