Registration Dossier
Registration Dossier
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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.
Endpoint summary
Administrative data
Description of key information
There were two subchronic oral toxicity studies on surrogates available which were conducted according to current guidelines and in compliance with GLP.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Two reliable oral subchronic toxicity studies are available for two surrogates that have comparable macro-composition to Saccharomyces cerevisiae, ext.
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 bw/day.
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
Justification for classification or non-classification
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.
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