Dietary administration of β-ionone epoxide to Sprague-Dawley rats for 90 days
| Autor: | Maodo Malick Diop, Shim-mo Hayashi, Mark R. Bauter, Jan Demyttenaere, Sean V. Taylor, Christie L. Harman, Gerhard Krammer, Odete Mendes, Jürgen Schnabel, Maria Bastaki, Michel Aubanel, Vivian Lu, Thierry Cachet, A.M. Api, Kevin J. Renskers |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
NOAEL
no-observed-adverse-effect level medicine.medical_specialty Urinalysis Health Toxicology and Mutagenesis EPA Environmental Protection Agency RSD relative standard deviation beta-Ionone epoxide Epoxide Motility EFSA European Food Safety Authority FEMA GRAS Toxicology AAALAC Association for Assessment and Accreditation of Laboratory Animal Care Applied Microbiology and Biotechnology Article MW molecular weight chemistry.chemical_compound Zona fasciculata RA1190-1270 Internal medicine medicine CAS Chemical Abstracts Service GRAS Generally Recognized as Safe FEMA Flavor and Extract Manufacturers Association ComputingMethodologies_COMPUTERGRAPHICS CFR Code of Federal Regulation Estrous cycle Hematology Toxicity Spermatid medicine.diagnostic_test business.industry GLP Good Laboratory Practice FDA Food and Drug Administration JECFA Joint FAO/WHO Expert Committee on Food Additives OECD Organisation of Economic Cooperation and Development flavoring ingredient medicine.anatomical_structure Endocrinology chemistry Toxicology. Poisons bw or BdW body weight fragrance material Rat ppm parts per million SD standard deviation business |
| Zdroj: | Current Research in Toxicology Current Research in Toxicology, Vol 2, Iss, Pp 192-201 (2021) |
| ISSN: | 2666-027X |
| DOI: | 10.1016/j.crtox.2021.05.001 |
| Popis: | Graphical abstract Highlights • GLP-compliant 90-day study on β-ionone epoxide following OECD guideline. • β-Ionone epoxide produces no adverse effects at doses up to 80 mg/kg bw/day in rats. • β-Ionone epoxide had no effect on reproductive functionality parameters. In a 90-day GLP-compliant study groups of Sprague-Dawley rats (10/sex/group) were fed diets containing β-ionone epoxide, a fragrance material and a flavoring substance, at dietary concentrations providing target intakes of 0, 20, 40 and 80 mg/kg bw/day. There were no deaths and no adverse changes in clinical observations, ophthalmological examinations, body weight, body weight gain, food consumption, food efficiency; hematology, serum chemistry, urinalysis parameters; or in macroscopic findings attributable to β-ionone epoxide administration. Increased absolute and relative liver weights in high dose females without correlating hepatic histopathological findings were considered non-adverse. Cortical vacuolation of adrenal zona fasciculata was observed in high-dose males but was considered non-adverse due to the nondegenerative nature of this alteration. β-Ionone epoxide did not influence estrus cyclicity in females and did not affect sperm morphology or epididymal sperm count, homogenization-resistant spermatid count and motility measurements in male rats. The no-observed-adverse-effect level (NOAEL) for administration of β-ionone epoxide in the diet was determined to be the highest dose tested of 80 mg/kg bw/day. |
| Databáze: | OpenAIRE |
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