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Diss Factsheets
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EC number: 627-085-2 | CAS number: 1238449-42-7
- 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
Ames test:
The test item was tested for its mutagenic potential in a Ames test according to OECD guideline no. 471 and EU method B.13/14. The test item was tested without and with metabolic activation in Salmonella typhimurium tester strains TA 1535, TA 100, TA 1537, TA 98 and Escherichia coli E. coli WP2 uvrA in concentrations of 33, 100, 333, 1000, 3000, 6000 µg/plate. No bacteriotoxic effect was observed under all test conditions. A biologically relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system. Thus, under the experimental conditions of this study, the test item is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
HPRT Test:
The test item was assessed for its potential to induce gene mutations at the HPRT locus using V79 cells of the Chinese hamster according to OECD guideline no. 476 and EU method B.17. The study was performed in two independent experiments, using identical experimental procedures. In the first experiment the treatment period was 4 hours with and without metabolic activation. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation. Based on the solubility properties of the test item the range finding pre-experiment test was performed using a concentration range of 39.1 to 2500 µg/mL and additionally the undiluted test item (5 µL/mL). The concentration range of the main experiments was limited by the occurrence of phase separation in the pre-experiment. The test item was dissolved in ethanol. No substantial and reproducible dose dependent increase of the mutation frequency was observed up to the maximum concentration with and without metabolic activation. Appropriate reference mutagens (EMS and DMBA), used as positive controls, induced a distinct increase in mutant colonies and thus, showed the sensitivity of the test system and the activity of the metabolic activation system. The test item did not induce gene mutations at the HPRT locus in V79 cells. Therefore, the test item is considered to be non-mutagenic in this HPRT assay.
Micronucleus Test:
The test item was tested in V79 cells with and without metabolic activation by S9 mix in an in vitro micronucleus assay according to OECD guideline no. 487. The test was carried out employing 2 exposure times with metabolic activation: 4 h and without metabolic activation: 4 h (experiment 1) and 24 h (experiment 2). The vehicle was acetone and the following test concentrations were used: in the first experiment 6.3, 12.5, 25.0, 50.0, 100.0, 200.0 µg/mL and in the second experiment 12.5, 25.0, 50.0, 100.0, 200.0 µg/mL. In this study, no biologically relevant increase in the number of micronucleated cells was observed either without S9 mix or after the addition of a metabolizing system. In both experiments in the absence and presence of metabolic activation after 4 and 24 hours treatment with the test substance the values (0.5 – 1.4% micronucleated cells) were close to the concurrent vehicle control values (0.5 – 1.0% micronucleated cells) and clearly within our historical negative control data range (0.1 - 1.8% micronucleated cells). Thus, under the experimental conditions chosen here, the conclusion is drawn that the test item has not the potential to induce micronuclei (clastogenic and/or aneugenic activity) under in vitro conditions in V79 cells in the absence and the presence of metabolic activation.
Justification for selection of genetic toxicity endpoint
Several equivalent and complementary in vitro studies with the test substance were performed.
Short description of key information:
The test item was tested for mutagenic potential in a reversed bacteria mutation assays (Ames test), a HPRT test and in an in vitro micronucleus assay. The test item revealed no mutagenic actvity in all tests.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
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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