Registration Dossier

Administrative data

Description of key information

In a GLP compliant OECD TG 404 study, 0.5 ml octadecylamines (Genamin 18R 100D) were semi-occlusively applied to the shaved skin of three New Zealand White rabbits for 4 hours. Up to 7 days after patch-removal moderate erythema and slight to moderate oedema were observed. Reversibility occurred after 14 days in one animal and 21 respectively 28 days in the two other animals.

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)

Additional information

There are no human data on acute toxicity for octadecylamines nor for any of the other primary alkylamines considered a chemical category with respect to chemical safety assessment. In animals, data from all alkylamines demonstrated a significant dermal irritative potential of this chemical category. C12 -18 -(even numbered)-alkylamines as well as tallow alkylamines and octadecenylamines were shown to be corrosive to rabbit skin, and, in consequence, not tested in rabbit eye. Octadecylamines and hydrogenated tallow alkylamines induced less severe effects in skin but caused severe eye irritation up to irreversible damage in the rabbit eye. For C12 -18 -(even numbered)-alkylamines, rat inhalation studies indicated irritative properties on the respiratory tract.

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Octadecylamines fulfill the requirements for classification as Irritant with the designation R38 - irritating to skin and R41 - risk of serious damage to eyes. Based on the dermal corrosive properties no testing for eye irritation was performed.