Octamethylenediamine

Endpoint summary

Description of key information

Dermal irritation/corrosivity to the intact dorsal skin of the white rabbit (BASF-Test, BASF AG, 1967; Valentine et al. 1987): corrosive
Acute irritation to the eye of the white rabbit (BASF-Test, BASF AG, 1967; Valenin et al. 1987): irreversible effects on the eyes, corrosive

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

Skin irritation/corrosion:

During the BASF-Tests (1963 and 1967) the fur of 2 rabbits was clipped and an 80% solution of the test substance in water was applicated using a soaked test patch (2.5 x 2.5 cm). The patch was applicated onto the back of the animals. After an occlusive exposure period of 1, 5 and 15 minutes as well as 20 hours the application area was washed with Lutrol/water (1:1). Furthermore the ears were wrapped for 20 hours with a patch soaked with a 80% solution of the substance in water. Skin effects were documentated 24 hours and 8 days after the removal of the test patches.

The test substance caused full thickness necrosis 24 hours after an occlusive exposure of 5 and 15 minutes which was not reversible within 8 days. Furthermore the occlusive exposure of 1 minute caused severe irritation and edema as well as marked erythema after 24 hours which were not reversible within 8 days while the necrosis aggravated to a marked one after 8 days.

During the tests described by Valentine et al. 1987 the test substance was applied to the clipped, intact skin of the back of 6 female rabbits under semi-occlusive wrapping for about 24 hours. Irritation was scored after 24 and 48 hours. All rabbits showed severe erythema with necrosis at 24 and 48 hours; at 48 hours necrosis extended beyond the treated areas. Severe edema was present in 5 rabbits at 24 and 48 hours; one rabbit showed no edema at 24 hours but moderate edema at 48 hours.

Eye irritation/corrosion:

During the BASF-Test (1963 and 1967) 50 mm3 of the test substance were introduced into the lower conjunctival sac of 2 rabbits' right eyes. The left eyes were used as control and treated with talcum powder. The eyes were not washed after the application. The animals were observed for 8 days with readings after 1 hour, 24 hours and 8 days. After an exposure of 1 hour the eyes treated with the test substance showed eye corrosion which was not reversible within 8 days. The control eyes showed slight redness after 1 hour of treatment which was fully reversible within 24 hours.

During the test described by Valenine et al. 1987 the unchanged test substance was introduced into the lower conjunctival sac of rabbits' right eyes. The left eyes were used as control. In one animal both eyes were rinsed with water approximately 20 seconds after application, the eyes of the other rabbit were not rinsed. The animals were observed for 7 days with readings after 4 hours, 1, 2, 3 and 7 days. A biomicroscope and fluorescein stain were used at examinations beginning the day after treatment. Both eyes treated with the test substance showed severe corneal opacity, moderate or severe iridic changes, severe conjunctival redness and chemosis with necrosis and copious blood-tinged discharge. These effects were not reversible within 7 days.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the positive well-conducted animal study, the test substance was classified as Category 1B skin irritant according to EU directive 67/548/EEC and EU classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

Based on the positive well-conducted animal study, the test substance was classified as a Category 1 eye irritant according to EU directive 67/548/EEC and EU classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.