Registration Dossier

Administrative data

Description of key information

There are no animal or in vitro studies available but a repeated insult patch study with human volunteers is available (see Section 7.10.4 Sensitisation data (humans)). This is considered as key information. Repeated insult patch tests were performed with human volunteers. Based on the data it is concluded that DBPP is not a skin sensitiser.

Key value for chemical safety assessment

Skin sensitisation

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

There are no animal studies available but a repeated insult patch study with human volunteers is available (see Section 7.10.4 Sensitisation data (humans)).

In the repeated insult patch test with DBPP (Shelanski, 1974), the test material was applied on the human skin of 50 human volunteers. After an exposure period of 24 h the patch was removed and the skin sites were examined. Gross changes, if present, were graded on a scale of 1 to 4. Absence of any visible changes were assigned a 0 value. After the patch was removed, the sites were rested for 24 h. If the contact sites manifested no changes, the test material was re-applied to the same site. This cycle was repeated in this manner for 15 applications except that from the third application the test material was diluted with water to a 5 % concentration.

After the 15thapplication, the participants rested for 2 weeks before being challenged. The sites of contact used previously were challenged with the test material, diluted to 5% concentrations in water, for 24 h under occlusion. After removal, the contact sites were examined immediately and following at intervals of 24 and 48 h.

After challenging, no visible skin changes signifying reaction to injury were observed in any of the 50 human volunteers.

 

Based on these test results, it could be concluded that DBPP is negative for skin sensitisation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

50 human volunteers scored negative after the challenge in a repeated insult patch test with DBPP. It is concluded that DBPP should not be classified as a skin sensitiser according to the CLP Regulation.