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EC number: 942-994-7 | CAS number: -
- 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 vitro
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions: only 4 strains tested
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- , no E.coli WP2 or S. typhimurium TA 102 tested
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- histidine locus
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix from liver homogenates of Aroclor 1254 induced male rats
- Test concentrations with justification for top dose:
- initial testing (plate incorporation; with and without S9 mix): 19.2-12000 µg/plate
repeat (plate incorporation; with and without S9 mix): 19-9600 µg/plate; - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Na-azide (NaN3, only TA 1535), nitrofurantoin (NF, only TA 100), 4-nitro-1,2-phenylene diamine (4-NPDA, TA 1537 and TA 98), 2-aminoanthracene (2-AA, all strains)
- Remarks:
- The positive controls NaN3, NF, and 4-NPDA were used without S9 mix; the positive control 2-AA was used with S9 mix.
- Details on test system and experimental conditions:
- Strains were obtained from Prof. B. Ames in 1982 and maintained properly.
METHOD OF APPLICATION: According to Ames et al. (Proc. nat. Acad. Sci. 70, 2281-2285, 1973; Mutation Res. 31, 347-364, 1975).
Plate incorporation for initial testing and independent repeat; for each strain and dose four plates were used in parallel, which was also valid for solvent and positive controls.
DETERMINATION OF CYTOTOXICITY
- mutant count: A toxic effect was assumed when there was a marked and dose-dependent reduction in the mutant count per plate, compared to the negative controls. - Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. This increase should be about twice that of negative controls.
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Evidence of mutagenic activity was not found. Neither a dose-related doubling of the mutant count nor a biologically relevant increase in the same, in comparison with the negative controls, was observed.
The positive controls had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Substance precipitation occurred at and above 1200 µg/plate.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Doses up to and including 19.2 µg/plate did not cause any bacteriotoxic effects. The total bacteria counts remained unchanged. No inhibition of growth was observed. At higher doses the substance had a strong, strain-specific bacteriotoxic effect, so that this range could only be used to a very limited extent up to 12000 µg/plate for evaluation purposes. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Executive summary:
A bacterial reverse mutation assay according to the protocol of Ames et al. (Proc. nat. Acad. Sci. 70, 2281-2285, 1973; Mutation Res. 31, 347-364, 1975) was conducted for the evaluation of point mutagenic effects. In this assay 4 strains of Salmonella typhimurium were used (TA 1535, TA 100, TA 1537, and TA 98). The initial plate incorporation test used test substance doses of 19.2-12000 µg/plate. Due to bacteriotoxic effects doses for independent repeat were lowered to a maximum of 9600 µg/plate.
Substance precipitation occurred at and above 1200 µg/plate. Doses up to and including 19.2 µg/plate did not cause any bacteriotoxic effect. The total bacteria counts remained unchanged and thus no inhibition of growth was observed. At higher doses the substance had a strong, strain-specific bacteriotoxic effect, so that this range could only be used to a very limited extent for evaluation purposes.
Evidence of mutagenic activity was not found. Neither a dose-related doubling of the mutant count nor a biologically relevant increase in the same, in comparison with the negative controls, was observed. The positive controls had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
For the assessment of genetic toxicity two Ames tests are available for the substance. Both were conducted comparable to the protocol of OECD TG 471, but have acceptable restrictions.
The first Ames test was carried out with the 5 tester strains S. Typhimurium TA 100, TA1535, TA98, TA1537, and E. coli WP2uvrA-. Doses up to 5000 µg/plate with and without S9 mix were employed in a range finding test and, due to bacteriotoxic effects, up to 1000 µg/plate in the mutagenicity test.
The test substance did not cause a doubling or more of the number of revertant colonies compared to the solvent control, whereas the positive controls increased the number of revertant colonies by more than twice, and thus indicated that the test was carried out appropriately.
The second Ames test used only 4 S. Typhimurium strains (TA 1535, TA 100, TA 1537, and TA 98), but was conducted more accurate compared to the first (e.g. additionally independent repeat of mutagenicity test, four replicate plates for each strain and dose). The initial plate incorporation test here used doses of 19.2-12000 µg/plate. Due to bacteriotoxic effects doses for independent repeat were lowered to a maximum of 9600 µg/plate.
Substance precipitation occurred at and above 1200 µg/plate. Doses up to and including 19.2 µg/plate did not cause any bacteriotoxic effect. The total bacteria count remained unchanged and thus no inhibition of growth was observed. At higher doses the substance had a strong, strain-specific bacteriotoxic effect, so that this range could only be used to a very limited extent for evaluation purposes.
Evidence of mutagenic activity was not found. Neither a dose-related doubling of the mutant count nor a biologically relevant increase in the same, in comparison with the negative controls, was observed. The positive controls had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.
Overall, the two negative Ames tests led to the conclusion that the substance is non-mutagenic in bacteria.
Justification for selection of genetic toxicity endpoint
The study with the more conscientiously conduction is selected. Nevertheless, both Ames-tests are relevant for the assessment of genetic toxicity.
Justification for classification or non-classification
According to Regulation (EC) No 1272/2008, Annex I, no classification is warranted for genetic toxicity.
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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