Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Reference
Name:
Saccharomyces cerevisiae, lysate
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
Reference substance:
Saccharomyces cerevisiae, lysate
PBT status:
the substance is not PBT / vPvB
Justification:

Saccharomyces cerevisiae lysate is readily biodegradable in ready biodegradation test and so it is considered neither persistent nor very persistent.


Due to its very high water solubility, the estimated log Kow of the water soluble fraction of saccharomyces cerevisaie lysate is considered very low and so this fraction is not suspected to be bioaccumulable. The insoluble fraction is made of cell wall and also not suspected of bioaccumulation. Therefore Saccharomyces cerevisiae lysate is neither bioaccumulable, nor very bioaccumulable.  


In the acute toxicity tests performed to fish and Daphnia and the toxicity test to the green algae, no toxicity was observed at the loading rate of 100 mg/L (WAF). So Saccharomyces cerevisiae lysate is not toxic to the tested aquatic organisms. Moreover, long-term effects are not expected on populations of aquatic organisms other than potentially providing nutrients. In addition, no toxicity of Saccharomyces cerevisiae or derivatives (yeast, yeast extracts and yeast cell wall fractions), is expected on terrestrial compartments. In the absence of adverse effects, no classification is required for Saccharomyces cerevisiae, lysate. according to CLP.


No data are 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, MLA and Micronucleus tests), permit to conclude on a non-potentially mutagenic or genotoxic effect of the substance. Taking together the results of the 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, lysate 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, lysate 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, lysate. Based on the available data, the substance should not be classified for mutagenicity, reprotoxicity and for repeated toxicity according to CLP.