Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
GLP compliance:
yes (incl. certificate)
Type of study:
mouse local lymph node assay (LLNA): BrdU-ELISA

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
CBA:J
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
dimethyl sulphoxide
Concentration:
40% 20% and 10%
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Key result
Parameter:
SI
Value:
ca. 0.89
Test group / Remarks:
40%
Key result
Parameter:
SI
Value:
ca. 0.96
Test group / Remarks:
20%
Key result
Parameter:
SI
Value:
ca. 1.14
Test group / Remarks:
10%
Cellular proliferation data / Observations:
CLINICAL OBSERVATIONS:
No mortality and no signs of systemic toxicity were noted in the test and control animals during the test.
Dryness of the skin was noted in all animals treated at 40%, 20% and 10% on day 6.
Residual test item was noted in one animal of the treated group at 10% on day 3.
An increase in ear thickness (+20.4%, +12.5% and+ 18.8%) was noted in animals treated at 10%, 20% and 40%, respectively. No significant increase in ear weight was noted in animals treated at 10%, 20% and 40%. Therefore, the test item has to be considered as not excessively irritant at these concentrations.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions, the test item does not have to be classified as a skin sensitizer.