Registration Dossier
Registration Dossier
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EC number: 805-675-2 | CAS number: 102340-61-4
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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)
- Qualifier:
- according to guideline
- 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. QA statement)
- 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: other: viability
- 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: other: viability
- 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: other: viability
- 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: other: viability
- 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: other: viability
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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)
- Qualifier:
- according to guideline
- 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
- 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
- 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.
Reference
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
Additional information
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.
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