PRODUCT SAFETY DATA SHEET Based upon Regulation (EC) No /2006

Transcription

1 1. IDENTIFICATION OF THE SUBSTANCE AND OF THE COMPANY 1.1 Product Identifier Trade Name: LBF Sterile No Sting Barrier Film 1ml & 2ml Foam Applicators Product code: 3824 & 3825 respectively 1.2 Intended use: To provide a barrier film 1.3 Details of the supplier of the safety data sheet Company: CliniMed Ltd Cavell House Knaves Beech Way Loudwater High Wycombe Bucks HP10 9QY Phone Number CliniMed +44 (0) Mobile +44 (0) arvind.patel@clinimed.co.uk 2. HAZARDS IDENTIFICATION This product is regulated as a medical device as in accordance with Directive 93/42/EEC as amended and labelled accordingly. The product is assessed and supplied with a safety data sheet in accordance with Regulation (EC) no 1272/ Classification Flammable liquids, Category 2 Acute aquatic toxicity, Category 1 Chronic aquatic toxicity, Category 2 Highly flammable Dangerous for the environment H225: Highly flammable liquid and vapour. H400: Very toxic to aquatic life. H411: Toxic to aquatic life with long lasting effects. R11: Highly flammable. R50: Very toxic to aquatic organisms. 2.2 Label elements The product is a medical device and therefore the labelling elements from the CLP regulations do not apply, according to Regulation (EC) No 1272/2008, Title I, Article 1, Section 5. The below illustrated pictograms, signal words and hazard statements are therefore only listed in the present MSDS and not necessarily present on the product labelling. Hazard pictograms: Signal word: Danger Hazard statements: H225 Highly flammable liquid and vapour. H410 Very toxic to aquatic life with long lasting effects. Precautionary statements: Page 1 of 14

2 Prevention: P210 Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P233 Keep container tightly closed. P261 Avoid breathing spray. P271 Use only outdoors or in a well-ventilated area. P273 Avoid release to the environment. 3. COMPOSITION / INFORMATION ON INGREDIENTS 3.2 Mixtures Chemical nature: Silicone Hazardous components Chemical Name CAS-No. EC-No. Classification (67/548/EEC) Classification (REGULATION (EC) No 1272/2008) Concentration % Hexamethyldisiloxane F; R11 N; R50 Flam. Liq. 2; H225 Aquatic Acute 1; H400 Aquatic Chronic 2; H411 >= 90 - <= 100 Substances with a workplace exposure limit : Decamethylcyclopentasiloxane >=1-<10 4. FIRST AID MEASURES On contact with eyes : Flush eyes with water as a precaution On skin contact : Following excessive contact, wash with water and soap as a precaution If inhaled : Remove to fresh air On ingestion: : Do not induce vomiting. Obtain medical attention Page 2 of 14

3 5. FIRE FIGHTING MEASURES Suitable extinguishing media : Water spray, alcohol-resistant foam, dry chemical, carbon dioxide. Unsuitable extinguishing : Water Jet media Hazards during fire fighting : Do not use high volume water jet as it may scatter and spread fire Flash back possible over considerable distance Vapours may form explosive mixtures with air Fire burns more vigorously than would be expected Exposure to combustion products may be a hazard to health. Special protective equipment / procedures Hazardous combustion products : Wear self-contained breathing apparatus for firefighting if necessary Use personal protective equipment : Carbon oxides Silicon oxides Formaldehyde 6. ACCIDENTALRELEASE MEASURES Personal precautions : In the event of spillage ensure all sources of ignition are removed. Soak up spillage with absorbent materials and place residue in a lidded metal container. Dispose of in accordance with local regulations. Precautions to protect the environment : Do not empty into drains Methods for cleaning up : Use absorbent materials and dispose of residue in accordance with local regulations. Clean area with water. 7. HANDLING AND STORAGE Advice on safe handling : Handle in accordance with good industrial hygiene and safety practice Keep away from heat and sources of ignition Advice on storage : Store in a well ventilated area away from heat and sources of ignition 8. CONTROLS PARAMETERS Value type Components CAS-No. (Form of exposure) Control parameters Basis Hexamethyldisiloxane TWA 200ppm DCC OEL Decamethylcyclopentasiloxane TWA 10 ppm DCC OEL Page 3 of 14

4 Derived No Effect Level (DNEL) according to Regulation (EC) No. 1907/2006: Exposure routes: Skin contact Potential health effects: Acute systemic effects Value: 25 mg/kg bw/day Exposure routes: Inhalation Potential health effects: Acute systemic effects Value: 266 mg/m3 Exposure routes: Skin contact Potential health effects: Long-term systemic effects Value: 25 mg/kg bw/day Exposure routes: Inhalation Potential health effects: Long-term systemic effects Value: 266 mg/m3 Exposure routes: Ingestion Potential health effects: Long-term systemic effects Value: 25 mg/kg bw/day Decamethylcyclopentasiloxane : Exposure routes: Inhalation Potential health effects: Acute systemic effects Value: 17.3 mg/m3 Exposure routes: Inhalation Potential health effects: Acute local effects Value: 4.3 mg/m3 Exposure routes: Inhalation Potential health effects: Long-term systemic effects Value: 17.3 mg/m3 Exposure routes: Inhalation Potential health effects: Long-term local effects Value: 4.3 mg/m3 Exposure routes: Ingestion Potential health effects: Acute systemic effects Value: 5 mg/kg bw/day Exposure routes: Ingestion Potential health effects: Long-term systemic effects Value: 5 mg/kg bw/day Predicted No Effect Concentration (PNEC) according to Regulation (EC) No. 1907/2006: Fresh water Value: mg/l Marine water Value: mg/l Fresh water sediment Value: 0.37 mg/kg Page 4 of 14

5 Marine sediment Value: mg/kg Soil Value: mg/kg Sewage treatment plant Value: >= 10 mg/l Decamethylcyclopentasiloxane : Fresh water Value: mg/l Marine water Value: mg/l Fresh water sediment Value: 2.39 mg/kg Marine sediment Value: mg/kg Soil Value: 3.34 mg/kg Sewage treatment plant Value: > 10 mg/l 8.2 Exposure controls General ventilation recommended Personal protection: Not required in normal use. 9. PHYSICAL AND CHEMICAL PROPERTIES 9.1 Information on basic physical and chemical properties Appearance: Wet Wipe Colour: White Odour: Slight Odour Odour Threshold: No data available ph: No data available Melting point/freezing point: No data available Initial boiling point and boiling range: 100 C Flash point: C, Method: Pensky-Martens closed cup Evaporation rate: No data available Flammability (solid, gas): Not applicable Upper explosion limit: No data available Lower explosion limit: No data available Vapour pressure: No data available Relative vapour density: No data available Relative density: 0.78 Solubility(ies) Water solubility: No data available Partition coefficient: n-octanol/water: No data available Auto-ignition temperature: No data available Decomposition temperature: No data available Viscosity, kinematic: 0.7 mm2/s Explosive properties: Not explosive Oxidizing properties: The substance or mixture is not classified as oxidizing. 9.2 Other information Molecular weight : No data available Page 5 of 14

6 10. STABILITY AND REACTIVITY 10.1 Reactivity Not classified as a reactivity hazard Chemical stability Stable under normal conditions Possibility of hazardous reactions Highly flammable liquid and vapour Vapours may form explosive mixture with air Can react with strong oxidising agents When heated to temperatures above 150 C in the presence of air, trace quantities of formaldehyde may be released Adequate ventilation is required Hazardous decomposition products will be formed at elevated temperatures 10.4 Conditions to avoid Handling operations that can promote accumulation of static charges. Heat, flames and sparks Incompatible materials Oxidizing agents 10.6 Hazardous decomposition products Carbon and Silicon oxides on combustion traces of formaldehyde 11. TOXICOLOGICAL INFORMATION 11.1 Information on toxicological effects Information on likely routes of Exposure: Inhalation Skin contact Ingestion Eye contact Acute toxicity: Not classified based on available information. Acute oral toxicity: LD50 (Rat): >16 ml/kg Assessment: The substance or mixture has no acute oral toxicity Acute inhalation toxicity: LC50 (Rat): ppm, Exposure time: 4 h, Test atmosphere: vapour Assessment: The substance or mixture has no acute inhalation toxicity Acute dermal toxicity: LD50 (Rat): > 2,000 mg/kg Assessment: The substance or mixture has no acute dermal toxicity Acute oral toxicity: LD50 (Rat): > 24,134 mg/kg Assessment: The substance or mixture has no acute oral toxicity Page 6 of 14

7 Acute inhalation toxicity: LC50 (Rat): 8.67 mg/l Exposure time: 4 h Test atmosphere: dust/mist Assessment: The substance or mixture has no acute inhalation toxicity Skin corrosion/irritation Not classified based on available information. Species: Rabbit Result: No skin irritation Serious eye damage/eye irritation Not classified based on available information. Species: Rabbit Result: No eye irritation Respiratory or skin sensitisation Skin sensitisation: Not classified based on available information. Respiratory sensitisation: Not classified based on available information. Assessment: Does not cause skin sensitisation. Test Type: Human repeat insult patch test (HRIPT) Species: Humans Remarks: No known sensitising effect. Based on test data Germ cell mutagenicity Not classified based on available information. Genotoxicity in vitro: Test Type: Bacterial reverse mutation assay (AMES) : Test Type: Chromosome aberration test in vitro : Test Type: Mutagenicity (in vitro mammalian cytogenetic test) : Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro) Genotoxicity in vivo: Test Type: Mutagenicity (in vivo mammalian bone-marrow cytogenetic test, chromosomal analysis) Application Route: Intraperitoneal injection Page 7 of 14

8 Germ cell mutagenicity- Assessment: Animal testing did not show any mutagenic effects. Genotoxicity in vitro: Test Type: Bacterial reverse mutation assay (AMES) Genotoxicity in vivo: Test Type: Unscheduled DNA synthesis (UDS) test with mammalian liver cells in vivo Application Route: inhalation (vapour) Germ cell mutagenicity- Assessment Animal testing did not show any mutagenic effects. Carcinogenicity Not classified based on available information Application Route: inhalation (vapour) Carcinogenicity - Assessment: Animal testing did not show any carcinogenic effects. Reproductive toxicity Not classified based on available information. Hexamethyldisiloxane Effects on fertility: Test Type: Two-generation reproduction toxicity study, male and female Application Route: inhalation (vapour) Symptoms: No effects on fertility Effects on foetal development: Test Type: Two-generation reproduction toxicity study, male and female Application Route: inhalation (vapour) Symptoms: No effects on foetal development Reproductive toxicity - Assessment: No evidence of adverse effects on sexual function and fertility, or on development, based on animal experiments. Effects on fertility: Test Type: Two-generation reproduction toxicity study Application Route: Inhalation Symptoms: No effects on fertility Effects on foetal development: Test Type: Two-generation reproduction toxicity study Application Route: Inhalation Symptoms: No effects on foetal development Reproductive toxicity - Assessment: No evidence of adverse effects on sexual function and fertility, or on development, based on animal experiments. STOT - single exposure Not classified based on available information. STOT - repeated exposure Page 8 of 14

9 Not classified based on available information. Exposure routes: Ingestion Assessment: No significant health effects observed in animals at concentrations of 100 mg/kg bw or less. Exposure routes: inhalation (vapour) Assessment: No significant health effects observed in animals at concentrations of 1 mg/l/6h/d or less. Exposure routes: Skin contact Assessment: No significant health effects observed in animals at concentrations of 200 mg/kg bw or less. Exposure routes: Skin contact Assessment: No significant health effects observed in animals at concentrations of 200 mg/kg bw or less. Exposure routes: Ingestion Assessment: No significant health effects observed in animals at concentrations of 100 mg/kg bw or less. Exposure routes: inhalation (vapour) Assessment: No significant health effects observed in animals at concentrations of 1 mg/l/6h/d or less. Repeated dose toxicity Application Route: Ingestion Application Route: inhalation (vapour) Application Route: Skin contact Application Route: Skin contact Application Route: Ingestion Application Route: inhalation (vapour) Aspiration toxicity Not classified based on available information. Further information Remarks: This material contains hexamethyldisiloxane (HMDS). Repeated inhalation exposure in rats to HMDS resulted in protoporphyrin accumulation in the liver. Without knowledge of the specific mechanism leading to the protoporphyrin accumulation the relevance of this finding to humans is unknown. Page 9 of 14

10 Remarks: Results from a 2 year repeated vapour inhalation exposure study to rats of decamethylcyclopentasiloxane (D5) indicate effects (uterine endometrial tumours) in female animals. This finding occurred at the highest exposure dose (160 ppm) only. Studies to date have not demonstrated if this effect occurs through a pathway that is relevant to humans. Based on the available information on its potential to cause harm to human health, Health Canada, in a 2008 screening assessment, has concluded that D5 is not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health ( 12. ECOLOGICAL INFORMATION Page 10 of 14

11 12.1 Toxicity Toxicity to fish: LC50 (Oncorhynchus mykiss (rainbow trout)): 0.46 mg/l Exposure time: 96 h Toxicity to algae: EC50 (Selenastrum capricornutum (green algae)): > 0.55 mg/l Exposure time: 96 h Remarks: No toxicity at the limit of solubility Based on test data M-Factor (Acute aquatic toxicity): 1 Toxicity to daphnia and other aquatic invertebrates (Chronic toxicity): NOEC: 0.08 mg/l Exposure time: 21 d Species: Daphnia sp. Ecotoxicology Assessment Chronic aquatic toxicity: Toxic to aquatic life with long lasting effects. Toxicity to fish (Chronic toxicity): Remarks: No toxicity at the limit of solubility Toxicity to daphnia and other aquatic invertebrates (Chronic toxicity): Remarks: No toxicity at the limit of solubility Ecotoxicology Assessment Chronic aquatic toxicity: This product has no known ecotoxicological effects Persistence and degradability Biodegradability: Result: Not readily biodegradable. Stability in water: Degradation half-life: 116 h ph: 7 Method: OECD Test Guideline 111 Biodegradability: Result: Not readily biodegradable. Biodegradation: 0.14 % Exposure time: 28 d Method: OECD Test Guideline Bioaccumulative potential Partition coefficient: noctanol/water: log Pow: >= 4 Bioaccumulation: Species: Pimephales promelas (fathead minnow) Bioconcentration factor (BCF): >= 500 Trophic magnification factor <1 Biomagnification factor <1 Does not biomagnify along the food chain. Page 11 of 14

12 12.4 Mobility in soil No data available 12.5 Results of PBT and vpvb assessment Assessment: Remarks: Decamethylcyclopentasiloxane (D5) meets the current REACh Annex XIII criteria for vpvb. However, D5 does not behave similarly to known PBT/vPvB substances. The weight of scientific evidence from field studies shows that D5 is not biomagnifying in aquatic and terrestrial food webs. D5 in air will degrade by reaction with naturally occurring hydroxyl radicals in the atmosphere. Any D5 in air that does not degrade by reaction with hydroxyl radicals is not expected to deposit from the air to water, to land, or to living organisms. Based on an independent scientific panel of experts, the Canadian Minister of the Environment has concluded that "D5 is not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long term harmful effect on the environment or its biological diversity, or that constitute or may constitute a danger to the environment on which life depends". 13. DISPOSAL CONSIDERATIONS Product disposal Dispose of in accordance with local regulations for domestic waste Packaging disposal Dispose of in accordance with local regulations. 14. TRANSPORT INFORMATION Road (ADR) UN No. : 3175 Proper Shipping Name : Solids containing flammable liquid Class : 4.1 Packing group : II Labels : : Limited Quantity; Exempt by provision 216 (sealed packets contain less than 10ml of packing group 2 flammable liquid absorbed into a solid material with no free liquid in the packet) Sea transport (IMDG) UN No. : 3175 Proper Shipping Name : Solids containing flammable liquid n.o.s Class : 4.1 Packing group : II Marine pollutant : Limited Quantity Labels : : Limited Quantity; Exempt by provision 216 (sealed packets contain less than 10ml of packing group 2 flammable liquid absorbed into a solid material with no free liquid in Page 12 of 14

13 the packet) Air transport (IATA) UN No. : 3175 Proper Shipping Name : Solids containing flammable liquid n.o.s Class : 4.1 Packing group : II Labels : : Limited Quantity; Exempt by provision 216 (sealed packets contain less than 10ml of packing group 2 flammable liquid absorbed into a solid material with no free liquid in the packet) 15. REGULATORY INFORMATION Labelling according to EEC Directive Symbols : R-phrases : R11 Highly flammable. R50/53 Very toxic to aquatic organisms. Hazard Statements : Not applicable to labelling of medical devices as per Article 1 5d of EC Regulation 1272/2008 Precautionary Statements : Not applicable to labelling of medical devices as per Article 1 5d of EC Regulation 1272/2008 National legislation / regulations Ozone depleting Chemicals : No ozone depleting chemicals are present or used in manufacture. Status EINECS : All ingredients listed or exempt TSCA : All chemical substances in this material are included on or exempted from listing on the TSCA Inventory of Chemical Substances. Page 13 of 14

14 16. ADDITIONAL INFORMATION The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance for safe handling, use, processing, storage, transportation, disposal and release and shall not be considered a warranty or quality specification of any type. The information provided relates only to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text. Material users should review the information and recommendations in the specific context of their intended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user s end product, if applicable. Page 14 of 14