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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:
2007
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Principles of method if other than guideline:
study performed as plate incorporation test (experiment I) and as pre-incubation test (experiment II);
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Target gene:
TA 1537: his C 3076; rfa-; uvrB-
TA 98: his D 3052; rfa-; uvrB-; R-factor
TA 1535: his G 46, rfa-; uvrB-;
TA100: his G 46; rfa-; uvrB-, R-factor
WP2 uvrA: trp-. uvrA-
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
from rat liver S9
Test concentrations with justification for top dose:
Pre-experiment/ experiment I: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate;
experiment II: 33, 100, 333, 1000, 2500 and 5000 µg/plate
Vehicle / solvent:
DMSO
Controlsopen allclose all
Positive controls:
yes
Remarks:
TA 1535, TA 100
Positive control substance:
sodium azide
Remarks:
without activation
Positive controls:
yes
Remarks:
TA 1537, TA 98
Positive control substance:
other: 4-nitro-o-phenylene-diamine
Remarks:
without activation
Positive controls:
yes
Remarks:
WP2 uvrA
Positive control substance:
methylmethanesulfonate
Remarks:
without activation
Positive controls:
yes
Remarks:
TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
Positive control substance:
other: 2-aminoanthracene
Remarks:
with activation
Untreated negative controls:
yes
Remarks:
with and without activation
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Remarks:
with and without activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation); preincubation;
DURATION
- Preincubation period: 60 min at 37°C
- Exposure duration: 48 h at 37°C

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
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 increase in revertant colony numbers of any of the five tester strains was observed following treatment with the substance at any dose level, neither in the presence nor in the absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally aknowledgement border of biological relevance.
In conclusion, it can be stated that the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.