Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
January 9, 2020
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
Justification for type of information:
1. SOFTWARE
ACD/TOX and DS/TOPKAT
2. MODEL
ACD/Tox Ames Test module and QSTR model of DS/TOPKAT

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report Date:
2020

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Results and discussion

Test results
Genotoxicity:
positive
Remarks on result:
mutagenic potential (based on QSAR/QSPR prediction)

Applicant's summary and conclusion

Conclusions:
It would be rational to predict both metal complexes 1 and 2 in Everzol SR98 would have genotoxicity, a positive result in Ames Test in a high possibility.
Executive summary:

In this report, we take advantage of ACD/TOX Ames Test result prediction module and DS/TOPKAT Ames Test result QSTR model, respectively, to predict the genotoxicity (Ames Test) of two metal complex components 1 and 2 of Everzol SR98 in combination with corresponding literatures. Althought the coordination agent 3 in both metal complexes was predicted to have a positive Ames Test result in a very low possibility by both ACD/Tox Ames Test and DS/TOPKAT Ames test QSTR models, the literature data indicated that both Cr3+ and Co3+ may have genotoxicity. Therefore, both components 1 and 2 in Everzol SR98 would have a positive result in Ames Test with a high possibility.