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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No LDP0200015
Purity 99.1%

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
Experiment I : 10;33;100;333;1000; and 2500 microg/plate
Experiment II : 3;10;33;100;333 and 1000 microg/plate
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
Concurrent untreated and solvent controls were performed
Negative solvent / vehicle controls:
yes
Remarks:
Concurrent untreated and solvent controls were performed
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA1535 and TA100 with a concentration of 10 microg/plate without metabolic activation
Untreated negative controls:
yes
Remarks:
Concurrent untreated and solvent controls were performed
Negative solvent / vehicle controls:
yes
Remarks:
Concurrent untreated and solvent controls were performed
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylene-diamine
Remarks:
TA1537 and TA98 with a concentration of 10 microg/plate and 50 microg/plate respectively without metabolic activation
Untreated negative controls:
yes
Remarks:
Concurrent untreated and solvent controls were performed
Negative solvent / vehicle controls:
yes
Remarks:
Concurrent untreated and solvent controls were performed
True negative controls:
no
Positive controls:
yes
Positive control substance:
methylmethanesulfonate
Remarks:
TA102 with a concentration of 4 microg/plate without metabolic activation
Untreated negative controls:
yes
Remarks:
Concurrent untreated and solvent controls were performed
Negative solvent / vehicle controls:
yes
Remarks:
Concurrent untreated and solvent controls were performed
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
TA1535, TA1537, TA98, TA100 and TA102 with a concentration of 2.5 microg/plate with metabolic activation

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
toxic effects, evident as a reduction in the number of revertants was observed at the higher concentration with and without metabolic activation in all strains used.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Therefore Cyclopropenyl Estragole is considered to be non-mutagenic in this Samonella Typhimurium reverse mutation assay.