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EC number: 202-401-8 | CAS number: 95-23-8
- 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
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- Water solubility
- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
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- Additional physico-chemical information
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- Nanomaterial specific surface area
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Genetic toxicity
- Carcinogenicity
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- Specific investigations
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- Additional toxicological data

Genetic toxicity: in vitro
Administrative data
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD and GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 5-amino-1,3-dihydro-2H-benzimidazol-2-one
- EC Number:
- 202-401-8
- EC Name:
- 5-amino-1,3-dihydro-2H-benzimidazol-2-one
- Cas Number:
- 95-23-8
- Molecular formula:
- C7H7N3O
- IUPAC Name:
- 5-amino-1,3-dihydro-2H-benzimidazol-2-one
- Details on test material:
- - Name of test material (as cited in study report): Aminolon - TTR
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 0 - 4 - 20 - 100 - 500 - 2500 - 5000 - 10000 µg per plate
- Vehicle / solvent:
- DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9
Migrated to IUCLID6: TA 100, TA 1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9
Migrated to IUCLID6: TA 1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9
Migrated to IUCLID6: TA 98, TA 1538
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-Methyl-N'-nitro-N-nitrosoguanidine (MNNG) WP2uvrA
- Remarks:
- without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation
Migrated to IUCLID6: TA98 , TA 100, TA 1535, TA 1537, TA 1538, WP2uvrA
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: TA98 , TA 100, TA 1535, TA 1537, TA 1538, WP2uvrA
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- BACTERIA
Bacteria are grown overnight in nutrient broth (25 g Oxoid Nutrient Broth No 2 /liter) at 37°C. The suitable amount of bacteria in the cell suspension is checked by nephelometry. For inoculation, stock cultures which are stored at -80°C, are used. The compound is tested with the strains Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538 and E. coli WP2uvrA.
TOXICITY AND DOSE RANGE FINDING
Preliminary toxicity tests were performed with all tester strains using two plates per dose to get information on mutagenicity and toxicity for calculation of an appropriate dose range. A reduced rate of spontaneously occuring colonies as well as visible thinning of the bacterial lawn were used as indicator for toxicity. Thinning of the bacterial lawn was controlled microscopically.
In combination with the second experiment, toxicity testing was performed as follows: 0.1 ml of the different dilutions of the test compound were thoroughly mixed with 0.1 ml of 10-6 dilution of the overnight culture of TA 100 and plated with histidine and biotin rich top agar (3 plates per dose). The solvent control is compared with the number of colonies per plate in the presence of the test compound. Results are given as a ratio of these values (= surviving fraction).
MUTAGENICITY TEST
Top agar is prepared for the Salmonella strains by mixing 100 ml agar (0.6 % agar, 0.5 % NaC1) with 10 ml of a 0.5 mM histidine-biotin solution. With E. coli histidine is replaced by tryptophan (2.5 ml, 0.5 mM). The following ingredients are added (in order) to 2 ml of molten top ager at 45°C:
0.1 ml of an overnight nutrient broth culture of the bacterial tester strain
0.1 ml test compound solution
0.5 ml S-9 Mix (if required) or buffer
After mixing, the liquid is poured into a petridish with minimal agar (1.5 % agar, Vogel-Bonner E medium with 2 % glucose). After incubation for 48 to 72 hours at 37°C in the dark, colonies (his+ revertants) are counted. - Evaluation criteria:
- After incubation for 48 to 72 hours at 37°C in the dark, colonies (his+ revertants) are counted.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538 and E. coli WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (tested up to 10000µg per plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Summarizing, it can be stated that Aminolon TTR is not mutagenic in these bacterial test systems neither with nor without exogenous metabolic activation at the dose levels investigated. - Executive summary:
Aminolon TTR was tested for mutagenicity with the strains TA 100, TA 1535, TA1537, TA 1538, TA 98 of Salmonella typhimurium and Escherichia coli WP2uvrA.
The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. A dose range of 7 different doses from 4 µg/plate to 10 000 µg/plate was used.
Control plates without mutagen showed that the number of, spontaneous revertant colonies was similar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies.
Toxicity: The test compound proved to be not toxic to the bacterial strains. 10 000 µg/plate was chosen as top dose level for the mutagenicity study.
Mutagenicity: In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. Also in the presence of a metabolic activation system, treatment of the cells with Aminolon TTR did not result in relevant increases in the number of revertant colonies.
Summarizing, it can be stated that Aminolon TTR is not mutagenic in these bacterial test systems neither with nor without exogenous metabolic activation at the dose levels investigated.
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