A toxicological evaluation of geranylgeraniol
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 g...
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| Vydané v: | Regulatory toxicology and pharmacology Ročník 124; s. 104975 |
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| Hlavní autori: | , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | English |
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Elsevier Inc
01.08.2021
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| ISSN: | 0273-2300, 1096-0295, 1096-0295 |
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| 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.
•Geranylgeraniol is an isoprenoid found in annatto (Bixa orellana) seeds.•Geranygeraniol was not mutagenic or clastogenic in vitro.•Geranygeraniol showed no in vivo genotoxicity.•The no observed adverse effect level for systemic toxicity in the 90-day study was 725 mg/kg bw/day. |
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| AbstractList | 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.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. 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. •Geranylgeraniol is an isoprenoid found in annatto (Bixa orellana) seeds.•Geranygeraniol was not mutagenic or clastogenic in vitro.•Geranygeraniol showed no in vivo genotoxicity.•The no observed adverse effect level for systemic toxicity in the 90-day study was 725 mg/kg bw/day. |
| ArticleNumber | 104975 |
| Author | Hirka, Gábor Murbach, Timothy Endres, John R. Béres, Erzsébet Glávits, Róbert Foster, John R. Szakonyiné, Ilona Pasics Preece, Kayla Vértesi, Adél |
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| CitedBy_id | crossref_primary_10_1016_j_fct_2022_112827 crossref_primary_10_3390_foods11091340 crossref_primary_10_1002_cbic_202100372 crossref_primary_10_3389_fphar_2022_878556 crossref_primary_10_1007_s11481_025_10226_1 crossref_primary_10_3389_fimmu_2021_724991 crossref_primary_10_1007_s10875_023_01621_5 |
| Cites_doi | 10.1111/j.1365-2621.1991.tb07980.x 10.1016/S0278-6915(02)00208-9 10.1016/0165-1110(86)90002-3 10.1016/j.fct.2003.11.007 10.1007/s13197-017-2579-7 10.1016/j.fct.2004.06.005 10.1080/09168451.2017.1415129 10.1128/AEM.00277-09 10.1016/0165-1161(75)90046-1 10.1080/01926230490465874 10.1016/j.tibtech.2003.10.001 10.1073/pnas.0600316103 10.3109/19390211.2012.653530 10.1016/0031-9422(89)80298-5 10.1016/S0278-6915(02)00133-3 10.1016/0165-1110(81)90030-0 10.1016/S0278-6915(03)00104-2 10.1016/S0027-5107(00)00064-6 10.1016/0165-1161(83)90010-9 |
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| Keywords | Safety Toxicity Geranylgeraniol Genotoxicity NOAEL |
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