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Two skin irritation/corrosion studies (both Klimisch 4) showed that corrosivity of 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine in rats, rabbits and mice is probably. Lack of documentation limits the value of these two studies, but the results are in reasonable agreement with the pH of the substance (pH >= 11.5) and its classification as corrosive.
Furthermore regarding to the eye irritation study with one rabbit 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine is considered to be corrosive to the eyes of rabbits when tested according to OECD 405.

Key value for chemical safety assessment

Additional information

Skin irritation

Studies in animals

The acute skin irritation properties of 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine were estimated in an occlusive test (duration of the occluded exposure not reported) (Klimmer, 1965). The undiluted substance (rats: 50 µl, rabbits: 100-200 µl) was applied to the depilated back skin of rats and rabbits, massaged into the skin by means of a glass rod and covered with gauze and adhesive tape.

The test item penetrated the skin well and caused swelling. Treatment resulted in irritation and inflammatory effects. The effects were more intensive with rabbits than with rats. Repeated application led to severe effects on the skin with formation of crusts and necroses. Therefore, under the conditions of this test, 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine is corrosive to the skin.

In addition, the acute skin irritation properties of 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine were estimated in an open test (Schmid, 1968). A dose of approx. 50 mg test item per animal was applied to the clipped skin of the right flank of each of 20 mice (2 experiments). There was no removal of test substance. 3/10 animals treated with the test substance died within 48 hours after treatment. In the second test, 1/10 mice died. (8/10 animals treated with the reference substance 3,3'-dimethyl-4,4'-diaminodicyclohexylmethane died within 48 hours.) Treatment resulted in necroses of the epidermis and ulcus formation. Scar formation and healing of all skin damages was observed within 2 months in the surviving animals.

Therefore, under the conditions of this study, 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine is corrosive to skin of mice.

Lack of documentation limits the value of the studies (both Klimisch 4), but the results are in reasonable agreement with the pH of the substance (pH >= 11.5) and its classification as corrosive.

Eye irritation

Studies in animals

The acute eye irritation properties of 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine were estimated in a Draize test according to OECD TG 405. An amount of 0.1 ml of the undiluted test substance was instilled into the left eye of one male albino rabbit, and the untreated right eye served as control. The eye remained unrinsed and there was no removal of test substance. The undiluted substance produced serious injury immediately (corrosive effects, opalescence). 24 hours after treatment conjunctiva showed necrosis and the test was interrupted. Therefore, under the conditions of this test 2,2,4(or 2,4,4) -trimethyl hexane -1,6- diamine is considered to be corrosive to eyes.

Justification for classification or non-classification

Because of the results of two skin irritation studies and the high pH-value (pH >= 11.5) the substance 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine must be classified as C (R 34 Corrosive, Causes burns) according EC Directive 67/548/EEC and Category 1C (Skin Corr., H314: Causes severe skin burns and eye damage) according EC Regulation 1272/2008. No further classification for "Serious eye damage/irritation" is necessary because of the aforementioned skin classification as "Corrosive".