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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Specific details on test material used for the study:
Haskel No. 9864-02

Method

Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Metabolic activation system:
rat-liver homogenate activation system (S9)
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Metabolic activation system:
rat-liver homogenate activation system (S9)
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Metabolic activation system:
rat-liver homogenate activation system (S9)
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
rat-liver homogenate activation system (S9)
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Metabolic activation system:
rat-liver homogenate activation system (S9)
Test concentrations with justification for top dose:
With activation: 10, 12, 24, 36, 48, 60 µg/plate
Without activation: 2, 4, 6, 8, 10 µg/plate
Vehicle:
Distilled water
Controlsopen allclose all
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
Positive control for assay in the presence of activation
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
Positive control for assay in the absence of activation
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
Positive control for assay in the absence of activation
Negative controls:
yes
Solvent controls:
yes
Remarks:
Negative control for assay in the absence of activation
Negative controls:
yes
Remarks:
S9 negative control included in the activated assay to reassure any activity of the compound in the absence of the S9 activator mixture
Details on test system and conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- All plates were incubated at 37 °C for 48 hours.

NUMBER OF REPLICATIONS: 2 plates
Statistics:
Average number of revertants from two plates

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified

Applicant's summary and conclusion

Conclusions:
The test item was tested in Salmonella typhimurium strains TA1535, TA1537, TA1538, TA98 and TA100. The test item was not mutagenic in the microbial assays either in the presence or absence of a liver microsomal system.