Miebo: genotox, carcinogenicity and repro: done or skipped?

“Perfluorohexyloctane was not mutagenic or clastogenic in a standard battery of genotoxicity tests, including a bacterial mutagenicity assay (Ames assay), an in vitro chromosome aberration assay using human peripheral lymphocytes, and an in vivo bone marrow micronucleus assay in rats.”

“Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of perfluorohexyloctane.”

“no adverse maternal or developmental effects were observed in rats at doses up to 162 times the recommended human ophthalmic dose (RHOD) ( see Data ). Maternal toxicity, miscarriages and reduced fetal weights were observed in rabbits at all doses tested, with the lowest dose as 41 times the RHOD.”

“CNS (Central Nervous System) safety pharmacology was assessed using Irwin test as part of a 7-day oral maximum tolerated dose (MTD) toxicity study in rats at 1 hour after oral dosing of F6H8 at doses up to 5000 mg/kg/day and did not cause CNS effects.”

“F6H8 was considered not to induce a mutagenic effect with the Ames test or induce structural chromosome aberrations in cultured human lymphocytes.”

“F6H8 was considered not to induce a mutagenic effect with the Ames test or induce structural chromosome aberrations in cultured human lymphocytes.”

“F6H8 was not clastogenic or aneugenic in the bone marrow micronucleus test of male rats up to a dose of 2000 mg/kg.”

“8 Carcinogenicity No studies were conducted.”

“Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of perfluorohexyloctane.”

“No additional safety pharmacology endpoints were assessed.”