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EC number: 202-719-7 | CAS number: 98-98-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 Apr to 05 May 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted 21 Jul 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, London, England
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Pyridine-2-carboxylic acid
- EC Number:
- 202-719-7
- EC Name:
- Pyridine-2-carboxylic acid
- Cas Number:
- 98-98-6
- Molecular formula:
- C6H5NO2
- IUPAC Name:
- pyridine-2-carboxylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains)
trp operon (for E. coli strains)
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, other: WP2 uvr A-
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbitone/β-naphthoflavone.
- Test concentrations with justification for top dose:
- First experiment (preliminary toxicity test): 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation.
Second experiment (mutation test): 50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: sterile distilled water
- Justification for choice of solvent/vehicle: the test substance was soluble in sterile distilled water at a level permitting testing up to the maximum recommended dose level of 5000 µg/plate.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Remarks:
- there was no solvent indicated for any of the positive control substances within the study report.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (direct plate incorporation)
- Cell density at seeding: 1 to 9.9 x 10E9 bacteria/mL
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: examination of the bacterial background lawn - Evaluation criteria:
- The test substance was judged to be mutagenic (positive) under the following conditions: a dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. If the preceeding conditions were not met, the results were judged to be non-mutagenic (negative).
- Statistics:
- Mean values and standard deviations were calculated.
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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- 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
Any other information on results incl. tables
Table 3: Results for the Ames test with Pyridine-2-carboxylic acid
EXPERIMENT 1 (Standard Plate Test, SPT) |
|||||
S9-Mix |
Without |
||||
Test Item (µg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|
VC |
106 ± 1.7 |
24 ± 7.9 |
25 ± 2.0 |
17 ± 3.8 |
14 ± 1.0 |
50 |
86 ± 7.5 |
18 ± 2.5 |
19 ± 1.0 |
20 ± 0.6 |
14 ± 1.0 |
150 |
102 ± 6.7 |
21 ± 3.5 |
24 ± 2.3 |
19 ± 3.8 |
13 ± 0.6 |
500 |
105 ± 11.0 |
19 ± 7.2 |
17 ± 7.8 |
19 ± 2.1 |
15 ± 2.0 |
1500 |
82 ± 6.6 |
24 ± 2.6 |
17 ± 3.1 |
19 ± 2.9 |
15 ± 5.2 |
5000 |
85 ± 8.5 |
20 ± 6.7 |
16 ± 6.1 |
13 ± 0.6 |
10 ± 3.0 |
PC (µg/plate) |
ENNG (3) |
ENNG (5) |
ENNG (2) |
4-NQO (0.2) |
9-AA (80) |
363 ± 62.1 |
208±14.7 |
719 ± 22.3 |
83 ± 2.5 |
490 ± 57.1 |
|
S9-Mix |
With |
||||
Test Item (µg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|
VC |
93 ± 7.0 |
18 ± 6.4 |
24 ± 3.2 |
27 ± 1.5 |
15 ± 3.5 |
50 |
104 ± 0.6 |
15 ± 5.5 |
18 ± 2.3 |
22 ± 5.5 |
14 ± 4.2 |
150 |
93 ± 13.7 |
12 ± 2.3 |
26 ±10.0 |
22 ± 4.4 |
17 ± 4.0 |
500 |
81 ± 7.6 |
11 ± 1.2 |
24 ± 4.6 |
21 ± 5.3 |
15 ± 5.9 |
1500 |
92 ± 14.0 |
17 ± 10.4 |
23 ± 4.7 |
20 ± 2.6 |
12 ± 3.8 |
5000 |
79 ± 16.0 |
11 ± 1.2 |
19 ± 2.1 |
15 ± 5.8 |
13 ± 3.1 |
PC (mg/plate) |
2-AA (1) |
2-AA (2) |
2-AA (10) |
BaP (5) |
2-AA (2) |
1423 ± 51.5 |
264 ± 20.2 |
230 ± 11.4 |
154 ± 30.7 |
250 ± 2.1 |
|
VC = Vehicle control; PC = Positive control
ENNG = N-ethyl-N-nitro-N-nitrosoguanidine
4-NQO = 4-Nitroquinoline-1-oxide
9-AA = 9-Aminoacridine
2-AA = 2-Aminoanthracene
B(a)P = Benzo(a)pyrene
EXPERIMENT 2 (Standard Plate Test, SPT) |
|||||
S9-Mix |
Without |
||||
Test Item (µg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|
VC |
112 ± 5.1 |
28 ± 1.0 |
26 ± 7.1 |
19 ± 4.0 |
9 ± 7.0 |
50 |
101 ± 26.2 |
28 ± 3.8 |
28 ± 6.5 |
25 ± 3.2 |
8 ± 2.1 |
150 |
109 ± 8.1 |
27 ± 2.0 |
25 ± 2.5 |
20 ± 2.6 |
6 ± 0.6 |
500 |
111 ± 4.7 |
24 ± 3.2 |
24 ± 2.9 |
17 ± 5.0 |
7 ± 2.0 |
1500 |
113 ± 10.7 |
27 ± 4.6 |
17 ± 6.7 |
18 ± 2.6 |
9 ± 5.0 |
5000 |
116 ± 9.6 |
29 ± 1.7 |
18 ± 4.0 |
16 ± 2.1 |
3 ± 1.0 |
PC (mg/plate) |
ENNG (3) |
ENNG (5) |
ENNG (2) |
4-NQO (0.2) |
9-AA (80) |
373 ± 57.9 |
212 ± 9.9 |
840 ± 14.7 |
269 ± 38.2 |
822 ± 116.3 |
|
S9-Mix |
With |
||||
Test Item (µg/plate) |
Base-pair substitution type |
Frameshift type |
|||
TA100 |
TA1535 |
WP2uvrA- |
TA98 |
TA1537 |
|
VC |
124 ± 9.2 |
13 ± 2.5 |
24 ± 6.7 |
18 ± 4.5 |
7 ± 4.0 |
50 |
113 ± 15.3 |
11 ± 1.7 |
27 ± 1.2 |
21 ± 1.5 |
6 ± 1.0 |
150 |
120 ± 22.6 |
11 ± 1.5 |
30 ± 7.8 |
21 ± 6.1 |
3 ± 2.6 |
500 |
106 ± 16.5 |
14 ± 2.6 |
23 ± 1.5 |
22 ± 6.0 |
10 ± 2.6 |
1500 |
106 ± 14.6 |
11 ± 2.0 |
23 ± 4.0 |
21 ± 3.5 |
6 ± 4.6 |
5000 |
113 ± 10.5 |
13 ± 3.8 |
18 ± 4.4 |
21 ± 6.7 |
6 ± 3.5 |
PC (µg/plate) |
2-AA (1) |
2-AA (2) |
2-AA (10) |
BaP (5) |
2-AA (2) |
1816 ± 292.2 |
301 ± 9.1 |
710 ± 108.0 |
305 ± 33.6 |
363 ± 45.1 |
|
VC = Vehicle control; PC = Positive control
ENNG = N-ethyl-N-nitro-N-nitrosoguanidine
4-NQO = 4-Nitroquinoline-1-oxide
9-AA = 9-Aminoacridine
2-AA = 2-Aminoanthracene
B(a)P = Benzo(a)pyrene
Applicant's summary and conclusion
- Conclusions:
- The test substance, pyridine-2-carboxylic acid, is non-mutagenic in a bacterial reverse mutation assay (negative for mutagenicity) with and without metabolic activation.
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