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.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
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: BALB/c 3T3 method
- Deviations:
- no
- Principles of method if other than guideline:
- BALB/c 3T3 cells were seeded and exposed to tested product in a concentration range. After 24h incubation, Neutral Red Uptake in the lysosomes/endosomes and in vacuoles of living cells was measured and used as quantitative indicator of cell number and viability.
- GLP compliance:
- yes (incl. QA statement)
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 system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 1 000
- Negative controls validity:
- valid
- Remarks:
- OD540= 0.801 ± 0.060
- Positive controls validity:
- valid
- Remarks:
- NR50= 0.094 ± 0.002 mg/ml
- Remarks on result:
- other: ORESVISTA results
- Remarks:
- NR50 > 1000 μg/ml MMAS < 25
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the study results, the substance Palmitoyl grapevine shoot extract is not not/mild irritant.
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