Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Based on the results of the three in vitro assays for genotoxicity [Ames (in vitro gene mutation study in bacteria), in vitro micronucleus test, and mutation at the tk locus of mouse lymphoma cells (in vitro gene mutation study in mammalin cells)], ammonium perrhenate is not considered to demonstrate genotox activity.


Justification for selection of genetic toxicity endpoint
No single study is selected as Ammonium perrhenate has been subject to good quality, guideline, studies for genotoxicity using Ames (in vitro gene mutation study in bacteria), in vitro micronucleus test, and mutation at the tk locus of mouse lymphoma cells (in vitro gene mutation study in mammalian cells), all of which were negative.

Short description of key information:
Ammonium perrhenate was negative in good quality, guideline, in vitro studies for genotoxicity: Ames (in vitro gene mutation study in bacteria) - OECD TG471, using Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537, up to a maximum recommended guideline concentration of 5000 ug/plate, both in the presence and absence of rat liver S9 metabolic activation; in vitro micronucleus test in human peripheral blood lymphocytes - OECD TG487, up to a maximum recommended guideline concentration of 10 mM, both in the presence and absence of rat liver S9 metabolic activation; and mutation at the thymidine kinase (tk) locus of mouse lymphoma L5178Y cells (in vitro gene mutation study in mammalin cells) - OECD TG476, up to a maximum recommended guideline concentration of 10 mM, both in the presence and absence of rat liver S9 metabolic activation.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Classification for mutagenicity generally requires positive results from appropriate in vivo studies. Negative results from the three in vitro assays [Ames (in vitro gene mutation study in bacteria), in vitro micronucleus test, and mutation at the tk locus of mouse lymphoma cells (in vitro gene mutation study in mammalin cells)] indicates that testing in vivo is not necessary, and that classification for genotoxicity is not justified.