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EC number: 203-643-7 | CAS number: 109-06-8
- 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 an Ames bacterial reverse mutation assay (Kubo 2002) the test substance was evaluated for its potential genetic toxicity with and without metabolic activation using Salmonella typhimurium strains TA98 and TA100. A preincubation test was performed up to a concentration of 1 mM of the test substance. No information was available on bacteriotoxicity and negative controls. It was concluded that the test substance is not mutagenic.
In another Ames test (Aeschbacher 1989), the test substance was evaluated for its potential genetic toxicity with and without metabolic activation using Salmonella typhimurium strains TA98, TA100 and TA102 with and without metabolic activation. The test strains were exposed to 10 nmol - 1 mmol/plate (6 dose levels) in a preincubation test. No information was available on bacteriotoxicity. It was concluded that the test substance is not mutagenic.
In the evaulation report of the EFSA (2013) and US EPA (2009), four studies were described. The original reports were not available, but these reports are from reliable authorities and therefore adequate for assessment. Claxton et al (1987) published the results of an Ames assay (plate incorporation assay) with Salmonella typhimurium strains TA97, TA98, TA100 and TA102. Concentrations up to 5 mg/plate were tested both with and without metabolic activation. No other information was available. It was concluded that the test substance is not mutagenic. In another reverse-mutation bacterial assay (summarized by the EPA 2009), Salmonella typhimurium strains TA97, TA98, TA100, TA102, TA 1535 and/or TA 1537 were exposed to the test substance at concentrations up to 5000 μg/plate with and without metabolic activation. No bacteriotoxic effect were observed at these concentrations. The test substance was not mutagenic under these test conditions in the presence or absence of metabolic. Vleminckx et al. (1993; summarized in EFSA 2013) ) published the results of an Ames assay performed with Salmonella typhimurium strains TA98, TA100 and TA 1535 and TA 1537 with and without metabolic activation. The test substance was tested ( plate incorporation) at test concentrations of 50, 160, 500, 1600 and 5000 nL/plate (highest concentration: 4722 μg/plate). No other information was available. It was concluded that the test substance is not mutagenic under these experimental conditions. Vleminckx et al (1993; summarized in EFSA 2013 and EPA 2009) also published the results of a HGPRT gene mutation assay with Chinese hamster V79 lung cells. Test concentrations were 4.5, 4.75, 5, 5.25 and 5.5 μl/mL (highest concentration tested was 5194 μg/mL). Cytotoxic effects were observed at 5.25 μL/mL. No other information was available. It was therefore concluded that the test substance is not mutagenic under these experimental conditions. Schriewer et al (1993; summarized in 2013) published the results of an Alkaline elution assay performed to assess the potential of the test substance to cause single strand breaks in DNA from Chinese hamster V79 lung cells. The test substance was tested at 2, 3, 4, 5 and 6 μl/mL (highest dose tested: 5666 μg/mL). No genetoxic effects (single strand breaks) occurred. It was therefore concluded that the test substance is not mutagenic under these experimental conditions.
Florin et al (1980) tested test substance in an Ames bacterial reverse mutation assay (spot test) using Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 both with and without metabolic activation. All test strains were exposed to 3 µmol/plate (279 µg/plate) of the test substance. No bacteriotoxic effect was observed at this concentration. It was concluded that the test substance is not mutagenic under these experimental conditions. However, since only one dose had been tested being well below the required 5000 µg/plate, this study could not be used for risk assessment.
Zimmermann et al (1986) evaluated the test substance for its potential to induce mitotic aneuploidy, mitotic recombination and anti-tubulin effects in yeast strain S. cerevisiae D61.M. The test substance was considerd to be weakly active regarding induction of chromosome loss and other genetic changes, but did not induce anti-tubulin effects. However, the effects were observed at very high doses and the effect is considered to be thresholded. Therefore, this substance is not considered to be gentoxic in this study.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the assessment of all available genotoxicity tests classification in accordance with EU Directive 67/548/EEC (DSD) and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 is not warranted
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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