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.
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 36 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 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
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
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- TA 1537, TA98, TA100 and TA102 are also used.
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no mutagenic potential
Applicant's summary and conclusion
- Conclusions:
- Bacterial Reverse Mutation Test in Salmonella typhimurium Tester strains for Emblica officinalis Extract confirms it is non-mutagenic . The study is performed in compliance with OECD guidelines No. 471.
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