Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Study period:
March 2017
Reliability:
1 (reliable without restriction)
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

Materials and methods

Principles of method if other than guideline:
The Leadscope® Model Applier software, which includes two (Q)SAR prediction methodologies that complement each other (expert rule-based alerts and statistical-based QSAR model), 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).

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium, other:
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks on result:
no mutagenic potential (based on QSAR/QSPR prediction)

Applicant's summary and conclusion

Conclusions:
No genotoxic potential based on QSAR