Nombre del producto

SECTION 2: Hazards identification

1272/2008 Specific M-Factor registration Index No) according to concentration (long-term) number Regulation limit (SCL) (EC) No.

Hazard statements

see section 16 Acute Toxicity Estimate No information available This product does not contain candidate substances of very high concern at a concentration >=0.1% (Regulation (EC) No.

Storage

Conditions Keep container tightly closed in a dry and well-ventilated place. 7.3. Specific end use(s) Usos específicos Solo para uso en investigaciones. Medidas de gestión del riesgo La información requerida se ofrece en esta Ficha de Datos de Seguridad. (RMM) SECTION 8: Exposure controls/personal protection 8.1. Control parameters Exposure Limits This product, as supplied, does not contain any hazardous materials with occupational exposure limits established by the region specific regulatory bodies. Biological occupational exposure This product, as supplied, does not contain any hazardous materials with biological limits limits established by the region specific regulatory bodies. Derived No Effect Level (DNEL) - Workers No information available Derived No Effect Level (DNEL) - General Public No information available. Predicted No Effect Concentration (PNEC) No information available. 8.2. Exposure controls Engineering controls No information available. Equipo de protección personal Eye/face protection Appropriate eye/face protection should be selected and used according to the chemical nature, hazards and use of this product and safety requirements of the local jurisdiction. Hand protection Appropriate hand protection should be selected and used according to the chemical nature, hazards and use of this product and safety requirements of the local jurisdiction. Skin and body protection Appropriate skin and body protection should be selected and used according to the chemical nature, hazards and use of this product and safety requirements of the local jurisdiction. Respiratory protection Appropriate respiratory protection should be selected and used according to the chemical nature, hazards and use of this product and safety requirements of the local jurisdiction. If exposure limits are exceeded or irritation is experienced, ventilation and evacuation may be required. General hygiene considerations Handle in accordance with good industrial hygiene and safety practice. Environmental exposure controls No information available. SECCIÓN 9: Propiedades físicas y químicas 9.1. Information on basic physical and chemical properties Physical state Solid Aspecto torta liofilizada Color Blanco a blancuzco Olor No hay información disponible. Umbral olfativo No hay información disponible Property Values

Remarks

Method Melting point / freezing point No data available No se conocen Initial boiling point and boiling No data available No se conocen range Inflamabilidad No data available No se conocen Flammability Limit in Air No se conocen Upper flammability or explosive No data available limits Lower flammability or explosive No data available limits Punto de inflamación No data available No se conocen Temperatura de autoinflamación No data available No se conocen Temperatura de descomposición No se conocen pH No data available No aplicable pH (como solución acuosa) No data available None known Viscosidad cinemática No data available No se conocen Viscosidad dinámica No data available No se conocen Water solubility No data available No se conocen Solubilidad(es) No data available No se conocen Coeficiente de reparto No data available No se conocen Presión de vapor No data available No se conocen Densidad relativa No data available No aplicable Densidad aparente No data available Liquid Density no hay datos disponibles Relative vapor density No data available No se conocen Particle characteristics Particle Size No hay información disponible Particle Size Distribution No hay información disponible

Further information

9.2.1. Information with regard to physical hazard classes No aplicable 9.2.2. Other safety characteristics No hay información disponible SECCIÓN 10: Estabilidad y reactividad 10.1. Reactivity Reactivity No information available. 10.2. Chemical stability Stability Stable under normal conditions. Datos de explosión Sensitivity to mechanical impact None. Sensitivity to static discharge None. 10.3. Possibility of hazardous reactions Possibility of hazardous reactions None under normal processing. 10.4. Conditions to avoid Conditions to avoid None known based on information supplied. 10.5. Incompatible materials Incompatible materials None known based on information supplied. 10.6. Hazardous decomposition products Hazardous decomposition products No se conocen de acuerdo con la información suministrada. SECCIÓN 11: Información toxicológica 11.1. Information on hazard classes as defined in Regulation (EC) No 1272/2008 Information on likely routes of exposure Product Information Inhalation Specific test data for the substance or mixture is not available. Eye contact Specific test data for the substance or mixture is not available. Skin contact Specific test data for the substance or mixture is not available. Ingestion Specific test data for the substance or mixture is not available. Symptoms related to the physical, chemical and toxicological characteristics Symptoms No information available. Acute toxicity Numerical measures of toxicity No information available The following values are calculated based on chapter 3.1 of the GHS document ATEmix (oral) 37,336.00 mg/kg 95.55 % of the mixture consists of ingredient(s) of unknown acute oral toxicity. 95.55 % of the mixture consists of ingredient(s) of unknown acute dermal toxicity. 95.55 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (gas). 95.55 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (vapor). 95.55 % of the mixture consists of ingredient(s) of unknown acute inhalation toxicity (dust/mist). Efectos retardados e inmediatos, así como efectos crónicos producidos por una exposición a corto y largo plazo Skin corrosion/irritation No information available. Serious eye damage/eye irritation No information available. Respiratory or skin sensitization No information available. Germ cell mutagenicity No information available. Carcinogenicity No information available. Reproductive toxicity No information available. STOT - single exposure No information available. STOT - repeated exposure No information available. Aspiration hazard No information available. 11.2. Information on other hazards 11.2.1. Endocrine disrupting properties Endocrine disrupting properties No information available. 11.2.2. Other information Otros efectos adversos No hay información disponible. SECCIÓN 12: Información ecológica 12.1. Toxicity Ecotoxicity The environmental impact of this product has not been fully investigated. Unknown aquatic toxicity Contains 77.95 % of components with unknown hazards to the aquatic environment. Chemical name Algae/aquatic plants Fish Toxicity to Crustacea microorganisms Alpha-cyclodextrin - LC50: >=100mg/L (96h, - Oncorhynchus mykiss) 12.2. Persistence and degradability Persistencia y degradabilidad No hay información disponible. 12.3. Bioaccumulative potential Bioaccumulation There is no data for this product. 12.4. Mobility in soil Movilidad en el suelo No hay información disponible. 12.5. Results of PBT and vPvB assessment PBT and vPvB assessment The product does not contain any substance(s) classified as PBT or vPvB above the threshold of declaration. Chemical name PBT and vPvB assessment Alpha-cyclodextrin The substance is not PBT / vPvB 12.6. Endocrine disrupting properties Endocrine disrupting properties No information available. 12.7. Other adverse effects No hay información disponible. SECTION 13: Disposal considerations 13.1. Waste treatment methods Waste from residues/unused Dispose of in accordance with local regulations. Dispose of waste in accordance with products environmental legislation. Contaminated packaging Do not reuse empty containers. SECCIÓN 14: Información relativa al transporte IATA 14.1 UN number or ID number Not regulated 14.2 14.3 Transport hazard class(es) Not regulated 14.4 Grupo de embalaje No regulado 14.5 Peligros para el medio No aplicable ambiente 14.6 Special precautions for user Disposiciones especiales Ninguno(a) IMDG 14.1 UN number or ID number Not regulated 14.2 14.3 Transport hazard class(es) No regulado 14.4 Grupo de embalaje No regulado 14.5 Peligros para el medio No aplicable ambiente 14.6 Special precautions for user Disposiciones especiales Ninguno(a) 14.7 Maritime transport in bulk No hay información disponible according to IMO instruments RID 14.1 UN number or ID number No regulado 14.2 14.3 Transport hazard class(es) No regulado 14.4 Grupo de embalaje No regulado 14.5 Peligros para el medio No aplicable ambiente 14.6 Special precautions for user Disposiciones especiales Ninguno(a) ADR 14.1 UN number or ID number No regulado 14.2 14.3 Transport hazard class(es) No regulado 14.4 Grupo de embalaje No regulado 14.5 Peligros para el medio No aplicable ambiente 14.6 Special precautions for user Disposiciones especiales Ninguno(a) SECCIÓN 15: Información reglamentaria 15.1. Safety, health and environmental regulations/legislation specific for the substance or mixture Unión Europea Take note of Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical agents at work. Authorizations and/or restrictions on use: This product does not contain substances subject to authorization (Regulation (EC) No. 1907/2006 (REACH), Annex XIV) This product does not contain substances subject to restriction (Regulation (EC) No. 1907/2006 (REACH), Annex XVII) Persistent Organic Pollutants No aplicable Ozone-depleting substances (ODS) regulation (EC) 1005/2009 No aplicable Inventarios Internacionales TSCA Contact supplier for inventory compliance status DSL/NDSL Contact supplier for inventory compliance status EINECS/ELINCS Contact supplier for inventory compliance status ENCS Contact supplier for inventory compliance status IECSC Regulado KECL Contact supplier for inventory compliance status PICCS Contact supplier for inventory compliance status AIIC Contact supplier for inventory compliance status NZIoC Contact supplier for inventory compliance status Leyenda: TSCA - Estados Unidos - Ley del Control de Sustancias Tóxicas, Sección 8(b), Inventario DSL/NDSL - Lista de Sustancias Nacionales y Lista de Sustancias no Nacionales de Canadá EINECS/ELINCS - Inventario Europeo de Sustancias Químicas Comercializadas/Lista Europea de Sustancias Químicas Notificadas ENCS - Sustancias Químicas Existentes y Nuevas de Japón IECSC - Inventario de Sustancias Químicas Existentes de China KECL - Sustancias Químicas Existentes y Evaluadas de Corea PICCS - Inventario de Productos y Sustancias Químicas de Filipinas AICS - Inventario de Sustancias Químicas de Australia (Australian Inventory of Chemical Substances) NZIoC - Inventario de Sustancias Químicas de Nueva Zelanda 15.2. Chemical safety assessment Informe de la seguridad química No hay información disponible SECCIÓN 16: Otra información Código o leyenda de las abreviaturas y siglas utilizadas en la hoja de datos de seguridad Leyenda SVHC: Substances of Very High Concern for Authorization: PBT: Persistent, Bioaccumulative, and Toxic (PBT) Substances vPvB: Very Persistent and very Bioaccumulative (vPvB) Substances STOT: Specific Target Organ Toxicity ATE: Acute Toxicity Estimate LC50: 50% Lethal Concentration LD50: 50% Lethal Dose Leyenda Section 8: Exposure controls/personal protection TWA TWA (promedio ponderado en el tiempo)