Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Butylethylamine is highly corrosive to the skin and may cause irreversible eye lesions following eye contact.

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

In accordance with Annex VIII, No. 8.2.1, column 2, testing is not required because the substance is a strong base and classified as a skin corrosive Cat 1A. Existing data confirm that the substance causes irreversible skin and eye effects.

The intact rabbit skin (six New Zealand White) had become necrotic after a 4-hour contact to Butylethylamine (neat, 500 mg under occlusive dressing) (Safepharm, 1980). Reportedly N-ethylbutylamine (neat substance, amount not reported) caused severe irritation and irreversible full thickness necrosis of the rabbit's dorsal skin after a 1-minute contact period (BASF, 1972).

Ethylbutylamine (0.05 mL) caused severe edema, corneal opacity, and corneal peeling of the rabbit’s eye at 1 hour after treatment. The symptoms were irreversible and aggravated until the end of the observation on day 8. Strong purulence was seen on days 1 and 8 after treatment, along with bleeding on day 8 (BASF, 1972).

The exprimental information is suitable for assessment, and in line with expected effects deduced from the physic-chemical data. The effects are absolutely clear and the study is therefore assigned as key study despite the low reliability that is generally attributable to short communications.

Effects on skin irritation/corrosion: highly corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Butylethylamine is classified in the regulation 1272/2008/EC and amendments as follows

Skin Corrosive Category 1A, and

Irreversible eye effects (Category 1)