2. Academic Validation
  3. A toxicological evaluation of geranylgeraniol

A toxicological evaluation of geranylgeraniol

  • Regul Toxicol Pharmacol. 2021 Aug;124:104975. doi: 10.1016/j.yrtph.2021.104975.
Kayla Preece 1,  Róbert Glávits 2,  John R Foster 3,  Timothy Murbach 4,  John R Endres 5,  Gábor Hirka 6,  Adél Vértesi 7,  Erzsébet Béres 8,  Ilona Pasics Szakonyiné 9
Affiliations

Affiliations

  • 1 AIBMR Life Sciences, Inc., 1425 Broadway, Suite 458, Seattle, WA, 98373, USA. Electronic address: kayla@aibmr.com.
  • 2 TOXI-COOP Zrt., Berlini Utca 47-49, H-1045, Budapest, Hungary. Electronic address: glavits.robert.dr@gmail.com.
  • 3 ToxPath Sciences Ltd, 1 Troutbeck Avenue, Congleton, Cheshire, CW12 4JA, United Kingdom. Electronic address: john.foster@regulatoryscience.com.
  • 4 AIBMR Life Sciences, Inc., 1425 Broadway, Suite 458, Seattle, WA, 98373, USA. Electronic address: tim@aibmr.com.
  • 5 AIBMR Life Sciences, Inc., 1425 Broadway, Suite 458, Seattle, WA, 98373, USA. Electronic address: john@aibmr.com.
  • 6 TOXI-COOP Zrt., Berlini Utca 47-49, H-1045, Budapest, Hungary. Electronic address: gabor.hirka@toxicoop.com.
  • 7 Toxi-Coop Zrt., Arácsi út 97, 8230, Balatonfüred, Hungary. Electronic address: adel.vertesi@toxicoop.com.
  • 8 Toxi-Coop Zrt., Arácsi út 97, 8230, Balatonfüred, Hungary. Electronic address: erzsebet.beres@toxicoop.com.
  • 9 TOXI-COOP Zrt., Berlini Utca 47-49, H-1045, Budapest, Hungary. Electronic address: ilona.pasics@toxicoop.com.
PMID: 34144118 DOI: 10.1016/j.yrtph.2021.104975
Abstract

Geranylgeraniol (GGOH) is an isoprenoid compound found in annatto seeds and an intermediate of the mevalonate pathway found within organisms serving various functions. Toxicological studies on its safety profile are not readily available. To assess the safety of GGOH, a molecularly distilled, food grade annatto oil, consisting of approximately 80% trans-GGOH, was subjected to a Bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test, and an in vivo mammalian micronucleus test in order to investigate its genotoxic potential and a 90-day repeated-dose oral toxicity study in rats in order to investigate its potential subchronic toxicity and identify any target organs. No evidence of mutagenicity or genotoxic activity was observed under the applied test systems. In the 90-day study, male and female Hsd. Han Wistar rats were administered daily doses of 0, 725, 1450, and 2900 mg/kg bw/day by gavage. Treatment-related adverse effects were observed in the forestomach at all dose levels and in the liver at the intermediate- and high-dose levels. Based on these results, the lowest observed adverse effect level (LOAEL) for local effects and the no observed adverse effect level (NOAEL) for systemic effects were determined as 725 mg/kg bw/day.

Keywords

Genotoxicity; Geranylgeraniol; NOAEL; Safety; Toxicity.

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