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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
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
None

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EEC B.14 (Ames test)
Principles of method if other than guideline:
None
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None
Specific details on test material used for the study:
None

Method

Target gene:
None
Species / strain
Species / strain:
other: TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell lines (if applicable):
E. coli WP2uvrA
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Rat-liver post mitochondrial supernatant (S9 fraction)
Test concentrations with justification for top dose:
0.05, 0.5, 5, 50, 500, 5000 μg/plate for pretest0.015, 0.05, 0.15, 0.5, 1.5, 5 μg/plate for TA100 without S9 activation on main test I & II0.5, 1.5, 5, 15, 50, 150 μg/plate for TA100 with S9 activation on main test I & II156, 313 ,625, 1250, 2500, 5000 μg/plate for TA 1535, TA 1537, TA 98 and WP2uvrA on main test I & II
Vehicle:
Solvent:DMSO
Controls
Negative controls:
yes
Remarks:
DMSO
Solvent controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
benzo(a)pyrene
Details on test system and conditions:
None
Rationale for test conditions:
None
Evaluation criteria:
Does not use statistical approach for data analysis. A number of revertant colonies treated with test sample solution shows twice or more as many as a number of revertant colonies treated with solvent. And it increase concentration-dependent.Th result is judged as "Positive" for mutagenicity
Statistics:
Does not use statistical approach for data analysis.

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity:
no
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Additional information on results:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
FAT 40554 is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.
Executive summary:

With or without S9 mix, the number of revertant colonies treated with test sample solution for TA100 shows more than twice as many as the one treated with solvent. And it increased concentration-dependent.

Pretest organized with 0.05, 0.5, 5, 50, 500, 5000 μg/plate.

With or without S9 mix, fatal effect was not observed. Without S9 mix, precipitation was observed on the concentration of 50μg/plate and more. With S9 mix, precipitation was observed on the concentration of 500μg/plate and more. With or without S9 mix, the number of revertant colonies treated with test sample solution for TA100 shows more than twice as many as the one treated with solvent.

Based on pretest result, TA100 without S9mix takes 0.015, 0.05, 0.15, 0.5, 1.5, 5 μg/plate and TA100 with S9mix takes 0.5, 1.5, 5, 15, 50, 150 μg/plate for main test I and II. (Table 2 and 4) Other species with or without S9 mix takes 156, 313 ,625, 1250, 2500, 5000 μg/plate. (Table 3 and 5) Based on main test result, with or without S9 mix, the number of revertant colonies treated with test sample solution for TA100 shows more than twice as many as the one treated with solvent. And it increased concentration-dependent. And without S9 mix, the number of revertant colonies treated with test sample solution for TA98 shows almost twice as many as the one treated with solvent. Based on above result, the test substance is judged as "Positive" for mutagenicity.

In conclusion, FAT 40554 is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.