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Diss Factsheets
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EC number: 217-682-2 | CAS number: 1929-82-4
- 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 vivo
Description of key information
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Peer reviewed secondary source with dose decriptor provided only.
- Principles of method if other than guideline:
- Secondary literature source no data about the method was available.
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data available
- Route of administration:
- oral: unspecified
- Vehicle:
- no data available
- Details on exposure:
- no data available
- Duration of treatment / exposure:
- no data available
- Frequency of treatment:
- no data available
- Post exposure period:
- no data available
- Remarks:
- Doses / Concentrations:
800 mg/kg
Basis:
no data - No. of animals per sex per dose:
- no data available
- Positive control(s):
- no data available
- Tissues and cell types examined:
- bone marrow
- Details of tissue and slide preparation:
- no data available
- Evaluation criteria:
- no data available
- Statistics:
- no data available
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- no data available
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Zeiger et al. (1988) evaluated the mutagenicity of the test item dissolved in DMSO via the preincubation assay using Salmonella typhimurium strains TA97, TA98, TA100, and TA1535. The assay was conducted, with and without metabolic activation using both, Aroclor 1254-induced hamster liver S-9 (HLI) and Aroclor 1254-induced rat liver S-9 (HRI). The test item evaluated at concentrations up to 666 μg/plate. In the absence of metabolic activation, no increase in revertant frequency was observed for all strains tested. An increase in revertants was observed for strains TA 100, TA 97 and TA 98. No increase in the number of revertant was observed for TA 1535 with and without metabolic activation. Consequently, the test item was regarded as mutagenic in the presence of metabolic activation.
Sui et al. (2009) used the test item to compare a new 384 multiwell based high throughput fluctuation Ames test version (Improved FAT) to the standard Ames approach (Ames Test). The test item, dissolved in DMSO, was evaluated in both assays using Salmonella typhimurium strains TA98 and TA100. The assays were conducted, with and without metabolic activation. The test concentrations were not provided. Ambiguously, the test item caused only a weak increase in revertant frequency for strain TA100 in the presence of metabolic activation in "Ames test", while with the "Improved FAT" method only negative results were observed for all strains tested. Hence, for the "Ames test method" the test item was judged to be mutagenic in the presence of metabolic activation only. For the "Improved FAT" method, the test item was regarded as non-mutagenic.
Yano et al. (2008) stated the final outcome of two further ames test in which the test item was regarded as non-mutagenic. One of these tests was conducted according to the current guidelines using a set of all required bacterial strains. Furthermore, Yano et al. (2008) reported that the test item did not cause a positive result in the in vitro HGPRT test, in the in vitro UDS assay and in an in vivo micronucleous test in mice.
Justification for selection of genetic toxicity endpoint
Sole in vivo study available.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under Directive 67/548/EEC. Based on the sum of the available data and according to the harmonised Annex I classification the substance is not considered to be classified for genetic toxicity under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the sum of the available and according to the harmonised Annex VI classification the substance is not considered to be classified for genetic toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.
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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