Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
yes
Type of study:
mouse local lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
unchanged (no vehicle)
Concentration:
Undiluted
No. of animals per dose:
4
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

Positive control results:
The control was considered to be a sensitiser under the conditions of the test.

In vivo (LLNA)

Results
Key result
Parameter:
SI
Value:
ca. 0.28
Test group / Remarks:
Value for blank was 0.52
Cellular proliferation data / Observations:
Zero clinical observations and mortailities.

Any other information on results incl. tables

Note that this was done at a single concentration; I assume because even at 100% there was no effect.

Applicant's summary and conclusion

Conclusions:
"The test material was considered to be a non-sensitiser under the conditions of the test.