2-pyridylamine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Remarks:

Comutagenic effect with norharman studied, only 2 strains tested.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Comutagenic effect with norharman tested; only 2 strains.

Principles of method if other than guideline:

Comutagenic effect of the test item with norharman (9H-pyrido[3,4-b]indole).

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-pyridylamine

EC Number:

207-988-4

EC Name:

2-pyridylamine

Cas Number:

504-29-0

Molecular formula:

C5H6N2

IUPAC Name:

pyridin-2-amine

Specific details on test material used for the study:

- Source: purchased from Tokyo Kasei Kogyo Co., Ltd., Tokyo.

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9-mix.

Test concentrations with justification for top dose:

200 µg per plate, 2 mg per plate.

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle:

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation method.
- Aminopyridine derivatives and norharman were dissolved together in 0.1 ml DMSO and mixed with 0.5 ml of S9 mix or 0.5ml of 100 mM sodium phosphate buffer (pH 7.4) and 0.1 ml of bacterial culture. The mixture was preincubated at 37°C for 20 min, and revertants were counted after incubation for 2 days. Aminopyridine derivatives were tested at amounts up to 2 mg per plate and norharman was added at 200 µg per plate.

DURATION
- Preincubation period: 20 min
- Exposure duration: 2 days
- Expression time (cells in growth medium): 2 days

SELECTION AGENT (mutation assays):

NUMBER OF REPLICATIONS:

METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED:

NUMBER OF CELLS EVALUATED:

NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells):

CRITERIA FOR MICRONUCLEUS IDENTIFICATION:

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:
- Any supplementary information relevant to cytotoxicity:

OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Methods, such as kinetochore antibody binding, to characterize whether micronuclei contain whole or fragmented chromosomes (if applicable):

- OTHER:

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

other: Combined with norharman.

Applicant's summary and conclusion

Conclusions:

The test item combined with norharman (9H-pyrido[3,4-b]indole) was non-mutagenic. This can be regarded as indication of the non-mutagenicity of the test item.

Executive summary:

The mutagenicity of the test item was studied with norharman (9H-pyrido[3,4-b]indole) in the bacterial reverse mutation assay, with and without metabolic activation by S9 mix. The strains tested were Salmonella typhimurium TA 98 and TA 100. The test item combined with norharman (9H-pyrido[3,4-b]indole) was non-mutagenic. This can be regarded as indication of the non-mutagenicity of the test item.