Registration Dossier

Administrative data

Description of key information

Three acute oral toxicity studies are available (two with mice and one with rat) of which two were performed according to OECD guidelines and in compliance with GLP. An acute dermal toxicity study was available performed according to OECD guidelines and in compliance with GLP.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Three acute oral toxicity studies are available (two with mice and one with rat). The studies with mice on Maxarome and Gistex are performed according to internationally accepted testing guidelines and in accordance with GLP. Maxarome and Gistex have a comparable macro-composition based on dry matter and salt free dry matter and therefore the study results can be used for Saccharomyces cerevisiae, ext. Both tests showed no mortality and the LD50 derived was > 2000 mg/kg bw.

The study with rats is not according to any internationally recognized guideline and before GLP and is performed with Gistex. This study could be used as supportive evidence.

Furthermore, an acute dermal toxicity study with rats was performed according to OECD and in compliance with GLP. Saccharomyces cerevisiae, ext. was used as test material in this study. No mortality was seen in this study and therefore the LD50 was determined to be >2000 mg/kg bw.

Justification for classification or non-classification

In absence of any mortality in studies with mice and rats (oral performed on surrogates and dermal route), Saccharomyces cerevisiae, ext. does not need to be classified according to DSD or CLP.