Registration Dossier
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EC number: 208-762-8 | CAS number: 540-97-6 D6
- 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
Genetic toxicity in vitro
Description of key information
Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without metabolic activation in Salmonella typhimurium strains TA1535, TA1537, TA100 and TA98 and Escherichia coli WP2 uvrA (OECD TG 471) (Verspeek-Rip, C., 1999).
Cytogenicity in mammalian cells: not required: in vivo micronucleus study available
Mutagenicity in mammalian cells: negative with and without metabolic activation in mouse lymphoma L5178Y cells (WIL, 2015).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Mouse micronucleus assay study (ip administration): Negative (OECD TG 474) (BioReliance, 2009).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Information is available for mutagenicity to bacterial and mammalian cells from in vitro studies, and for cytogenicity from an in vivo micronucleus assay.
D6 has been tested in a reliable study conducted in accordance with OECD 471 and in compliance with GLP (Verspeek-Rip, C., 1999). No evidence of test substance induced increase in the number of revertants was observed when the substance was tested in the presence and absence of metabolic activation in Salmonella typhimurium strains TA1535, TA1537, TA100 and TA98 and Escherichia coli WP2uvrA, in either the initial or the independent repeat experiment. Appropriate solvent and positive controls were included and gave expected responses. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
In vitro cytogenicity testing is not required as there is a reliable in vivo micronucleus assay available.
In vitro mutagenicity: D6 has been tested for mutagenicity in mouse lymphoma cells L5178Y cells in a reliable study conducted according to OECD TG 476, in compliance with GLP (WIL, 2015a). No cytotoxicity was observed, and no increase in mutant frequency above the Global Evaluation Frequency was observed in either the absence or presence of exogenous metabolic activation when tested up to concentrations limited by the solubility of the test substance. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity in mouse lymphoma L5178Y cells under the conditions of the test.
D6 has been tested in a reliable in vivo micronucleus assay in ICR mice conducted according to OECD TG 474 and in compliance with GLP (BioReliance, 2009). No statistically significant increase in the incidence of micronucleated polychromatic erythrocytes relative to control was observed in any test substance group up to limit concentrations at 24 and 48 hours after intraperitoneal administration of the test substance. Reductions in PCE/EC ratio (up to 11%) were observed in some test article groups, indicating that the test article had reached the target tissue. Administration of cyclophosphamide (the positive control) induced marked increases in micronucleated polychromatic erythrocytes. It is concluded that the test substance is negative for the induction of micronuclei in vivo under the conditions of the test.
Justification for classification or non-classification
Based on reliable in vitro and in vivo data, D6 does not require classification for mutagenicity according to Regulation (EC) No 1272/2008.
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