Registration Dossier
Registration Dossier
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EC number: 454-720-9 | CAS number: 161596-47-0
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)
- Rationale for reliability incl. deficiencies:
- other: Described in SNIF 05-04-1850-00 lead notification under NONS. Original reports not read.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- Original report not seen
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 454-720-9
- EC Name:
- -
- Cas Number:
- 161596-47-0
- Molecular formula:
- C11 H9 N O3
- IUPAC Name:
- 2-{[(2R)-oxiran-2-yl]methyl}-2,3-dihydro-1H-isoindole-1,3-dione
Constituent 1
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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):
positive with metabolic activation
positive without metabolic activation
The material gave a positive Ames test with and without metabolic activation. - Executive summary:
The material gave a positive Ames test with and without metabolic activation.
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