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EC number: 695-716-9 | CAS number: 1174931-74-8
- 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
Genetic toxicity in vitro
Description of key information
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
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to guideline; under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9
- Test concentrations with justification for top dose:
- Preliminary test: 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 ug/plate.
Main test: 31.6, 100, 316, 1000, 2500 and 5000 ug/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: without S9: sodium azide, 4-nitro-o-phenylene-diamine or methylmethanesulfonate; with S9: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Experiment 1 was performed in agar (plate incorporation method); Experiment 2 was performed using the preincubation method.
DURATION
- Preincubation period: 60 minutes at 37 degrees C (for experiment 2 only).
- Expression time (cells in growth medium): Plates were incubated at 37 degrees C for at least 48 hours in the dark (for both experiment 1 and 2).
NUMBER OF REPLICATIONS: For each strain and dose level, including the controls, three plates were used. In experiment 2, there was one case where only 2 plates were evaluated.
DETERMINATION OF CYTOTOXICITY
- Method: Cytotoxicity can be detected by a clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control.
OTHER: To establish the dose-range, a preliminary experiment was performed using the plate incorporation method using the strains TA98 and TA100. Vehichle and eight doses (3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 μg/plate) of the test material were plated (in triplicate) with and without S9 mix. - Evaluation criteria:
- For the test material to be evaluated as positive, it must cause a clear dose-related increase in the number of revertants and/or a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without the metabolic activation. A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high.
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher than the reversion rate of the solvent control.
According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary. A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system. - 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:
- no cytotoxicity
- Remarks:
- A reduction in the number of revertants was observed in the TA100 strain at 1000 ug/plate without S9, but was not considered as biologically relevant due to a lack of a dose-response relationship.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Observed at 5000 ug/plate without S9 activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of this study the test material did not induce gene mutations in the strains tested. The test material can therefore considered as non-mutagenic in the bacterial reverse mutation assay. - Executive summary:
The study was performed to evaluate the potential mutagenicity of the test substance in a bacterial reverse mutation assay using S.typhimurium strains TA98, TA100, TA1535, TA1537 and TA102, in both the presence and absence of S9 mix. The study was performed to GLP and was designed to the requirements of OECD guideline 471, EU Method B.13/14 and EPA OPPTS 870.5100. In a preliminary toxicity assay, the maximum dose tested was 5000 ug/plate. Based on the findings of the preliminary toxicity assay, the doses tested were 31.6, 100, 316, 1000, 2500 and 5000 μg/plate in the presence and absence of S9 activation. Positive controls appropriate for each strain, in the presence and absence of S9 mix, were included. Two independent tests were conducted, with experiment 1 employing the use of the plate incorporation method and experiment 2 using the preincubation method.
The test substance did not induce any significant, reproducible increases in the observed number of revertant colonies in any of the strains tested, either in the presence or absence of S9-mix. No toxic effects of the test item were noted in any of the strains used up to the highest dose group evaluated with and without metabolic activation in experiment I and II with the exception of a toxic effect observed in tester strain TA 102 in experiment II at a concentration of 5000 μg/plate (without metabolic activation). The reduction in the number of revertants down to a mutation factor of 0.5 found in experiment II in tester strain TA 100 at a concentration of 1000 μg/plate (without metabolic activation) was regarded as not biologically relevant due to lack of a dose-response relationship.The sensitivity of the test system and the metabolic activity of the S9-mix were clearly demonstrated by the increases in the numbers of reverant colonies induced by the positive control substances. It was concluded that, under the conditions of this assay, the test substance gave a negative, i.e. non-mutagenic response in S.typhimurium strains TA98, TA100, TA1535, TA1537 and TA102 in both the presence and absence of S9 mix.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The study was performed to evaluate the potential mutagenicity of the test substance in a bacterial reverse mutation assay using S.typhimurium strains TA98, TA100, TA1535, TA1537 and TA102, in both the presence and absence of S9 mix. The study was performed to GLP and was designed to the requirements of OECD guideline 471, EU Method B.13/14 and EPA OPPTS 870.5100. In a preliminary toxicity assay, the maximum dose tested was 5000 ug/plate. Based on the findings of the preliminary toxicity assay, the doses tested were 31.6, 100, 316, 1000, 2500 and 5000 μg/plate in the presence and absence of S9 activation. Positive controls appropriate for each strain, in the presence and absence of S9 mix, were included. Two independent tests were conducted, with experiment 1 employing the use of the plate incorporation method and experiment 2 using the preincubation method.
The test substance did not induce any significant, reproducible increases in the observed number of revertant colonies in any of the strains tested, either in the presence or absence of S9-mix. No toxic effects of the test item were noted in any of the strains used up to the highest dose group evaluated with and without metabolic activation in experiment I and II with the exception of a toxic effect observed in tester strain TA 102 in experiment II at a concentration of 5000 μg/plate (without metabolic activation). The reduction in the number of revertants down to a mutation factor of 0.5 found in experiment II in tester strain TA 100 at a concentration of 1000 μg/plate (without metabolic activation) was regarded as not biologically relevant due to lack of a dose-response relationship.The sensitivity of the test system and the metabolic activity of the S9-mix were clearly demonstrated by the increases in the numbers of reverant colonies induced by the positive control substances. It was concluded that, under the conditions of this assay, the test substance gave a negative, i.e. non-mutagenic response in S.typhimurium strains TA98, TA100, TA1535, TA1537 and TA102 in both the presence and absence of S9 mix.
Justification for selection of genetic toxicity endpoint
One study available; GLP compliant and has a Klimisch score 1.
Justification for classification or non-classification
The test substance does not meet classification criteria under EU Directive 67/548/EEC for mutagenicity.
The test substance does not meet classification criteria under Regulation (EC) No 1272/2008 for mutagenicity.
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