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EC number: 812-028-8 | CAS number: 612543-60-9
- 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
OECD 471: not mutagenic in bacteria
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-11-11 to 2015-02-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 07-1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- HIS operon (S. thyphimurium)
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 mix from Aroclor 1254-pretreated rats with standard co-factors
- Test concentrations with justification for top dose:
- 1st series: 5, 16, 50, 160, 500, 1600 and 5000 µg/plate
2nd series: 8.192, 20.48, 51.2, 128, 320, 800, 2000 and 5000 µg/plate
In the two series with S9 mix, 10 % S9 in the S9 mix were used. - Vehicle / solvent:
- dimethylformamide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Remarks:
- without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-aminoanthracene
- Remarks:
- with S9 mix
- Details on test system and experimental conditions:
- Acceptance Criteria
The assay was to be considered valid if all the following criteria were met:
The vehicle control counts fell within the laboratory’s historical control ranges.
The positive control chemicals induced increases in revertant numbers of >= 1.5-fold (in strain TA102), >= 2-fold (in strains TA98 and TA100) or >= 3-fold (in strains TA1535 and TA1537) the concurrent vehicle control confirming discrimination between different strains, and an active S-9 preparation. - Evaluation criteria:
- For valid data, the test article was considered to be mutagenic if:
A concentration related increase in revertant numbers was >= 1.5-fold (in strain TA102), >= 2-fold (in strains TA98 or TA100) or >= 3-fold (in strains TA1535 or TA1537) the concurrent vehicle control values.
The positive trend/effects described above were reproducible.
The test article was considered positive in this assay if both of the above criteria were met.
The test article was considered negative in this assay if neither of the above criteria were met.
Results which only partially satisfied the above criteria were dealt with on a case-by-case basis. Biological relevance was taken into account, for example consistency of response within and between concentrations and (where applicable) between experiments. - Statistics:
- n.a.
- Key result
- Species / strain:
- other: all tested strains
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- With and without addition of S9 mix as the external metabolizing system, the test material was not mutagenic under the experimental conditions described.
- Executive summary:
Study design
The mutagenic potential of the test item was examined in a GLP study according to OECD GL 471 using Salmonella typhimurium tester strains TA 98, TA 100, TA 102, TA 1535 and TA 1537. The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pretreated rats was used. Two independent experimental series were performed. In the two series with S9 mix, 10 % S9 in the S9 mix was used. The test item was dissolved in dimethylformamide and tested at concentrations ranging from 8.192 - 5000 μg/plate.
Results
In experiment 1, evidence of toxicity was observed at >= 1600 μg/plate in strain TA1535 in the absence of S9 and strain TA102 in the presence of S9. Precipitation was observed on the test plates at concentrations of >= 1600 μg/plate for all strains in the absence and presence of S9. In experiment 2, evidence of toxicity was observed at 5000 μg/plate in strains TA98, TA100 and TA1535 in the absence and presence of S9, strain TA1537 in the absence of S9 and strain TA102 in the presence of S9 and at >= 800 µg/plate in strain TA1537 in the presence of S9 only. Precipitation was observed on the test plates at concentrations of 800 or >= 2000 μg/plate in strains TA100, TA1535, TA1537 and TA102 in the absence of S9 and at 5000 μg/plate in strain TA98 in the absence and presence of S9. Each treatment with the test materials used as positive controls led to a clear increase in revertant colonies, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used. Following test item treatments of all the test strains in the absence and presence of S9, no increases in revertant numbers were observed that were >= 1.5-fold (in strain TA102), >= 2-fold (in strains TA98 or TA100) or >= 3-fold (in strains TA1535 or TA1537) the concurrent vehicle control.
Conclusion
With and without addition of S9 mix as the extemal metabolizing system, the test item was not mutagenic under the experimental conditions described.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the provided information there is no need for classification according to the EU Regulation (EC) No 1272/2008 on Classification,Labelling and Packaging of Substances and Mixtures.
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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