Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
GLP compliance:
not specified
Type of study:
mouse local lymphnode assay (LLNA)

Test material

Reference
Name:
Unnamed

In vivo test system

Test animals

Species:
mouse
Strain:
CBA/Ca
Sex:
female

Study design: in vivo (LLNA)

Concentration:
10, 25, 50%
Details on study design:
Altogether 28 female CBA/Ca mice were allocated to the study. The test material was used in 10, 25 and 50% concentration dissolved in 1% Pluronic PE200. For control purposes treatment groups with solvent, undiluted active and placebo gel formulations were included. The animals were treated for three consecutive days followed by a 3-day treatment-free period. On last day of the study the cell proliferation in the local lymph nodes was measured by tritiated methyl thimidine (3HTdR) and the obtained values were used to calculate stimulation indices (SI).

Results and discussion

In vivo (LLNA)

Results
Remarks on result:
other: The result is not spesified
Cellular proliferation data / Observations:
No mortality or systemic clinical symptoms were observed during the study. Tolperison hydrochloride tested up to the maximum attainable concentration (50%) in Pluronic solvent was shown to have sensitization potential because the calculated SI value was greater than the threshold value of 3.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No treatment related effects were observed on the treated sites in any of the groups.