Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
Version / remarks:
2001
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Version / remarks:
2003
GLP compliance:
yes (incl. QA statement)
Type of study:
mouse local lymph node assay (LLNA)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
mouse
Strain:
other: CBA/JHsd
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
propylene glycol
Remarks:
diluting vehicle
Concentration:
Five groups of 5 female CBA/JHsd mice were dosed for 3 consecutive days with 0% (vehicle control), 5%,
10%, 25%, 50% TS on both ears. Propylene glycol was used as the diluting vehicle.
One group of 5 female mice was dosed for 3 consecutive days with 25% hexylcinnamaldehyde
(HCA) in 4:1 acetone:olive oil (AOO) as a positive control and one group of 5 female mice was dosed for 3 consecutive days
with AOO as a positive control vehicle
No. of animals per dose:
Five animals per dose
Positive control substance(s):
hexyl cinnamic aldehyde (CAS No 101-86-0)

Results and discussion

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: The SI values calculated for the substance concentrations 5 and 10 % group was 1.22 and 1.40 respectively.
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: see Remark
Remarks:
Mean DPM/animal values for the experimental groups treated with test substance concentrations 5 %, 10 % were 412.65 and 474.85 DPM respectively. Test substance concentration 25 % and 50 % - five mice were found dead on the test day 1, and, therefore, were not evaluated past this time point. The mean DPM/animal value for the 0 % vehicle control group was 339.25 DPM, 25 % positive control was 4945.05 and 0 % Positive Control Vehicle was 507.85

Any other information on results incl. tables

No statistically significant differences in mean body weights and body weight gains compared to the vehicle control group were observed at any test concentration. All animals dosed at either 25% or 50% test substance concentrations were found dead on test day 1 after one dose. No abnormalities were detected during gross examination. No clinical signs of toxicity were observed in the 5% or 10% test substance concentrations. No statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at any test concentration. Stimulation indexes of less than 3.0 were observed at the 5% and 10% test concentrations of the TS. Therefore, the EC3 value (the estimated concentration required to induce a threshold positive response, i.e., stimulation index = 3) for the test substance under the conditions of this study was not calculable. A 25% concentration of the positive control, HCA, produced a dermal sensitization response in mice. Therefore, the LLNA test system was valid for this study with the TS. Under the conditions of this study, the TS did not produce a dermal sensitization response in mice.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based on the data, the TS is not a dermal sensitizer at doses up to 10%.