Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
The repeated dose oral toxicity of the registration substance is derived based on the read-across approach.
The supporting substance CAS 71786 -60 -2 was tested for its repeated dose toxicity according to the OECD Guideline 408.
The oral administration of Ethanol, 2,2'-iminobis , NC12-18-alkyl derives (a substance used in industry) to Han Wistar rats for 13 weeks caused adverse findings in the eyes at 125 mg/kg/day (lenticular opacification/cataract and degeneration) and stomach at 30 and 125 mg/kg/day (epithelial hyperplasia (acanthosis) and hyperkeratosis). The findings in the nonglandular stomach are considered to be due to local irritant effects of the test formulations. There were also rodent-specific findings in the thyroid glands (follicular cell hypertrophy), that was likely secondary to induction of liver enzymes, and a minor and non adverse effect on hepatocellular glycogen (increased rarefaction). In view of the presence of adverse findings in the eyes at 125 mg/kg/day the systemic no-observed-adverse-effect level (NOAEL) in this study was considered to be 30 mg/kg/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 30 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Reliable and robust read-across based on the category formation. Consistent results obtained in the two available studies.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The repeated dose oral toxicity of the registration substance is derived based on the read-across approach.
The supporting substance CAS 71786 -60 -2 was tested for its repeated dose toxicity according to the OECD Guideline 408, in which the eye was identified as the target organ at 125 mg/kg/day. No systemic effect was found at 30 mg/kg/day. No classification is warranted.
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