Registration Dossier
Registration Dossier
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EC number: 289-817-3 | CAS number: 90028-28-7 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Phyllanthus emblica L., Euphorbiaceae.
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- Sample sent to INTOX PVT. LTD. , 375, Urawade, Tal. Mulshi, Dist. Pune, Maharashtra, 412115, India for analysis.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 39 days
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Emblic, ext.
- EC Number:
- 289-817-3
- EC Name:
- Emblic, ext.
- Cas Number:
- 90028-28-7
- IUPAC Name:
- Beta-Glucogallin and Gallic acid are the main constituents of Emblica officinalis extract.
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- isolated skin discs
- Source species:
- rat
- Cell type:
- other:
- Cell source:
- other: Epidermal surface of skin disc
- Source strain:
- Wistar
- Vehicle:
- water
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
Test animals
- Species:
- rat
- Strain:
- Wistar
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Value:
- > 10.78 - < 10.78
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- The In-Vitro Skin Corrosion Study by TER ( Transcutaneous Electrical Resistance Test Method) for Emblica officinalis Extract concludes that Emblica officinalis Extract is Non-corrosive as per the United Nations (UN) Gloally Harmonised System (GHS) for classification of Chemicals. The Study is performed as per OECD Guideline for testing of Chemicals Guideline No. 430.
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