Registration Dossier

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:
20.08.2007 - 17.10.2007
Reliability:
1 (reliable without restriction)

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
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Formula: C12H14ClN5O4.
Appearance: White to pale yellow solid.
expiry date: 31 December 2007.

Method

Species / strain
Species / strain / cell type:
other: TA97a, TA98, TA100, TA102 and TA1535
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
62, 185, 556, 1667 and 5000 μg per plate without external metabolisation, and 62, 185, 556, 1667 and 5000 μg per plate with S9-mix from Aroclor 1254 induced microsomes of rat liver as an external metabolising system.
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: Sodium Azide, 4-Nitro-o-phenylene-diamine, t-Butyl-hydroperoxide, 2- Aminoanthracene, 1,8-Dihydroxy-anthraquinone, 7,12-Dimethylbenz[a]anthracene, 2-Nitrofluorene

Results and discussion

Test results
Species / strain:
other: TA97a, TA98, TA100, TA102 and TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
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'.

Any other information on results incl. tables

All positive control groups showed significantly increased mutation frequencies which demonstrate the sensitivity of the test system.

No toxicity of the test substance to the bacteria was observed up to 5000 μg per plate.

In none of the concentrations tested and with none of the strains used an increase of the mutation frequency to more than the threshold values (250 % of the controls for strains TA98 and TA1535, 167 % of the controls for strains TA97a, TA100 and TA102) was obtained. Metabolic activation did not change these results.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

According to the results obtained in this study, "Fam-stage-1" is non-mutagenic in the Ames test with the strains TA97a, TA98, TA100, TA102 and TA1535 with and without an external metabolising system up to 5000 μg/plate, which is the limit concentration for this kind of test.