Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

For in vitro gene mutations two studies were available. An Ames test with Gistex Standard powder AGGL (batch PHS2 A04), performed according to OECD 471 and in compliance with GLP, was not mutagenic under the conditions employed in that study (Ommen, B van, 2000). The study is performed according to internationally accepted testing guidelines and in accordance with GLP. The study was performed on a yeast extract compliant with the macro-composition in the introduction of this document. The other Ames study was performed with Ohly autolysat Kat (Hefeautolysat) and can be used as supportive evidence.

Furthermore, an in vivo micronucleus test according to OECD 474 and compliant with GLP was performed with two test materials (Willems and Immel, 1989): Maxarome powder, natural food flavour from primary grown yeast (lot 8829-03) and Gistex standard powder, autolyzed yeast extract, FM 8850-03). It was concluded that the results of the micronucleus test did not provide any indication of chromosomal damage and/or damage to the mitotic apparatus in bone marrow cells of mice treated orally with a high dose of either Gistex or Maxarome. The study is performed according to internationally accepted testing guidelines and in accordance with GLP. The study was performed on a yeast extract compliant with the macro-composition of Saccharomyces cerevisiae, ext.


Short description of key information:
Two Ames tests showed no genotoxicity. Two in vivo micronucleus studies in mice did not show any chromosomal damage.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the in vitro and in vivo data available (for surrogates) it can be concluded that Saccharomyces cerevisiae is not mutagenic and needs not to be classified according to DSD or CLP.