Registration Dossier

Administrative data

Description of key information

With regard to  the skin irritation studies with rabbits and rats, 3-aminomethyl-3,5,5-trimethylcyclohexylamine (Isophorone diamine) has to be considered to be corrosive to the skin.
Furthermore regading to the eye irritation study with a rabbit 3-Aminomethyl-3,5,5-trimethylcyclohexylamine is considered to be corrosive to the eyes of rabbits when tested according to OECD TG 405.

Key value for chemical safety assessment

Additional information

Skin irritation

Studies in animals

A study was conducted with 6 adult rabbits and 0.5 ml undiluted 3-aminomethyl-3,5,5-trimethylcyclohexylamine (Isophorone diamine) was applied to the shorn dorsal skin of the animals ( intact and scarified) and covered with gauze and adhesive tape for 24 hours (IBR, 1977). The results were assessed at patch removal (24h) and 48 hr later (72 h), the skin had become hard and leatherlike. Edema scoring was not possible. Similar severity of effects was observed at both readings, i.e. there was no indication of reversibility within the observation period. In the study Isophorone diamine is described to be a severe irritant according to the scoring system used. Thus, under the conditions and according to the results of this study isophorone diamine has to be considered to be corrosive to the skin of rabbits.

Cited from SIAR for SIAM 18 (Paris, April 2004):

"In a study with rabbits and rats, undiluted 3-aminomethyl-3,5,5-trimethylcyclohexylamine was massaged into the depilated back skin of the animals and covered with gauze and adhesive tape. Under these conditions (duration of the exposure not reported), 3-aminomethyl-3,5,5-trimethylcyclohexylamine penetrated the skin and caused swelling, irritation and inflammatory effects. Repeated application led to severe effects with formation of crusts and necroses. Effects were more pronounced with rabbits than with rats (Klimmer, 1965). Lack of documentation limits the value of the study, but the result is in reasonable agreement with the pKb of the substance (ca. 3.6; VEBAChemie, 1975), with its classification as corrosive, and with observations in occupational medicine."

Eye irritation

Studies in animals

Cited from SIAR for SIAM 18 (Paris, April 2004):

"In a study according to OECD TG 405 with rabbits (Small white Russian), undiluted 3-aminomethyl-3,5,5-trimethylcyclohexylamine produced serious injury (corrosive effects, opalescence) almost immediately after application. Twenty-four hours after application of the test substance, conjunctivae showed necrosis (Hüls AG, 1983b)."

Justification for classification or non-classification

Because of the results of the skin irritation studies the substance isophorone diamine is classified as C (R 34; Causes burns) according 67/548/EEC and Category 1C, (H314: Causes severe skin burns and eye damage) according CLP regulation (1272/2008). No further classification for "Serious eye damage/irritation" is necessary because of the aforementioned skin classification as "Corrosive".