AMBI Fade Cream Oily Skin. 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 AMBI Fade Cream Oily Skin Relevant identified uses of the substance or mixture and uses advised against Recommended use Skin care product. Fades dark spots. Restrictions on use Use in accordance with product literature. Details of the supplier of the safety data sheet Manufacturer Valeant Pharmaceuticals North America, LLC Bridgewater, NJ United States valeant.com Telephone (General) Emergency telephone number Manufacturer Manufacturer US Infotrac International Infotrac 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) Classification of the substance or mixture Skin Mild Irritation 3 Eye Mild Irritation 2B Skin Sensitization 1B Label elements WARNING Hazard statements Causes mild skin irritation May cause an allergic skin reaction Causes eye irritation Precautionary statements Page 1 of 18

2 Other hazards Prevention Wear protective gloves. Wash thoroughly after handling. Response IF ON SKIN: Wash with plenty of soap and water. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Storage/Disposal Store at room temperature 15 30C (59 86F). Section 3 Composition/Information on Ingredients Substances 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 Cetyl Alcohol CAS: EINECS:253 N/A : Skin Irrit. 2; Eye Irrit. 2A Disodium EDTA CAS: EINECS:205 N/A : NDA Ethylparaben CAS: EINECS:204 N/A : Skin Irrit. 2; Eye Irrit. 2A Fragrance mandarin sage NDA N/A : NDA Glycerin CAS: EINECS:200 N/A : Skin Irrit. 3; Eye Irrit. 2B Glyceryl stearate CAS: EINECS:204 N/A : NDA Glycine soja protein CAS: EINECS: N/A : NDA Hydroquinone Isopropyl Myristate Lactic acid Methylparaben CAS: EINECS: CAS: EINECS: CAS: EINECS: CAS: EINECS: % N/A : Skin Irrit. 2; Eye Dam. 1; Eye Irrit. 2A; Skin Sens. 1; Acute Tox. Oral 4; Muta. 2; Carc. 1A; Carc. 2; Aquatic Acute 1 : NDA N/A : Skin Corr. 1A; Eye Dam. 1 N/A : Skin Irrit. 2; Eye Irrit. 2A Page 2 of 18

3 Octinoxate CAS: EINECS:226 2% : NDA PEG 100 CAS: N/A : NDA PEG 16 soy sterol CAS: N/A : NDA Pentaerythrityl tetra di t butyl hydroxyhydrocinnamate Potassium cetyl phosphate Propylparaben Sodium ascorbyl phosphate Sodium Metabisulfite Stearic acid Tocopheryl Acetate Water CAS: EINECS: CAS: EINECS: CAS: EINECS: CAS: CAS: EINECS: CAS: EINECS: CAS: EINECS: CAS: EINECS: N/A N/A N/A N/A : NDA : NDA : NDA : NDA N/A : Skin Irrit. 2; Eye Dam. 1; Eye Irrit. 2A; Acute Tox. Oral 4 N/A : Skin Irrit. 2; Eye Irrit. 2A; Muta. 1; Carc. 1A; Repr. 1 N/A N/A : NDA : Classification Criteria Not Met N/A Designates that the chemical percentage of composition is not available as it is considered a trade secret. Section 4: First Aid Measures Description of first aid measures Inhalation Skin Eye Ingestion No adverse effects anticipated by breathing small amounts. If large amounts are inhaled, remove to fresh air. IF ON SKIN: Wash with plenty of soap and water. If skin irritation occurs: Get medical advice/attention. 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. If swallowed, get medical help or contact a Poison Control Center immediately. Most important symptoms and effects, both acute and delayed Indication of any immediate medical attention and special treatment needed Section 5: Fire Fighting Measures Extinguishing media Suitable Extinguishing Media Carbon dioxide, dry chemical powder, appropriate foam or water fog. Page 3 of 18

4 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 Emergency Procedures Environmental 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. Ventilate area. Contain spilled product. For small spills, add suitable absorbent material. Scoop up and place in an appropriate liquid tight container equipped with a tight cover for disposal. For large spills, dike spilled material or otherwise contain material to ensure runoff does not reach a waterway. Place spilled material in an appropriate, liquid tight container equipped with a tight cover for disposal. Minimize contact of spilled material with soils to prevent runoff to surface waterways. Dispose of in accordance with Section 13. Prevent spilled material from entering storm sewers or drains, waterways, and contact with soil. Methods and material for containment and cleaning up Containment/Clean up Measures Section 7 Handling and Storage Precautions for safe handling Handling Avoid contact with eyes. Avoid prolonged or repeated exposure to skin or mucous membranes, and breathing mists/vapors. Use in a well ventilated area, away from all sources of ignition. Keep container closed. Wash thoroughly with soap and water after handling. Conditions for safe storage, including any incompatibilities Storage Keep tightly closed. Store at room temperature. Section 8 Exposure Controls/Personal Protection Control parameters Exposure Limits/Guidelines Refer to the occupational exposure limits / guidelines for the individual product components. Exposure Limits/Guidelines Result ACGIH Canada Quebec NIOSH OSHA Sodium Metabisulfite TWAs 5 mg/m3 TWA 5 mg/m3 TWAEV 5 mg/m3 TWA Not established Page 4 of 18

5 ( ) Hydroquinone ( ) Glycerin ( ) TWAs 1 mg/m3 TWA 2 mg/m3 TWAEV Not established 2 mg/m3 TWA Ceilings Not established Not established 2 mg/m3 Ceiling (15 min) Not established TWAs Not established 10 mg/m3 TWAEV (mist) Not established 15 mg/m3 TWA (mist, total particulate); 5 mg/m3 TWA (mist, respirable fraction) Exposure Control Notations ACGIH Sodium Metabisulfite ( ): Carcinogens: (A4 Not Classifiable as a Human Carcinogen) Hydroquinone ( ): Carcinogens: (A3 Confirmed Animal Carcinogen with Unknown Relevance to Humans) Sensitizers: (dermal sensitizer) Exposure controls Engineering Measures/Controls Personal Protective Equipment Pictograms No special controls are required under conditions of intended use. Local exhaust ventilation should be provided when handling bulk product. 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 Wear eye/face protection,. Hands Wear protective gloves. Skin/Body General Industrial Hygiene Considerations Environmental Exposure Controls No special personal protection required under conditions of intended use. In the event of a bulk spill, wear appropriate protective clothing. Handle in accordance with good industrial hygiene and safety practice. Section 9 Physical and Chemical Properties Information on Physical and Chemical Properties Material Description Physical Form Liquid Cream Appearance/Description Color White Odor Mandarin sage. General Properties Boiling Point No data available Melting Point/Freezing Point Not relevant Decomposition Temperature Not relevant ph 3.7 to 4.7 Specific Gravity/Relative Density 0.91 to 0.99 Water=1 Water Solubility Insoluble Viscosity No data available Volatility Vapor Pressure No data available Vapor Density Not relevant Evaporation Rate No data available White cream with mandarin sage odor. Page 5 of 18

6 Flammability Flash Point Not relevant UEL Not relevant LEL Not relevant Autoignition Not relevant Environmental Octanol/Water Partition coefficient No data available Section 10: Stability and Reactivity Reactivity Chemical stability Stable under normal temperatures and pressures. Stable under normal temperatures and humidities. Possibility of hazardous reactions Conditions to avoid Avoid exposure to extreme heat or cold. Incompatible materials Hazardous decomposition products Section 11 Toxicological Information Information on toxicological effects Components Stearic acid (N/A) Acute Toxicity: Ingestion/Oral Human LD mg/kg; Skin Rabbit LD50 >5 g/kg Glycerin (N/A) Hydroquinone (2%) Acute Toxicity: Ingestion/Oral Rat LD mg/kg; Behavioral:General anesthetic; Behavioral:Muscle weakness; Liver:Other changes; Irritation: Skin Rabbit 500 mg 24 Hour(s) Mild irritation Acute Toxicity: Ingestion/Oral Rat LD mg/kg; Skin Mammal LD mg/kg; Skin Rabbit LD50 >2000 mg/kg 24 Hour(s); Irritation: Skin Human 2 % Mild irritation GHS Properties Classification Respiratory sensitization Serious eye damage/irritation Acute toxicity Aspiration Hazard Carcinogenicity Classification criteria not met Eye Mild Irritation 2B Classification criteria not met Classification criteria not met Classification criteria not met Skin corrosion/irritation Skin Mild Irritation 3 Skin sensitization STOT RE Skin Sensitizer 1B Classification criteria not met Page 6 of 18

7 STOT SE Toxicity for Reproduction Germ Cell Mutagenicity Classification criteria not met Classification criteria not met Classification criteria not met Potential Health Effects Inhalation Acute (Immediate) Chronic (Delayed) Skin Acute (Immediate) Chronic (Delayed) Eye Acute (Immediate) Chronic (Delayed) Ingestion Acute (Immediate) Chronic (Delayed) Under normal conditions of use, no health effects are expected. Under normal conditions of use, no health effects are expected. May cause mild irritation. Repeated and prolonged exposure may cause sensitization. Causes eye irritation. Under normal conditions of use, no health effects are expected. May be harmful if swallowed. Under normal conditions of use, no health effects are expected. Carcinogenic Effects CAS IARC NTP Sodium Metabisulfite Group 3 Not Classifiable Not Listed Hydroquinone Group 3 Not Classifiable Evidence of Carcinogenicity 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 Waste characterizations and compliance with applicable laws are the responsibility solely of the waste generator. Packaging waste Dispose of content and/or container in accordance with local, regional, national, and/or international regulations. Section 14 Transport Information Page 7 of 18

8 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 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 EU EINECS EU ELNICS TSCA Cetyl Alcohol Yes Yes No Yes Octinoxate Yes Yes No Yes Tocopheryl Acetate Yes Yes No Yes Disodium EDTA Yes Yes No Yes Pentaerythrityl tetradi t butyl hydroxyhydrocinnamate Yes Yes No Yes Ethylparaben Yes Yes No Yes Methylparaben Yes Yes No Yes Propylparaben Yes Yes No Yes Glycerin Yes Yes No Yes Glycine soja protein Yes Yes No Yes Hydroquinone Yes Yes No Yes Lactic acid Yes Yes No Yes Sodium ascorbyl phosphate No No Yes No Glyceryl stearate Yes Yes No Yes PEG 16 soy sterol No No No No PEG Yes No No Yes Potassium cetyl phosphate No Yes No No Sodium Metabisulfite Yes Yes No Yes Stearic acid Yes Yes No Yes Isopropyl Myristate Yes Yes No Yes Water Yes Yes No Yes Page 8 of 18

9 Canada Labor Canada List of Prohibited and Restricted Cosmetic Ingredients (The Cosmetic Ingredient Hotlist) Restricted (Restricted to hair dye products, nail products and Cyanoacrylate based adhesives. Permitted at concentrations <=0.3% as an oxidizing colouring agent for hair dyes. The inner and outer labels of hair dye products containing Hydroquinone must carry a cautionary statement, in English and French, to the effect: 'Contains Hydroquinone,'' ''Do not use to dye eyelashes or eyebrows,'' ''Rinse eyes immediately if the product comes into contact with eyes.'' Permitted at concentrations <=0.02% in two component (acrylic) Hydroquinone artificial nail systems (after mixing for use). The inner and outer labels of nail products containing Hydroquinone must carry a cautionary statement, in English and French, to the effect: ''Avoid skin contact,'' ''Read directions carefully before using.'' Permitted at concentrations <=0.1% in Cyanoacrylate adhesive products. The inner and outer labels of Cyanoacrylate adhesive products containing Hydroquinone must carry a cautionary statement, in English and French, to the effect: ''Avoid skin contact.'' ''Read directions carefully before using.'') 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 Page 9 of 18

10 the most current edition of the 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 Lactic 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 Uncontrolled product Sodium Metabisulfite according to WHMIS classification criteria Uncontrolled product Stearic acid according to WHMIS classification criteria Uncontrolled product Pentaerythrityl tetra di t butyl hydroxyhydrocinnamate according to WHMIS classification criteria Page 10 of 18

11 Uncontrolled product Disodium EDTA according to WHMIS classification criteria (including 3.5%) Cetyl Alcohol D2B Hydroquinone D1B, D2B Uncontrolled product Glycerin according to WHMIS classification criteria Uncontrolled product Water according to WHMIS classification criteria Uncontrolled product PEG according to WHMIS classification criteria Canada WHMIS Ingredient Disclosure List Sodium Metabisulfite % Stearic acid % Hydroquinone % Lactic acid % PEG % Europe Other EU CLP (1272/2008) Annex VI Table 3.2 Classification Sodium Metabisulfite Xn; R22 R31 Xi; R41 Page 11 of 18

12 Xn; R22 Carc.Cat.3; R40 Xi; Hydroquinone R41 R43 N; R50 Muta.Cat.3; R68 EU CLP (1272/2008) Annex VI Table 3.2 Concentration Limits Hydroquinone %<=C: N; R:50 EU CLP (1272/2008) Annex VI Table 3.2 Labelling Sodium Metabisulfite Xn R: S:(2) Page 12 of 18

13 Hydroquinone Xn N R: S: (2) 26 36/37/39 61 EU CLP (1272/2008) Annex VI Table 3.2 Safety Phrases Sodium Metabisulfite S:(2) Hydroquinone S:(2) 26 36/37/39 61 United States Environment U.S. CAA (Clean Air Act) 1990 Hazardous Air Pollutants Hydroquinone Page 13 of 18

14 U.S. CERCLA/SARA Hazardous Substances and their Reportable Quantities Hydroquinone 100 lb final RQ; 45.4 kg final RQ U.S. CERCLA/SARA Section 302 Extremely Hazardous Substances EPCRA RQs Hydroquinone lb EPCRA RQ Page 14 of 18

15 U.S. CERCLA/SARA Section 302 Extremely Hazardous Substances TPQs Hydroquinone 500 lb lower TPQ; lb upper TPQ U.S. CERCLA/SARA Section 313 Emission Reporting Hydroquinone 1.0 % de minimis concentration United States California Environment U.S. California Proposition 65 Carcinogens List Page 15 of 18

16 Hydroquinone Not Listed U.S. California Proposition 65 Developmental Toxicity Hydroquinone Not Listed U.S. California Proposition 65 Reproductive Toxicity Female Page 16 of 18

17 Hydroquinone Not Listed U.S. California Proposition 65 Reproductive Toxicity Male Hydroquinone Not Listed Section 16 Other Information Revision Date Last Revision Date Preparation Date Disclaimer/Statement of Liability 30/July/ /July/ /July/2015 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 Page 17 of 18

18 any special, incidental or consequential damages. Page 18 of 18