Registration Dossier

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.