Registration Dossier

Administrative data

Description of key information

This is good quality skin irritation data which indicates moderate skin irritation potential for Ethanol, 2,2’-iminobis-,N-(hydrogenated tallow alkyl) derivs. CAS No 90367-28-5 (registered as 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4).  We have a Klimisch 1 in-vitro data which has been interpreted as indicating eye irritation potential.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

This is good quality skin irritation data which indicates moderate skin irritation potential for Ethanol, 2,2’-iminobis-,N-(hydrogenated tallow alkyl) derivs. CAS No 90367-28-5 (registered as 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4). We have in-vitro data which has been interpreted as indicating eye irritation potential, based on the knowledge that for this chemical class, in-vitro studies tend to underestimate irritation potential. It is not felt to be scientifically justified on animal welfare grounds to do an in-vivo study. The available information is sufficient for classification and labeling purposes.

Justification for selection of skin irritation / corrosion endpoint:

This study is a Klimisch 1 GLP study to current guidelines, the result is consistent with an earlier less compliant study (Guest 1991) where the test substance was not so clearly specified.

Justification for selection of eye irritation endpoint:

The available study is an in-vitro study which is interpreted as indicating eye irritation potential, supported by the skin irritation data, where the in-vitro test was shown to significantly underestimate the skin irritation potential.  It is not scientifically justified to carry out an animal study to confirm the in-vitro data given the weight of evidence of irritation data for this substance.

Effects on skin irritation/corrosion: moderately irritating

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

This is good quality skin irritation data which indicates moderate to severe skin irritation potential for Ethanol, 2,2’-iminobis-,N-(hydrogenated tallow alkyl) derivs. CAS No 90367-28-5 (registered as 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol CAS No 1218787-30-4). This results in an EU CLP (GHS) classification as a Category 2 Skin irritant with hazard phrase H315. The in-vitro skin irritation study, was interpreted as positive as the viablility of 50.2 was so close to the 50% threshold and we have good evidence that our fatty amine chemistry is less active in-vitro than in the rabbit. Based on this it is justified to also classify as Category 2 for Eye irritation with Hazard statement H319.