SAFETY DATA SHEET. SECTION 1: Identification of the substance/mixture and of the company/undertaking

Transcription

1 SAFETY DATA SHEET SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Trade name or designation of the mixture Registration number Synonyms Issue date Version number 06 Revision date Supersedes date OLUXE FOAM 0.05% CLOBETASOL PROPIONATE FOAM 0.05% * DERMADEX FOAM 0.05% * FORMULATION CODES: 929A, 973A * STIEFEL PRODUCT * CLOBETASOL PROPIONATE, FORMULATED PRODUCT 17May April April Relevant identified uses of the substance or mixture and uses advised against Identified uses Uses advised against 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 medicinal use of the product. In this instance patients should consult prescribing information/package insert/product label or consult their pharmacist or physician. For health and safety information for individual ingredients used during manufacturing, refer to the appropriate safety data sheet for each ingredient. Cosmetic Product No other uses are advised Details of the supplier of the safety data sheet 1.4. Emergency telephone number SECTION 2: Hazards identification 2.1. Classification of the substance or mixture Stiefel Laboratories, Inc. (a GSK company) GlaxoSmithKline UK 980 Great West Road Brentford, Middlesex TW8 9GS UK UK General Information (normal business hours): GlaxoSmithKline US 5 Moore Drive Research Triangle Park, NC USA US General Information (normal business hours): Address: msds@gsk.com Website: TRANSPORT EMERGENCIES (by country / geographic region): Africa / EU / Israel / Middle East (English / European languages): +44 (0) Asia Pacific (except China): China: Middle East / Africa (Arabicspeaking countries): +44 (0) United States: available 24 hrs/7 days; multilanguage response Classification according to Directive 67/548/EEC or 1999/45/EC as amended Exempt from requirements product regulated as a medicinal product, cosmetic product or medical device. Classification according to Regulation (EC) No 1272/2008 as amended Exempt from requirements product regulated as a medicinal product, cosmetic product or medical device Label elements Label according to Regulation (EC) No. 1272/2008 as amended Exempt from requirements product regulated as a medicinal product, cosmetic product or medical device. Supplemental label information Not applicable. Material name: OLUXE FOAM 0.05% Version No.: 06 Revision date: 19April2012 Issue date: 17May / 9

2 2.3. Other hazards This product is flammable. Aerosol containers may violently rupture when exposed to the heat of fire. Caution Pharmaceutical agent. Caution The toxicological properties of this material have not been fully investigated. Not expected to be a health hazard during normal handling. Health effects information is based on hazards of components. Possible effects of overexposure in the workplace include: irritation; headache; symptoms of hypersensitivity (such as skin rash, hives, itching). May cause steroid withdrawal rash. No information is available about the potential of this product to produce adverse environmental effects. SECTION 3: Composition/information on ingredients 3.1. Mixtures General information Chemical name % CASNo. / EC No. REACH Registration No. INDEX No. Notes PROPANE Classification: DSD: F+;R Flam. Gas 1;H220 ISOBUTANE Classification: DSD: F+;R Flam. Gas 1;H220 NBUTANE Classification: DSD: F+;R Flam. Gas 1;H220 CLOBETASOL PROPIONATE 0.05 Classification: DSD: Repr. Cat. 2;R61, Repr. Cat. 3;R62, R Repr. 1B;H360Df, STOT RE 2;H373, Aquatic Chronic 4;H413 2Phenoxyethanol 0.5 to 1.0 Classification: DSD: Xn;R22, Xi;R Acute Tox. 4;H302, Eye Irrit. 2;H CETAMACROGOL 1000 BP 4.0 to 5.0 Classification: >84.0 DSD: Xi;R Skin Irrit. 2;H315, Eye Irrit. 2;H319 SECTION 4: First aid measures General information 4.1. Description of first aid measures Inhalation Skin contact Preplacement and periodic health surveillance is not usually indicated. The final determination of the need for health surveillance should be determined by local risk assessment. Using appropriate personal protective equipment, move exposed subject to fresh air. If breathing is difficult or ceases, ensure and maintain ventilation. Give oxygen as appropriate. The exposed subject should be kept warm and at rest. Obtain medical attention in cases of known or possible over exposure, or with symptoms including chest pain, difficulty breathing, loss of consciousness or other adverse effects, which may be delayed. Using appropriate personal protective equipment, remove contaminated clothing and flush exposed area with large amounts of water. Obtain medical attention if skin reaction occurs, which may be immediate or delayed. Material name: OLUXE FOAM 0.05% Version No.: 06 Revision date: 19April2012 Issue date: 17May / 9

3 Eye contact Ingestion 4.2. Most important symptoms and effects, both acute and delayed 4.3. Indication of any immediate medical attention and special treatment needed SECTION 5: Firefighting measures General fire hazards 5.1. Extinguishing media Suitable extinguishing media Unsuitable extinguishing media 5.2. Special hazards arising from the substance or mixture 5.3. Advice for firefighters Special protective equipment for firefighters Special fire fighting procedures Wash immediately with clean and gently flowing water. Continue for at least 15 minutes. Obtain medical attention. Never attempt to induce vomiting. Do not attempt to give any solid or liquid by mouth if the exposed subject is unconscious or semiconscious. Wash out the mouth with water. If the exposed subject is fully conscious, give plenty of water to drink. Obtain medical attention. Possible effects of overexposure in the workplace include: irritation; headache; symptoms of hypersensitivity (such as skin rash, hives, itching); May cause steroid withdrawal rash. No specific antidotes are recommended. In allergic individuals, exposure to this material may require treatment for initial or delayed allergic symptoms and signs. This may include immediate and/or delayed treatment of anaphylactic reactions. Ocular symptoms may be indicative of allergic reaction. This product is flammable. Water is recommended for fires involving packaging. SECTION 6: Accidental release measures Toxic, corrosive or flammable thermal decomposition products are expected when the product is exposed to fire. Since toxic, corrosive or flammable vapours might be evolved from fires involving this material, self contained breathing apparatus and full protective equipment are recommended for firefighters. For single units (packages): No special requirements needed. For larger amounts (multiple packages/pallets) of product: Since toxic, corrosive or flammable vapours might be evolved from fires involving the associated packaging, self contained breathing apparatus might be considered for fire fighters. If possible, contain and collect firefighting water for later disposal Personal precautions, protective equipment and emergency procedures For nonemergency personnel Stop leak and eliminate all sources of ignition (no smoking, sparks or flames). Fence or cordon the affected area and do not allow individuals to touch or walk through the spilled material unless wearing appropriate protective clothing. Wear protective clothing and equipment consistent with the degree of hazard. Vapoursuppressing foam or water spray may be used to control vapours as appropriate. For emergency responders Use personal protection recommended in Section 8 of the MSDS Environmental precautions Prevent entry into waterways, sewers, surface drainage systems and poorly ventilated areas Methods and material for containment and cleaning up 6.4. Reference to other sections SECTION 7: Handling and storage 7.1. Precautions for safe handling 7.2. Conditions for safe storage, including any incompatibilities 7.3. Specific end use(s) Cosmetic Product SECTION 8: Exposure controls/personal protection 8.1. Control parameters Occupational exposure limits GSK CLOBETASOL PROPIONATE ( ) Spread an inert absorbent on the spill and place in a suitable, properly labelled container for recovery or disposal. Equipment used for cleanup should be earthed (grounded) and nonsparking. No specific decontamination or detoxification procedures have been identified for this product. Water can be used for cleanup and decontamination operations. For personal protection, see section 8. For waste disposal, see section 13. Handle in open or well ventilated areas. Keep this material away from all forms of ignition such as open flames, mechanical sparks, frictional heat and hot surfaces. Keep material in sealed containers in a cool, wellventilated area away from sources of ignition. Type 8 HR TWA Value 2 mcg/m3 Form OHC 4 Skin Material name: OLUXE FOAM 0.05% Version No.: 06 Revision date: 19April2012 Issue date: 17May / 9

4 GSK Type UK. EH40 Workplace Exposure Limits (WELs) Type NBUTANE (106978) Biological limit values STEL TWA EU No biological exposure limits noted for the ingredient(s). United Kingdom No biological exposure limits noted for the ingredient(s). Recommended monitoring procedures Derived No Effect Level (DNEL) Predicted no effect concentrations (PNECs) 8.2. Exposure controls Appropriate engineering controls Individual protection measures, such as personal protective equipment General information Eye/face protection Skin protection Hand protection Other Respiratory protection Thermal hazards Hygiene measures Environmental exposure controls Hazard guidance and control recommendations Value Form 4 Reproductive hazard Value 1810 mg/m3 750 ppm 1450 mg/m3 600 ppm Wear approved safety glasses with side shields if eye contact is possible. An eye wash station should be available. Wash hands and arms thoroughly after handling. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Appearance Odour Physical state Form Colour Odour threshold ph Melting point/freezing point Initial boiling point and boiling range Flash point Evaporation rate Flammability (solid, gas) Liquid. Aerosol container. Foam. White. Upper/lower flammability or explosive limits Flammability limit lower (%) Flammability limit upper (%) Explosive limit lower (%) Material name: OLUXE FOAM 0.05% Version No.: 06 Revision date: 19April2012 Issue date: 17May / 9

5 Explosive limit upper (%) Vapour pressure Vapour density Relative density Solubility(ies) Partition coefficient (noctanol/water) Decomposition temperature Viscosity Explosive properties Oxidizing properties 9.2. Other information Percent volatile 40.3 % estimated SECTION 10: Stability and reactivity Reactivity Chemical stability Possibility of hazardous reactions Conditions to avoid Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50 degrees C. Do not puncture or incinerate when empty. Do not overheat containers, they might violently rupture Incompatible materials Hazardous decomposition products SECTION 11: Toxicological information General information Information on likely routes of exposure Ingestion Inhalation Skin contact Eye contact Symptoms Information on toxicological effects Acute toxicity CETAMACROGOL 1000 BP ( ) Acute Oral LD50 Toxic, corrosive or flammable thermal decomposition products are expected when the product is exposed to fire. This product contains active ingredient(s) with the following activity: Exposure from ingestion may occur. Exposure from inhalation may occur. Direct contact may occur. Direct contact may occur. Possible effects of overexposure in the workplace include: irritation; headache; symptoms of hypersensitivity (such as skin rash, hives, itching); May cause steroid withdrawal rash. Not expected to be toxic following ingestion. Assessment based upon effects of individual components. Species Rat CLOBETASOL PROPIONATE ( ) Acute Oral LD50 Skin corrosion/irritation Serious eye damage/eye irritation Respiratory sensitisation Skin sensitisation Germ cell mutagenicity Carcinogenicity Rat Minor irritation might occur following direct contact. Test results > 2000 mg/kg > 2000 mg/kg Irritation might occur following direct contact with eyes. May cause reddening, swelling and pain. Assessment based upon effects of individual components. No studies have been conducted. Allergic skin reactions might occur following repeated contact with this material in susceptible individuals. Symptoms of hypersensitivity may include skin rash, hives and itching. Not expected to be genotoxic, based on effects of individual components. No studies have been conducted. Material name: OLUXE FOAM 0.05% Version No.: 06 Revision date: 19April2012 Issue date: 17May / 9

6 Reproductive toxicity Specific target organ toxicity single exposure Specific target organ toxicity repeated exposure Aspiration hazard Mixture versus substance information Other information Not expected to produce adverse effects on fertility or development under occupational exposure conditions. Contains components which have been classified as: This material produced developmental toxicity in studies with experimental animals. See effects of repeat exposure. Adverse effects might occur in the following organ(s) following overexposure: adrenal glands; immune system. No studies have been conducted. No studies have been conducted. SECTION 12: Ecological information Toxicity No information is available about the potential of this material to produce adverse environmental effects. Local regulations and procedures should be consulted prior to environmental release. CLOBETASOL PROPIONATE ( ) Aquatic Acute Activated Sludge Respiration Algae Crustacea Fish IC50 NOEC EC50 NOEC EC50 NOEC EC Persistence and degradability NOEC Species Activated sludge Activated sludge Green algae (Selenastrum capricornutum) Algae Water flea (Daphnia magna) Daphnia Rainbow trout (Juvenile Oncorhyncus mykiss) Rainbow trout (Juvenile Oncorhyncus mykiss) Test results > 100 mg/l, 3 hours, Nominal 100 mg/l, 3 hours > 4.2 mg/l, 72 hours, Measured 1.3 mg/l, 72 hours > 1.4 mg/l, 48 hours, Measured 1.4 mg/l, 48 hours > 0.75 mg/l, 96 hours, Measured 0.75 mg/l, 96 hours Biodegradability Percent degradation (Aerobic biodegradationinherent) CLOBETASOL PROPIONATE < 5 %, 14 days Modified ZahnWellens, Primary biodegradation, loss Bioaccumulative potential Partition coefficient noctanol/water (log Kow) 2Phenoxyethanol 1.16 PROPANE 2.36 ISOBUTANE 2.76 NBUTANE Mobility in soil Mobility in general Results of PBT and vpvb assessment Other adverse effects SECTION 13: Disposal considerations Waste treatment methods Residual waste Contaminated packaging EU waste code Disposal methods/information Observe all local and national regulations when disposing of this product. Collect for recycling or recovery if possible. The disposal method for rejected products/returned goods must ensure that they cannot be resold or reused. Material name: OLUXE FOAM 0.05% Version No.: 06 Revision date: 19April2012 Issue date: 17May / 9

7 SECTION 14: Transport information The SDS should accompany all shipments for reference in the event of spillage or accidental release. Only authorised persons trained and competent in accordance with appropriate national and international regulatory requirements may prepare dangerous goods for transport. ADR Not regulated as dangerous goods. Not subject to ADR, see SP 601. IATA UN number ID UN proper shipping Consumer Commodity name Transport hazard 9 class(es) Subsidiary class(es) Packing group Not applicable Environmental hazards Labels required 9 ERG Code Special precautions May be able to ship as an Excepted or Limited Quantity. for user IMDG UN number UN UN proper shipping Aerosols name Transport hazard 2.1 class(es) Subsidiary class(es) Packing group Not applicable Environmental hazards Marine pollutant No Labels required 2.1 EmS No. FD, SU Special precautions May be able to ship as an Excepted or Limited Quantity. for user Transport in bulk This substance/mixture is not intended to be transported in bulk. according to Annex II of MARPOL 73/78 and the IBC Code IATA IMDG SECTION 15: Regulatory information Safety, health and environmental regulations/legislation specific for the substance or mixture EU regulations Material name: OLUXE FOAM 0.05% Version No.: 06 Revision date: 19April2012 Issue date: 17May / 9

8 Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex I Regulation (EC) No. 1005/2009 on substances that deplete the ozone layer, Annex II Regulation (EC) No. 850/2004 on persistent organic pollutants, Annex I as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 1 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 2 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex I, part 3 as amended Regulation (EC) No. 689/2008 concerning the export and import of dangerous chemicals, Annex V as amended Regulation (EC) No. 166/2006 Annex II Pollutant Release and Transfer Registry Regulation (EC) No. 1907/2006, REACH Article 59(1) Candidate List as currently published by ECHA Authorisations Regulation (EC) No. 143/2011 Annex XIV Substances Subject to Authorisation Restrictions on use Regulation (EC) No. 1907/2006, REACH Annex XVII Substances subject to restriction on marketing and use as amended Directive 2004/37/EC: on the protection of workers from the risks related to exposure to carcinogens and mutagens at work Directive 92/85/EEC: on the safety and health of pregnant workers and workers who have recently given birth or are breastfeeding Other EU regulations Directive 96/82/EC (Seveso II) on the control of majoraccident hazards involving dangerous substances National regulations Chemical safety assessment SECTION 16: Other information List of abbreviations References Information on evaluation method leading to the classification of mixture Full text of any statements or Rphrases and Hstatements under Sections 2 to 15 Revision information Training information GSK Hazard Determination R12 Extremely flammable. R22 Harmful if swallowed. R36 Irritating to eyes. R38 Irritating to skin. R48/20/21 Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin. R53 May cause long term adverse effects in the aquatic environment. R61 May cause harm to the unborn child. R62 Possible risk of impaired fertility. H220 Extremely flammable gas. H302 Harmful if swallowed. H315 Causes skin irritation. H319 Causes serious eye irritation. H360D May damage the unborn child. H361f Suspected of damaging fertility. H373 May cause damage to organs through prolonged or repeated exposure. H413 May cause long lasting harmful effects to aquatic life. TRANSPORT INFORMATION: Material Transportation Information Material name: OLUXE FOAM 0.05% Version No.: 06 Revision date: 19April2012 Issue date: 17May / 9

9 Disclaimer Issue date Revision date The information and recommendations in this safety data sheet are, to the best of our knowledge, accurate as of the date of issue. Nothing herein shall be deemed to create any warranty, express or implied. It is the responsibility of the user to determine the applicability of this information and the suitability of the material or product for any particular purpose. 17May April2012 Material name: OLUXE FOAM 0.05% Version No.: 06 Revision date: 19April2012 Issue date: 17May / 9