Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Isobutyraldehyde did not cause ear swelling or cell proliferation in a combined MEST and radioisotopic assay.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

NTP 1990 reported a study, where isobutyraldehyde was tested on female B6C3F1 mice. The doses of isobutyraldehyde ranged from 3% to 30% in a solution of 4 parts acetone to one part olive oil (4:1) for induction and 30% for challenge. Mice received 20 µL by direct dermal application for 5 consecutive days to a shaved and dermabraded site. DNFB (1-fluoro-2,4-dinitrobenzene) (98%) was used as a positive control at a concentration of 0.5%. Measurement of the contact hypersensitivity was accomplished by the radioisotopic assay and the mouse ear swelling test (MEST). No statistically significant dose-dependent contact hypersensitivity response to isobutyraldehyde was demonstrated in mice with or without adjuvant.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information classification for skin sensitisation is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.