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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.
There were two subchronic oral toxicity studies on surrogates available which were conducted according to current guidelines and in compliance with GLP.
Two reliable oral subchronic toxicity studies are available for two
surrogates that have comparable macro-composition to Saccharomyces
In the study performed with MDA11 no treatment related effect were found
up to the highest dose tested and thus the NOAEL was set at 2000 mg/kg
In the study with MBE20 hypertrophy of the urinary bladder epithelium in
males and females of the mid- and high-dose groups is considered to be
treatment-related. Since the urinary bladder was not affected at the low
dose lowel, the NOAEL is placed at 300 mg/kg bw/day.
Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: urinary bladder
Based on the data available for two surrogates Saccharomyces cerevisiae
extract does not need to be classified for repeated dose toxicity
according to DSD or CLP.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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