Registration Dossier
Registration Dossier
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EC number: 607-813-5 | CAS number: 25830-77-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- bacterial forward mutation assay
Test material
- Reference substance name:
- 2-[(3S)-2,6-dioxooxan-3-yl]isoindole-1,3-dione
- EC Number:
- 607-813-5
- Cas Number:
- 25830-77-7
- Molecular formula:
- C13 H9 N O5
- IUPAC Name:
- 2-[(3S)-2,6-dioxooxan-3-yl]isoindole-1,3-dione
- Test material form:
- solid
Constituent 1
Method
- Details on test system and experimental conditions:
- Mutagenicity:
Test compound was examined in the
Salmonella/microsome assay (Ames Test) for
mutagenic potential in the standard Salmonella
plate incorporation assay and in the
pre-incubation modification using seven tester
strains. The tests were carried out in the
presence and absence of phenobarbital-induced rat
liver homogenate (S-9) fraction in duplicate
assays.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
Applicant's summary and conclusion
- Conclusions:
- Based on the available information the substance is not classified
- Executive summary:
Mutagenicity: Test compound was examined in the Salmonella/microsome assay (Ames Test) for mutagenic potential in the standard Salmonella plate incorporation assay and in the pre-incubation modification using seven tester strains. The tests were carried out in the presence and absence of phenobarbital-induced rat liver homogenate (S-9) fraction in duplicate assays.
Based on the available information the substance is not classified.
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.
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