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Genotoxicity and subchronic toxicity studies of Lipocet®, a novel mixture of cetylated fatty acids
Author(s) -
Brilli Elisa,
Tarantino Germano
Publication year - 2021
Publication title -
journal of applied toxicology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.784
H-Index - 87
eISSN - 1099-1263
pISSN - 0260-437X
DOI - 10.1002/jat.4101
Subject(s) - genotoxicity , toxicity , no observed adverse effect level , corn oil , pharmacology , chemistry , body weight , gastrointestinal tract , food science , toxicology , biology , biochemistry , endocrinology , organic chemistry
Cetylated fatty acids (CFAs) are a group of fats that contain a single ester group within a hydrocarbon chain, which are reported to have beneficial biological effects. A novel mixture of CFAs produced by combining fatty acids derived from refined olive oil with cetyl esters (Lipocet®) is proposed for use as a food ingredient and was therefore subjected to a nonclinical safety assessment. The safety of Lipocet® was evaluated in a bacterial reverse mutation test and an in vitro mammalian cell micronucleus test, followed by a 90‐day oral (gavage) toxicity study. In the 90‐day study, Sprague–Dawley rats were administered with the vehicle (corn oil) or Lipocet® at 1,500, 3,000, or 4,500 mg/kg body weight/day for 90 days. A comparator reference control group received noncetylated fatty acids derived from olive oil at 4,500 mg/kg body weight/day to identify any effects that may be expected following consumption of high doses of fat. Lipocet® was nongenotoxic in vitro. In the 90‐day study, changes observed in hematological and clinical biochemistry parameters were minor in nature and/or showed poor dose dependency. Histopathology findings in the gastrointestinal tract and lungs were noted but were not associated with a clear dose response and were likely incidental. Moreover, Lipocet® was just as well tolerated as the reference control. Therefore, 4,500 mg/kg body weight/day (the highest dose tested) was considered the no‐observed‐adverse‐effect‐level. These results support the safety of Lipocet® for use as a food ingredient.