Registration Dossier
Registration Dossier
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EC number: 601-350-2 | CAS number: 115241-16-2
Endpoint summary
Administrative data
Description of key information
No repeated dose toxicity studies are available for N-Formylaminosorbose. However, there is a repeated dose toxicity study for the structural analogue N-Formylaminosorbit (CAS 89182-60-5):
Oral, subacute 4 weeks (Rat-Wistar, GLP, OECD TG 407): NOAEL = 1000 mg/kg
[Bayer AG, Report No. PH-34477, 2006-05-31]
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
No repeated dose toxicity studies are available for N-Formylaminosorbose. However, there is a repeated dose toxicity study for the structural analogue N-Formylaminosorbit (CAS 89182-60-5):
In a subacute oral toxicity study in rats N-Formylaminosorbit was administered daily via gavage in demineralized water to 5 male and 5 female Wistar rats per dose group, in doses of 0, 40, 200 and 1000 mg/kg body weight for a period of 4 weeks. The animals were regularly observed and weighed. Food intake was determined. FOB as well as MA/LMA tests and clinical laboratory investigations on blood samples were performed. Organs and tissues were subjected to gross and histopathological investigations and selected organs were weighed.
Survival was not affected by treatment and no adverse effects were detected up to and including the highest dose group.
Therefore, the NOAEL in male and female rats was established to be 1000 mg/kg body weight/day.
Justification for classification or non-classification
Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.
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