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Diss Factsheets
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EC number: 204-155-7 | CAS number: 116-75-6
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The absence of point mutation-inducing activities was demonstrated by the negative outcome in a Bacterial Reverse Mutation Test and an In Vitro Mammalian Cell Mutation Assay. The absence of chromosome aberration-inducing activities was demonstrated by the negative outcome in an In Vitro Mammalian Chromosome Aberration Test. In conclusion testing of the test substance revealed no evidence of mutagenic activity in bacteria and mammalian or human cells. Therefore the test itrem is not considered to be mutagenic.
Justification for selection of genetic toxicity endpoint
Due to the variety of possible genotoxic effects, selection of a single refernce in order to cover genetic toxicity is not sufficient. Therefore a battery of three in vitro studies was assessed:
KEY_471_2003_RCC_774500 Ames / KEY_476_2013_Harlan_1489102_HPRT / KEY_473_2013_Harlan_1489101_CALY
Short description of key information:
KEY_471_2003_RCC_774500 Ames
In this Bacterial Reverse Mutation Test (AMES-Test) with and without metabolic activation, the test substance did not induce genmutations in the genom of the tester strains used. Therefore the test item is considered to be non-mutagenic in this Salmonella and Escherichia coli Reverse Mutation Assay.
KEY_476_2013_Harlan_1489102_HPRT
In this In Vitro Mammalian Cell Mutation Assay (HPRT-Test), with and without metabolic activation, the test substance did not induce an increase of the mutation frequency. Therfore the test substance is considered to be non-mutagenic in this In Vitro Mammalian Cell Mutation Assay.
KEY_473_2013_Harlan_1489101_CALY
In this In Vitro Mammalian Chromosome Aberration Test (CA-Test), with and without metabolic activation, the test substance did not induce an increase of the number of structural chromosome aberrations or numerical aberrations. In conclusion, it can be stated that the test substance is considered not to be clastogenic or aneugenic in this Chromosom Aberration Test in Human Lymphpcytes In Vitro.
In conclusion, it can be stated that the test substance did not induce point or genmutations, chromosome mutations (structural aberrations) or genomic mutations (numerical aberrations) in this battery of in vitro genetic toxicity tests.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The test substance did not reveal any mutagenic effects in the bacterial reverse mutation assay, in the in vitro gene mutation study in mammalian cells, and in the human lymphocytes chromosome aberration test.
Since these findings do not meet the criteria for classification with respect to Mutagenicity or Germ Cell Mutagenicity according to the rules laid down in Directive 67/548EEC and in Regulation (EC) No 1272/2008, classification is not warrantable.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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