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Lee Tae Ho,Park Sun Young,Kim Ji Young,Choi Jang-Duck,Moon Guiim 한국응용생명화학회 2023 Applied Biological Chemistry (Appl Biol Chem) Vol.66 No.-
In this study, an analysis method was established for the quantification of residues of halquinol and its metabolites in livestock and fishery products using liquid chromatography–tandem mass spectrometry (LC–MS/MS). We selected beef, pork (muscle and fat), chicken, egg, milk, flat fish, eel, and shrimp as target samples for validation of the method owing to them being typical livestock and fishery products. Validation of the developed analysis method was performed using liquid chromatography–tandem mass spectrometry (LC–MS/MS) at three concentration levels (0.5, 1, and 2 × the maximum residue limits) following the Codex Alimentarius (CODEX) guidelines (CAC/GL 71–2009). For all samples, correlation coefficients (R2) exceeded 0.99, recoveries ranged between 75.59 and 119.36%, and coefficients of variation (CV) ranged between 1.39 and 28.66%, thus satisfying CODEX guidelines. In addition, inter-laboratory validation was conducted, and the resulting recoveries and CVs satisfied the CODEX guidelines; LOQ was established as 10 μg kg–1 for pig muscle and 5 μg kg–1 for the other samples. Therefore, the analysis method developed in this study can accurately and precisely screen for and quantify halquinol and its metabolites in livestock and fishery products.
Kim Min Ji,Kim Ji Young,Choi Jang Duck,Moon Guiim 한국독성학회 2024 Toxicological Research Vol.40 No.1
As veterinary drugs available for fish is very restricted, there is growing trials for repurposing livestock drugs as aquatic animal drugs. Tylosin is one of the most effective antibiotics to treat bacterial infections approved for livestock, and would be used in fish. Hence, we investigated the toxicological and microbiological aspects of tylosin to establish health-based guidance value (HBGV) and maximum residue limit (MRL) in fishes, and reevaluated the microbiological acceptable daily intake (mADI) based on updated relevant data and international guildeline. Lastly, exposure assessment was performed to confirm the appropriateness of MRL. By investigating available microbiologcial studies on tylosin, the microbiological point of departure was determined as 0.308 μg/mL, which was mean 50% minimum inhibitory concentration ( MIC50), obtained from the Food Safety Committee of Japan (FSCJ) evaluation report. Furthermore, as a factor for the derivation of mADI, the volume of colon content was recently changed to 500 mL in compliance with the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guidelines. This was previously defined as the mass of colon content (220 g). We applied correction factor 0.224 to the mean MIC50 for tylosin in the equation of mADI, since the drug is transformed to metabolites with reduced activity prior to entering the colon and bound to fecal materials within the colon of human. The mADI was evaluated as 0.01 mg/kg bw/day. Finally, the hazard index, calculated by dividing the estimated chronic dietary exposure by mADI, did not exceed 100%, suggesting that chronic dietary exposure to tylosin residues from veterinary use was unlikely to be a public health concern. Overall, this study contributes significantly in updating HBGV by application of the concept of mADI for the first time in Korea based on the revised microbiological risk assessment guidelines and in providing scientific rationale for the risk management of veterinary drug residues in food.