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Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

2-aminopyridine-3-ol was not mutagenic in an Amestest according to OECD guideline 471 in strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 with and without metabolic activation.

In an in vitro mammalian cell gene mutation test according to OECD guideline 476 the substance did not induce gene mutations in Chinese hamster V79 cells (hprt-locus) with and without metabolic activation.

In a mouse lymphoma assay in cell line L5178Y (tk+/--locus) according to OECD guideline 476 the substance induced a substantial and reproducible dose dependent increase in mutant colony numbers in the absence of metabolic activation.The ratio of small versus large colonies was shifted towards small colonies, indicating clastogenic activity. With metabolic activation no relevant increase in mutation frequency was observed.

In an in vitro chromosome aberration test in Chinese hamster V79 cells the substance induced structural chromosome aberrations both in the presence and absence of metabolic activation.

 

 

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (positive)

Genetic toxicity in vivo

Description of key information

2-aminopyridine-3-ol was tested in an in vivo micronucleus study on NMRI mice according to OECD guideline 474.

In a pre-experiment the highest dose tested of 50 mg/kg/bw showed clear signs of toxicity.

In the main study the analysis of the blood samples treated with 50 mg/kg bw showed that the test item could be quantified in the blood of the treated animals (data of only 2 males per test group reported), whereby the concentration in blood samples taken 1 h after the treatment were higher than in those taken at the 4 h interval, indicating the bioavailability of the test substance.

 

Under the test conditions 2-aminopyridine-3-ol was not clastogenic and/or aneugenic in the bone marrow cells of mice.

 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification