Registration Dossier
Registration Dossier
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EC number: 200-888-1 | CAS number: 75-64-9
Endpoint summary
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
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