Registration Dossier

Diss Factsheets

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:
2018
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

Constituent 1
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

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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