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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 84-2
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
100, 333, 667, 1000, 3330 or 5000 µg/plate
Note: The highest dose level used in the main assays was determined in a preliminary toxicity test with TA 100 exposed to 0 (untreated), 0 (solvent), 6.05 – 4540 µg a.i./plate with and without metabolic activation.

Results and discussion

Test results
Species / strain:
other: all strains tested
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: No cytotoxicity up to 5000 µg per plate

Any other information on results incl. tables

Genotoxicity: On basis of a preliminary test a mutation assay with concentrations of 0 (solvent, i.e. dimethylsulfoxide) 100, 333, 667, 1000, 3330, 5000 µg Piperonyl Butoxide per plate, with and without S-9 activation was conducted. Triplicate plates per strain, dose and condition were used. In both independent assays, no positive responses were observed with any of the strains used, in the presence as well as in the absence of microsomal enzymes. In contrast, the positive control substances produced marked increases in the incidences of revertant colonies in all strains both with and without metabolic activation.

Citotoxicity: no observed

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative

The results of the dose range-finding study indicate that no appreciable toxicity was observed up to 5000 µg per plate.
No positive responses were observed with any of the strains used, in the presence as well as in the absence of microsomal enzymes. These results were confirmed in an independent assay
Piperonyl Butoxide was not mutagenic when tested on S. typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538, with or without S9-mix activation