Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The data on DIBP are not extensive, but are consistent with findings for other phthalate diesters (e.g. DBP, DEHP) and indicate an

overall absence of genotoxic activity (EU 2003; 2008).

In two Salmonela assays (with or without metabolic activation) DIBP returned a negative response.

One study reported effects in a non standard commet assay but this is of unkown relevance given the non standard nature of the

assay, the cell types examined and an absence of historical data.

In 13 week mouse feeding study performed by NTP with DBP (dose levels up to 20,000 ppm) analyses of peripheral blood samples taken

from males and females showed no increased incidences of micronucleated normochromatic erythrocytes.

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.


Short description of key information:
DIBP is non-genotoxic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

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