Registration Dossier
Registration Dossier
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EC number: 949-711-6 | CAS number: -
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
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 read across repeated dose toxicity study is available. Further, toxic effects of Saccharomyces cerevisiae cell wall, extracted after repeated exposure via the dermal route are not considered to be of any relevance or concern. Dermal absorption of Saccharomyces cerevisiae cell wall, extracted is not expected to be higher than the oral absorption and no toxic effect was recorded in the acute oral toxicity study performed with Saccharomyces cerevisiae cell wall, extracted. In consequence, a study in experimental animals on toxicity via repeated dermal exposure is not considered to be required.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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