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Review on the One-year Repeated Dose Oral Toxicity Study in Dogs for the Toxicological Evaluation of Pesticides (Agricultural Chemicals) (Decision of the Expert Committee on Pesticide, FSCJ, 21 December 2017). 农药(农用化学品)毒理学评价用犬一年重复剂量口服毒性研究综述(农药专家委员会决定,FSCJ,2017年12月21日)。
Pub Date : 2018-12-21 eCollection Date: 2018-12-01 DOI: 10.14252/foodsafetyfscj.2018008s

In the toxicological evaluation of pesticides (agricultural chemicals), their toxicities have been evaluated based on studies in rodents such as rats and mice as well as in non-rodents such as rabbits and dogs. Here, reflecting a research performed under the Food Safety Commission of Japan (FSCJ) grant on pesticide toxicity study1), international trends and also scientific points of view, the necessity of chronic dog toxicity studies was reconsidered for the use in toxicological evaluation of pesticides.

在农药(农用化学品)的毒理学评估中,已根据对啮齿动物(如大鼠和小鼠)以及非啮齿动物(如兔子和狗)的研究对其毒性进行了评估。在此,根据日本食品安全委员会(FSCJ)对农药毒性研究1)、国际趋势和科学观点进行的研究,重新考虑了犬慢性毒性研究用于农药毒理学评估的必要性。
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引用次数: 1
Induction of Mucosal Humoral Immunity by Subcutaneous Injection of an Oil-emulsion Vaccine against Salmonella enterica subsp. enterica serovar Enteritidis in Chickens. 皮下注射肠沙门氏菌油乳剂疫苗对黏膜体液免疫的诱导作用。鸡血清型肠炎。
Pub Date : 2018-11-20 eCollection Date: 2018-12-01 DOI: 10.14252/foodsafetyfscj.2018003
Yuuichi Ishida, Eishi Sakai, Katsuo Sato, Einori Sugiyama, Kazuyuki Mima, Akira Taneno, Hirofumi Shimomura, Longzhu Cui, Yoshikazu Hirai

Salmonella enterica subsp. enterica serovar Enteritidis (SE) is one of the major causes of food poisoning. Much effort has been made to develop a vaccine for the prevention of SE colonization and infection in poultry. However, the effect of inactivated whole-cell SE vaccines on the bacterial attachment has not been clarified. This study investigated the immune responses to a killed whole-cell SE vaccine in chickens and the effect of vaccination on the bacterial attachment of SE to cultured Vero cells. A 1 ml dose of 108-109 CFU viable SE bacterial cells was orally administered to chickens at 4 weeks or 10 months post vaccination. The number (CFU) of SE in 1 g of cecal droppings was counted on day 6 after administration. The SE CFUs were significantly lower (p < 0.05) in the vaccinated chickens, not only at 4 weeks but also at 10 months after vaccination, than in the unvaccinated control chickens. Anti-SE IgG and anti-SE IgA were detected using enzyme-linked immunosorbent assay (ELISA) in serum and intestinal and oviduct fluid samples from vaccinated chickens. Adhesion of heat-killed SE cells to Vero cells was reduced by pre-treatment of the bacteria by the vaccinated chicken-derived intestinal fluid, indicating the potential of the vaccine-induced antibody to prevent SE adhesion to epithelial cell surfaces.

肠道沙门氏菌亚种血清型肠炎(SE)是引起食物中毒的主要原因之一。为研制一种预防SE在家禽中的定植和感染的疫苗,人们已经付出了很大的努力。然而,灭活的全细胞SE疫苗对细菌附着的影响尚未明确。本研究研究了鸡对全细胞灭活SE疫苗的免疫反应,以及疫苗接种对SE细菌附着在培养的Vero细胞上的影响。在疫苗接种后4周或10个月,将1 ml剂量的108-109 CFU活SE细菌细胞口服给鸡。给药后第6天计数1 g盲肠粪便中SE的数量(CFU)。接种疫苗后4周和10个月的SE CFUs均显著低于未接种疫苗的对照组(p < 0.05)。采用酶联免疫吸附法(ELISA)检测接种鸡血清和肠、输卵管液中抗se IgG和抗se IgA的含量。经接种鸡源性肠液预处理后,热杀灭的SE细胞与Vero细胞的粘附减少,这表明疫苗诱导的抗体有可能阻止SE粘附在上皮细胞表面。
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引用次数: 4
Dexamethasone (Veterinary medicinal products). 地塞米松(兽药)。
Pub Date : 2018-09-28 eCollection Date: 2018-09-01 DOI: 10.14252/foodsafetyfscj.2018005s

Food Safety Commission of Japan (FSCJ) conducted a risk assessment of dexamethasone (CAS No. 50-02-2), a synthetic adrenocortical hormone, using mainly the evaluation reports from the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and the European Medicines Agency (EMEA). Major adverse effects of dexamethasone were observed in the decrease in white blood cell count (WBC), atrophy of thymus and spleen as well as the decrease in adrenal weights, which were found in various toxicity studies. These effects are attributable to the glucocorticoid action. FSCJ supported the EMEA's judgment "dexamethasone lacks structural similarity with known carcinogens", and concluded that this drug is unlikely to be carcinogenic. Teratogenicity was observed in rats developmental toxicity studies and the no-observed-adverse-effect level (NOAEL) for fetus was 10 μg/kg bw/day. The effect observed at the lowest dose in various toxicological studies was decreased WBC in rats in an endocrinological study. The NOAEL in this study was 1μg/kg bw/day. JECFA and EMEA specified an acceptable daily intake (ADI) based on the pharmacological action, the induction of tyrosine aminotransferase activity (TAT), in rat liver. However FSCJ judged this endpoint is not appropriate to establish an ADI, because the increase of TAT in response to glucocorticoid was a physiological response, and the relationship of changes in TAT with the toxicological findings was obscure. Consequently, FSCJ specified the ADI for dexamethasone at 0.01μg/kg bw/day, based on NOAEL of 1μg/kg bw/day, which was obtained in rats in an endocrinological study, applying a safety factor of 100.

日本食品安全委员会(FSCJ)主要利用粮农组织/世卫组织食品添加剂联合专家委员会(JECFA)和欧洲药品管理局(EMEA)的评估报告,对合成肾上腺皮质激素地塞米松(CAS No. 50-02-2)进行了风险评估。地塞米松的主要不良反应是在各种毒性研究中发现的白细胞计数(WBC)减少、胸腺和脾脏萎缩以及肾上腺重量下降。这些影响可归因于糖皮质激素的作用。FSCJ支持EMEA“地塞米松与已知致癌物缺乏结构相似性”的判断,认为该药物不太可能致癌。在大鼠发育毒性研究中观察到致畸性,对胎儿的无观察到不良反应水平(NOAEL)为10 μg/kg bw/day。在一项内分泌学研究中,在各种毒理学研究中观察到的最低剂量的效果是减少了大鼠的白细胞。本研究NOAEL为1μg/kg bw/day。JECFA和EMEA根据大鼠肝脏中酪氨酸转氨酶活性(TAT)的药理作用规定了可接受的每日摄入量(ADI)。然而,FSCJ认为这个终点不适合建立ADI,因为TAT对糖皮质激素的反应是一种生理反应,TAT变化与毒理学结果的关系尚不清楚。因此,FSCJ根据一项内分泌学研究中大鼠的NOAEL为1μg/kg bw/day,应用安全系数为100,将地塞米松的每日推荐摄入量定为0.01μg/kg bw/day。
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引用次数: 0
Prevalence of Antibiotics Resistant Listeria monocytogenes Strains in Nigerian 
Ready-to-eat Foods. 尼日利亚耐抗生素单核细胞增生李斯特菌流行情况
即食食品。
Pub Date : 2018-09-28 eCollection Date: 2018-09-01 DOI: 10.14252/foodsafetyfscj.2018002
Daniel O Ebakota, Onilude A Abiodun, Obayagbona O Nosa

The Listerial flora and Listeria monocytogenes bio-load associated with 411 ready-to-eat (RTE) foods sold at several locations in southern Nigeria was evaluated using phenotypic procedures which included serial dilution and pour plate techniques. Selected L. monocytogenes strains phenotypically identified from the RTE foods were further identified using virulence gene markers and 16srRNA amplification procedures. All the 90 L. monocytogenes strains cultured from the RTE foods were subjected to antibiogram analysis using disc diffusion. Some of the antibiotics employed included; Ceftazidine, cefuroxime, gentamicin, ofloxacin, augumentin, tetracycline and erythromycin. L. monocytogenes L. ivanovii, L. grayi, L.welshimeri, L. seeligeri and L. innocua were detected in the RTE foods. Haemolysin (hlyA) gene, Internalin gene (inlA) and invasive gene (iap) were detected in all L. monocytogenes isolates. L. monocytogenes LMEW70 with accession number KY053295 was 93% similar to L. monocytogenes L1846. All the L. monocytogenes isolates were resistant to amoxicillin, cloxacillin, augumentin and ceftazidime.

使用表型程序(包括连续稀释和倒盘技术)对尼日利亚南部几个地点销售的411种即食食品相关的李斯特菌群和单核增生李斯特菌生物负荷进行了评估。通过毒力基因标记和16srRNA扩增程序,进一步鉴定从RTE食品中鉴定出的具有表型特征的单核增生乳杆菌菌株。采用圆盘扩散法对从RTE食品中培养的90株单核增生乳杆菌进行抗生素谱分析。使用的一些抗生素包括;头孢他嗪,头孢呋辛,庆大霉素,氧氟沙星,奥古汀,四环素和红霉素。在RTE食品中检出单增李斯特菌伊万诺氏李斯特菌、格雷李斯特李斯特菌、韦氏李斯特李斯特李斯特菌和无尾李斯特李斯特李斯特李斯特李斯特菌。所有单核增生乳杆菌分离株均检测到溶血素(hlyA)基因、内毒素(inlA)基因和侵袭基因(iap)。加入号为KY053295的L. monocytogenes LMEW70与L. monocytogenes L1846相似度为93%。所有单核增生乳杆菌分离株均对阿莫西林、氯西林、奥古汀和头孢他啶耐药。
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引用次数: 8
Desmedipham (Pesticides). Desmedipham(杀虫剂)。
Pub Date : 2018-09-28 eCollection Date: 2018-09-01 DOI: 10.14252/foodsafetyfscj.2017018s

Food Safety Commission of Japan (FSCJ) conducted a risk assessment of desmedipham (CAS No. 13684-56-5), a carbanilate herbicides, based on results from various studies. Major adverse effects of desmedipham were suppressed body weight, hemolytic anemia, methemoglobinemia and follicular cell hypertrophy in thyroid. Neither carcinogenicity, reproductive toxicity, nor genotoxicity relevant to human health was observed on desmedipham. Desmedipham, at the dose with maternal toxicity, caused external anomalies such as mandibular malformation and cleft palate, visceral anomalies such as ventricular septum defect, and skeletal anomalies such as defect of sternum and asymmetric alignment of seternebral hemicentres in developmental toxicity studies in rats. No teratogenetic effects were observed in rabbits. The lowest no-observed-effect level (NOAEL) obtained in all studies was 3.2 mg/kg bw/day in a two-year combined chronic toxicity/carcinogenicity in rats. FSCJ specified an acceptable (ADI) of 0.032 mg/kg bw/day, applying a safety factor of 100 to the NOAEL. The lowest NOAEL for adverse effects elicited by a single oral administration of desmedipham was 90 mg/kg bw/day obtained from the developmental toxicity study in rabbits (the 2nd study in the Table 2). Consequently, FSCJ specified an acute reference dose (ARfD) of 0.9 mg/kg bw applying a safety factor of 100 to the NOAEL.

日本食品安全委员会(FSCJ)根据多项研究结果,对氨基甲酸酯类除草剂地菊醚(CAS No. 13684-56-5)进行了风险评估。地地黄的主要不良反应是抑制体重、溶血性贫血、高铁血红蛋白血症和甲状腺滤泡细胞肥大。没有观察到地米黄的致癌性、生殖毒性和与人类健康相关的遗传毒性。在大鼠发育毒性研究中,具有母体毒性剂量的地米地黄可引起颌骨畸形、腭裂等外部异常,室间隔缺损等内脏异常,胸骨缺损、胸椎半中心排列不对称等骨骼异常。家兔未见致畸作用。在所有研究中获得的最低无观察效应水平(NOAEL)为3.2 mg/kg bw/day,对大鼠进行了两年的慢性毒性/致癌性联合研究。FSCJ规定了0.032毫克/千克体重/天的可接受(ADI),对NOAEL应用100的安全系数。单次口服地米黄引起的最低NOAEL为90 mg/kg体重/天,这一结果来自兔的发育毒性研究(表2中的第二项研究)。因此,FSCJ规定急性参考剂量(ARfD)为0.9 mg/kg体重,NOAEL的安全系数为100。
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引用次数: 0
Dicyclanil (Veterinary Medicinal Products). 双环苯胺(兽药产品)。
Pub Date : 2018-09-28 eCollection Date: 2018-09-01 DOI: 10.14252/foodsafetyfscj.2018007s

Food Safety Commission of Japan (FSCJ) conducted a risk assessment of dicycranil (CAS No. 112636-83-6), a pyrimidine-derived insect growth regulator, using the evaluation reports from the Joint FAO/WHO Expert Committee on Food Additives (JECFA), the European Medicines Agency (EMEA), and also the Australian government. In an 18-month chronic toxicity/carcinogenicity study in mice, increased incidences of hepatocellular adenomas and carcinomas were observed in females in the 500 ppm group. In spite of a recent experiment implying the possible indirect genotoxicity of dicyclanil on the carcinogenicity, dicyclanil is unlikely to exert the carcinogenicity in vivo through the genotoxic mechanism judging from other studies. FSCJ recognized it as feasible to set the threshold value. Adverse effects detected at the lowest dose in various toxicological studies were the increased plasma levels of cholesterol and phospholipid at 100 ppm (equivalent to 2.7 mg/kg bw/day in males and 3.5 mg/kg bw/day in females) in a 90-day subacute toxicity study in dogs. No-observed-adverse-effect level (NOAEL) of this study was 20 ppm (equivalent to 0.61 mg/kg bw/day in males and 0.71 mg/kg bw/day in females). On the other hand, the NOAEL in a long term study, a 12-month chronic toxicity study in dogs was 25 ppm (equivalent to 0.71 mg/kg bw/day in males) based on increased level of plasma cholesterol observed only in males at 150 ppm (equivalent to 4.4 mg/kg bw/day in males and 5.1 mg/kg bw/day in females). The increased cholesterol levels in plasma were common in both studies in dogs. It was appropriate to choose the NOAEL for the effect on cholesterol in the longer term treatment, and thus FSCJ adopted the NOAEL of 0.71 mg/kg bw/day. Consequently, FSCJ specified the ADI of 0.0071 mg/kg bw/day for dicyclanil based on the NOAEL of 0.71 mg/kg bw/day in the 12-month chronic toxicity study in dogs, by applying a safety factor of 100.

日本食品安全委员会(FSCJ)利用粮农组织/世卫组织食品添加剂联合专家委员会(JECFA)、欧洲药品管理局(EMEA)和澳大利亚政府的评估报告,对嘧啶衍生昆虫生长调节剂双氰腈(CAS No. 112636-83-6)进行了风险评估。在一项为期18个月的小鼠慢性毒性/致癌性研究中,在500ppm组中观察到雌性肝细胞腺瘤和癌的发病率增加。尽管最近有实验表明,双环苯胺可能对致癌性有间接的遗传毒性,但从其他研究来看,双环苯胺不太可能通过遗传毒性机制在体内发挥致癌性。FSCJ认为设置阈值是可行的。在各种毒理学研究中发现的最低剂量的不良反应是,在对狗进行的为期90天的亚急性毒性研究中,血浆胆固醇和磷脂水平在100 ppm时增加(相当于雄性2.7 mg/kg体重/天,雌性3.5 mg/kg体重/天)。本研究的未观察到不良反应水平(NOAEL)为20 ppm(相当于男性0.61 mg/kg体重/天,女性0.71 mg/kg体重/天)。另一方面,在一项长期研究中,在一项为期12个月的狗的慢性毒性研究中,NOAEL为25 ppm(相当于雄性0.71 mg/kg体重/天),基于血浆胆固醇水平升高,仅在雄性中观察到150 ppm(相当于雄性4.4 mg/kg体重/天,雌性5.1 mg/kg体重/天)。在两项对狗的研究中,血浆中胆固醇水平升高是很常见的。在长期治疗中,选择NOAEL对胆固醇的影响是合适的,因此FSCJ采用0.71 mg/kg bw/day的NOAEL。因此,FSCJ在12个月的狗慢性毒性研究中,根据0.71 mg/kg bw/day的NOAEL,通过应用100的安全系数,规定了双环苯胺的每日推荐摄入量为0.0071 mg/kg bw/day。
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引用次数: 0
Dexamethasone (Veterinary medicinal products). 地塞米松(兽药)。
Pub Date : 2018-09-01 DOI: 10.14252/foodsafetyfscj.2017005s
Food Safety Commission of Japan (FSCJ) conducted a risk assessment of dexamethasone (CAS No. 50-02-2), a synthetic adrenocortical hormone, using mainly the evaluation reports from the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and the European Medicines Agency (EMEA). Major adverse effects of dexamethasone were observed in the decrease in white blood cell count (WBC), atrophy of thymus and spleen as well as the decrease in adrenal weights, which were found in various toxicity studies. These effects are attributable to the glucocorticoid action. FSCJ supported the EMEA's judgment "dexamethasone lacks structural similarity with known carcinogens", and concluded that this drug is unlikely to be carcinogenic. Teratogenicity was observed in rats developmental toxicity studies and the no-observed-adverse-effect level (NOAEL) for fetus was 10 μg/kg bw/day. The effect observed at the lowest dose in various toxicological studies was decreased WBC in rats in an endocrinological study. The NOAEL in this study was 1μg/kg bw/day. JECFA and EMEA specified an acceptable daily intake (ADI) based on the pharmacological action, the induction of tyrosine aminotransferase activity (TAT), in rat liver. However FSCJ judged this endpoint is not appropriate to establish an ADI, because the increase of TAT in response to glucocorticoid was a physiological response, and the relationship of changes in TAT with the toxicological findings was obscure. Consequently, FSCJ specified the ADI for dexamethasone at 0.01μg/kg bw/day, based on NOAEL of 1μg/kg bw/day, which was obtained in rats in an endocrinological study, applying a safety factor of 100.
日本食品安全委员会(FSCJ)主要利用粮农组织/世卫组织食品添加剂联合专家委员会(JECFA)和欧洲药品管理局(EMEA)的评估报告,对合成肾上腺皮质激素地塞米松(CAS No. 50-02-2)进行了风险评估。地塞米松的主要不良反应是在各种毒性研究中发现的白细胞计数(WBC)减少、胸腺和脾脏萎缩以及肾上腺重量下降。这些影响可归因于糖皮质激素的作用。FSCJ支持EMEA“地塞米松与已知致癌物缺乏结构相似性”的判断,认为该药物不太可能致癌。在大鼠发育毒性研究中观察到致畸性,对胎儿的无观察到不良反应水平(NOAEL)为10 μg/kg bw/day。在一项内分泌学研究中,在各种毒理学研究中观察到的最低剂量的效果是减少了大鼠的白细胞。本研究NOAEL为1μg/kg bw/day。JECFA和EMEA根据大鼠肝脏中酪氨酸转氨酶活性(TAT)的药理作用规定了可接受的每日摄入量(ADI)。然而,FSCJ认为这个终点不适合建立ADI,因为TAT对糖皮质激素的反应是一种生理反应,TAT变化与毒理学结果的关系尚不清楚。因此,FSCJ根据一项内分泌学研究中大鼠的NOAEL为1μg/kg bw/day,应用安全系数为100,将地塞米松的每日推荐摄入量定为0.01μg/kg bw/day。
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引用次数: 1
Staphylococcal Enterotoxins: Food Poisoning and Detection Methods 葡萄球菌肠毒素:食物中毒及检测方法
Pub Date : 2018-07-04 DOI: 10.1201/9781315109091-9
Xin Wang, Yinduo Ji
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引用次数: 0
Campylobacter Species 弯曲杆菌物种
Pub Date : 2018-07-04 DOI: 10.1201/9781315109091-12
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引用次数: 25
Salmonella Species 沙门氏菌的物种
Pub Date : 2018-07-04 DOI: 10.1201/9781315109091-11
MILk ChOCOLATe
The genus Salmonella can be subdivided into more than 2,400 serotypes. Salmonella enterica subsp. enterica serotype Typhimurium (S. Typhimurium) and Salmonella enterica subsp. enterica serotype Enteritidis (S. Enteritidis) are the most frequently isolated serotypes in humans in Ireland. Serotypes are further subdivided by their resistance to bacteriophages (phage types or lystotypes), antibiotics or heavy metals; their biochemical characteristics (biovars or biotypes) or their sensitivity to or production of bacteriocins.
沙门氏菌属可细分为2400多种血清型。肠炎沙门氏菌亚种。肠炎血清型鼠伤寒(S.Typhimurium)和沙门氏菌肠炎亚种。肠炎杆菌血清型肠炎杆菌(S.Enteritidis)是爱尔兰人类最常见的分离血清型。血清型根据其对噬菌体(噬菌体型或裂解型)、抗生素或重金属的耐药性进一步细分;它们的生物化学特征(生物变体或生物型)或它们对细菌素的敏感性或产生细菌素。
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引用次数: 125
期刊
Food safety (Tokyo, Japan)
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