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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1983
- Deviations:
- yes
- Remarks:
- (no E.coli or TA 102 strain tested, only 2-amino anthracene as positive control with metabolic activation, only one experiment)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- - Name of test material (as cited in study report): FAT 66031/B
- Analytical purity: 88.1%
- Lot/batch No.: Mg. 636 vom 21.7.87, BSG ex Pa 34/34.
- Storage condition of test material: 4°C, light protected
Constituent 1
Method
- Target gene:
- his-operon
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix) prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Pre-Experiment: 1, 3, 10, 33, 100, 333, 1000 and 5000 µg/plate
Experiment: 10.0, 100.0, 333.3, 1000.0 and 5000.0 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: H20 bidest
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- bidest. water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: 4-nitro-o-phenylene-diamine (NOPD); 2-aminoanthracene (2AA)
- Remarks:
- (-S9) sodium azide (TA 1535, 100), 4-NOPD (TA 1537, 1538, 98); (+S9) 2-aminoanthracene (all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 72 hours at 37°C
NUMBER OF REPLICATIONS: 3 plates per condition; only one experiment - Evaluation criteria:
- A test substance is considered as mutagen if in strain TA 100 the number of reversions is at least twice as high with two concentrations of the substance, and in strains TA 1535, TA 1537, TA 1538, and TA 98 it is at least three times higher with two concentrations of the test substance as compared to the spontaneous reversion rate. If in a repeated experiment there is a clear increase in the reversion rate by factors as indicated even in only one strain, then this also leads to the substance being classified as a mutagen.
Also, a continuous dose-dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic properties of the test substance, regardless whether the highest dose induces the above described enhancement factors or not. Such findings would perhaps not be sufficient to declare the substance mutagenic. However, it recommends further testing to exclude mutagenicity. - Statistics:
- Revertant colony numbers were calculated as average and standard deviation. No statistical analysis test was performed.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The test article precipitated weakly at 5000.0 µg/plate.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No toxic effects were observed in all strains. No reduction of revertant numbers for more than 70% was found in any strain used.The plates incubated with the test substance showed normal background growth up to 5000.0 µg/plate in the strains used with and without S9 mix. The test article did not induce an increase in revertant colony numbers in the absence and in the presence of S9 mix in all the strains used.
Results:
Dose µg/plate | metabolic activation | TA 1535 | TA 1537 | TA 1538 | TA 98 | TA 100 |
0 | - | 16 | 16 | 14 | 27 | 154 |
10 | - | 12 | 6 | 11 | 26 | 192 |
100 | - | 13 | 19 | 10 | 22 | 205 |
333.3 | - | 20 | 13 | 16 | 21 | 182 |
1000 | - | 18 | 21 | 10 | 25 | 187 |
5000 | - | 14 | 18 | 13 | 25 | 169 |
Sodium azide | - | 1542 | 1599 | |||
4-NOPD | - | 323 | 1963 | 1761 | ||
0 | + | 16 | 19 | 23 | 51 | 139 |
10 | + | 12 | 21 | 23 | 36 | 150 |
100 | + | 11 | 19 | 22 | 46 | 150 |
333.3 | + | 14 | 22 | 23 | 51 | 173 |
1000 | + | 10 | 22 | 26 | 41 | 179 |
5000 | + | 11 | 12 | 25 | 43 | 154 |
2-Aminoanthracene | + | 1025 | 373 | 2144 | 1928 | 1550 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item did not induce point mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test substance is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
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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