Registration Dossier
Registration Dossier
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EC number: 453-580-6 | CAS number: 89604-91-1
Skin sensitisation
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
- 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
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