Review of the toxicology, human exposure and safety assessment for bisphenol A diglycidylether (BADGE).

BADGE (whose chemical names are bisphenol A diglycidylether and 2,2-bis(4-(2,3-epoxypropyl)phenyl)propane) is the lowest molecular weight oligomer in commercial epoxy resins and the major component in commercial liquid epoxy resins. The major application areas for epoxy resins are protective coatings and civil engineering. Additional applications include printed circuit boards, composites, adhesives and tooling, while a relatively small amount of epoxy resins (< 10%) finds use in protective coatings inside food and drink cans. The use of BADGE in food-contact applications was first regulated through EC Directive 2002/16/EC and amended in EC Directive 2004/13/EC with migration levels in food-contact applications being generally well below the regulatory thresholds. The paper discusses the commercial use of BADGE focusing on the current knowledge of human exposure from canned food applications. To assess the safety of this application, the exposure data are compared with no adverse effect levels (NOAEL) from various toxicological investigations with BADGE including reproductive and developmental assays, endocrine toxicity investigations, and sub-chronic and chronic assays. Consumer exposure to BADGE is almost exclusively from migration of BADGE from can coatings into food. Using a worst-case scenario that assumes BADGE migrates at the same level into all types of food, the estimated per capita daily intake for a 60-kg individual is approximately 0.16 microg kg(-1) body weight day(-1). A review of one- and two-generation reproduction studies and developmental investigations found no evidence of reproductive or endocrine toxicity, the upper ranges of dosing being determined by maternal toxicity. The lack of endocrine toxicity in the reproductive and developmental toxicological tests is supported by negative results from both in vivo and in vitro assays designed specifically to detect oestrogenic and androgenic properties of BADGE. An examination of data from sub-chronic and chronic toxicological studies support a NOAEL of 50 mg kg(-1) body weight day(-1) from the 90-day study, and a NOAEL of 15 mg kg(-1) body weight day(-1) (male rats) from the 2-year carcinogenicity study. Both NOAELS are considered appropriate for risk assessment. Comparing the estimated daily human intake of 0.16 microg kg(-1) body weight day(-1) with the NOAELS of 50 and 15 mg kg(-1) body weight day(-1) shows human exposure to BADGE from can coatings is between 250,000 and 100,000-fold lower than the NOAELs from the most sensitive toxicology tests. These large margins of safety together with lack of reproductive, developmental, endocrine and carcinogenic effects supports the continued use of BADGE for use in articles intended to come into contact with foodstuffs.     

丙烯酰胺生殖毒性和发育毒性效应性生物标志物研究

目的：研究丙烯酰胺对机体造成的生殖毒性和发育毒性,并找出丙烯酰胺生殖毒性和发育毒性的效应性生物标志物。方法：通过对SD雄鼠灌胃22.5、11.25、5.625mg/（kg·d）的丙烯酰胺溶液,分析对其睾丸和附睾的影响,还对精子畸形率和睾丸内抗氧化酶系统进行评价,通过研究丙烯酰胺在动物模型中产生的效应性生物标志物来评价其生殖毒性。采用饮水给予怀孕第6d的孕鼠20.0、10.0、5.0mg/（kg·d）的丙烯酰胺,在怀孕0、7、12、16、20d称量体重并每天监测其饮水消耗量,观察胎鼠身长、尾长和骨骼发育情况;对断乳后的幼鼠采用直接饮水接触丙烯酰胺,在3—6w每周处死部分幼鼠,对其脏器和血液进行分析,通过研究丙烯酰胺在动物模型中产生的效应性生物标志物来评价其发育毒性。结果：丙烯酰胺显著增加了SD大鼠精子畸形率,显著降低了SD大鼠睾丸内抗氧化酶的活性;同时,丙烯酰胺导致幼鼠尾长的发育异常,幼鼠的肝、肾、脾、甲状腺发生组织病变,骨骼畸形率显著增加。结论：精子畸形率、睾丸内抗氧化物酶能够反应丙烯酰胺的生殖毒性,可作为丙烯酰胺生殖毒性的效应生物标志物;幼鼠尾长、骨骼畸形、组织病理学改变可反应丙烯酰胺的发育毒性,可作为丙烯酰胺的发育毒性的效应生物标志物。     

Effect of mineral salts, carbachol, and pilocarpine on nutrient digestibility and ruminal characteristics in cattle

Fifty percent concentrate diets containing 2% sodium bicarbonate, sodium chloride, or no additional mineral salts were fed at a rate of 86 g dry matter/kg body weight X 75/d to three barren Holstein cows fitted with ruminal fistulas in a 3 X 3 Latin square design. Dietary adaptation was 14 d followed by 4 d collection. Ruminal pH, liquid volume, liquid dilution rate, and particulate rate of passage were increased with dietary mineral salts. Six Holstein cows fitted with ruminal fistulas were administered .01 mg carbachol/kg body weight/d, .10 mg pilocarpine/kg body weight/d, or saline placebo via subcutaneous, osmotically controlled pumps in a replicated 3 X 3 Latin square design. Treatments were administered for a 14-d adaptation period followed by an 8-d collection period. Both carbachol and pilocarpine increased liquid dilution rate, particulate rate of passage, and percent cellulolytic bacteria, whereas liquid volume was reduced.     

95%水胺硫磷慢性毒性和致癌性研究

目的研究95%水胺硫磷的慢性毒性和致癌性,提出其未观察到有害作用水平。方法480只断乳SD大鼠按体重随机分成4组,每组120只,雌雄各半。4组大鼠喂饲含有不同浓度水胺硫磷的块料,对照组、低剂量组、中剂量组和高剂量组的剂量分别是0、0.6、6和30mg/kg饲料,试验期2年。观察大鼠日常表现,检测体重、进食量、血常规、凝血时间、血生化、胆碱酯酶、尿常规等指标并进行大体和病理组织学检查,计算食物利用率、脏器系数和肿瘤发生率。结果试验第6、18、24个月,高剂量组雌性大鼠胆碱酯酶活性显著低于对照组(P0.01);试验第6、12、18和24个月,中、高剂量组雄性大鼠胆碱酯酶活性显著低于对照组(P0.01)。各组大鼠的其他指标,包括肿瘤发生率差异均无统计学意义。结论根据胆碱酯酶的检测结果确定水胺硫磷的未观察到有害作用水平:雌性为0.468mg/(kgBW·d)(中剂量),雄性为0.037mg/(kgBW·d)(低剂量)。未见致癌作用。     

Determination of trans‐ and cis‐Urocanic Acid in Relation to Histamine,Putrescine, and Cadaverine Contents in Tuna (Auxis Thazard) at Different Storage Temperatures

Scombroid fish poisoning is usually associated with consumption of fish containing high levels of histamine. However, reports indicate that some cases have responded to antihistamine therapy while ingested histamine levels in these cases were low. Potentiation of histamine toxicity by some biogenic amines, and release of endogenous histamine by other compounds such as cis‐urocanic acid (UCA) are some hypotheses that have been put forth to explain this anomaly. Very little is known about the effects of storage conditions on the production of both UCA isomers and biogenic amines in tuna. Thus, the production of trans‐ and cis‐UCA, histamine, putrescine, and cadaverine in tuna during 15 d of storage at 0, 3, and 10 °C and 2 d storage at ambient temperature were monitored. The initial trans‐ and cis‐UCA contents in fresh tuna were 2.90 and 1.47 mg/kg, respectively, whereas the levels of putrescine and cadaverine were less than 2 mg/kg, and histamine was not detected. The highest levels of trans‐ and cis‐UCA were obtained during 15 d storage at 3 °C (23.74 and 21.79 mg/kg, respectively) while the highest concentrations of histamine (2796 mg/kg), putrescine (220.32 mg/kg) and cadaverine (1045.20 mg/kg) were obtained during storage at room temperature, 10 and 10 °C, respectively. Histamine content increased considerably during storage at 10 °C whereas trans‐ and cis‐UCA contents changed slightly. The initial trans‐UCA content decreased during storage at ambient temperature. Thus, unlike histamine, concentrations of trans‐ and cis‐UCA did not result in elevated levels during storage of tuna.     

丹凤牡丹花功能性成分及急性毒性的研究

目的测定丹凤牡丹花的功能性成分组成,并研究其急性毒性。方法对丹凤牡丹花的主要功能性成分(蛋白质、抗坏血酸、总黄酮、花色苷、氨基酸及部分微量元素)的含量进行测定。按小鼠20 g/kg·bw给予干丹凤牡丹花提取液,灌胃1次,连续观察14 d,主要观察动物体重及器官变化,记录其死亡情况。结果丹凤干牡丹花的蛋白质、总黄酮(以芦丁计)、总抗坏血酸的含量分别为14.4 g/100 g、36.6 mg/g、117.9 mg/100 g;共检出17种氨基酸,必需氨基酸和呈味氨基酸含量较高,其中谷氨酸含量最高,达到了1.348%,赖氨酸的含量为0.585%;无机元素钾、钠、镁、钙、铁、磷的含量丰富,K/Na比较高;小鼠经口最大耐受剂量大于20 g/kg·bw,按急性毒性分级标准判定为无毒。结论丹凤牡丹花中蛋白质、总黄酮、总抗坏血酸、花色苷、矿物元素钾、钠、镁、钙、铁、磷含量均较高,氨基酸组成优良合理,必需氨基酸和呈味氨基酸含量较高,且急性经口毒性属无毒,是一种很好的天然保健食品资源。     

Absence of adverse effects of sodium metabisulphite in manufactured biscuits: results of subacute (28-days) and subchronic (85-days) feeding studies in rats

Sulphites are extensively used in the food and drinks industry. Their toxicity has been previously evaluated by addition to the diet or drinking water of laboratory animals. Because interactions between sulphites and food constituents occur, the present work was conducted to determine the subacute and subchronic toxicity of sulphite-bound compounds in a finished product: manufactured biscuits. The studies were performed on Sprague Dawley rats for 28 and 85 days of dietary exposure. Diets were prepared from sulphited or untreated (controls) biscuits with the addition of sugar, protein, vitamins and minerals according to the nutritional requirements of the animals. Groups of 10 male and 10 female rats were administered diets containing sulphited biscuits at levels of 0, 10, 35 and 75%, corresponding to 10-15, 35-45, 150-170 and 310- 340mg S0₂/kg diet. In both studies, no death or clinical abnormalities were reported. Growth rate, food consumption and food conversion efficiency were not affected by treatment. No dose-related changes were observed for haematology, clinical chemistry, ocular examination, renal-function, urinalysis, organ weights or gross and microscopic examinations. The liver concentrations of vitamins A, B₁, C and E were not significantly changed except for an increase in vitamin E in high-dose males after 28 days' exposure. Based on these data, the no-observed-adverse-effect level (NOAEL) of sulphites in baked biscuits was judged to be 310mg SO₂/kg diet or 25mg/kg body weight/day.     

Mutagenicity and safety evaluation of the water extract of Camellia oleifera Abel

Abstract: The purpose of this study was to evaluate the mutagenicity and safety of water extract of the fruit hull of Camellia oleifera Abel (WECO), which was prepared using hot‐reflux method. The oral maximum tolerated dose (MTD) of WECO was above 20 g/kg body weight both in rats and in mice, which can be regarded as virtually nontoxic. No mutagenicity was found in Ames test, mouse bone marrow cell micronucleus test and mouse sperm abnormality test. In the subacute study, the SD rats were administered orally at 0.5, 1, or 2 g/kg/BW for 30 d. There were no treatment‐related toxic effects from WECO. No significant differences were found in parameters of body weight, hematology value, clinical chemistry value, and organ/body weight ratio. The level of no observed adverse effect level (NOAEL) for WECO was 2 g/kg/BW for subacute toxicity study. Practical Application: With the gradual increase in tea oil production, it was in urgent need of dealing with Camellia fruit hull, which was always discarded because of low economic benefits. Camellia fruit hull has been shown to have significant antioxidant effects including DPPH radical‐scavenging ability and ferric‐reducing antioxidant power ( Zhang and others 2010 ). Toxicological evaluation of WECO provided a safety assurance of WECO for developing dietary supplements and functional foods.     

Oral Toxicity of Cold Plasma‐Treated Edible Films for Food Coating

No prior research has investigated whether the cold plasma treatment (CPT) resulted in the formation of toxic compounds. Therefore, this study carried out the experiment to check the safety of edible films treated with cold plasma by examining their acute and subacute oral toxicity in a rat model. Single‐dose acute (5000 mg/kg body weight) and 14‐d subacute (1000 mg/kg body weight/day) oral toxicity of cold plasma‐treated edible films was assessed for male and female Sprague–Dawley (SD) rats. Rats administered 5000 mg/kg of edible film did not show the signs of acute toxicity or death after 14 d of observation. Similarly, no signs of acute toxicity or death were recorded during 14 d in rats administered 1000 mg/kg/day of edible film treated with cold plasma. Although changes in the levels of several blood components (hematocrit, hemoglobin, bilirubin, creatinine, and aspartate aminotransferase) of samples were observed, the changes compared to the control were considered to be toxicologically irrelevant as their levels were within normal physiological ranges. Macroscopic analysis showed there were no changes in color or texture of representative liver sections of SD rats following the oral administration of edible films with CPT (F‐CP) or without CPT (F‐NT). The results demonstrate that the cold plasma‐treated edible film possessed very low toxicity, suggesting that CPT does not generate harmful by‐products in the edible film.     

Safety evaluations on ethanolic extract of red cabbage (Brassica oleracea L.) in mice

The present study has carried out safety evaluations on an ethanolic extract of red cabbage (RC) leaves in terms of acute and subchronic oral toxicity tests as per Organisation for Economic Cooperation and Development (OECD) guidelines in Swiss albino mice. Single-dose administration of RC extract (1000, 2000, 3000, 4000, or 5000 mg/kg body weight) to Swiss albino mice did not manifest toxicity or any significant adverse behavioral alterations. Chronic administration of RC extract (1000, 2000, and 3000 mg/kg body weight) for 28 d also did not register any significant alterations in fluid intake, organ weights, plasma lipid profile, plasma creatine kinase-MB, lactate dehydrogenase, aspartate transaminase, alanine transaminase, creatinine, electrolytes, and calcium levels, and the total blood count showed a nonsignificant change. However, significant reduction in body-weight gain, food intake, red blood cell count, and hemoglobin content along with higher alkaline phosphatase, bilirubin, and urea levels was observed in mice treated with 3000 mg/kg body weight for 28 d. Since there was no mortality up to a dose of 5000 mg/kg body weight, 50% lethal dose (LD(50)) could not be determined, and hence, it can be assumed that, LD(50) of RC extract is >5000 mg/kg. No observable adverse effect level dose of the RC extract was found to be 2000 mg/kg body weight. Hence, consumption of RC extract for various medicinal purposes is safe. Practical Application: RC is a popularly consumed foodstuff that has been ubiquitously reported to exert medicinal properties. It is mandatory to understand the highest permissible consumption limit of any food supplement to avoid toxicity. This study establishes the safe dose of RC. These results can be of relevance for the scientific fraternity as well as laymen who consume this vegetable or its phytochemical preparation.     

Mutagenicity and Safety Evaluation of Water Extract of Fermented Toona Sinensis Roemor Leaves

ABSTRACT:  The purpose of this study was to evaluate the mutagenicity and safety of water extract of fermented Toona sinensis Roemor leaves (WFTS). The WFTS was prepared by fermenting Toona sinensis Roemor leaves anaerobically for 14 d, and then extracting with boiling water. The mutagenic effects of WFTS were investigated using Ames test. No mutagenicity was found toward all tester strains ( Salmonella typhimurium TA98, TA100, TA102, TA1535). In the acute oral toxicity study, a single limit dose of 2.5 or 5 g/kg body weight (bw) WFTS was given to male Sprague-Dawley (SD) rats, then the rats were observed for 14 d. No acute lethal effect at a maximal dose of 5 g/kg bw WFTS was observed in rats. In the subacute study, the male rats were administered daily by gavage at a dose of 0.5 or 1 g/kg bw/d of WFTS for 28 d. The results indicated that no significant toxic effect was found in the parameters of body and organ weight, as well as hematological, biochemical, urinary, and pathological parameters between control and the WFTS-treated rats. The level of no observed adverse effect level (NOAEL) of WFTS in male rats was 1 g/kg bw for subacute toxicity study.     

Acute and Subacute Toxicity Assessment of Lutein in Lutein‐Deficient Mice

Dietary lutein consumption is lower than the actual recommended allowances to prevent macular degeneration; thus dietary lutein supplements have been recommended. This study aimed to investigate potential adverse effect of lutein from Tagetes erecta in lutein‐deficient (LD) male mice. Preliminary acute toxicity study revealed that the LD₅₀ exceeded the highest dose of 10000 mg/kg BW. In a subacute study, male mice were gavaged with 0, 100, 1000 mg/kg BW/day for a period of 4 wk. Plasma lutein levels increased dose dependently (P < 0.01) after acute and subacute feeding of lutein in LD mice. Compared to the control (peanut oil without lutein) group, no treatment‐related toxicologically significant effects of lutein were prominent in clinical observation, ophthalmic examinations, body, and organ weights. Further, no toxicologically significant findings were eminent in hematological, histopathological, and other clinical chemistry parameters. In the oral subacute toxicity study, the no‐observed‐adverse‐effect level (NOAEL) for lutein in LD mice was determined as 1000 mg/kg/day, the highest dose tested.     

Enhanced E/Z Isomerization of (All‐E)‐lycopene by Employing Iron(III) Chloride as a Catalyst

Catalytic isomerization of (all‐E)‐lycopene to Z‐isomers using iron(III) chloride was investigated and optimized under various conditions of solvents, concentrations of iron(III) chloride, and reaction temperatures. The total contents of Z‐isomers converted were higher in the order of CH₂Cl₂ (78.4%) > benzene (61.4%) > acetone (51.5%) > ethyl acetate (50.8%) at 20 °C for 3 h using 1.0 × 10^?3 mg/mL iron(III) chloride for 0.1 mg/mL (all‐E)‐lycopene. However, the decomposition of lycopene was markedly accelerated in CH₂Cl₂: the remaining lycopene after the reaction for 3 h and 12 h was only 79.4% and 47.5%, respectively. As the concentration of catalyst increased in acetone, the Z‐isomerization ratio of lycopene increased to more than 80%, followed by rapid degradation of lycopene to undetectable levels using >4.0 × 10^?3 mg/mL iron(III) chloride with the above concentration of (all‐E)‐lycopene. Finally, greater isomerization (79.9%) was attained at 60 °C in acetone for 3 h in the presence of 1.0 × 10^?3 mg/mL iron(III) chloride, largely without decomposition of lycopene (remaining ratio of total amount of lycopene isomers after the reaction, 96.5%). As iron(III) chloride has found general use as a food additive for iron fortification and acetone is also widely used in the food field, this method can be applied to the food and beverage processing industry.     

胍基乙酸对建鲤生产性能、体成分及肌肉能量代谢关键酶的影响

研究胍基乙酸(guanidinoacetic acid,GAA)对建鲤生产性能、体成分及肌肉能量代谢的影响。选取600尾平均体重为(23.23±0.14)g的建鲤随机分为4组,每组5个重复,每个重复30尾,分别投喂基础饲料(对照组)和在基础饲料中添加250、500和1 000 mg/kg GAA的试验饲料,试验为期42 d。结果表明:与对照组相比,添加250、500 mg/kg GAA可显著降低饵料系数(P0.05),但对体重、特定生长率、增重率、平均日采食量和成活率均无显著影响(P0.05)。添加GAA可显著提高脏体指数(P0.05),对肝体指数无显著影响(P0.05)。GAA对肌肉中粗脂肪、粗蛋白和粗灰分含量无显著影响(P0.05)。250 mg/kg GAA组可显著降低肌肉中丙酮酸激酶活性(P0.05);250、500 mg/kg GAA组显著降低琥珀酸脱氢酶活性(P0.05);1 000 mg/kg GAA组显著降低肌酸激酶活性(P0.05);GAA组均显著提高肌糖原含量(P0.05)。结果表明,饲料中添加胍基乙酸可降低肌肉中能量代谢关键酶的活性来改善其能量代谢,提高饲料转化率,以添加250 mg/kg GAA效果较好。     

Mineral analysis in rabbit meat from Galicia (NW Spain)

A total of 54 rabbits 50, 70 and 90 days old, were taken from farms in Galicia (NW Spain); 18 rabbits of each age were sampled. The minerals in the muscle meat from the back legs of the rabbits were analysed, and the following average concentrations were found: ash 1.21/100 g, potassium 388 mg/100 g; phosphorus 237 mg/100 g; sodium 60 mg/100 g; magnesium 27 mg/100 g; calcium 8.7 mg/100 g; zinc 10.9 mg/kg; iron 5.56 mg/kg; copper 0.78 mg/kg; and manganese 0.33 mg/kg.

The high potassium and low sodium concentration may make rabbit meat particularly recommended for hypertension diets. Rabbit meat is rich in phosphorus, and 100 g provides approximately 30% of the recommended daily intake. However, rabbit meat provides less zinc and iron than meats of other species. The Galician rabbit meat analysed in this study, shows higher copper and manganese, and lower calcium contents than those found in the literature for rabbit meat of other origins.     

Content and Bioaccessibility of Aluminium in Duplicate Diets from Southern Spain

Aluminium is found naturally in foods and beverages, but levels increase notably during processing, packaging, storage, and cooking, as a consequence of its presence in food additives and the wide use of aluminium utensils and vessels. Dietary intake of Al was estimated in 2 population groups in southern Spain (families and university students) in a duplicate diet sampling study. Diets were sampled for 7 consecutive days, and Al was determined in acid‐mineralized samples with electrothermal atomization‐atomic absorption spectrometry (ETA‐AAS). Mean values for Al intake were 2.93 and 1.01 mg/d in families and students, respectively, ranging from 0.12 to 10.00 mg/d. Assuming an average adult weight of 60 kg, the mean dietary exposures to aluminium were 0.34 and 0.12 mg/kg body weight/week in these groups, which amounted to 17% and 6% of the 2 mg/kg body weight estimated as the tolerable weekly intake by the Joint FAO/WHO Expert Committee on Food Additives. Bioaccessibility of dietary Al tested with in vitro studies ranged from 0.30 to 17.26% (absorbable fraction). The highest aluminium intakes were observed in subjects consuming diets with a low adherence to the Mediterranean diet, which were associated to high consumption of processed and canned food. On the contrary, subjects consuming diets with a high adherence to the Mediterranean diet patterns showed the lowest Al intakes. The present findings are useful for giving both a reliable estimate of total aluminium dietary intake and tolerable intake levels according to usual dietary habits.     

甜叶菊苷M的毒理学安全性评价

甜叶菊苷M是在甜叶菊中发现的糖苷类物质,已被确定为一种潜在的甜味剂.本研究依据食品安全国家标准,采用小鼠急性经口毒性试验、Ames试验、小鼠骨髓红细胞微核试验、小鼠精母细胞染色体畸变试验和28 d经口毒性试验对甜叶菊苷M进行了安全性评价.结果显示:甜叶菊苷M对雌雄小鼠急性经口MTD值均大于10000 mg/kg·bw,...     

复方紫草抗氧化剂的毒性初步评价

以乙醇提取法获得紫草提取物(Z)和甘草提取物(G),以碱提酸沉法获得槐米提取物(H),再辅以柠檬酸(N)和VE(E),按Z:G:H:N:E 为10:5:5:2:1 的比例复配成复方紫草抗氧化剂(FZK)。以FZK 为受试物,通过小鼠经口急性毒性实验、小鼠骨髓细胞微核实验、小鼠骨髓细胞染色体畸变实验等毒理学实验对FZK 的毒性进行了评价。结果表明：小鼠经口最大耐受剂量均大于16000mg/kg bw,FZK 急性毒性分级为无毒级。剂量小于8000mg/kg bw 条件下,FZK 对小鼠嗜多染红细胞微核率无促提高作用,对小鼠骨髓细胞染色体无致畸作用。该食品添加剂不存在致突变性。     

癞葡萄水提物的降糖效果研究

为研究癞葡萄水提物对正常小鼠及四氧嘧啶型糖尿病小鼠血糖浓度的影响,将不同剂量(250mg/kg体重、500mg/kg体重和750mg/kg体重)的水提物灌胃给予禁食12h的正常小鼠和四氧嘧啶型糖尿病小鼠。试验结果表明,癞葡萄水提物对正常小鼠的血糖浓度没有影响,而对四氧嘧啶型糖尿病小鼠的血糖浓度有显著影响。其中500mg/kg剂量组糖尿病小鼠的血糖值在灌胃4h后较相应的初始血糖值下降45.28%,糖尿量提高38.39%;给予500mg/kg水提物治疗15d后,糖尿病小鼠血糖值较治疗前下降59.88%,同时对小鼠体重的恢复有一定的促进作用。结果表明癞葡萄水提物对四氧嘧啶型糖尿病小鼠具有良好的预防和治疗效果。     

Nonclinical Safety Assessment of Morus alba L. Fruits: Study of 90‐D Toxicity in Sprague Dawley Rats and Genotoxicity in Salmonella

Morus alba L. is a traditional herb with a long history of consumption, both as an edible fruit and as medicine. However, its safety evaluation has not yet been established. The objective of this study was to evaluate subchronic oral toxicity and genotoxicity of M. alba L. fruits (MFE). The subchronic toxicity after daily oral administration of MFE at 0, 40, 200, and 1000 mg/kg for 90 d was examined in Sprague Dawley (SD) rats. MFE administration did not lead to death, adverse effects, change in food and water consumption, and body weight gain. Significant toxic effects were not found within the parameters of organ weight, biochemical values, and hematological and urine analysis between the control and the MFE group. The genotoxicity of MFE was assayed by Ames test in Salmonella typhimurium strains TA98, TA102, and TA1535. No genotoxicity was found in all the tested strains. Thus in this study, a no‐observed‐adverse‐effect level for MFE in 90 d repeated oral toxicity study in rats was determined to be greater than 1000 mg/kg regardless of gender. The results also suggested that MFE does not have a genotoxicity potential.