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:

The available data for DIBP comes from an early study, using what would now be considered a non-standard protocol. In this study a group of five guinea pigs were treated with multiple topical applications of an 0.1 M solution of the test substance in acetone:dioxane:corn oil (1:1:2) over a two-week period. The final observations were compared to the initial observations to determine potential sensitization by the test material. A group of five control guinea pigs were treated with only the solvent mixture. Twenty four and forty-eight hours after the last application, the reactions in the control and test groups were similar. Based on the results of this study using the Kodak Drop-on Method, it was determined that diisobutyl phthalate was a not a dermal sensitizer.Whilst this data may not be the most modern it is currently in accordance with the much wider literature on the class of phthalate esters.

Supporting information is available for the homologues DBP and DEHP (EU 2003, 2008) which were also negative for skin sensitisation potential.

It is concluded that DIBP is not a potential sensitiser.

EU (2003) European Union Risk Assessment Report: dibutyl phthalate, volume 29. Office for Official Publications of the European Communities, Luxembourg.

EU (2008) European Union Risk Assessment Report: bis(2-ethylhexyl) phthalate (DEHP), volume 80. Office for Official Publications of the European Communities, Luxembourg.


Migrated from Short description of key information:
DIBP is not a dermal sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
No information is available, however based on an absence of structural chemical alerts together with a long history of use it would not be expected that DIBP would be a respiratory sensitisatier.

Justification for classification or non-classification

The available data together with supporting information for other phthalate diesters indicates that DIBP does require classification for sensitisation.