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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

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.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Reference:
Composition 0
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 information:
Composition 1
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
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification