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short-term repeated dose toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
Justification for type of information:
According to the data requirements as outlined in Annexes VIII-IX, 8.6 of Regulation (EC) 1907/2006, Column 2, a repeated dose toxicity study shall be via the most appropriate route of administration, having regard to the likely route of human exposure. The oral route is considered the most appropriate route of exposure, for which key repeated dose toxicity study is available. Further, toxic effects of Saccharomyces cerevisiae lystae after repeated exposure via the inhalation route are not considered to be of any relevance or concern because exposure of humans via inhalation is unlikely taking into account the very low vapour pressure of “Saccharomyces cerevisiae, lysate” which is estimated to be 4.60 x 10-2 Pa at 20 °C and with a mass median aerodynamic diameter of 185.075 µm with less than 1% of particles having a size <= 10 µM. In consequence, a study in experimental animals on toxicity via repeated inhalation exposure is not considered to be required.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion