Saccharomyces cerevisiae cell wall, extracted

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies)

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
The acute dermal toxicity study was waived based on the results of an acute oral toxicity study.
An OECD 423 TG test (acute toxic class method) was performed with the target substance Saccharomyces cerevisiae cell wall, extracted in femate rats. Initially, three females were treated at dose level of 2000 mg/kgbw. As no mortality was observed, a confirmatory group was treated at the same dose level. No mortality was observed in this group; therefore, no further testing was required. Results from this test showed that no mortality occurred and all animals were symptom-free up to the 14-day observation period. Also, there were no test item related body weight changes and there was no evidence of macroscopic changes at necropsy. Hence, it can be concluded that the acute oral LD50 value of Saccharomyces cerevisiae cell wall, extracted was above 2000 mg/kg bw in female rats and the substance is not classified according to the CLP criteria for acute oral toxicity endpoint.
As Saccharomyces cerevisiae cell wall, extracted does not meet the criteria for classification as an acute toxic or STOT SE by the oral route, an acute dermal toxicity study does not need to be conducted.

Results and discussion

Clinical signs:

other: other: