Registration Dossier
Registration Dossier
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EC number: 231-818-8 | CAS number: 7757-79-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In vitro
Potassium nitrate is not mutagenic in Salmonella typhimurium strains TA 1535, TA 1537, A 1538, TA 98, TA 100, and TA 92 with and without metabolic activation. No chromosomal aberrations were induced in a Chinese hamster fibroblast cell line without metabolic activation. In a study comparable to OECD guideline 479, no SCEs were induced in lymphocytes. In addition, an OECD guideline 476 and EC guideline B.17 study showed no effects on the thymidine kinase locus in L5178Y mouse lymphoma cells.
No in vivo studies are required, as all in vitro studies showed no genotoxicity.
Justification for selection of genetic toxicity endpoint
Several publications, Ames and Chromosome aberration, and a Mouse Lymphoma test are available on the substance, all showing no adverse effects.
Short description of key information:
Potassium nitrate appeared to be not mutagenic in Ames tests, in chromosome aberration studies and in a Mouse Lymphoma Assay according to OECD 476 and EC B.17, both done with and without metabolic activation.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
According to Annex I of Regulation (EC) No. 1272/2008 potassium nitrate is not classified based on the available data showing negative results from in vitro mammalian mutagenicity assays. No data from in vivo studies is available as this is not required based on the negative outcome of multiple in vitro studies.
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