Registration Dossier
Registration Dossier
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EC number: 284-511-6 | CAS number: 84929-27-1 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Vitis vinifera, Vitaceae.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: SENS-IS assay
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- other: SENS-IS assay with EpiSkin model, an in vitro reconstructed human epidermis from normal human keratinocytes cultured on collagen matrix at the air-liquid interface.
Test material
- Reference substance name:
- Grape, red, ext.
- EC Number:
- 284-511-6
- EC Name:
- Grape, red, ext.
- Cas Number:
- 84929-27-1
- IUPAC Name:
- 5-[(1E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol; 5-[(2R,3R)-6-hydroxy-2-(4-hydroxyphenyl)-4-[(1E)-2-(4-hydroxyphenyl)ethenyl]-2,3-dihydro-1-benzofuran-3-yl]benzene-1,3-diol
- Test material form:
- solid
Constituent 1
In vitro test system
- Details on the study design:
- The test system used in this study was the EpiSkin model, an in vitro reconstructed human epidermis from normal human keratinocytes cultured on collagen matrix at the air-liquid interface. This model is histological similar to the in vivo human epidermis, with a functional horny layer.
Results and discussion
In vitro / in chemico
Results
- Key result
- Parameter:
- other: Number of overexpressed genes
- Value:
- 1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained for the positive and negative controls were within accaptance criteria and validated the study.
Regarding the sensitization biomarkers, the substance gave negative results (less than 7 genes in the "SENS-IS" or "ARE" gene group) when tested at 1, 10, 50, and 100% in olive oil.
Therefore, besed on these results, the substance Palmitoyl grapevine shoot extract did not demonstrate an in vitro sensitizing potential in the SENS-IS assay. - Executive summary:
The results obtained for the positive and negative controls were within accaptance criteria and validated the study.
Regarding the sensitization biomarkers, the substance gave negative results (less than 7 genes in the "SENS-IS" or "ARE" gene group) when tested at 1, 10, 50, and 100% in olive oil.
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