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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

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

Test material

Reference
Name:
Unnamed
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Purity : 96.7 %

Method

Target gene:
histidine
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: 5% and 10% v/v consisted of an S9 fraction fraction (Aroclor 1254 induced rat liver homogenate)
Test concentrations with justification for top dose:
The test concentration was selected based on the solubility and precipitation tests. Cytotoxicity to the tester strain was tested at 0.019, 0.039, 0.078, 0.156, 0.312, 0.625, 1.25, 2.5, 5.0 mg test item/plate. Cytotoxicitywas observed at 5.0 mg/plate in the presence of metabolic activation. Hence, 5.0 mg was selected as the highest concentration to be tested in the mutagenicity study.

Trial I: dose levels of 0.156, 0.312, 0.625, 1.25, 2.5 and 5.0 mg/plate with and without S9 mix.
Trial II: dose levels of 2.0, 0.8, 0.32, 0.0512 mg/plate with and without S9 mix.
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
mitomycin C
Statistics:
Simple linear regression analysis was performed to all strains to assess the dose dependent nature of any increase in revertant colonies.

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium, other: all tester strains
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at 5.0 mg/plate with metabolic activation
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
The analysis of the results of Trial I and II did not reveal any statistically significant increase in the number of revertant colonies both in the presence and in the absence of metabolic activation.
The linear regression analysis did not reveal any significant increase in the number of revertant colonies in both the trial.

Applicant's summary and conclusion

Conclusions:
It is concluded that d-trans Allethrin 75/25, up to 5.0 mg/plate, both in the absence and in presence of metabolic activation, is non mutagenic to all the five Salmonella thyphi. tester strain, TA 1537, TA1535, TA98, TA100 and TA102 when tested under the specified conditions.