Registration Dossier
Registration Dossier
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EC number: 412-570-1 | CAS number: 119462-56-5 PERKALINK 900
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: The test was conducted according to EU Method B.13/14 and compliant with GLP.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene
- EC Number:
- 412-570-1
- EC Name:
- 1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene
- Cas Number:
- 119462-56-5
- Molecular formula:
- C18H16N2O4
- IUPAC Name:
- 3-methyl-1-({3-[(3-methyl-2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)methyl]phenyl}methyl)-2,5-dihydro-1H-pyrrole-2,5-dione
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: Dimethylsulphoxide
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (5000 µg/plate)
- Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The test substance was not mutagenic in S. typhimurium strains TA98, TA100, TA1535 and TA1537 at doses up to 5000 µg/plate either in the presence or absence of metabolic activation provided by rat liver S9 fraction.
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