.beta.-D-Glucopyranoside, (2R)-3,4-dihydro-2,8-dimethyl-2-[(4R,8R)-4,8,12-trimethyltridecyl]-2H-1-benzopyran-6-yl

Skin sensitisation

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

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Test material

Test material information

Constituent 1

Reference substance name:

(2S,3R,4S,5S,6R)-2-{[(2R)-2,8-dimethyl-2-[(4S,8S)-4,8,12-trimethyltridecyl]-3,4-dihydro-2H-1-benzopyran-6-yl]oxy}-6-(hydroxymethyl)oxane-3,4,5-triol

EC Number:

805-675-2

Cas Number:

102340-61-4

Molecular formula:

C35H56O7

IUPAC Name:

(2S,3R,4S,5S,6R)-2-{[(2R)-2,8-dimethyl-2-[(4S,8S)-4,8,12-trimethyltridecyl]-3,4-dihydro-2H-1-benzopyran-6-yl]oxy}-6-(hydroxymethyl)oxane-3,4,5-triol

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.