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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene mutation study in bacteria

Everzol SR98 have two components, metal complex 1 and metal complex 2. Both metal complexes may be dissociated into coordination compound 3 and metal ions Cr3+ and Co 3+ under the effect of gastric acid. We applied two Ames Test prediction softwares, ACD/Tox Ames Test prediction model and DS/TOPKAT Ames Test QSAR model, to predict a positive Ames Test result for the compound 3 in a very low possibility. On the other hand, eitherCr3+ or Co2+exhibited genotoxicity according to literature-reported data. Furthermore, Co3+ may be transferred into Co2+ in vivo. Therefore, it would be rational to predict both metal complexrs 1 and 2 in Everzol SR98 would have genotoxicity, a positive result in Ames Test in a high possibility.

Link to relevant study records
in vitro gene mutation study in bacteria
Type of information:
Adequacy of study:
key study
Study period:
January 9, 2020
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:
ACD/Tox Ames Test module and QSTR model of DS/TOPKAT
equivalent or similar to guideline
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Remarks on result:
mutagenic potential (based on QSAR/QSPR prediction)
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Additional information

Justification for classification or non-classification