Ficha de Datos de Seguridad Conforme al Reglamento (CE) Nº 1907/2006 (REACH) Denominación: Prednicarbato

Transcripción

1 1.- Identificación de la sustancia o del preparado y de la sociedad o empresa Identificación de la sustancia o del preparado Denominación: Prednicarbato Identificación de la sociedad o empresa: Acofarma Distribución S.A. C/ Llobregat, 20. Pol. ind. Santa Margarita , Terrassa (Barcelona). España. Tel: / Fax: Teléfono de urgencias: Acofarma Distribución S.A. Telf Horario: lunes a jueves de 9 a 18 h, viernes de 8 a 15 h (horario de verano: lunes a viernes de 8 a 15 h). 2.- Identificación de los peligros Clasificación de la sustancia o de la mezcla De acuerdo al Reglamento (EC) No1272/2008 Toxicidad aguda (por inhalación), categoría 4. Toxicidad aguda (cutánea), categoría 4. Toxicidad agua (oral), categoría 4. Elementos de la etiqueta Pictograma Palabra de advertencia Atención Indicación(es) de peligro H332. Nocivo en caso de inhalación. H312: Nocivo en contacto con la piel. H302: Nocivo en caso de ingestión. Declaración(es) de prudencia P261: Evitar respirar el polvo/el humo/el gas/la niebla/los vapores/el aerosol. P280: Llevar guantes/prendas/gafas/máscara de protección. Otros Peligros - ninguno(a) 3.- Composición/información sobre los componentes CAS-Nº: PM: 488,57 g/mol Fórmula molecular: C27H3608 EINECS-Nº Primeros auxilios After inhalation: If breathed in, move person into fresh air. If not breathing give artificial respiration. Call a physician. Página 1 de 4

2 After ingestion: if swallowed, wash out mouth with water provided person is conscious. Never give anything by mouth to an unconscious person. Call a physician. After skin contact:: In case of contact, immediately wash skin with soap and copious amounts of water. Remove contaminated clothes. Call a physician. After eye contact: Separate the eyelids with fingers and flush with copious amounts of water for 15 minutes. Call a physician. Most important symptoms and effects, both acute and delayed Symptoms: No information available. Effects: No information available. Indication of immediate medical attention and special treatment needed Treatment : Treat symptomatically. No further information available. 5.- Medidas de lucha contra incendios Extinguishing media: Water spray, carbon dioxide, dry chemical powder or appropriate foam. Special risks: Emits toxic fumes under fire conditions: Carbon dioxide, carbon monoxide As with all dry powders it is advisable to ground mechanical equipment in contact with dry material to dissipate the potential buildup of static electricity. Special Protective Equipment for Firefighters: Wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes. 6.- Medidas a tomar en caso de vertido accidental Procedure(s) of personal precaution(s): Use personal protective equipment. Avoid breathing dust. Ensure adequate ventilation. Evacuate personnel to safe areas. Methods for cleaning up: Sweep up, place in a bag labelled and tightly closed for disposal according to local / national regulations (see section 13). Avoid raising dust. Ventilate area and wash spill site after material pickup is complete. Environmental precautions: Prevent further leakage or spillage. Do not let product enter drains. 7.- Manipulación y almacenamiento Handling: Do not breathe dust. Do not get in eyes, on skin or on clothing. Avoid prolonged or repeated exposure. Provide appropriate exhaust ventilation at places where dust is formed. Wash thoroughly after handling. Storage: Keep container tightly closed in a dry and well-ventilated place.. Store in a temperature controlled room. 8.- Controles de exposición/protección personal Engineering controls: Use in a chemical fume hood. Safety shower and eye bath. General hygiene measures: Wash contaminated clothing before reuse. Wash thoroughly after handling and before eating or drinking. Página 2 de 4

3 Personal protective equipment: Respiratory protection: A exposure risk assessment should be done in order to choose appropriate respiratory protection. Use respirators and components tested and under appropriate government standards such as NIOSH (US) or CEN (EU). Hand protection: Rubber gloves, according to EU Directive 89/686/EEC and the standard EN374 derived from it. Eye protection: Chemical safety goggles, according to EN166. Body protection: Protect skin exposed. 9.- Propiedades físicas y químicas Appearance: Crystalline powder, white or almost white Odour: n/a Odour threshold: n/a ph: n/a Melting point/freezing point: ºC Initial boiling point and boiling range: n/a Flash point: n/a Evaporation rate: n/a Flammability (solid, gas): n/a Upper/lower flammability or explosive limits: n/a Vapour pressure: n/a Vapour density: n/a Relative density: n/a Solubility(ies): n/a Partition coefficient: n-octanol/water: n/a Auto-ignition temperature: n/a Decomposition temperature: n/a Viscosity: n/a Explosive properties: n/a Oxidising properties: n/a 10.- Estabilidad y reactividad Reactivity: No information available. Chemical stability: Stable under recommended storage conditions Possibility of hazardous reactions: No information available Conditions to avoid: No information available Incompatible materials: strong oxidizing agents. Hazardous decomposition products: Carbon oxides 11.- Información toxicológica Acute toxicity data: LD50 (oral, rat): > 8000 mg/kg LD (oral, mouse): 3102 mg/kg LD50 (subc, rat): 1366 mg/kg LD50 (topic, rabbit): > 1250 mg/kg Skin corrosion/irritation: No information available Página 3 de 4

4 Serious eye damage/irritation: No information available Respiratory or skin sensitization: SUBACUTE TOXICITY scu, rat) Dose: 0,2 mg/kg. Produce a dose-dependent inhibition in gain of body weight and decrease lymphocytes and increase segmented neutrophils. [Product monograph: Dermatop] (scu,rat) Dose: 0,8 mg/kg. Increase serum GOT and GPT levels and decrease weight of adrenals. The changes were reversible and considered typical of large doses of corticosteroids. [Product monograph: Dermatop] Germ cell mutagenicity: Ames test: Negative Micronucleus test: Negative HGPRT mutation assay: Negative Carcinogenicity: No information available Reproductive toxicity: REPRODUCTIVE HAZARD: In a study of the effect of Prednicarbate on fertility, pregnancy, and postnatal development in rats, no effect was noted on the fertility or pregnancy of the parent animals or postnatal development of the offspring after administration of up to 0.80 mg/kg of Prednicarbate subcutaneously. Prednicarbate has been shown to be teratogenic and embryotoxic in rats and rabbits at doses 1900 times and 45 times, respectively, the recommended human dose. Corticosteroids ar generally teratogenic in laboratory animals when administered systematically at relatively low dosages. The more potent corticosteroids have been shown to be teratogenic in animals after dermal application. There are not adequate and well-controlled studies of the teratogenic effects of topically applied corticosteroids in pregnant women. STOT-single exposure: No information available STOT-repeated exposure: No information available Aspiration hazard: No information available Route of exposure: Skin contact: May be harmful if absorbed through skin. May cause skin irritation. Eye contact: may cause eye irritation: May cause eye irritation Inhalation: May be harmful if inhaled. May cause respiratory tract irritation Ingestion: May be harmful if swallowed Absence of specific data There isn t specific data Informaciones ecológicas Toxicity: n/a Persistence and degradability: n/a Bioaccumulative potential: n/a Mobility in soil: n/a Other adverse effects: n/a 13.- Consideraciones relativas a la eliminación Waste treatment methods: Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Observe all federal, state, and local environmental regulations. Packaging: Contaminated packaging must be handled in the same way as the material: it must be managed by an authorized external company according to all federal, state and local regulations. Uncontaminated Página 4 de 4

5 packaging be treated as household waste or recyclable material. Certificate of the final treatment must be submitted by the external company Información relativa al transporte No sometido a las normas de transporte de mercancías peligrosas Información Reglamentaria La hoja técnica de seguridad cumple con los requisitos de la Reglamento (CE) No. 1907/ Otras informaciones Texto de códigos H mencionados en la sección 2 Fecha de emisión: 14/07/2015 Los datos suministrados en esta ficha de seguridad se basan en nuestro actual conocimiento. Describen tan sólo las medidas de seguridad en el manejo de este producto y no representan una garantía sobre las propiedades descritas del mismo. Página 5 de 4