Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
yes
Remarks:
substance for positive control : the reference used is not the same than these specified in the study plan (different supplier and reference). This deviation has no effect on the test because the substance is the same
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: semi-solid
Details on test material:
yellow orange semi-solid
purity : 46.8%
For technical reasons (solubility and stability of mixtures), the commercial substance is tested (50% in mixture of triglyceride capric caprylic)

Test animals

Species:
human

Test system

Type of coverage:
other: in vitro assay
Preparation of test site:
other: in vitro assay
Vehicle:
other: paraffine oil
Controls:
yes, concurrent vehicle
Amount / concentration applied:
Test item at 10% and 100%
Duration of treatment / exposure:
Treatment : 42 min
Post-incubation : 42 h
Number of animals:
3 per assay

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
100
Remarks on result:
other:
Remarks:
Basis: other: test assay 1 (10%). Time point: treatment : 42 minutes and revovery period : 42 hours. (migrated information)
Irritation / corrosion parameter:
other:
Value:
100
Remarks on result:
other:
Remarks:
Basis: other: test assay 2 (100%). Time point: treatment : 42 minutes and revovery period : 42 hours. (migrated information)
Irritation / corrosion parameter:
other:
Value:
1.4
Remarks on result:
other:
Remarks:
Basis: other: positive control. Time point: treatment : 42 minutes and revovery period : 42 hours. (migrated information)
Irritation / corrosion parameter:
other:
Value:
3.3
Remarks on result:
other:
Remarks:
Basis: other: negative control (PBS). Time point: treatment : 42 minutes and revovery period : 42 hours. (migrated information)
Irritation / corrosion parameter:
other:
Value:
10
Remarks on result:
other:
Remarks:
Basis: other: negative control (paraffine oil). Time point: treatment : 42 minutes and revovery period : 42 hours. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the experimental conditions used, the test item at the concentrations 10% and 100% is not irritant on SkinEthic skin irritation test.
Executive summary:

The aim of the study was to evaluate teh skin irritation potential of the test item Tocopheryl Glucoside.

The study was conduced on reconstructed human epidermis (SkinEthic skin irritation test) according OECD guideline n°439.

Culture cells were exposed to test item at 10% and 100% during 42 minutes and the viability was meseared using MTT coloration test.

In the test conditions used, the test item at 10% and 100%, corresponding to tocopheryl Glucoside concentration at 4,68 and 46,8%, was not irritant.