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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Human patch test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- The aim of the study is to evaluate the potential skin irritation after contact with the substance according to a 48 hours closed patch test under occlusion on human volunteers.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Human patch test under occlusion
- Deviations:
- no
- Principles of method if other than guideline:
- The specific patch (Finn Chambers) contaning the product (quantity: 20µl, diluted at 10%) is applied on the back skin of 25 human volunteers. The product is left in contact with the skin during 48 hours. The potential side effects (skin erythema and oedema reactions) are evaluated by a dermatologist 15 minutes, 1 hour and 24 hours after the removal of the patch.
- GLP compliance:
- not specified
- Remarks:
- The laboratory is ISO 9001. The test is in conformity with the Declaration of Helsinki, EU 2001/20/EC of 4/4/2001, Directive of the Ministry of Health of 2/5/2012 on good clinical practice and the Directive of the Ministry of Health of 22/5/2013 on GLP.
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
Test animals
- Species:
- other: human
- Strain:
- not specified
Test system
- Type of coverage:
- occlusive
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 20µl, diluted at 10%
- Duration of treatment / exposure:
- 48 hours
- Observation period:
- 15 minutes, 1 hour and 24 hours.
- Number of animals:
- 25
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: Human 1 to 25
- Time point:
- other: 15 minutes
- Score:
- ca. 0.04
- Max. score:
- 1
- Reversibility:
- other: Not applicable as non-irritating
- Remarks on result:
- no indication of irritation
- Remarks:
- For mean human 1 to 25
- Irritation parameter:
- edema score
- Basis:
- other: Human 1 to 25
- Time point:
- other: 15 minutes
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable as non-irritating
- Remarks on result:
- no indication of irritation
- Remarks:
- For mean human 1 to 25
- Irritation parameter:
- erythema score
- Basis:
- other: Human 1 to 25
- Time point:
- other: 1 hour
- Score:
- ca. 0.04
- Max. score:
- 1
- Reversibility:
- other: Not applicable as non-irritating
- Remarks on result:
- no indication of irritation
- Remarks:
- For mean human 1 to 25
- Irritation parameter:
- edema score
- Basis:
- other: Human 1 to 25
- Time point:
- other: 1 hour
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable as non-irritating
- Remarks on result:
- no indication of irritation
- Remarks:
- For mean human 1 to 25
- Irritation parameter:
- erythema score
- Basis:
- other: Human 1 to 25
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable as non-irritating
- Remarks on result:
- no indication of irritation
- Remarks:
- For mean human 1 to 25
- Irritation parameter:
- edema score
- Basis:
- other: Human 1 to 25
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable as non-irritating
- Remarks on result:
- no indication of irritation
- Remarks:
- For mean human 1 to 25
Applicant's summary and conclusion
- Interpretation of results:
- other: The test item is not irritant for skin
- Conclusions:
- The potential skin irritation of the product has been assessed according to amended Draize classification. On the basis of the data obtained, the test item Palmitoyl grapevine shoot extract is deemed to be non irritating "dermatologically tested".
- Executive summary:
Refer to attached study report.
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