Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Data source

Reference
Reference Type:
other: QSAR
Title:
Leadscope model applier
Year:
2017

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Results and discussion

Test results
Key result
Genotoxicity:
negative

Applicant's summary and conclusion

Conclusions:
Absence of mutagenic risk for CDD has been confirmed by mutagenicity potential predictions using appropriate (Q)SAR methodologies. The Leadscope® Model Applier software, which contains both expert rule-based alerts and statistical-based QSAR models, has been used for the assessment. Negative results for bacterial mutagenicity have been obtained with both statistical (Salmonella Mut v3) and expert alerts (Bacterial Mut v2).