Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Adequacy of study:
other information

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 429 (2002), Local Lymph Node Assay (LLNA).
GLP compliance:
yes

In vivo test system

Test animals

Species:
other: CBA/Ca mice. Local lymph nodes were investigated.

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
3 groups dosed with test substance (5 mice each)
1 negative control group (5 animals)
1 positive control group (5 animals)

Three epicutaneous applications of DMSO solutions with test
substance concentrations of 5, 10 and 18.6 % w/w
Only DMSO for the negative control group
25 % hexyl cinnamic aldehyde in acetone:oil, 4:1for the
positive control group.

Concentration of test material and vehicle used for each challenge:
Not applicable.
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
3 groups dosed with test substance (5 mice each)
1 negative control group (5 animals)
1 positive control group (5 animals)

Three epicutaneous applications of DMSO solutions with test
substance concentrations of 5, 10 and 18.6 % w/w
Only DMSO for the negative control group
25 % hexyl cinnamic aldehyde in acetone:oil, 4:1for the
positive control group.

Concentration of test material and vehicle used for each challenge:
Not applicable.
No. of animals per dose:
Number of animals in test group: 5
Number of animals in negative control group: 5

Results and discussion

Any other information on results incl. tables

Signs of irritation during induction:
No local reactions were observed.

Evidence of sensitisation of each challenge concentration:
The test substance is regarded as a sensitizer in the Local
Lymph Node Assay (LLNA), as the stimulation indices (SI)
calculated for each of the 3 dosed groups were higher than
3.

Group A (5%) SI=7.3
Group B (10%) SI=9.6
Group C (18.6%) SI=7.6

The stimulation index of the positive control was 8.8.
The stimulation index of the negative control was 1.0.

Other observations:
No systemic effects were observed, except for a slightly
reduced motor activity in one animal of the medium dosed
group, which is not attributed to the test substance.

Applicant's summary and conclusion

Interpretation of results:
other: irritant