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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- Skin sensitization Maximization Study in Guinea Pigs
- Type of information:
- experimental study
- Remarks:
- Skin Sensitiation Maximization Study performed at sa-FORD, Plot V -10, MIDC Industrial Area, Taloja, Dist Raigad, Navi Mumbai, PIN: 410208, Maharashtra, India
- Adequacy of study:
- key study
- Study period:
- 49 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 406 (Skin Sensitisation)
- Version / remarks:
- In-Vivo test was done
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Draize test
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 vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- other: Control and treatment Group
- Dose level:
- 100mg
- No. with + reactions:
- 0
- Total no. in group:
- 15
- Clinical observations:
- No sensitization
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Substance is not a Sensitizer as per GHS classification.
- Conclusions:
- The study "In-vivo Skin Sensitization Maximization in Guinea Pigs" confirms that Emblica officinalis Extract is considered as a Non-Sensitizer as per the GHS classification of Chemicals. And the study is in complience with OECD guideline No. 406.
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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