Registration Dossier
Registration Dossier
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EC number: 202-599-6 | CAS number: 97-65-4
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:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EEC 84/449 B4
- GLP compliance:
- yes
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Itaconic acid
- EC Number:
- 202-599-6
- EC Name:
- Itaconic acid
- Cas Number:
- 97-65-4
- Molecular formula:
- C5H6O4
- IUPAC Name:
- 2-methylidenebutanedioic acid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver preparation from Aroclor 1254-induced rats (S9 mix)
- Test concentrations with justification for top dose:
- Itaconic acid was dissolved in water and dose levels used in the main assays were: 100, 500, 1000, 1500 and 2000 µg/plate without S9 mix and 100, 500, 1000, 2500 and 5000 µg/plate in presence of S9 mix.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Minimum concentration of test substance at which toxicity to bacteria was observed:
with metabolic activation : slightly toxic to TA 98 at 2500 ug/plate
without metabolic activation : highly toxic to TA 100 and TA 98 at 5000 ug/plateApplicant's summary and conclusion
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