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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:
supporting study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: U.S. EPA Pesticide Assessment Guidelines Subdivision F, 84-2
Deviations:
no
Remarks:
Conducted according to guideline in effect at time of study conduct
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 95%

Method

Target gene:
histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA1537, TA97, TA98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S9
Test concentrations with justification for top dose:
Without activation: 0, 5, 10, 50, 100, 500, 750 µg/plate
With activation: 0, 10, 50, 100, 500, 1000, 2500 µg/plate
Controls
Untreated negative controls:
yes
Remarks:
DMSO
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene(all strains +S9), N-methyl-N'-nitro-N-nitrosoguanidine (TA1535 and TA100 -S9), 9-aminoacridine (TA97), 2-nitrofluorene (TA98)

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA1537, TA97, TA98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
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'.

Any other information on results incl. tables

Except for strain TA98 in the presence of an activation system, no significant increases in revertants, compared with controls, were observed. In trial 1 with strain TA98 in the presence of an activation system, a significant (p<0.01) increase in revertants, compared to controls, was indicated at 1000 µg/plate. The probability of a positive linear dose response was 0.0041. In trial 2, significant increases in revertants were indicated at 50 and 5000 µg/plate. However, there was no positive linear dose response. Therefore, the results of Trial 2 indicated a nonpositive mutagenic response. A third trial was performed. No significant increases in revertants were indicated. This test substance was judged to be not mutagenic in strain TA98 in the presence of an activation system based on the results of nonpositive mutagenic responses in two of three trials.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test substance was nonmutagenic when tested in Salmonella typhimurium strains TA1535, TA97, TA98 and TA100 in the absence and presence of S9.
Executive summary:

The test substance was nonmutagenic when tested in Salmonella typhimurium strains TA1535, TA97, TA98 and TA100 in the absence and presence of an exogenous metabolic activation system (S9). The maximum concentration tested was 750 µg/plate without activation and 2500 µg/plate with activation. Statistical analyses were performed on the number of revertants obtained for each strain in two trials. Except for strain TA98 in the presence of an activation system, no significant increases in revertants, compared with controls, were observed. A third trial was conducted with strain TA 98 in the presence of an activation system. The test substance was judged to be not mutagenic in strain TA98 in the presence of an activation system based on the results of nonpositive mutagen responses in two of the three trials.