Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
THE MUTAGENICITIES OF SEVEN COUMARIN DERIVATIVES AND A FURAN DERIVATIVE (NIMBOLIDE) ISOLATED FROM THREE MEDICINAL PLANTS
Author:
Uwaifo A.0.
Year:
1984
Bibliographic source:
Journal of Toxicology and Environmental Health

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Aesculin was tested in a preliminary quantitative mutagenicity assay at 4 different doses (0.2 μg, 2 μg, 20 μg, 500 μg), as recommended in the protocol of Ames et al. (1975). Triplicates were set up for each dose, and the experiment was repeated three times.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Method

Species / strainopen allclose all
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Metabolic activation system:
rat liver S-9 fraction
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Metabolic activation system:
rat liver S-9 fraction
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Metabolic activation system:
rat liver S-9 fraction
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Metabolic activation system:
rat liver S-9 fraction
Species / strain:
other: TA 92 and TA 94
Metabolic activation:
with and without
Metabolic activation system:
rat liver S-9 fraction
Test concentrations with justification for top dose:
0.2 μg, 2 μg, 20 μg, 500 μg

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not determined
Key result
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not determined
Key result
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not determined
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not determined
Key result
Species / strain:
other: TA 92 and TA 94
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not determined

Applicant's summary and conclusion

Executive summary:

Esculin can safely be described as being nonmutagenic in the Ames test system, even though this conclusion is based partly on the results obtained in a spot test.