Establishment of Acceptable Daily Intakes (ADIs) and Risk Assessment for Ephedrine, Menichlopholan, Anacolin, and Etisazole Hydrochloride
1
조회
0
다운로드
1
인용
0
참고문헌
키워드
초록
BACKGROUND: Prior to implementing a positive list system (PLS), there is a need to establish acceptable daily intake (ADI) and maximum residue limit (MRL) for vetꠓerinary drugs that have been approved a few decades ago in South Korea. On top of that, chronic dietary exposure assessment of veterinary drug residues should be perꠓformed to determine whether the use of these veterinary drugs would cause health concerns or not. METHODS AND RESULTS: To establish the ADI, the relevant toxicological data were collected from evaluaꠓtion reports issued by international organizations. A slightly modified global estimate of chronic dietary exꠓposure (GECDE) model was employed in the exposure assessment owing to the limited residual data. Therefore, only the ADI of ephedrine was established due to inꠓsufficient data for the other veterinary drugs. Thus, inꠓstead of ADI, the threshold of toxicological concern (TTC) value was used for the other drugs. Lastly, the hazꠓard index (HI) was calculated, except for etizazole hydroꠓchloride, due to the potential of mutagenicity. CONCLUSION(S): The HI values of ephedrine, meniꠓchlopholan, and anacolin were found to be as high as 6.4%, suggesting that chronic dietary exposure to the resiꠓdues from these uses was unlikely to be a public health concern. Further research for exposure assessment of vetꠓerinary drug residues should be performed using up-toꠓdate Korean national health and nutrition examination survey (KNHANES) food consumption data. In addition, all relevant available data sources should be utilized for identifying the potentials of toxicity.
Abstract
BACKGROUND: Prior to implementing a positive list system (PLS), there is a need to establish acceptable daily intake (ADI) and maximum residue limit (MRL) for vetꠓerinary drugs that have been approved a few decades ago in South Korea. On top of that, chronic dietary exposure assessment of veterinary drug residues should be perꠓformed to determine whether the use of these veterinary drugs would cause health concerns or not. METHODS AND RESULTS: To establish the ADI, the relevant toxicological data were collected from evaluaꠓtion reports issued by international organizations. A slightly modified global estimate of chronic dietary exꠓposure (GECDE) model was employed in the exposure assessment owing to the limited residual data. Therefore, only the ADI of ephedrine was established due to inꠓsufficient data for the other veterinary drugs. Thus, inꠓstead of ADI, the threshold of toxicological concern (TTC) value was used for the other drugs. Lastly, the hazꠓard index (HI) was calculated, except for etizazole hydroꠓchloride, due to the potential of mutagenicity. CONCLUSION(S): The HI values of ephedrine, meniꠓchlopholan, and anacolin were found to be as high as 6.4%, suggesting that chronic dietary exposure to the resiꠓdues from these uses was unlikely to be a public health concern. Further research for exposure assessment of vetꠓerinary drug residues should be performed using up-toꠓdate Korean national health and nutrition examination survey (KNHANES) food consumption data. In addition, all relevant available data sources should be utilized for identifying the potentials of toxicity.
참고문헌 (31)
- Falowo AB, "Veterinary drug residues in meat and meat products : Occurrence, detection and implications", Veterinary Medicine and Pharmaceuticals, 3, pp.19~ (2019)[DOI]
- "2020 Food Balance Sheet" (2021)[URL]
- OECD-FAO Agricultural Outlook 2022-2031, "OECD-FAO Agricultural Outlook", 189~195 (2022)
- "Fipronil in eggs:Factsheet – December 2017" (2018)[URL]
- EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), "Scientific opinion on safety evaluation of Ephedra species for use in food", EFSA Journal, 11(11), pp.3467~ (2013), EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS)[DOI]
- Rim HJ, "Studies on the chemotherapy of trematode infections in Korea", Korean University Medical Journal, 12(2), pp.425~457 (1975)
- Lerche P, "Veterinary Anesthesia and Analgesia", pp.178~182 (2015), John Wiley & Sons
- Çayır A, "Genotoxicity of commercial fungicide Cabrio Plus on human cell", Cytotechnology, 68(5), pp.1697~1704 (2016)[DOI]
- Xujia Zhang, "Assessing the toxicity of the benzamide fungicide zoxamide in zebrafish (Danio rerio): Towards an adverse outcome pathway for beta-tubulin inhibitors", Environmental Toxicology and Pharmacology, 78, pp.103405~ (2020), Elsevier BV[DOI]
- European Food Safety Authority and World Health Organization, "Review of the Threshold of Toxicological Concern (TTC) approach and development of new TTC decision tree", EFSA Supporting Publications, 13(3), pp.1006E~ (2016)[DOI]
- Axelrod J, "Studies on sympathomimetic amines. I. The biotransformation and physiological disposition of l-ephedrine and l-norephedrine", Journal of Pharmacology and Experimental Therapeutics, 109(1), pp.62~73 (1953)
- Joseph E. Sinsheimer, "Species differences in the metabolism of norephedrine in man, rabbit and rat", Biochemical Journal, 136(3), pp.763~771 (1973), Portland Press Ltd.[DOI]
- R.T. WILLIAMS, "COMPARATIVE METABOLISM OF SOME AMPHETAMINES IN VARIOUS SPECIES", Frontiers in Catecholamine Research, pp.927~932 (1973), Elsevier[DOI]
- Martti Marvola, "Effect of Acetylated Derivatives of some Sympathomimetic Amines on the Acute Toxicity, Locomotor Activity and Barbiturate Anaesthesia Time in Mice", Acta Pharmacologica et Toxicologica, 38(5), pp.474~489 (2009), Wiley[DOI]
- Graham BE, "A pharmacologic study of ortho-methoxy-betaphenyl-Isopropyl methylamine hydrochloride, and 13 related methoxy analogues", Journal of Pharmacology and Experimental Therapeutics, 94(2), pp.150~166 (1948)
- Chen KK, "The effect of repeated administration of ephedrine", Journal of Pharmacology and Experimental Therapeutics, 27(1), pp.77~86 (1926)
- Warren MR, "Acute toxicity of vasopressor amines; Comparative data", Journal of Pharmacology and Experimental Therapeutics, 86(3), pp.284~286 (1946)
- Catherine A. Hilliard, "Chromosome aberrations in vitro related to cytotoxicity of nonmutagenic chemicals and metabolic poisons", Environmental and Molecular Mutagenesis, 31(4), pp.316~326 (1998), Wiley[DOI]
- Douglas B. McGregor, "Reactivity of catecholamines and related substances in the mouse lymphoma L5178Y cell assay for mutagens", Environmental and Molecular Mutagenesis, 11(4), pp.523~544 (1988), Wiley[DOI]
- Milena Radakovic, "Evaluation of the effects of ephedrine on human lymphocytes in the comet assay", Acta veterinaria, 61(4), pp.363~371 (2011), National Library of Serbia[DOI]
- Richard D. Storer, "Revalidation of the in vitro alkaline elution", rat hepatocyte assay for DNA damage: improved criteria for assessment of cytotoxicity and genotoxicity and results for 81 compounds, Genetic Toxicology, pp.1996, 368(2)[DOI]
- Zeiger E, "Salmonella mutagenicity tests : IV. Results from the testing of 300 chemicals", Environmental and Molecular Mutagenesis, 11(S12), pp.1~157 (1988)
- Ivan Berlin, "Pharmacodynamics and pharmacokinetics of single nasal (5 mg and 10 mg) and oral (50 mg) doses of ephedrine in healthy subjects", European Journal of Clinical Pharmacology, 57(6-7), pp.447~455 (2001), Springer Science and Business Media LLC[DOI]
- John T. Liles, "Pressor Responses to Ephedrine Are Mediated by a Direct Mechanism in the Rat", Journal of Pharmacology and Experimental Therapeutics, 316(1), pp.95~105 (2005), American Society for Pharmacology & Experimental Therapeutics (ASPET)[DOI]
- Martti Marvola, "Pharmacokinetics and Locomotor Activity Increasing Effect of Ephedrine in Mice", Acta Pharmacologica et Toxicologica, 43(5), pp.381~386 (2009), Wiley[DOI]
- "Principles and methods for the risk assessment of chemicals in food. Environmental Health Criteria 240 Chapter 5:Dose-response assessment and derivation of healthbased guidance values" (2008)[URL]
- Creina S Stockley, "Dispositional factors do not contribute to the enantiospecificity of the cardiovascular effects of phenylpropanolamine", Clinical Pharmacology and Therapeutics, 55(1), pp.35~43 (1994), Springer Science and Business Media LLC[DOI]
- P. S. Sever, "The metabolism of (-)-ephedrine in man", European Journal of Clinical Pharmacology, 9(2-3), pp.193~198 (1975), Springer Science and Business Media LLC[DOI]
- M. M. Rahman, "NITROXYNIL UNCOUPLES OXIDATIVE PHOSPHORYLATION IN THE CELL MITOCHONDRIA AND A DRUG WHEREVER INJECTABLES ARE PREFERRED OVER DRENCHES", Bangladesh Journal of Veterinary Medicine, 15(1), pp.45~49 (2017), Bangladesh Journals Online (JOL)[DOI]
- J. Vanhee, "Etisazole: An animal antifungal agent with skin sensitizing properties in man", Contact Dermatitis, 6(6), pp.443~443 (1980), Wiley[DOI]
- K. E. Malten, "Therapeutics for pets as neglected causes of contact dermatitis in housewives", Contact Dermatitis, 4(5), pp.296~299 (1978), Wiley[DOI]