灵芝孢子油急性毒性及致突变性研究

目的了解灵芝孢子油的毒理学安全性。方法小鼠急性毒性试验和遗传毒性试验(Ames试验、小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸形试验)。结果灵芝孢子油的小鼠经口LD50>20 g.kg-1BW,为实际无毒级物质;在Ames试验、小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸形试验中均呈阴性反应,未显示致突变作用。结论灵芝孢子油基本无毒性和无致突变性。     

藿莲香Ⅱ号复方的致突变性研究

目的根据《食品安全性毒理学评价程序和方法》(GB15193-2003)对中药复方藿莲香Ⅱ号进行相关的毒理学评价。方法应用急性毒性试验、小鼠骨髓嗜多染红细胞微核试验、小鼠骨髓细胞染色体畸变试验和Ames试验检测该复方的急性毒性和致突变性。结果急性经口毒性试验:雌性、雄性小鼠经口最大无毒浓度(MTD)为10g/kg体质量,属实际无毒;致突变实验:小鼠骨髓嗜多染红细胞微核试验、小鼠骨髓细胞染色体畸变试验和Ames试验结果均为阴性,显示在本实验条件下,该配伍未见有致突变性作用。结论藿莲香Ⅱ号未见有致突变性作用。     

薏苡仁多糖急性毒性及遗传毒性试验研究

目的了解薏苡仁多糖的毒理学安全性。方法小鼠急性毒性试验和遗传毒性试验（Ames试验、小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸形试验）。结果薏苡仁多糖的小鼠经口LD50〉20g·kg^-1;在Ames试验、小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸形试验中均呈阴性反应,未显示有遗传毒性作用。结论薏苡仁多糖基本无毒性。     

血红素铁胶囊的致突变性

目的探讨血红素铁胶囊的致突变性。方法采用常规的小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸变试验和Ames试验。结果褪黑素片小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸形试验和Ames试验结果均为阴性。结论在本试验条件下,血红素铁胶囊未显示有致突变作用。     

中药复方藿莲香Ⅰ号的遗传毒理学研究

目的：根据前期藿莲香Ⅰ号药效学研究结果,进一步研究该复方的急性毒性和致突变作用,为其进一步应用的安全性提供理论依据。方法应用急性毒性实验、小鼠骨髓嗜多染红细胞微核试验、小鼠骨髓细胞染色体畸变试验和Ames试验检测该组分配伍复方的急性毒性和致突变性。结果急性经口毒性试验：雌性、雄性小鼠经口MTD均大于10g＆#183;kg-1,属实际无毒。致突变实验：小鼠骨髓嗜多染红细胞微核试验、小鼠骨髓细胞染色体畸变试验和Ames试验结果均为阴性,显示在本实验条件下,该中药复方未见有致突变性作用。结论中药复方藿莲香Ⅰ号未见有明显的急性毒性和致突变作用,表明该药物安全性良好。     

降血糖活性成分Bellidifolin遗传毒性研究

目的研究降血糖活性成分Bellidifolin的遗传毒性。方法整体试验采用小鼠骨髓嗜多染红细胞微核实验；体外试验采用鼠伤寒沙门菌组氨酸营养缺陷型TA97、TA98、TA100、TA102四个菌株，对Bellidifolin进行Ames实验。结果小鼠骨髓嗜多染红细胞微核发生率结果显示Bellidifolin高、中、低剂量组与阴性对照组比较均差异无显著性(均P＞0.05)；Ames实验显示,在实验设置浓度和加S9或不加S9的实验条件下，受试物对各菌株所诱发的回变菌落数,均未超过对照的2倍。结论实验结果为阴性，未见Bellidifolin有致突变性作用。     

复方虫草合剂的急性毒性和致突变性研究

目的研究复方虫草合剂的急性毒性和致突变性。方法小鼠急性毒性试验、Ames试验、小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸变试验。结果该复方虫草合剂对雌雄小鼠经口的最大耐受剂量均大于15g.kg-1BW,属于无毒级。Ames试验、小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸变试验结果均为阴性。结论在本次试验条件下,该复方虫草合剂为无毒物质,未显示有遗传毒性作用。     

苦荞降糖胶囊的致突变性研究

目的研究苦荞降糖胶囊的致突变性。方法分别采用Ames试验、小鼠骨髓嗜多染红细胞微核试验和小鼠精子畸形试验对基因水平和细胞水平的遗传损伤进行检测。结果该胶囊在0.1、0.5、1.0、2.0和5.0mg/皿的剂量下对TA97、TA98、TA100和TA102四株试验菌株均未引起自发回变菌落数增加;在1250和5000mg/kg体重剂量下均未引起小鼠骨髓嗜多染红细胞微核率和小鼠精子畸形率升高(字2检验,P>0.05)。结论该胶囊在基因水平和细胞水平均不具有致突变性。     

三氯甲烷致突变性研究

饮用水水源受有机物污染后,经氯化消毒可产生以三氯甲烷为主的三卤甲烷类化合物。三氯甲烷的致突变性研究目前很少报导。为此,作者用Ames试验,小鼠骨髓嗜多染红细胞微核试验及鳙鱼外周血有核红细胞微核试验,对三氯甲烷(AR)进行了致突变性研究。 材料和方法 Ames试验 按照Ames的标准方法,选用TA98及TA100两种菌株,在有、无S9的条     

塑身胶囊的安全性毒理学研究

目的了解塑身减肥胶囊毒理学安全性,确保其食用安全。方法按《保健食品安全性毒理学评价程序和检验方法规范》进行小鼠急性毒性试验、Am es试验、小鼠骨髓嗜多染红细胞微核试验、小鼠精子畸变试验。结果受试物对小鼠经口LD 50>10g.kg-1,为实际无毒物;在Am es试验、小鼠骨髓嗜多染红细胞微核试验和小鼠精子畸变试验中均显示呈阴性反应,未显示致突变作用。结论塑身胶囊经口急性毒性LD 50>10g.kg-1;根据急性毒性分级,属实际无毒,且无致突变性,在正常摄入情况下对人体是安全的。     

赤苷脉通注射液的致突变研究

目的探讨中药制剂赤苷脉通注射液的致突变性。方法采用鼠伤寒沙门氏组氨酸营养缺陷型菌株回复突变实验(Ames实验)、中国仓鼠肺成纤维细胞(CHL)染色体畸变实验和小鼠骨髓微核实验来检测赤苷脉通注射液的致突变作用。结果 Ames实验中,赤苷脉通注射液在312.5～5 000μg.皿-1剂量范围内,无论加或不加S9,鼠伤寒沙门氏菌组氨酸缺陷型TA97,TA98,TA100,TA102和TA1535 5株菌的回复突变菌落数均未出现剂量依赖性的增加;染色体畸变实验中,非活化条件或代谢活化条件下,药物质量浓度为1 200,600和300μg.mL-1时,细胞的染色体畸变率均未出现剂量依赖性增加;微核实验中,在1 150,575和287.5mg.kg-1剂量组中均未见骨髓中含微核的嗜多染红细胞数增加。结论在该实验室条件下,Ames实验、CHL细胞染色体畸变实验和小鼠骨髓微核实验结果均为阴性,即中药制剂赤苷脉通注射液无潜在的遗传毒性。     

红景天苷注射液遗传毒性的研究

目的：检测红景天苷注射液的遗传毒性。方法：应用微生物回复突变实验（Ames实验,5 000、500、50、5.0、0.5μg/皿）、体外培养CHO细胞染色体畸变实验（2 0001、000、500μg/mL）和小鼠骨髓微核实验法（1 500、750、375μg/kg）检测红景天苷注射液的遗传毒性。结果：红景天苷注射液对鼠伤寒沙门菌无致突变性,对体外培养CHO细胞染色体无致畸变作用,对ICR小鼠无诱发骨髓嗜多染红细胞微核的效应,三个实验结果均呈阴性。结论：红景天苷注射液不具有遗传毒性。     

天麻细粉片毒性及安全性的实验研究

目的观察天麻细粉片在实验动物中的毒性和安全性。方法急性毒性试验采用昆明种小鼠和SD大鼠各20只,雌雄各半,天麻细粉片剂量为15．0异,kg体重,观察14d,记录中毒表现。Ames试验采用了菌株TA97、TA98、TA100和TA102,在加S9与不加S9的条件下加入天麻细粉片,剂量分别为8、40、200、1000、5000μg／皿。小鼠骨髓细胞微核试验和精子畸变试验均采用昆明种小鼠,天麻细粉片剂量为1．25、2．50、5．00g／kg体重,用环磷酰胺40mg/kg体重为阳性对照。30d喂养试验采用SD大鼠,雌、雄各40只,天麻细粉片剂量为2．81、5．62、11．25g/kg体重,连续给予30d,观察动物一般状况和体重,测定血液学及血液生化学指标、脏器系数。并进行组织病理学检查。结果急性毒性试验结果显示天麻细粉片在小鼠和大鼠中的最大耐受剂量（MTD）均〉15．0g／kg体重,属无毒级。天麻细粉片的Ames试验、小鼠骨髓细胞微核试验和精子畸变试验结果均为阴性。30d喂养试验显示动物一般状况良好,各剂量天麻细粉片对动物的体重、进食量、食物利用率以及脏器重量和脏器系数均无明显影响．对动物的血常规和血清生化指标也无明显影响。病理检查显示高剂量天麻细粉片对动物的肝、肾、胃肠、脾、卵巢（睾丸）等组织无明显毒性。结论本实验条件下天麻细粉片未见明显毒性或致畸和致突变作用。     

银参胶囊遗传毒性研究

目的探讨银参胶囊的遗传毒性。方法选用SPF级健康ICR小鼠,通过Ames试验、小鼠骨髓细胞微核试验、小鼠睾丸染色体畸变试验等遗传毒性试验验证银参胶囊的安全性。结果 Ames试验中,银参胶囊在8~5 000μg/皿剂量范围内,无论是否加入哺乳动物肝脏微粒体酶(S9),鼠伤寒沙门菌TA97,TA98,TA100,TA102等4株菌的回复突变菌落数均未出现剂量依赖性增加;微核试验中,2 500,5 000,10 000 mg/kg剂量组均未见骨髓中含微核的嗜多染红细胞数增加;小鼠睾丸染色体畸变试验中,药物质量分数为2 500,5 000,10 000 mg/kg时,细胞的染色体畸变率均未出现剂量依赖性增加。结论银参胶囊未显示致突变作用,可初步判定其在遗传毒性方面是安全的。     

N,N-diethylphenylacetamide, an insect repellent: absence of mutagenic response in the in vitro Ames test and in vivo mouse micronucleus test

N,N-diethylphenylacetamide (DEPA), a promising new insect repellent, was tested for mutagenicity in the in vitro Ames Salmonella/microsome mutagenicity test and the in vivo mouse micronucleus test. For the Ames test, DEPA was assayed both in the presence and absence of Aroclor 1254-induced rat-liver S-9 mix (5 and 20% S-9 fraction), using five tester strains of Salmonella typhimurium--TA97a, TA98, TA100, TA102 and TA104. For the micronucleus test, mice were exposed to DEPA through ip injection for 2 and 5 days in separate experiments, and bone marrow and peripheral blood were sampled 6 and 48 hr after the final injection, respectively. DEPA did not induce a mutagenic response in the Ames test, and mouse bone marrow and peripheral blood micronucleus tests. DEPA was not considered cytotoxic, as a depression of the percentage PCE was not observed at any dose in the range of 1 to 100 mg/kg body weight with either treatment protocol of the micronucleus test.     

Safety evaluation of polyphenols extracted from hop bracts.

Hop bract polyphenols contain polyphenols as promising functional ingredients. To assess the safety of topical hop bract polyphenols, Hopsphenon, we examined acute, 14-day, 28-day and 90-day toxicity tests in rats, and mutagenicity tests using Ames test and micronucleus test in mice. The acute, 14-day, 28-day and 90-day toxicity tests revealed that Hopsphenon produced no symptoms of significant injury. The lethal dose of hop bract polyphenols is greater than 2000 mg/kg. The Ames test in the absence of S9 mix for TA98 and in the presence of S9 mix for TA1537 revealed that Hopsphenon had slight mutagenicity at a high dose of 5000 microg/plate; however, in the micronucleus test, Hopsphenon was negative. These tests demonstrated that hop bract polyphenols are safe and do not cause any detrimental effects in vivo under the conditions investigated in this study.     

Genotoxic effects of N-nitrosodicyclohexylamine in isolated human lymphocytes

Dicyclohexylamine x nitrite is classified as an "experimental equivocal tumorigenic agent" by the National Toxicology Program. Since no genotoxic effects of the substance itself are known, the reported tumorigenic potential of dicyclohexylamine x nitrite could be due to generation of N-nitrosodicyclohexylamine (N-NO-DCHA), which occurs under conditions of use and can be detected in foils that contain dicyclohexylamine x nitrite. Therefore, we investigated possible mutagenic properties of N-NO-DCHA in the Ames test and the cytokinesis-block micronucleus assay with human lymphocytes. Since N-NO-DCHA is not commercially available, the substance was synthesized and purified by thin-layer chromatography. Identity was confirmed by gas chromatography/mass spectroscopy (GC/MS) and 1H- and 13C-NMR. More than 97% purity was achieved. Stability and availability in the solvent were checked by GC/MS. N-NO-DCHA induced micronuclei in isolated human lymphocytes at a dose range of 15-100 micrograms/ml (= 71.4-476.2 microM), exceeding the base rate significantly at one or two nontoxic concentrations in four out of six experiments. For the Ames test, arochlor-1254-, beta-naphthoflavone/phenobarbital- and pyrazole-induced S9-fractions were used with Salmonella typhimurium TA100, TA1535, TA98 and TA104. No effects were seen in the Ames test, with the exception of microcolony induction at doses higher than 250 micrograms (= 1.2 mmol) N-NO-DCHA/plate using TA104 and 20% arochlor-1254 induced S9 at pH 6.5. In conclusion, N-NO-DCHA was negative in the Ames test using TA98, TA100 and TA1535, inconclusive using TA104, and weakly genotoxic in the in vitro micronucleus test with isolated human lymphocytes. With regard to the tumorigenicity of the majority of nitrosamines, our data underline the necessity of further studies on possible genotoxic effects of N-NO-DCHA.     

Safety evaluation of water extracts of Toona sinensis Roemor leaf.

The purposes of this study were to evaluate the safety of water extracts of Toona sinensis Roemor leaf (TSL-1). The mutagenic properties of TSL-1 was investigated using the Ames test, and no mutagenicity was found toward all tester strains (Salmonella typhimurium TA98, TA100, TA102 and TA1535). In the acute oral toxicity study, a single limit dose of 5000 mgTSL-1/kg bw was given to male and female ICR mice, then observed for a 14-day period. In the subacute study, TSL-1 was administered as oral daily dose of 1000 mg/kg bw/day for 28 days. The results showed no acute lethal effect at a maximal tested dose of 5000 mg/kg bw TSL-1 in male and female mice. The subacute toxicity showed the oral administration of 1000 mg/kg bw for consecutive 28 days was safe in male mice. TSL-1 treated female mice showed decreases of food intake and kidney relative weight in acute oral toxicity test, and decreases of body weight gain, food intake and lung relative weight in subacute toxicity trial. However, no remarked toxic effects were found in the biochemical and histopathological parameters of TSL-1 treated female mice. These effects whether related to the major components or other ingredients in TSL-1 need to elucidate in the further studies.     

Study of mutagenicities of phthalic acid and terephthalic acid using in vitro and in vivo genotoxicity tests

Genotoxicities of phthalic acid (PA) and terephthalic acid (TPA) were examined using three mutagenicity tests: Ames, chromosome aberration (CA), and micronucleus (MN). In the Ames test, these two agents did not produce any mutagenic responses in the absence or presence of S9 mix on the Salmonella typhimurium strains TA98, TA100, TA102, TA1535, or TA1537. The CA test also showed that PA and TPA exerted no significant cytogenetic effect on Chinese hamster ovary (CHO) cells. In the mouse MN test, no significant alteration in occurrence of micronucleated polychromatic erythrocytes was observed in ICR male mice ip administered any of these agents at doses of 0, 20, 100, 500, 2500 or 12,500 microM/kg. These results indicate that PA and TPA produced no mutagenic effects using these in vitro and in vivo mutagenic test systems.