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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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