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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:
31st July to 26th September 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: - Study generated according to generally valid and/or internationally accepted testing guidelines - Performed according to GLP - Test parameters based on specific testing guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
Annex V (Ames)
Deviations:
no
Principles of method if other than guideline:
N/A
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): FP-100
- Physical state: Solid, pale yellow
- Analytical purity: >99%
- Purity test date: No details provided in report
- Lot/batch No.: 060511
- Expiration date of the lot/batch: September 2007
- Storage condition of test material: At room temperature at about 20°C. Protection from light is desirable.
- Other: All test item handling was performed in the dark.

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with
Metabolic activation system:
Phenobarbital/5,6-benzoflavone induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 156 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 5000 µg/plate
Vehicle / solvent:
Solvent: Dimethylsulphoxide
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 313 µg/plate
Evaluation criteria:
The test substance was judged positive when the number of revertant colonies increased twice or more than that of the negative control in a dose dependent manner and a reproducibility of the test results was also assured. in other cases, it was judged negative.
Statistics:
None were used

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Observations:
No significant increase in the number of revertant colonies
in the test substance treatment groups was observed in any
test strains with or without S9 mix.


The test substance precipitatied at 313 micrograms/plate
without S9 mix and 1250 microgrames/plate with S9 mix.

Bacterial growth inhibition was not observed at any dose
level.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: preliminary test

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

The test substance was judged negative because the number of revertant colonies for the test substance treatment groups in all test strains was less than twice that of the negative control regardless of a presence or absence of S9 mix.
The number of revertant colonies in the positive controls were above two times that of the negative control. The test results showed that the numbers of revertant colonies in the negative control and positive controls were within the range of the historical data at Hita laboratory. It was also confirmed that the test system was free from bacterial contamination, which indicates the test results to be valid.
From the above results, it was concluded that FP-100 had no ability to induce mutations under the present test conditions.
Executive summary:

The ability of FP-100 to induce mutations was investigated by using Salmonella typhimurium strains TA100, TA1535, TA98 and TA1537 and Escherichia coli strain WP2uvrA with a pre-incubation method in the presence of a metabolic activation system (S9 mix).

As a result , the mutagenicity of the test substance was judged negative because the numbers of reventant colonies in the test substance treatment groups were less than two times that of each negative control in all test strains. therfore, it is conlcuded that FP-100 has no ability to induce mutations under the present test conditions.