1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)

Endpoint summary

Additional information

Octopirox was tested for point mutagenic activitiy in the Ames-test using various strains of Salmonella typhimurium. All tests were carried out in the presence and in the absence of a metabolizing system (S9 -mix). Testing for chromosomal mutation potential was performed in a chromosomal aberration test invivo as well as in the micronucleus test in vivo following oral or intraperitoneal administration. None of these mutagenicity assays revealed indications of genotoxic properties. Additionally, a DNA binding study in vivo using radiolabelled Octopirox revealed also no indication of genotoxic activity mediated by DNA-binding. Based on all available data it is concluded that Octopirox is not mutagenic.

Short description of key information:
Octopirox was investigated for genetic toxicity using a variety of bacterial, cell based and in-life mutation tests. All mutagenicity assays, both in vitro and in vivo revealed no genotoxic potential. Additionally, Octopirox does not disclose any indication on a very low limit of detection for a genotoxic acitivity in vivo mediated by DNA binding after subcutaneous administration.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Octopirox was tested for point mutation and chromosomal muation in various test systems both in vitro and in vivo. In none of these tests indications of genotoxic activity were observed. Based hereupon Octopirox is regarded to be non-mutagenic and thus labelling and classification does not apply.