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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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar 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

Method

Target gene:
Histidine operon (hisG46, hisC3076, hisD3052); Lipopolysaccharide barrier (LPA); DNA excision repar (uvrB)
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
mammalian microsomal enzymes
Test concentrations with justification for top dose:
with s9 mix; 25, 50, 100, 250, 1000, and 5000 ug/plate
without s9 mix: 10, 25, 50, 120, 600, and 3000 ug/plate
Confirmatory assay:
with s9 mix: 100, 250, 500, 1000, 2500 and 5000 ug/plate
without s9 mix: 50, 100, 250, 500, 1000 and 3000 ug/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle:
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: multiple postive controls (depedning on strain and metabolic activation)
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Preincubation period:
- Exposure duration: 48 hours
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):


SELECTION AGENT (mutation assays):
SPINDLE INHIBITOR (cytogenetic assays):
STAIN (for cytogenetic assays):


NUMBER OF REPLICATIONS:


NUMBER OF CELLS EVALUATED:


DETERMINATION OF CYTOTOXICITY
- Method: growth inhibition


OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:


OTHER:
Evaluation criteria:
TA98, TA100, WP2uvrA: A postive result must produce at least a 2-fold increase the mean revertants per plate of at least one tester strain over the mean revertants per plate fo the control. A dose response in the mean number of revertants per plate must also occur.
TA1535 and TA1537: A postive result must produce at least a 3-fold increase the mean revertants per plate of at least one tester strain over the mean revertants per plate fo the control. A dose response in the mean number of revertants per plate must also occur.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Test article precipitate was observed on the plates at doses equal to or greater than 3000 ug/plate.
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 with metabolic activation
negative without metabolic activation