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 05 Revision date CICATRIN POWDER CICATRIN POWDER 15G * CICATRIN POWDER 50G * CICATRIN PO CUTANEO * CICTRIN POLVO * ZINC BACITRACIN AND NEOMYCIN SULFATE, FORMULATED PRODUCT 24April April Relevant identified uses of the substance or mixture and uses advised against Identified uses Medicinal Product 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. No other uses are advised Details of the supplier of the safety data sheet 1.4. Emergency telephone number SECTION 2: Hazards identification GlaxoSmithKline UK 980 Great West Road Brentford, Middlesex TW8 9GS UK UK General Information (normal business hours): Address: msds@gsk.com Website: TRANSPORT EMERGENCIES:: UK Incountry toll call: +(44) International toll call: available 24 hrs/7 days; multilanguage response 2.1. Classification of the substance or mixture The mixture has been assessed and/or tested for its physical, health and environmental hazards and the following classification applies. 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 Other hazards Assume that this product is capable of sustaining combustion. Caution Pharmaceutical agent. See section 11 for additional information on health hazards. Possible effects of overexposure in the workplace include: symptoms of hypersensitivity (such as skin rash, hives, itching, and difficulty breathing). SECTION 3: Composition/information on ingredients 3.2. Mixtures Version No.: 05 Revision date: 24April2014 Issue date: 24April / 8

2 General information Chemical name % CASNo. / EC No. REACH Registration No. INDEX No. Notes Starch Classification: DSD: GLYCINE 1 < 3 Classification: DSD: NEOMYCIN SULFATE <1 Classification: DSD: Xi;R36, R Skin Sens. 1;H317, Eye Irrit. 2;H319 ZINC BACITRACIN <1 Classification: DSD: R52/53 Aquatic Chronic 3;H LCYSTEINE < 0.3 Classification: DSD: Xn;R Tox. 4;H302 L()THREONINE < 0.2 Classification: DSD: Regulation No. 1272/2008. DSD: Directive 67/548/EEC. M: Mfactor vpvb: very persistent and very bioaccumulative substance. PBT: persistent, bioaccumulative and toxic substance. #: This substance has been assigned Community workplace exposure limit(s). Composition comments The full text for all R and Hphrases is displayed in section 16. SECTION 4: First aid measures General information Ensure that medical personnel are aware of the material(s) involved, and take precautions to protect themselves Description of first aid measures Inhalation Move to fresh air. Call a physician if symptoms develop or persist. Skin contact 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 Wash off with soap and water. Get medical attention if irritation develops and persists. Rinse with water. Get medical attention if irritation develops and persists. Rinse mouth. Get medical attention if symptoms occur. Direct contact with eyes may cause temporary irritation. Possible effects of overexposure in the workplace include: symptoms of hypersensitivity (such as skin rash, hives, itching, and difficulty breathing). Treat symptomatically. Assume that this product is capable of sustaining combustion Version No.: 05 Revision date: 24April2014 Issue date: 24April / 8

3 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 Water fog. Foam. Dry chemical powder. Carbon dioxide (CO2). During fire, gases hazardous to health may be formed. Selfcontained breathing apparatus and full protective clothing must be worn in case of fire. Move containers from fire area if you can do so without risk. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures For nonemergency Keep unnecessary personnel away. For personal protection, see section 8. personnel For emergency responders Keep unnecessary personnel away. Use personal protection recommended in Section 8 of the SDS Environmental precautions Avoid discharge into drains, water courses or onto the ground 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) Medicinal Product Stop the flow of material, if this is without risk. Following product recovery, flush area with water. For personal protection, see section 8. For waste disposal, see section 13. Avoid prolonged exposure. Observe good industrial hygiene practices. Store in original tightly closed container. Store away from incompatible materials (see Section 10 of the SDS). SECTION 8: Exposure controls/personal protection 8.1. Control parameters Occupational exposure limits GSK Components Type Value Note GLYCINE (CAS 56406) L()THREONINE (CAS 72195) LCYSTEINE (CAS 52904) NEOMYCIN SULFATE (CAS ) ZINC BACITRACIN (CAS ) UK. EH40 Workplace Exposure Limits (WELs) Components Type Starch (CAS ) Recommended monitoring procedures Derived No Effect Level (DNEL) Predicted no effect concentrations (PNECs) 8.2. Exposure controls 8 HR TWA 5000 mcg/m3 OHC 1 8 HR TWA 5000 mcg/m3 OHC 1 OHC 2 PROVISIONAL 8 HR TWA 2000 mcg/m3 OHC 1 SKIN SENSITISER 1 Reproductive hazard 8 HR TWA 1500 mcg/m3 OHC 1 Value Form TWA 4 mg/m3 Respirable. 10 mg/m3 Inhalable Follow standard monitoring procedures Version No.: 05 Revision date: 24April2014 Issue date: 24April / 8

4 Appropriate engineering controls Good general ventilation (typically 10 air changes per hour) should be used. Ventilation rates should be matched to conditions. If applicable, use process enclosures, local exhaust ventilation, or other engineering controls to maintain airborne levels below recommended exposure limits. If exposure limits have not been established, maintain airborne levels to an acceptable level. Individual protection measures, such as personal protective equipment General information Personal protection equipment should be chosen according to the CEN standards and in discussion with the supplier of the personal protective equipment. Eye/face protection If contact is likely, safety glasses with side shields are recommended. (eg. EN 166) Skin protection Hand protection For prolonged or repeated skin contact use suitable protective gloves. Select suitable chemical resistant protective gloves (EN 374) with a protective index 6 (>480min permeation time). Other Wear suitable protective clothing. (EN for splashes, EN ISO for dust) Respiratory protection Thermal hazards Hygiene measures In case of insufficient ventilation, wear suitable respiratory equipment. Wear appropriate thermal protective clothing, when necessary. Always observe good personal hygiene measures, such as washing after handling the material and before eating, drinking, and/or smoking. Routinely wash work clothing and protective equipment to remove contaminants. Environmental exposure controls Hazard guidance and Environmental manager must be informed of all major releases. control recommendations 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) Solid. Powder.Bottle. Upper/lower flammability or explosive limits Flammability limit lower (%) Flammability limit upper (%) Vapour pressure Vapour density Relative density Solubility(ies) Solubility (water) Solubility (other) Partition coefficient (noctanol/water) Autoignition temperature Decomposition temperature Viscosity Explosive properties Oxidizing properties 9.2. Other information No relevant additional information available. SECTION 10: Stability and reactivity Reactivity The product is stable and nonreactive under normal conditions of use, storage and transport Version No.: 05 Revision date: 24April2014 Issue date: 24April / 8

5 10.2. Chemical stability Material is stable under normal conditions Possibility of hazardous reactions No dangerous reaction known under conditions of normal use Conditions to avoid Heat, flames and sparks. Contact with incompatible materials. Minimise dust generation and accumulation. Avoid dispersal of dust in the air (i.e., clearing dust surfaces with compressed air) Incompatible materials Acids Hazardous decomposition products SECTION 11: Toxicological information General information Irritating and/or toxic fumes and gases may be emitted upon the products decomposition. Occupational exposure to the substance or mixture may cause adverse effects. Information on likely routes of exposure Ingestion Inhalation Skin contact Eye contact Symptoms Information on toxicological effects toxicity Components GLYCINE (CAS 56406) Oral LD50 LCYSTEINE (CAS 52904) Oral LD50 May cause skin irritation. May be irritating to eyes. The possible symptoms of overexposure include: symptoms of hypersensitivity (such as skin rash, hives, itching, and difficulty breathing). Species Rat Rat NEOMYCIN SULFATE (CAS ) Oral LD50 Mouse * Estimates for product may be based on additional component data not shown. Skin corrosion/irritation Serious eye damage/eye irritation Respiratory sensitisation Skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity single exposure Specific target organ toxicity repeated exposure Aspiration hazard Mixture versus substance information Other information May be irritating to the skin. May be irritating to eyes. Test results 7930 mg/kg 1890 mg/kg > 8000 mg/kg Contains a potential skin sensitizer. May cause an allergic skin reaction. None known. None known. SECTION 12: Ecological information Not likely, due to the form of the product. No information available. Caution Pharmaceutical agent Toxicity No information is available about the potential of this product to produce adverse environmental effects. Contains a substance which causes risk of hazardous effects to the environment. The product contains a substance which may cause longterm adverse effects in the environment Version No.: 05 Revision date: 24April2014 Issue date: 24April / 8

6 Components GLYCINE (CAS 56406) Aquatic Fish EC50 ZINC BACITRACIN (CAS ) Aquatic Algae NOEC Crustacea EC50 Fish EC50 Species Fathead minnow (Adult Pimephales promelas) Algae Water flea (Daphnia magna) Rainbow trout (Adult Oncorhyncus mykiss) Test results > 100 mg/l > 10 mg/l 34 mg/l, 48 hours 74 mg/l, 96 hours * Estimates for product may be based on additional component data not shown Persistence and degradability Photolysis Halflife (Photolysisatmospheric) GLYCINE Biodegradability Percent degradation (Aerobic biodegradationready) GLYCINE Percent degradation (Aerobic biodegradationsoil) ZINC BACITRACIN Bioaccumulative potential Partition coefficient noctanol/water (log Kow) GLYCINE 3.21 LCYSTEINE Mobility in soil Adsorption Soil/sediment sorption log Koc GLYCINE Mobility in general Volatility Henry's law GLYCINE 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 Special precautions SECTION 14: Transport information ADR Not regulated as dangerous goods. 4.6 Hours Estimated % BOD20 > 50 %, 20 Days 0 Estimated 0 atm m^3/mol Estimated Dispose of in accordance with local regulations. Empty containers or liners may retain some product residues. This material and its container must be disposed of in a safe manner (see: Disposal instructions). Empty containers should be taken to an approved waste handling site for recycling or disposal. Since emptied containers may retain product residue, follow label warnings even after container is emptied. The Waste code should be assigned in discussion between the user, the producer and the waste disposal company. Collect and reclaim or dispose in sealed containers at licensed waste disposal site. Dispose in accordance with all applicable regulations Version No.: 05 Revision date: 24April2014 Issue date: 24April / 8

7 IATA Not regulated as dangerous goods. IMDG Not regulated as dangerous goods Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code SECTION 15: Regulatory information MARPOL Annex II applies to liquids used in a ship's operation that pose a threat to the marine environment. These materials may not be transported in bulk Safety, health and environmental regulations/legislation specific for the substance or mixture EU regulations 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. 1907/2006, REACH Annex XIV Substances subject to authorization, as amended 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 Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work Directive 94/33/EC on the protection of young people at work Other regulations National regulations Chemical safety assessment SECTION 16: Other information List of abbreviations References The product is classified and labelled in accordance with EC directives or respective national laws. This Safety Data Sheet complies with the requirements of Regulation (EC) No 1907/2006. Follow national regulation for work with chemical agents. No Chemical Safety Assessment has been carried out. GSK Hazard Determination Version No.: 05 Revision date: 24April2014 Issue date: 24April / 8

8 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 Disclaimer The classification for health and environmental hazards is derived by a combination of calculation methods and test data, if available. R22 Harmful if swallowed. R36 Irritating to eyes. R43 May cause sensitization by skin contact. R52/53 Harmful to aquatic organisms, may cause longterm adverse effects in the aquatic environment. H302 Harmful if swallowed. H317 May cause an allergic skin reaction. H319 Causes serious eye irritation. H412 Harmful to aquatic life with long lasting effects. Product and Company Identification: Product and Company Identification Composition / Information on Ingredients: Ingredients Physical & Chemical Properties: Transport Information: Agency Name and Packaging Type/Transport Mode Selection Regulatory Information: United States Follow training instructions when handling this material. 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 Version No.: 05 Revision date: 24April2014 Issue date: 24April / 8