Pub Date : 2020-03-27eCollection Date: 2020-03-01DOI: 10.14252/foodsafetyfscj.D-20-00001
FSCJ conducted a risk assessment of monepantel (CAS No.887148-69-8), a parasiticide based on results from various studies. Data on pharmacokinetics (cattle) and residues (cattle) were newly submitted. Negative results were obtained in all genotoxicity and carcinogenicity studies. The no-observed-adverse-effect level (NOAEL) obtained in all studies was 100 ppm (equivalent to 3 mg/kg bw per day for both sexes). In the 52-week chronic toxicity study in dogs, FSCJ specified an ADI for monepantel at 0.03 mg/kg bw per day based on NOAEL of 3 mg/kg bw per day, by applying a safety factor of 100.
{"title":"Monepantel (Veterinary Medicinal Products).","authors":"","doi":"10.14252/foodsafetyfscj.D-20-00001","DOIUrl":"https://doi.org/10.14252/foodsafetyfscj.D-20-00001","url":null,"abstract":"<p><p>FSCJ conducted a risk assessment of monepantel (CAS No.887148-69-8), a parasiticide based on results from various studies. Data on pharmacokinetics (cattle) and residues (cattle) were newly submitted. Negative results were obtained in all genotoxicity and carcinogenicity studies. The no-observed-adverse-effect level (NOAEL) obtained in all studies was 100 ppm (equivalent to 3 mg/kg bw per day for both sexes). In the 52-week chronic toxicity study in dogs, FSCJ specified an ADI for monepantel at 0.03 mg/kg bw per day based on NOAEL of 3 mg/kg bw per day, by applying a safety factor of 100.</p>","PeriodicalId":73044,"journal":{"name":"Food safety (Tokyo, Japan)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2020-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7101469/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37788657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2019-12-27eCollection Date: 2019-12-01DOI: 10.14252/foodsafetyfscj.D-19-00020
The Food Safety Commission of Japan (FSCJ) conducted a risk assessment of fosfomycin (CAS No. 23155-02-4), using documents submitted for the ‟re-examination" of veterinary medicinal products. The data used for the assessment include ADME of fosfomycin Ca, residue of fosfomycin Ca and of fosfomycin Na, acute toxicity of fosfomycin Ca and fosfomycin Na. Data on subacute toxicity, reproductive and developmental toxicity, genotoxicity and microbiological effect are also included. The lowest-observed-adverse-effect level (LOAEL) in these toxicity studies was 175 mg (titer)/kg body weight (bw) per day based on adverse effects including diarrhea, autopsy findings such as erosion, hyperplasia, and exfoliation of glandular stomach mucosa, and histopathological findings such as erosion of the stomach and ileum mucosa observed as adverse effects in the 35-day subacute toxicity study in rats. Fosfomycin was not teratogenic in rats and rabbits. FSCJ considered that fosfomycin is not a genotoxic carcinogen. The toxicological ADI of fosfomycin was established to be 0.175 mg/kg bw per day by applying a safety factor of 1000 based on the LOAEL of 175 mg (titer)/kg bw per day. On the other hand, the microbiological ADI was calculated to be 0.019 mg/kg bw per day, which is lower than the toxicological ADI. Thus, FSCJ established the ADI for fosfomycin as 0.019 mg/kg bw per day.
{"title":"Fosfomycin (Veterinary Medicinal Products): Summary.","authors":"","doi":"10.14252/foodsafetyfscj.D-19-00020","DOIUrl":"https://doi.org/10.14252/foodsafetyfscj.D-19-00020","url":null,"abstract":"<p><p>The Food Safety Commission of Japan (FSCJ) conducted a risk assessment of fosfomycin (CAS No. 23155-02-4), using documents submitted for the ‟re-examination\" of veterinary medicinal products. The data used for the assessment include ADME of fosfomycin Ca, residue of fosfomycin Ca and of fosfomycin Na, acute toxicity of fosfomycin Ca and fosfomycin Na. Data on subacute toxicity, reproductive and developmental toxicity, genotoxicity and microbiological effect are also included. The lowest-observed-adverse-effect level (LOAEL) in these toxicity studies was 175 mg (titer)/kg body weight (bw) per day based on adverse effects including diarrhea, autopsy findings such as erosion, hyperplasia, and exfoliation of glandular stomach mucosa, and histopathological findings such as erosion of the stomach and ileum mucosa observed as adverse effects in the 35-day subacute toxicity study in rats. Fosfomycin was not teratogenic in rats and rabbits. FSCJ considered that fosfomycin is not a genotoxic carcinogen. The toxicological ADI of fosfomycin was established to be 0.175 mg/kg bw per day by applying a safety factor of 1000 based on the LOAEL of 175 mg (titer)/kg bw per day. On the other hand, the microbiological ADI was calculated to be 0.019 mg/kg bw per day, which is lower than the toxicological ADI. Thus, FSCJ established the ADI for fosfomycin as 0.019 mg/kg bw per day.</p>","PeriodicalId":73044,"journal":{"name":"Food safety (Tokyo, Japan)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.14252/foodsafetyfscj.D-19-00020","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37592980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To elucidate the effect of citric acid on the stability of dissolved ozone, half-lives of ozone in a citric acid solution was investigated. Prolongation of the half-life of ozone was clearly shown in the presence of citric acid in ozonized water. In the presence of ethylenediaminetetraacetic acid (EDTA), the half-life of ozone was decreased. The addition of various concentrations of citric acid to the EDTA solution, however, reversed the half-life in a concentration-dependent manner. These indicate that citric acid suppresses ozone self-decomposition in water. A citric acid-mediated suppression mechanism of ozone self-decomposition involving hydroxy radical (HO•) was proposed as follows: HO• formed by the radical chain reaction process of ozone is scavenged by a way of abstracting the hydrogen atom bound to a carbon atom located α-position of a carbonyl group. The radical chain reaction of ozone is, thus, suppressed. These findings demonstrate that the addition of citric acid to ozonized water is useful for the stabilization of ozone. This ability may contribute to the application of ozone sterilization in food production processes.
{"title":"Effect of Citric Acid on Prolonging the Half-life of Dissolved Ozone in Water.","authors":"Yoshichika Hirahara, Kazuyoshi Iwata, Katsuhiko Nakamuro","doi":"10.14252/foodsafetyfscj.D-19-00005","DOIUrl":"https://doi.org/10.14252/foodsafetyfscj.D-19-00005","url":null,"abstract":"<p><p>To elucidate the effect of citric acid on the stability of dissolved ozone, half-lives of ozone in a citric acid solution was investigated. Prolongation of the half-life of ozone was clearly shown in the presence of citric acid in ozonized water. In the presence of ethylenediaminetetraacetic acid (EDTA), the half-life of ozone was decreased. The addition of various concentrations of citric acid to the EDTA solution, however, reversed the half-life in a concentration-dependent manner. These indicate that citric acid suppresses ozone self-decomposition in water. A citric acid-mediated suppression mechanism of ozone self-decomposition involving hydroxy radical (HO•) was proposed as follows: HO• formed by the radical chain reaction process of ozone is scavenged by a way of abstracting the hydrogen atom bound to a carbon atom located α-position of a carbonyl group. The radical chain reaction of ozone is, thus, suppressed. These findings demonstrate that the addition of citric acid to ozonized water is useful for the stabilization of ozone. This ability may contribute to the application of ozone sterilization in food production processes.</p>","PeriodicalId":73044,"journal":{"name":"Food safety (Tokyo, Japan)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2019-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.14252/foodsafetyfscj.D-19-00005","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37592978","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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