Registration Dossier

Administrative data

Description of key information

Available information indicates that all AAI substances corrosive to skin, and the same should be expected for Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine/Imidazoline).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

All substances within the AAI group show the same reactive groups, show similar composition of amide, imidazoline, and some dimer structures of both, with the length of original EA amines used for production as biggest difference. Inherent reactivity and toxicity is not expected to differ much between these substances.

All in vivo skin irritation/corrosion studies performed on AAI substances all indicate them to be corrosive following 4 hour exposure. There do not seem to be big differences in response with the variation on EA length used for the production of the AAI.

Consequently, similar results can be expected for Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine/Imidazoline).

 

The table below provides an overview of all available for the group of AAI:

    TO + DETA                           in vivo: Corrosive: Cat.1C

    TO + TEPA                           in vivo: Corrosive: Cat.1C

    C16-18, C18 unsat + TEPA   in vivo: Corrosive: Cat.1C

An indication for possible threshold effects for irritation comes from an available sensitisation study on Fatty acids C16-18, C18 unsat reaction products with tetraethylenepentamine.

In a Guinea pig maximization study for dermal sensitization, a preliminary irritation study evaluated irritation from epidermal exposures to the substance for 24 hrs under occlusion. The highest non-irritating concentration for epidermal exposures was established at 1% in 0.9% NaCl. Epidermal concentrations of 5% resulted to moderate and confluent erythema.

 

There are no eye irritation studies available on an AAI substance. Corrosion to the eye is expected based on dermal corrosion.

There are no data from inhalation studies. However, exposure by inhalation is not likely considering the high boiling point (> 300 °C) and very low vapour pressure (0.00017 mPa at 25°C for DETA based AAI). Furthermore, as the substance is classified as corrosive, no acute toxicity testing should normally be conducted.



Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Tall oil fatty acids, reaction products with polyethylenepolyamines (Amidoamine/Imidazoline) is expected to be corrosive following 4 hours application to the skin. Consequently, it should be classified Corrosive, Cat. 1C.

Corrosive to eyes is assumed for substances for which dermal corrosion has been established and no additional classification is required.

 

There is no data from inhalation studies. However, in view of the very low vapour pressure of AAI in general, exposure by inhalation is not likely.