Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

Two reliable studies (Klimisch rating 1 and 2) in guinea pigs are available for DIBK. Both studies report no sensitization response in any of the tested animals. In addition, an invalid study reporting some sensitization effects (2 out of 5 animals) is available. However, the low number of animals used in this study does not allow to derive any definitive conclusions and the purity of the test material was only 65%.


Migrated from Short description of key information:
A GLP-studies according to OECD guideline 406 and a GLP-study according to the footpad method are available for diisobutyl ketone.

Respiratory sensitisation

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

No experimental data on respiratory sensitization is available for diisobutyl ketone. However, based on the negative results from the skin sensitization studies it can be concluded that DIBK is not expected to have any respiratory sensitization potential.


Migrated from Short description of key information:
No experimental data on respiratory sensitization is available for diisobutyl ketone.

Justification for classification or non-classification

Pure DIBK did not induce sensitization in any of the tested animals. Hence, no classification for sensitization is required according to EU criteria.