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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:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

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
Reference substance name:
2,3-Pyridinedicarboxylic acid, 5-methyl-,dimethylester
IUPAC Name:
2,3-Pyridinedicarboxylic acid, 5-methyl-,dimethylester
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): CL 301,589
- Physical state: solid, yellow powder
- Analytical purity: 99.5%
- Storage condition of test material: Room temp.
- Lot/batch No.: AC 9736-103

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
rat liver S-9
Test concentrations with justification for top dose:
0, 312.5, 625, 1250, 2500 and 5000 µg/Plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
other: N-Methyl-N-nitro-N-nitrosoguanidine; 9-Aminoacridine hydrochloride, 2-Aminoanthracene
Details on test system and experimental conditions:
The test article was prepared fresh on the day(s) of testing at different concentrations in DMSO. The test material appeared to be fully soluble in the vehicle at all doses.
Evaluation criteria:
For each dose level, the mean value and standard deviation for revertants per plate were calculated. If the mean value for a given dose point was equal to or greater than twice the mean concurrent vehicle control value for TA98 and TA100 or three times the concurrent vehicle control for strains TA1535, TA1537, TA1538 and WP2 uvrA-, the result for that dose point was considered to be positive. A positive result for the assay is defined as a reproducible dose associated increase in the mean numbers of revertant colonies over at least three concentrations of the test material with at least one positive dose point.
The final decision regarding the genotoxic potential is guided by reasoned scientific judgment.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle 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

2,3-Pyridinedicarboxylic acid, 5-methyl-, 2,3-dimethyl ester was judged to be negative for mutagenicity in six tester strains of bacteria up to and including a dose level of 5000 µg/plate in the presence and absence of S-9 metabolic activation, under the given test conditions.
Executive summary:

2,3-Pyridinedicarboxylic acid, 5-methyl-, 2,3-dimethyl ester was assayed in the microbial mutagenicity assay at concentrations up to and including 5000 µg/plate with and without metabolic activation (Aroclor induced rat liver S-9). The assay was conducted with six bacterial strains: S.typhimurium TA98, TA100, TA1535, TA1537, TA1538 and E.coli WP2 uvrA- using the plate incorporation assay method. Five dose levels were used with three replicates per dose point. The assay was conducted twice to confirm the results.

Results obtained in these assays indicated that the test material was not mutagenic at doses up to 5000 µg/plate with or without metabolic activation.

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