Registration Dossier
Registration Dossier
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EC number: 949-711-6 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The substance "Saccharomyces cerevisiae call wall, extracted" is not readily biodegradable, not bioaccumulable and it does not show any aquatic toxicity to freshwater aquatic organisms. In addition, long-term effects are not expected on populations of aquatic organisms other than potentially providing nutrients and no toxicity is expected on terrestrial compartments. Moreover, "Saccharomyces cerevisiae cell wall, extracted" is not classified for any health effect. On the basis of these properties, "Saccharomyces cerevisiae cell wall, extracted" is neither PBT, not vPvB.
No data is available to evaluate the carcinogenicity of the substance, hence no classification is determined. The negative results obtained in the three in vitro key studies (Ames test, read-across MLA and Micronucleus test), permit to conclude on a non-mutagenic or genotoxic effect of the substance. Taking together the results of the read-across key rat oral combined repeated and reproductive toxicity study (OECD TG 422 study) performed on Saccharomyces cerevisiae, lysate showing no adverse effects on reproductive performance and no effects at the maximum dose tested, with a NOAEL of 1000 mg/kg bw/d, and all the evidence on the long history of safe-use of Saccharomyces cerevisiae yeast and its various derivative substances, it was concluded that Saccharomyces cerevisiae cell wall, extracted is not expected to be a reproductive or developmental toxicant. Based on the available data, the substance should not be classified for mutagenicity and reprotoxicity according to CLP. Based on all the reliable repeated dose toxicity data available on the target substance Saccharomyces cerevisiae cell wall, extracted as well as on the various Saccharomyces cerevisiae derivative substances or the whole SC yeast organism (ranging from subacute to chronic), no toxicity upon repeated exposure is expected for the registered substance Saccharomyces cerevisiae cell wall, extracted. Based on the available data, the substance should not be classified for mutagenicity, reprotoxicity and for repeated toxicity according to CLP.
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