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Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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)
Reference:
Composition 0
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 information:
Composition 1
Species:
human
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
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)
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Colipa Program on optimization of existing in vitro eye irritation assays for entry into formal validation : technology transfer and intra/inter laboratory evaluation of epiocular assay for chemicals. Harbell et al. 2009. The toxicologist, 108, 1, 79
Principles of method if other than guideline:
In vitro test on reconstructed human epithelium cornea
GLP compliance:
no
Remarks:
but performed in quality environment
Test material information:
Composition 1
Species:
human
Vehicle:
other: paraffine oil
Controls:
yes, concurrent vehicle
Duration of treatment / exposure:
Treatment during 30 min or 1h30
Post-incubation during 2h or 18h
Number of animals or in vitro replicates:
2
Irritation parameter:
other: viability
Basis:
other: test item assay 1 (10%)
Score:
99.6
Irritation parameter:
other: viability
Basis:
other: test item assay 2 (100%)
Score:
93.7
Irritation parameter:
other: viability
Basis:
other: positive control
Score:
43.7
Irritation parameter:
other: viability
Basis:
other: negative control (liquid PBS)
Score:
9.8
Irritation parameter:
other: viability
Basis:
other: negative control (solid PBS)
Score:
18.4
Irritation parameter:
other: viability
Basis:
other: negative control (paraffin oil)
Score:
7
Irritation parameter:
other: vaibility
Basis:
other: positive control (liquid methyl acetate)
Score:
43.7
Irritation parameter:
other: viability
Basis:
other: positive control (solid methyl acetate)
Score:
35.9

Moistening (first treatment) : 30 minutes in CO2 steriliser

Treatment (liquids) : 30 minutes in CO2 steriliser

Treatment (solids) : 90 minutes in CO2 steriliser

Rinse : 12 minutes

Post-incubation : 120 minutes (liquids) or 18 hours (solids) in CO2 steriliser

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the test conditions used, Tocopheryl Glucoside at 10% and 100% was not irritant on human epithelium cornea in vitro test.
Executive summary:

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

The study was conduced on reconstructed human epithelium cornea.

Culture cells were exposed to test item at 10% and 100% during 30 min or 1h30 (for 10% and 100% test item concentrations respectively) 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.

Additional information

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

The tests conducted to evaluate the skin and eye irritation potential of tocopheryl glucoside were in vitro tests.

The results show that test item at 10% and 100%, corresponding to tocopheryl glucoside concentrations at 4,68 and 46,8 %, was not irritant neither for skin, nor for eyes.