3-pyridylamine

Genetic toxicity: in vitro

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:

2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2009

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

Test material information

Constituent 1

Reference substance name:

3-pyridylamine

EC Number:

207-322-2

EC Name:

3-pyridylamine

Cas Number:

462-08-8

Molecular formula:

C5H6N2

IUPAC Name:

pyridin-3-amine

Test material form:

other: Pale pink crystalline solid

Details on test material:

Purity: 99.9%
Batch no.: MR11718HR

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

100, 300, 1000, 3000 and 5000 µg/plate

Vehicle / solvent:

Demineralized water

Controls

Untreated negative controls:

yes

Remarks:

Demineralized water (solvent)

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

mitomycin C

other: 2-Aminoanthracene

Evaluation criteria:

A concentration-dependent increase in the number of revertants of at least one tester strain
over the vehicle control value and/or outside the historical control range is indicative of
genotoxic activity.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

limit concentration: 5000µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

3-Aminopyridine did neither precipitate nor induce bacteriotoxicity up to the highest
concentration of 5000 μg/plate.

Applicant's summary and conclusion

Conclusions:

3-Aminopyridine caused neither base-pair substitutions nor frameshift mutations in different strains of S. typhimurium in the presence and absence of metabolic activation when tested up to the maximum recommended concentration. Based on these results it was concluded, that the test
substance is "Ames negative" in a test performed
under regulatory acceptable standards.