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EC number: 807-250-7 | CAS number: 147263-99-8
- 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
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:
- 15-22 May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Vehicle / solvent:
- Dimethyl sulfoxide (DMSO):
Manufacturer: SIGMA-ALDRICH
Batch No.: SZBD1830V
Expiry date: 16 June 2016
Distilled water:
Manufacturer: TEVA Zrt.
Batch No.: 0790713
Expiry date: 31 July 2016
N,N-Dimethylformamide (DMF):
Manufacturer: SIGMA-ALDRICH
Batch No.: SZBD2210V
Expiry date: 24 July 2016 - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO, Distilled Water, DMF
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylene-diamine (NPD), 2-aminoanthracene (2AA)
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle 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 the test, the test item had no mutagenic activity - Executive summary:
The mutagenic potential has been assessed by exposure to S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A in DMSO, Distilled water and DMF with and without S9 metabolic activations in accordance with the OECD 471 test guideline in compliance with GLP. Under the conditions of the test, the test substance was shown to have no mutagenic activity to bacterium tester strains.
Reference
In the Range Finding Test the concentrations examined were: 2500, 1000, 316, 100, 31.6, 10 and 3.16 μg/plate.
The observed numbers of revertant colonies were in the normal range. Minor differences compared to the solvent control numbers were observed in some sporadic cases. However, they had no biological significance and were within the historical control range in all cases; thus, they were considered as reflecting the variability of the test system.
Slight precipitate was detected on the plates in all examined strains in the highest concentration with and without metabolic activation. There was no insolubility or signs of inhibitory, cytotoxic effect of the test item in the Preliminary Range Finding Test.
Examined concentrations in the main tests were 2500, 1250, 625, 312.5, 156.25, 78.125 and 39.063 test item/plate.
In the Initial Mutation Test and Confirmatory Mutation Test none of the observed revertant colony numbers were above the respective biological threshold value. There were no reproducible dose-related trends and no indication of any treatment effect.
Using the plate incorporation method (Initial Mutation Test), the highest revertant rate was observed in Salmonella typhimurium TA100 bacterial strain without metabolic activation at 312.5 μg/plate concentration. The mutation factor value was 1.20. The observed mutation factor values were below the biologically relevant threshold limit and the numbers of revertant colonies were within the historical control range.
Using the pre-incubation method (Confirmatory Mutation Test), the highest revertant rate was observed in Salmonella typhimurium TA1537 bacterial strain with metabolic activation at 39.063 μg/plate concentration. The mutation factor value was 1.35. However, there was no dose response, the observed mutation factor values were below the biologically relevant threshold limit and the numbers of revertant colonies were within the historical control range.
Higher numbers of revertant colonies compared to the solvent control were detected in the Initial Mutation Test and Confirmatory Mutation Test in some other sporadic cases. However, the numbers of revertant colonies were below the biologically relevant threshold value and they were within the historical control range, so they were considered as reflecting the biological variability of the test.
Lower revertant counts compared to the solvent control were observed in the Initial Mutation Test and Confirmatory Mutation Test in some sporadic cases with and without metabolic activation. The mean numbers of revertant colonies were in the historical control range, thus they were considered as biological variability of the test system.
Slight precipitate was detected on the plates in all examined strains in the Initial Mutation Test in the highest concentration with and without metabolic activation.
There was no insolubility or signs of inhibitory, cytotoxic effect of the test item in the Initial Mutation Test and the Confirmatory Mutation Test in any of the examined bacterial strains at any concentrations with or without metabolic activation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for selection of genetic toxicity endpoint
Data have been generated according to current internationally recognised study guidelines and in accordance with GLP
Justification for classification or non-classification
The mutagenic potential has been assessed by exposure to S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A in DMSO, Distilled water and DMF with and without S9 metabolic activations in accordance with the OECD 471 test guideline in compliance with GLP. Under the conditions of the test, the test substance was shown to have no mutagenic activity to bacterium tester strains.
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