Registration Dossier
Registration Dossier
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EC number: 204-016-0 | CAS number: 112-91-4
Endpoint summary
Administrative data
Description of key information
NOAEL = 50 mg/kg bw/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 50 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
A combined repeated dose/reproduction screening toxicity study according to OECD 422 has been performed with Dodecanenitrile (CAS 2437-25-4).
These results from Dodecanenitrile can be regarded as valid for Oleylnitrile as the tested substance is actually the same: They share the same chemical structure, and only differ in the average length of the alkyl chain. Therefore the inherent toxicological mechanism is considered to be similar, only the bioavailability is assumed to be possible bigger for the nitriles with the shorter alkyl chains. Consequently, one can consider the results from Dodecanenitrile as a worst case assumption for Oleylnitrile.
The overall NOAEL is 50 mg/kg based on effects at next higher dose level of 250 mg/kg. Effects observed at 250 mg/kg/day: All animals pushed their heads through the bedding after administration and open field activity and locomotor activity were reduced. Histopathological findings were observed in the stomach, consisting of increased incidence of ulceration, erosion and mucosal necrosis in the forestomach and glandular stomach, and a minimal hypertrophy of the zona fasciculata of adrenal glands in some females. Clinical biochemistry data revealed several effects for hemoglobin and corpuscular hemoglobin concentration and platelet count in males.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: stomach
Justification for classification or non-classification
Classification for STOT-RE Cat.2 is indicated when severe toxicity is observed at levels of 100 mg/kg bw/day or below during a sub-chronic (90-day) repeated dose study. In case of shorter study duration as a 28-day the equivalent guidance value becomes 300 mg/kg bw/day. The OECD 422 study can be compared with a 28-day study, although the females are exposed longer (generally over 43 days).The combined repeated dose/reproduction screening toxicity study shows that the level of 250 mg/kg bw/day results to only limited toxicity. Hence no classification for STOT-RE is required.
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