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Diss Factsheets
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EC number: 919-697-6 | CAS number: -
- 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
The mutagenic potential of the substance was evaluated in a Salmonella/microsome test with the S. typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in the presence and absence of S9 mix according to OECD TG 471 (Nern, 2011). Evidence of mutagenic activity was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed in any of the strains tested. Based on this test, the test substance was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.
In another test on point mutagenic effects the substance was investigated at the hypoxanthine-guanine phosphoribosyl transferase locus (HPRT test) in Chinese hamster V79 cells according to OECD TG 476 (Hall, 2011). The assay was performed in two independent experiments. The cells were exposed to the test item for 4 hours in the first and second experiment with and without metabolic activation. In both experiments no substantial and reproducible dose dependent increase of the mutation frequency was observed for the test item in the cultures with and without S9 mix when tested up to cytotoxic concentrations. Based on these results the test substance is considered to be non-mutagenic in the HPRT assay.
In an in vitro micronucleus test with Chinese hamster V79 cells (OECD TG 487) the substance was examined for chromosome breakage (clastogenic effects) and misdistribution of chromosomes (aneugenic effects) (Sutter and Jung, 2011). The negative/solvent control and appropriate positive controls with known mutagens demonstrated the suitability and sensitivity of the test system. The test item showed no biologically relevant increase in the frequency of micronucleus containing V79 cells in the absence (4 hours or 24 hours treatment) or in the presence of S9 mix (4 hours treatment) when tested up to cytotoxic or precipitating concentrations. Thus, the substance did not induce clastogenic or aneugenic effects in the in vitro micronucleus test.
Justification for selection of genetic toxicity endpoint
No study was selected, since all relevant key studies (Ames test,
HPRT test and micronucleus test in vitro) were negative.
Short description of key information:
Salmonella/microsome test (Ames test; strains TA 98, TA 100, TA 102,
TA 1535 and TA 1537 ): negative (+/- S9 mix)
HPRT test (V79 cells): negative (+/- S9 mix)
Micronucleus test in vitro (Chinese hamster V79 cells): negative (+/- S9
mix)
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the study results (negative in Ames test, HPRT test and micronucleus test in vitro) a classification according to Regulation (EC) No.1272/2008 (CLP) is not required.
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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