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EC number: 283-294-5
CAS number: 84604-16-0
Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Saccharomyces cerevisiae, Saccharomycelaceae.
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)
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.
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