Registration Dossier

Administrative data

Description of key information

Irritation:
- skin: corrosive
- eye: 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:

In a primary skin irritation study according to OECD guideline 404, tert-butylamine showed 1 hour after the 3 minutes treatment necroses with full skin thickness destructions. These effects increased until the 24 hour observation were additionally 1 out of 3 animals showed fissures. The necroses described were well movable and the edges protruded. No effect of recovery of local findings was observed during the 72 hours observation period (RCC 1992; reliability score: 1). A second primary skin irritation study validated these corrosive results. Undiluted tert-butylamine exposure times of 1, 5 and 15 min caused soft to leather-like or hard irreversible necroses involving all layers of the skin (BASF AG 1962; reliability score: 2). A third study equivalent to OECD guideline 404, showed after a 3 minute exposure clear to severe red spots and slightly clear edema. 60 min and 4 h of exposure caused necrosis and clear edema in the entire area (Hida Institute 1992, reliability score: 1).

Eye irritation:

In a primary eye irritation study in rabbits, 50 µL of the test substance were applied to the conjunctival sac of one eye in 2 animals and caused after 10 min corrosion predominantly expressed by irreversible corneal opacity (BASF AG 1962; reliability score 2). In a study according to Draize the test substance completely destroyed the eye (Young 1970; reliability score 4).


Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin:

Due to the reported severe effects seen, tert-butylamine is considered as corrosive to the skin.

Eye:

Due to the reported severe corneal injury, tert-butylamine is considered as corrosive to the eye.

EU classification according to Annex VI of Directive 67/548/EEC: C, R35

EU classification according to Annex VI of Directive 67/548/EEC: Xn, R20/22