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Diss Factsheets
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EC number: 269-682-7 | CAS number: 68309-95-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Three in vitro mutagenicity studies have been conducted. Two of these (an Ames test and a Mouse lymphoma TK locus assay) gave clear negative results both in the presence and absence of metabolic activation. The in vitro chromosome aberration study conducted using CHO cells, however, gave a marginally clastogenic result in the presence of metabolic activation. On the basis of this ambiguous result an in vivo mouse micronucleus study has been conducted in order to further investigate the mutagenic potential of the substance. This in vivo study, using the intraperitoneal route of exposure at dosages causing clinical signs and decreases of PCE/NCE ratio, gave a negative result thus mitigating the concern raised by the results of the in vitro chromosome aberration study. The substance is therefore considered to be non-mutagenic.
Short description of key information:
An Ames test in five strains of Salmonella typhimurium has been conducted in compliance with GLP according to OECD Guideline 471. Duplicate experiments were conducted in order to confirm the results of the study. This study was negative with and without metabolic activation.
An in vitro chromosome aberration study in CHO cells has been conducted in compliance with GLP according to OECD Guideline 473. The substance was suspiciously clastogenic in the presence of metabolic activation when tested to toxic concentrations with Chinese hamster ovary cells in vitro.
A GLP compliant in vitro mouse lymphoma assay has been conducted according to a method equivalent to OECD Guideline 476. It was concluded that the substance is not mutagenic in mouse lymphoma L5178Y cells, with and without metabolic activation, when tested at concentrations extending into the toxic range.
A GLP compliant in vivo mouse micronucleus study has been conducted in accordance with OECD Guideline 474. The test material was considered to be non-genotoxic when tested by the intraperitoneal route of exposure and causing toxic signs and decreases in the PCE/NCE ratio.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
An in vivo mouse micronucleus study gave a negative result, mitigating a concern raised by an ambiguous in vitro chromosome aberration study. There are no other reasonable grounds for concern and hence there is no need to classify the substance as mutagenic.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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