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Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 3',5-diallyl[biphenyl]-2,4'-diol and 5,5'-diallyl[biphenyl]-2,2'-diol
Cas Number:
947686-05-7
Molecular formula:
C18H18O2
IUPAC Name:
Reaction mass of 3',5-diallyl[biphenyl]-2,4'-diol and 5,5'-diallyl[biphenyl]-2,2'-diol
Test material form:
solid

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium LT2 strains: TA97a, TA98, TA100, TA102 and TA1535
Metabolic activation:
with and without
Vehicle / solvent:
DMSO

Results and discussion

Test results
Species / strain:
other: TA97a, TA98, TA100, TA102, TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Based on the results of this study it is concluded that Magnolia Officinalis Bark Extract is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.