Registration Dossier

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.