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Diss Factsheets

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:
1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other: OECS QSAR Toolbox
Title:
Unnamed
Year:
1996

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

Constituent 1
Chemical structure
Reference substance name:
Trifluoromethane
EC Number:
200-872-4
EC Name:
Trifluoromethane
Cas Number:
75-46-7
Molecular formula:
CHF3
IUPAC Name:
Trifluoromethane

Method

Target gene:
hisD3052 (for S.typhimurium TA98)
hisG46 (for S.typhimurium TA100)
hisG46 (for S.typhimurium TA1535)
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: S. typhimurium TA1538
Metabolic activation:
with and without
Metabolic activation system:
Type and composition of metabolic activation system:
- source of S9 : S9 mix from rat liver homogenates
Test concentrations with justification for top dose:
10, 50, 100%
Controls
Negative solvent / vehicle controls:
yes
Remarks:
air
Positive controls:
yes
Positive control substance:
other:

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Decrease in revertant colonies in strain TA1335 at 100% test article both with and without S9
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Decrease in revertant colonies in strain TA1335 at 100% test article both with and without S9
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Decrease in revertant colonies in strain TA1335 at 100% test article both with and without S9
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Decrease in revertant colonies in strain TA1335 at 100% test article both with and without S9
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Decrease in revertant colonies in strain TA1335 at 100% test article both with and without S9
Vehicle controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Based on the 50% reduction in the number of revertants per plate in the both the presence and absence of metabolic activation at 100% of test substance in the toxicity assay, the top dose for the assay was set at 100% of test substance per plate in both the presence and absence of S9 activation.


 


In the mutation assay, there was no significant mutagenic response in any of the 5 strains, either in the presence or absence of metabolic activation. Strain TA98 at 25% of test substance exhibited a mean that was 2.1 times the mean of the 100% air control. However, this was due to a single high plate count and was not considered biologically relevant.


 


The positive controls exhibited a significant increase in mutant colonies in all strains both with and without S9. A reduction in the number of revertants per plate was observed with both 100% of test substance and 100% nitrogen in strains TA1538, TA98, and TA100 both with and without S9 indicating this effect was most likely due to oxygen deprivation and not test substance associated toxicity.

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
Negative with and without metabolic activation.
This study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).
Executive summary:

The test substance was determined to be negative for mutagenic activity, both with and without metabolic activation, when tested at 10, 50, and 100% in a bacterial reverse mutation assay using Salmonella strains TA98, TA100, TA1535, TA1537 and TA1538.