Registration Dossier

Administrative data

Endpoint:
specific investigations: other studies
Adequacy of study:
other information

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Principles of method if other than guideline:
Test procedure:
96/54/EG, B.42 (LLNA);

OECD 429 (2002)

Results and discussion

Details on results:
Compared to vehicle treated animals there was an increase

in the cell counts in the highest dose group. this change
was of no statistical significance but the "positive level"
of index 1.4 has been increased. This result shows that
there is an inidcation for a skin sensitzizing effect after
administration of a concentration of 50 % test item in this
test system.


The "positive level" of ear swelling has not been reached

or exceeded in any dose group.

A statistically significant increase compared to vehicle
treated animals regarding ear weight and ear swelling was
detected in the mid and the highest dose group. These
results point to an acute irritating (inflammatory)
response. Such an irritating property can also be combined
with a strong skin sensitizing potential of a test compound.
However, the positive level has not been exceeded though

the increases were of statistical significance.


The results show that the test item has has a weak
sensitizing potential in mice after dermal application of a
50 % concentration. In addition, a non-specific (irritating)
activation can not be excluded after application of a 10 and
50 % concentration. The concentration of 10 % turned out to
be the NOEL for the parameters investigated in this study
with respect to skin sensitization.

Applicant's summary and conclusion