Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: semi-solid
Details on test material:
Yellow orange semi-solid
Batch : TVE07151CX
Purity : 93,7 %

In vivo test system

Test animals

Species:
mouse
Strain:
CBA
Sex:
female

Study design: in vivo (LLNA)

Vehicle:
acetone/olive oil (4:1 v/v)
Concentration:
10, 25 and 50%
No. of animals per dose:
4

Results and discussion

In vivo (LLNA)

Results
Parameter:
SI
Remarks on result:
other: The observed SI values were 2.04, 1.87 and 1.58 at concentrations of 10%, 25% and 50% (w/v) respectively.

Any other information on results incl. tables

An inversely proportional minimal trend to the concentrations was recorded. This may be explained by the test item being applied diluted in the vehicule. Therefore, the availability of the test item over the ear skin and its skin penetration is different.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions of this study and at the tested concentrations (10, 25 and 50%), the test item, Tocopheryl Glucoside, gave a negative result in the murine Local Lymph Node Assay, indicative of the absence of skin sensitization properties.
Therefore the test item should not be classified as a skin sensitizer according to the criteria of CLP Regulation.
Executive summary:

The objective of the study was to evaluate the potential acute toxicity of the test item, Tocopheryl Glucoside, to induce contact hypersensitivity using the murine Local Lymph Node Assay (LLNA). The study was conducted according the OECD guideline n°429.

The test item was administred by topical application to the dorsal surface of ears at concentrations of 10%, 25% and 50% (w/v). The test item was prepared in a acetone/olive oil (4/1, v/V) preparation.

The resultas were expressed as desintegrations per minute (dpm) per group and as dpm/node. The obtained values were used to calculate de Stimulation Indice (SI).

Under the experimental conditions of the study, no local reactions were observed in nay animals, no notable increase in ear thickness was observed in any tested concentrations. The SI of the positive control was considered valid. The oberved SI walues were 2.04, 1.87 and 1.58 at concentrations 10%, 25% &nd 50% respectively. No notable lymphoproliferation was noted with the test item in any tested concentrations.

Therefore, the test item gave negative result in the LLNA test, inidcate of the absence of skin sensitization properties. The test item should not be classified as a skin sensitizer according to the criteria of CLP regulation.