Registration Dossier
Registration Dossier
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EC number: 201-051-3 | CAS number: 77-71-4
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- (Q)SAR
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, and documentation / justification is limited
- Justification for type of information:
- Documentation about the justification is provided in attachment (See Supporting information). The reliability assessment of the prediction is presented in the attached document as well (QPRF).
Data source
Reference
- Reference Type:
- other: QSAR model
- Title:
- VEGA in silico platform v.1.1.4
- Year:
- 2 019
- Bibliographic source:
- Mutagenicity (Ames test) model (ISS) 1.0.2
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: ECHA guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 5,5-dimethylhydantoin
- EC Number:
- 201-051-3
- EC Name:
- 5,5-dimethylhydantoin
- Cas Number:
- 77-71-4
- Molecular formula:
- C5H8N2O2
- IUPAC Name:
- 5,5-dimethylimidazolidine-2,4-dione
Constituent 1
- Specific details on test material used for the study:
- CC1(C)NC(=O)NC1=O
Results and discussion
Test results
- Genotoxicity:
- negative
- Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
Any other information on results incl. tables
The prediction was deemed to be not reliable on the basis of the parameters listed above. The molecule does not fall into the applicability domain of the model.
Applicant's summary and conclusion
- Conclusions:
- The molecule was predicted to be NON-mutagenic.
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