Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2007-12-03 till 2007-12-19
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.
according to guideline
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)
Details on test animals and environmental conditions:
Mice, CBA/Ca01aHsd, female, age 8 – 12 weeks, 5 mice per test group.
acetone/olive oil (4:1 v/v)
A preliminary test was performed first to detect the highest application solution. The maximum technically applicable concentration was found to be 50%. Based on the results of this preliminary test the test item was assayed at three concentrations: 12,5%, 25%, 50% (w/v).
No. of animals per dose:
5 mice per test group; 3 test groups (3 different concentrations) and 1 Negative Control Group (vehicle) were tested.
Positive control substance(s):
other: p-Phenylenediamine
Positive control results:
The stimulation index observed in the historical positive control group of the BSL study no. 073846 with 1% p-Phenylendiamine was 8.1.
other: disintegrations per minute (DPM)
Remarks on result:
other: Table 3: Radioactive determination of the test substance groups. If not noted individually, results include both lymph nodes of an animal.

Summary Results:

None of the three tested concentrations of the test item reached the stimulation index of 3.

The stimulation index at a concentration of 12.5% was 0.8

The stimulation index at a concentration of 25% was 0,7

The stimulation index at a concentration of 50% was 0.9

Weight development of all animals was within the expected range, which includes a weight loss of up to 2 g throughout the study.

At the daily clinical observation the animals did not show any visible clinical symptoms.

Interpretation of results:
not sensitising
Migrated information
The EC3 value (derived by linear interpolation) could not be stated, as all measure points were below the stimulation index of three.
Considering the reported data of this sensitization test it can be stated that the test item causes no reactions identified as sensitization, as the stimulation index was below 3.0 for each concentration tested.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
The stimulation index is far below 1.0 for each concentration tested.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No respiratory sensitisation is expected due to the absence of any skin sensitisation potential.

Migrated from Short description of key information:

Justification for classification or non-classification

According to the GHS criteria, listed in Annex I, the substance does not have to be classified as a hazardous substance regarding sensitisation.