Registration Dossier

Administrative data

Description of key information

In a GLP compliant OECD TG 404 study, 0.5 ml (Z)-octadec-9-enylamine (Noram O) were semi-occlusively applied to the shaved skin of one New Zealand White rabbits for 3 and 4 hours.  Following the 3 minute exposure moderate to severe erythema and edema but no necrosis were observed. Following 4 hour exposure average Draize scores after 24 hours were 4.0 for erythema and 4.0 for oedema. At the same time necrosis was noted and the study was terminated for humane reasons.

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

There are no human data on acute toxicity for (Z)-octadec-9 -enylamines 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. (Z)-octadec-9 -enylamines, as well as tallow alkylamines and C12 -18 -(even numbered)-alkylamines were shown to be corrosive to rabbit skin, and, in consequence, not tested in rabbit eye. Hydrogenated tallow alkylamines and octadecylamines 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: corrosive

Effects on eye irritation: highly irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

(Z)-octadec-9 -enylamines fulfill the requirements for classification as Corrosive with the designation R34 - causes burns. Additionally, based on data from the EU risk assessment report, which classifies C12-18-(even numbered)-alkylamines as irritating to respiratory tract, classification as Xi, R37 – irritation to respiratory system – is indicated for all other corrosive primary alkylamines based on read-across. Based on the dermal corrosive properties no testing for eye irritation was performed.