含草本提取物染发剂的慢性毒性及致癌性研究  

Chronic toxicity and carcinogenicity of a hair dye with herbal extracts

作　　者：熊习昆[1] 郑穗生[1] 袁进 张嘉宁 古梅英[1] 徐名衬 张龙杰[1] 张映辉 黄俊明[1] 顾为望 XIONG Xi-kun;ZHENG Sui-sheng;YUAN Jin;ZHANG Jia-ning;GU Mei-ying;XU Ming-chen;ZHANG Long-jie;ZHANG Ying-hui;HUANG Jun-ming;GU Wei-wang(Institute of Toxicology of Guangdong Provincial Center for Disease Control and Prevention,Guangzhou Guangdong 511430,China;Laboratory Animal Center of Southern Medical University,Guangzhou Guangdong 511430,China)

机构地区：[1]广东省疾病预防控制中心卫生毒理所,广东广州511430 [2]南方医科大学实验动物中心,广东广州511430

出　　处：《毒理学杂志》2019年第5期375-380,共6页Journal of Toxicology

摘　　要：目的研究一种含草本提取物染发用终产品可能的慢性毒性及致癌性效应,并对其作出安全性评价。方法大鼠经口给予2 000、1 000和500 mg/kg·bw·d某品牌洗染香波,持续104周。产品中所含的染发剂有效成份为P-苯二胺1. 4%、间苯二酚0. 4%、苯基甲基吡唑啉酮0. 2%、4-氨基-2-羟基甲苯0. 175%、2,4-二氨基苯氧乙醇HCl 0. 15%和N,N-双(2-羟乙基)-p-苯二胺硫酸盐0. 1%。另外还含黑桑果、苏木皮、墨旱莲、五倍子、枸杞果、山茱萸果、何首乌根、地黄根和人参根等提取物共2%。结果大鼠一般生理体征、行为、皮毛等各剂量组与对照组比较无明显改变;前期食物利用率及体重略低于对照组,后期无明显差异;除52周雌性高剂量组与对照组比较,肾及肾体比指标升高外,雌雄动物其他脏器指标、血液学及血液生化学指标未见有生物学意义改变;各剂量组与对照组比较,各器官组织各类型肿瘤发生率、恶性肿瘤发生率、多发性肿瘤及肿瘤发生时间差异无统计学意义。结论受试样品104周经口慢性毒性试验的最大无有害作用剂量(NOAEL)值为1 000 mg/kg·bw;受试样品对SD大鼠的致癌性结果为阴性。Objective To evaluate the safety and cancer risks of a herb-based hair dye. Methods SPF SD rats were dosed via oral gavage at dose levels of 500,1000 and 2 000 mg/kg·bw per day for 104 weeks. The hair dye components include p-Phenylenediamine1. 4%,resorcinol 0. 4%,phenyl methyl pyrazolone 0. 2%,4-Amino-2-hydroxytoluene 0. 175%,2,4-Diaminophenoxyethanol HCl 0. 15%,N,N-bis(2-hydroxyethyl)-p-phenylenediaminesulfate 0. 1%,also herbal extracts about Morus Nigra Fruit Extract,Caesalpinia Sappan Bark Extract,Eclipta Prostrata Extract,Galla Rhois Gallnut Extract,Lycium Barbarum Fruit Extract,Cornus Officinalis Fruit Extract,Polygonum Multiflorum Root Extract,Rehmannia Glutinosa Root Extract,Panax Ginseng Root Extract,in a total amount of 2%. Result No significant change in either physiological activities,stereotypic behaviour,or skin of rats was observed. There was less amount of food consumption and a little body weight loss on the initial stage compared to the untreated controls. But no marked weight loss was discovered later. Except from the 52 weeks higher dose female rats group has a small rise on kidney and kidney to body weight ratio,there was no other abnormalities detected in organs,haematology and blood biochemistry levels. No statistically significant increase in the incidence of various types of tumours,malignancies and multiple tumours was found compare to the untreated controls. Conclusion The chronic toxicity in the 2-year feeding studies in SD rats has a NOAEL of 1 000 mg/kg·bw. The carcinogenicity result were negative on rats.

关 键 词：染发剂 提取物 慢性毒性 致癌性 

分 类 号：R994.6[医药卫生—毒理学]