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in vivo mammalian somatic cell study: gene mutation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:

Please see further information in expert statement, in 'attached justification'.

The in vitro results for ammonium manganese(3+) pyrophosphate α-, β- phases are the following: negative ames study, negative in vitro citogenicity study, negative results with metabolic activation but positive results without metabolic activation (short and long-term treatments) in in vitro mammalian gene mutation study. However, the weak positivity may be due to an interference with the test system rather than an intrinsic genotoxic/mutagenic potential of the test item.

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Materials and methods

Results and discussion

Applicant's summary and conclusion