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.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Remarks:
- Sample sent to sa-FORD, Plot V -10, MIDC Industrial Area, Taloja, Dist Raigad, Navi Mumbai, PIN: 410208, Maharashtra, India
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 51 days
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Sample sent to sa-FORD, Plot V -10, MIDC Industrial Area, Taloja, Dist Raigad, Navi Mumbai, PIN: 410208, Maharashtra, India for analysis.
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- 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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Control animals:
- no
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - < 5 000 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Acute Oral Toxicity study for Emblica officinalis extract was performed on wistar Rat (female) and is classified as 'Category 5 or unclassified' in Compliance with the OECD guidelines No. 423.
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