Registration Dossier
Registration Dossier
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EC number: 283-294-5 | CAS number: 84604-16-0 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Saccharomyces cerevisiae, Saccharomycelaceae.
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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