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Diss Factsheets
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EC number: 292-642-5 | CAS number: 90669-48-0
- 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
In vitro data
Bacterial reverse mutation
The potential of the test material to cause gene mutation in bacterial strains was determined in a GLP study conducted in accordance with standardised guidelines OECD 471, EU Method B.13/14 and EPA OPPTS 870.5100. Four strains of Salmonella typhimurium (TA1535, TA1537, TA98 and TA100) and one Escherichia coli strain (WP2P uvrA) were treated in the presence and absence of a rat liver derived metabolic activation system (S9 mix). In two separate assays, the test material did not induce any significant, reproducible increases in the observed number of revertant colonies in any of the tester strains used in the assay either in the presence or in the absence of metabolic activation. The test material is therefore considered to be non-mutagenic to the bacterial tester strains used under the specific conditions of the assay.
Chromosome aberration
In a GLP compliant chromosome aberration study performed according to the standardised guidelines OECD 473, EU Method B.10 and UK department of Health Committee on Mutagenicity Guidelines for the Mutagenicity Testing of Chemicals, the test material was determined to be non-clastogenic. Under the conditions of the test the human lymphocyte did not produce a statistically significant increase in the frequency of cell aberrations in the absence or presence of metabolic activation. Therefore the test material is considered to be non-mutagenic.
Mammalian cell gene mutation
A GLP compliant study was performed according to the standardised guidelines OECD 476, EU Method B.17, US EPA OPPTS 870.5300, and would be acceptable to the Japanese METI/MHLW guidelines for testing of new chemical substances. The study was designed to assess the potential mutagenicity of the test material on the thymidine kinase, TK +/-, locus of the L5178Y mouse lymphoma cell line, both in the absence and presence of metabolic activation (S9 mix). Under the conditions of the study the test material did not induce any toxicologically significant dose-related increases in the mutant frequency at any dose level, with or without metabolic activation, in either the first or the second experiment. Therefore the test material was considered to be non-mutagenic to L5178Y cells under the conditions of this assay.
All three studies were performed under GLP conditions and in accordance with standardised guidelines with a sufficient level of detail to assess the accuracy and reliability of the data. Since the Ames test was conducted with the registered substance it was assigned a reliability score of 1 according to the criteria of Klimisch (1997); the chromosome aberration test and mouse lymphoma assay were conducted with the read across substance, hydrocarbon waxes (petroleum), oxidised, and were assigned a reliability score of 2.
Justification for selection of genetic toxicity endpoint
As multiple studies are presented to address genetic toxicity, not one single study was selected as the key study as they represent different types of genetic toxicity and are therefore not comparable.
Short description of key information:
IN VITO DATA
Reverse mutation in bacteria: Negative (S. typhimurium strains TA 1537 TA 1535, TA 100 and TA98 and E. coli strain WP2 uvrA+/- metabolic activation), OECD 471, EU Method B.13/14, EPA OPPTS 870.5100, Vértesi (2012)
Chromosome aberration (hydrocarbon waxes (petroleum), oxidised): Negative (human lymphocytes) with and withou metabolic activation, OECD 473, EU Method B.10, Wright (2004)
Gene mutation in mammalian cells (hydrocarbon waxes (petroleum), oxidised): Negative (thymidine kinase, TK +/-, locus of the L5178Y mouse lymphoma cell line) with and without metabolic activation, OECD 476m EU Method B.17, US EPA OPPTS 870.5300, Japanese METI/MHLW guidelines, Flanders (2012)
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008 (CLP), and Directive 67/548/EEC (DSD),
the substance does not require classification for genetic toxicity based on the overall negative response noted in the available genetic toxicity studies.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.