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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.