Registration Dossier

Diss Factsheets

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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
study only performed with TA98 and TA100
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2,4-dichloro-α,α,α-trifluorotoluene
EC Number:
206-278-1
EC Name:
2,4-dichloro-α,α,α-trifluorotoluene
Cas Number:
320-60-5
Molecular formula:
C7H3Cl2F3
IUPAC Name:
2,4-dichloro-1-(trifluoromethyl)benzene
Details on test material:
- Name of test material (as cited in study report): 2.4-Dichloro BTF
- Substance type: organic
- Physical state: liquid
- Analytical purity: 99.8%
- Lot/batch No.: 930150

Method

Target gene:
TA 98: his D 3052; rfa-; uvrB-; R-factor:frameshift-mutations
TA 100: his G 46; rfa-; uvrB-; R-factor:basepair substitutions
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 98
Species / strain / cell type:
S. typhimurium TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9 Mix
Test concentrations with justification for top dose:
Exp. I: 33.3, 100.0, 333.3, 1000.0, 2500.0 and 5000.0 ug/plate
Exp. II: 33.3, 66.6, 100.0, 333.3, 1000.0 and 2500.0 ug/plate
Controls
Untreated negative controls:
yes
Remarks:
concurrent untreated and solvent controls
Positive controls:
yes
Positive control substance:
other: without S9 mix sodium azide for TA100 and 4-nitro-o-phenylene-diamine for TA98. With S9 mix 2-aminoanthracene, 2-AA for both strains

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at highest concentrations
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
at highest concentrations
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

No substantial increases in revertant colony numbers of any of the two tester strains were observed following treatment with the substance at any dose level, with or without metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of significance.

Categories Display