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Diss Factsheets

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
According to Ames, BN; McCann, J and Yamasake, E, Mutation Res., 31, 347-364 (1975).
GLP compliance:
no
Remarks:
predates GLP
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyridine-2-carbonitrile
EC Number:
202-880-3
EC Name:
Pyridine-2-carbonitrile
Cas Number:
100-70-9
Molecular formula:
C6H4N2
IUPAC Name:
pyridine-2-carbonitrile
Test material form:
solid

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Species / strain / cell type:
Saccharomyces cerevisiae
Details on mammalian cell type (if applicable):
D4
Metabolic activation:
with and without
Metabolic activation system:
S9 rat liver
Test concentrations with justification for top dose:
0 (solvent control), 0.1, 1.0, 5.0, 10, 20, 25, 50 uL per plate Substance was tested over a series of concentrations such that there was either quantitative or qualitative evidence of some chemically-induced physiological effects at the high dose level. the low dose in all cases was below a concentration that demonstrated any toxic effect. The dose range employed for the evaluation of this substance was from 0.1 uL to 20 uL per plate. Since the substance did not exhibit toxicity at these doses, the tests with the Salmonella strains were repeated using two higher doses of 24 uL and 50 uL per plate. The substance was toxic to all the Salmonella strains at 50 uL per plate dose level.
Vehicle / solvent:
DMSO
Controls
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
other: N-Methyl-N-nitro-N-nitrosoguanidine; 2-anthramine
Details on test system and experimental conditions:
Per Ames protocol - no deviations noted.
Rationale for test conditions:
Test compound was examined for mutagnic activity in a series of in vitro microbial assays employing Salmonella and Saccharomyces indicator organisms. The substance was tested directly and in the presence of liver microsomal enzyme preparations from Aroclor-induced rats.
Evaluation criteria:
Strains TA-1535; TA-1537 and TA-1538 - if the solvent control value is within the normal range, a chemical that produces a positive dose rsponse over three concentrations with the lowest increase equal to twice the solvent control value is considered to be mutagenic.
Strains TA-98, TA-100 and D4: If the solvent control value is within the normal range, a chemical that produces a positive dose response over three concentrations with the highest increase equal to twice the solvent control vlaue for TA-100 and 2-3 times the solven control value for strains TA-98 and D4 is considered to be mutagenic. For these strains, the dose-response increase should start at approximately the solvent control value.
Statistics:
not stated

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 nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
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 nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
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 nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
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 nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Key result
Species / strain:
Saccharomyces cerevisiae
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
2-Cyanopyridine did not demonstrate mutagenic activity in any of the strains tested and was considered not mutagenic under these test conditions.
Executive summary:

2-Cyanopyridine did not demonstrate mutagenic activity in any of the strains tested and was considered not mutagenic under these test conditions.