Registration Dossier

Administrative data

Description of key information

Proprietary guideline and GLP-compliant studies demonstrate that 2-butyl-2-ethylpropanediol is not a skin irritant but is a mild eye irritant and requires classification under Regulation (EC) No 1272/2008.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

BEPD was investigated for skin irritation potential in two comparable rabbit studies. Slight, reversible irritation was observed in each study. Based on the results of these studies, BEPD is not classifiable as a skin irritant.

Eye irritation

BEPD was found to be a mild eye irritant in two comparable studies in the rabbit and is classified in Category 2 for eye irritation under CLP.


Justification for selection of skin irritation / corrosion endpoint:
Two studies are available - a weight of evidence approach is followed for this endpoint.

Justification for selection of eye irritation endpoint:
Two studies are available - a weight of evidence approach is followed for this endpoint.

Effects on eye irritation: irritating

Justification for classification or non-classification

The available data indicate that 2-butyl-2-ethylpropanediol is not classified for skin irritation, but is classified under Regulation (EC) No 1272/2008 as Irritating to Eyes (Category 2).