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EC number: 907-672-2
CAS number: -
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
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.
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.
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