毒理学学科发展报告2010-2011（简本）
一、引言
毒理学是研究外源化学、物理及生物因素对生物体和环境生态系统的损害效应及其作用机制，以及预防、救治或改善措施的综合性学科。它具有多元与集成、学术研究与管理服务、基础与应用并重的学科特点。进入21世纪以来，毒理学已成为维护环境友好与生态平衡、保障人们生命安全与健康生活、促进经济可持续发展、推动社会文明进步的重要科技力量。
二、本学科的发展概况
毒理学与中医药学一样，在中国有着久远的发展历史。早在炎帝时代，就有“神农尝百草，一日而遇七十毒”的记载。我国现代毒理学是从20世纪50年代起步，90年代中期至今是我国毒理学的快速发展期。随着我国公共卫生体系的构建和完善、环境保护与生态平衡的维护，对毒理学科学技术的需求不断增加，也使毒理学学科发展面临更大的机遇。近年毒理学学科的发展，涌现出毒理基因组学、毒物代谢组学、毒代动力学、纳米毒理学等一批新的技术理论和分支学科，目前我国毒理学学科体系已基本形成。
毒理学作为一门独立的学科，其内涵有三大领域，即描述毒理学、机制毒理学和管理毒理学。目前我国毒理学学科的分支体系日趋完善，并已发展和形成了许多分支学科，这些分支学科大体可从两个方面来进行划分：其一是从学科分支分类，包括生化与分子毒理、免疫毒理、生殖毒理、遗传毒理、环境与生态毒理、分析毒理、临床毒理、管理毒理等；其二是从研究或应用对象分类，如工业毒理、放射毒理、军事毒理、法医毒理、药物毒理、食品毒理、兽医药毒理、药物依赖毒理、纳米与新型材料毒理、生物毒素毒理、中毒与救治等。
近几年来，我国毒理学科技实力快速增长，毒理学科研、教学和管理队伍规
模不断扩大，高层次科技人才不断涌现。随着国家对毒理学领域科研投入的增加，我国毒理学科技创新能力得到大幅提升，一方面毒理学的基础研究水平和国际影响力稳步上升，另一方面包括环境污染物、各类生活日用产品中残留物的分析检测和安全性评价等毒理学应用性技术平台建设也得到快速发展。毒理学科技成果在外源环境污染物、工业与农业化学品、药品、食品、化妆品、健康相关产品、新型材料如纳米材料等的安全性评价和危险度管理诸多方面发挥了不可替代的作用。特别是近年来，毒理学知识和科学技术在核、化、生突发事件的应急处置和医学救治，在北京奥运会和上海世博会等重大社会公共活动的安全保障，在履行国际公约、禁毒，在处理日本遗留化学武器、集体中毒、环境污染等重大事件中，发挥了关键性作用。在未来涉及国家安全、经济发展战略、人类健康事业和社会和谐稳定等很多重大问题上，毒理学科技力量将会发挥更大的作用。
三、近年来本学科的主要进展和成就
（一）毒理学基础研究进展
随着国家对毒理学领域科研投入的增长，我国毒理学基础研究水平不断提升，在国际学术刊物发表论文数量逐年攀升，年发表SCI论文已接近400篇，并且学术论文质量也在不断提高，国际影响力逐渐扩大。
1. 靶器官毒性机理
近年来，在对一些重要工业毒物、环境污染物、食品污染物以及生物制剂、中西药物、新材料等的靶器官毒性研究中，既采用了传统的体内和体外实验模型与方法，也适时引进或建立了一系列先进的靶器官毒理学研究模型与技术方法，比较准确地描述了外源化学物对整体动物或体外原代培养组织细胞的靶器官毒作用的性质、强度、可逆性及机制，为各类受试品危险度评价积累了大量的基础数据和科学依据。
2. 环境内分泌干扰物
日益增多的研究资料表明，人类多种生殖系统疾病与外源化学物（或药物）有关。国内学者采用体外与整体动物实验相结合、实验室研究与人群队列研究相结合，系统阐述了包括多种农药、杀虫剂在内的多个内分泌干扰物的生殖毒性特点和相关机理；证明环境内分泌干扰物(EDCs)，尤其是一些持久性有机污染物，可导致性分化异常、生殖道畸形、生精障碍、性功能异常、死（畸）胎和自然流产、恶性肿瘤、多囊卵巢综合征和出生缺陷等，为生殖毒性危险度评价和人群干预措施研究提供了重要理论依据。
3. 生物标志物
多年来生物标志物一直是毒理学研究的重点领域之一。近年来，我国学者发现了多个化学物作用于机体的接触标志物和效应标志物。基因分析技术在易感性标志研究中得到广泛应用，在比较不同基因型携带者在相同暴露条件下的反应差异、确定危害效应机制和敏感人群识别中显示出了重要性。中美学者合作关于苯的职业暴露、代谢产物、血液学早期改变的复杂关系的研究成果，在促使美国安全生产管理局将苯的职业暴露限值降至1ppm水平中起到了重要作用。
4. 氧化应激损伤
在现代毒理学研究中，氧化应激损伤成为研究热点之一，它主要涉及自由基、活性氧、氧化应激在有害因素的毒性作用中的反应机制。近年来，我国学者在该领域的研究也取得了较好的进展，多个实验室构建了抗氧化研究技术平台，提出了抗氧化剂复合链理论，研究揭示了多个化合物或污染物的氧化应激损伤作用与机制，开展了中药和天然药物的抗氧化力的测定和评价。
5. DNA损伤修复
近几年国内关于DNA损伤修复研究，取得了重要的研究进展。阐述了DNA修复基因在不同类型化学物或电离辐射致细胞损伤响应过程中的作用机制；揭示了DNA-PK复合物在DNA损伤修复和细胞有丝分裂调节通路间的“cross-talk”作用；阐明了p53蛋白选择性调控分子Apak在细胞DNA损伤反应中的调控p53蛋白活性及分子机制；发现基于Axin的多蛋白复合体通过其组分的动态变化控制p53的活性，从而决定细胞抉择或凋亡或周期阻滞的命运；在新鉴定的DNA修复反应基因的功能研究取得突破，如揭示JWA在DNA氧化损伤修复反应中的功能机制。研究结果分别在一些国际著名学术刊物如Nature Cell Biology、Cancer Research、JBC、Nucleic Acids Research上发表。
6. 表观遗传效应
表观遗传变化是指DNA序列没有发生变化，可通过有丝分裂和减数分裂在细胞和世代间传递的基因表达改变。近几年我国学者在此方面的研究已取得明显进展，如在结晶型NiS、BaP以及电离辐射等因素诱发细胞恶性转化模型中，揭示了表观遗传效应及其对细胞基因组稳定性和细胞恶性转化的影响。纳米材料的表观遗传学效应也受到重视。放射毒理对表观遗传效应有另外一种表述，即辐射旁效应和基因组不稳定性。研究揭示细胞间缝隙连接对表达旁效应的重要性，发现细胞胁迫机制和活性氧分子如NO在辐射旁效应中的分子调节作用等。
(二) 应用毒理学研究进展
近几年来，我国毒理学工作者针对国内环境、食品、药品、职业等安全性的社会需求和存在问题，积极开展有针对性的相关研究，在毒理学研究技术平台的建设与应用方面，均取得了显著成效。
1. 维护环境安全
研究成果体现在环境污染物检测及其在生物体内的吸收、分布、转化和排泄
规律，一般毒性作用与机制；环境化学污染物对人和哺乳动物的“致突变、致癌、致畸变”等特殊毒性作用与机制；环境化学污染物对人体健康产生危害的规律及预防策略；环境污染物的毒性评定方法、对人体损害作用的早发现和早防治措施。研究领域涉及大气环境毒理学、土壤环境毒理学、水环境毒理学等。
2. 促进职业安全
以工业毒理为主，紧紧围绕职业病预防控制、工业化学物对健康危害等领域开展研究工作，为职业病预防治疗提供了强有力的技术支撑。对铅、有机溶剂以及高分子化合物等的神经毒性作用机制、相应暴露生物标志物以及排铅药物等均进行了深入细致的研究。在职业接触人群生物标志物研究方面，发现了多个毒性效应标志物和易感性标志物。
3. 保障食品安全
我国出台了多个关于食品安全方面的行政立法，颁布了《食品容器和包装材料安全性评价毒理试验要求》、《新资源食品安全性评价规程》、《转基因植物及其产品食用安全检测大鼠90天喂养试验》等食品安全性毒理学评价的标准和技术规范，新建了一系列食品安全监测、预警与评价方法和技术，使我国食品毒理研究和安全性评价技术整体水平显著提高，并逐渐与国际接轨。
4. 保障药品安全
近年来我国药品安全事故频发，形势较为严峻。从20xx年的“鱼腥草”事件、“欣弗”事件，到20xx年的“刺五加”事件、“茵栀黄”事件，再到20xx年的“糖脂宁”事件、“双黄连”事件和“甲氨蝶呤注射液”污染事件。为此我国加强了药物安全监管及药物毒理学研究力度，开始关注中草药的毒性问题。在实验动物管理、药物毒理学专业研究机构建设、毒性病理学诊断技术、新技术新方法的应用等方面均取得了长足的进步。发布了一批药物安全性评价技术指导原则，至20xx年已有
39家毒理学研究与安全性评价中心（GLP）通过国家食品药品监督管理局（SFDA）认证，药物毒理和安全性评价研究逐步与国际规范化管理接轨。
5. 新材料安全
进入21世纪以来，新材料如纳米材料不断涌现，其生物安全性引起人们关注，由此形成了毒理学的一门新的分支学科——纳米毒理学。尽管纳米材料生物安全性的研究在我国起步不久，但在国家科技部“973”项目等的资助下，已经形成了具有一定规模和国际竞争力的纳米毒理和生物安全性研究的科研队伍，纳米毒理学科研工作在多个方面处于国际先进水平行列，为纳米材料安全性评价奠定了良好的基础。
(三) 管理毒理学研究进展
管理学与毒理学以特殊的方式联系在一起，逐步形成和发展成为现代管理毒理学。近年来在国内制定和颁布的许多公共卫生与环境生态保护的政策和法令中，毒理学科研成果和基础数据、理论成为制定相关政策和法律的重要科学依据。自20世纪80年代后期以来，我国陆续制定和公布了一系列试验指导原则，用于毒理学实验方法和程序的标准化管理。针对食品、药品的安全性、化学品管理等，近几年又加紧起草、公布和实施了一系列毒理学试验指导原则和标准程序。
实验动物工作的规范化是保证国内GLP实验室与国际接轨的必要条件。我国的实验动物工作正在逐步走向规范化、法制化管理。各种相关法规和文件中对实验动物的分级、饲养管理以及动物试验的环境条件和设施设备等，均制定了规范化的规定和要求，有意识地加强了替代、减少和优化原则（3Rs）的贯彻，重视了动物福利，有效地防止了因实验动物质量而对药品安全性评价所造成的影响。另一方面，国内的GLP实验室也按照国际惯例，陆续建立本机构的“动物管理与使用委员会（IACUC）”，实行动物试验的伦理审查制度。至20xx年，我国共有27家机构通过了国际实验动物评估和认可管理委员会（AAALAC）的认证。
为确保实验研究的质量和可靠性，我国自20世纪90年代中期开始，逐步推行国际通用的良好实验室规范（GLP）。SFDA明确规定，一类新药及注射剂的非临床安全性评价研究，必须由通过《药物非临床研究质量管理规范（GLP）》认证检查的实验室完成。国内部分GLP中心通过了OECD成员国的GLP检查。在国家科技部 “十一五”科技支撑计划项目的支持下，我国农药毒理学的GLP体系开始建立，20xx年10月，农业部开展了第一批GLP实验室考核。20xx年环保部公布了第一批新化学物质登记测试机构名单。这些工作为提高我国化学品测试的技术水平、将来实现国际上化学品测试数据互认奠定了坚实的基础。
四、促进本学科发展的建议
近几年来，毒理学学科发展非常迅速，而且，社会对毒理学学科发展和专业人才需求量还在不断增长，毒理学学科对人们健康事业、国民经济发展和社会稳定的重要性将会得到进一步的体现。
（一）扩展毒理学领域、满足日益增长的社会需求
在我国现行的国家学科体系中，毒理学还不是一门独立的一级学科，它归属于预防医学下设的“卫生毒理学”学科，所有的招生、教学、人才培养和人才评价体系都是在此架构之下实施。我国目前实际招收从事毒理学研究的硕士、博士生的高等院校和科研院所不仅涉及医科、药科、中医药和军医大学，而且还涉及工业、农业、林业、海洋（事）、水产、理工、国家CDC以及相关科研院所等。很多院校和研究机构是挂靠其他专业招收从事毒理学科研的研究生，这很不利于毒理学专门人才的成长和专业人才队伍建设。“卫生毒理学”学科明显存在局限性，其不能包含环境毒理学、生态毒理学、药物毒理学、兽医毒理学等很多毒理学分支学科，导致这些分支学科的地位和作用未得到应有的体现。因此，有必要树立起“大毒理学”的概念，将目前的卫生毒理学专业扩展为毒理学专业，以一级学科的规模设置各分支学科专业，赋予毒理学学科更大的发展空间和领域。同时，由中国毒理学会等权威学术团体组织建立国家毒理学继续教育培训体系，培养更
高层次毒理学科技人才。要建立起与人才培养配套的毒理学人才评价机制，开拓社会急需毒理学人才的成长空间。很多西方发达国家和地区，已经建立了国家“毒理学家资格认证”体系，而且受到政府、企业和毒理学工作者的积极响应。国际毒理学联合会（IUTOX）也正在积极推动该项工作的国际间互认。在此大环境下，我国很有必要加大力度推行此项工作，使之成为国家毒理学人才培养和学科队伍建设的重要举措。
（二）建立中国国家毒理学计划、营造毒理学创新环境
鉴于毒理学的多学科交叉和多部门管理的特点，建议借鉴美国国家毒理学规划（NTP）和欧洲化学品管理局（ECHA）经验，结合我国实际，尽快建立有中国特色的毒理学研究和安全性评价机制和协调机构，即中国国家毒理学计划（CNTP），由政府有关部门联合推行，发挥全国性专业学术团体如中国毒理学会、中国预防医学会卫生毒理学会等在政府决策咨询和制定、指导与协调毒理学规划方面的作用。要确定主攻目标，加强毒理学科学基础研究，协调和指导全国毒理学测试技术方案和安全评价体系，开发和验证改进测试方法，及时为卫生、管理及研究机构、科学和医学界及公众提供有关潜在有毒化学品的信息；集中国家重点实验室、科研机构或高校资源、互通信息，组织全国各地区有基础的单位进行有计划、多方位、多层次的联合攻关，充分利用各自的优势，改变毒理学研究工作中的小而全、重复分散、交叉重叠的被动局面；加强各机构之间的沟通与合作，建立公用信息库，尽可能做到资源共享，包括技术与信息的共享。
（三）基础研究与应用并重，提升毒理学科技创新能力
毒理学具有多学科交叉融合的特色，既有基础研究，又有针对性强、符合社会需求的应用研究。毫无疑问，毒理学机制、人群易感危险因素和易感机理、理论模型等深入的基础性研究，是各类应用技术创新的思想源泉和推动力。在国家层面上要有切实的措施，稳定一批潜心毒理学基础研究的科研队伍，这对于毒理学学科发展是至关重要的。反过来，创新平台与实用技术，不但能解决国家的一
些重大需求问题，而且又能大大促进基础研究的系统深入。
毒理学研究需要瞄准实际问题与国家重大需求问题，注重实验室研究与现场人群研究相结合。应统筹好全国的科研力量，整合优势科技资源，组成学科交叉互补的国家级科研团队，组织实施毒理学领域重大科研计划的协同攻关研究。
未来毒理学研究要重点关注环境重点污染物、新物质、新材料的毒理学和危险度评定，从基因毒性、表观遗传毒性、生物膜和重要亚细胞结构毒性，以及毒性作用信号通路和网络机制、毒性生物标志物等方面深入开展基础研究；巩固系统毒理学研究，加强毒理学替代法和新技术、新方法的创建和应用；进一步加强管理毒理学与健康危险度评定研究工作。
建议建立有国家政府部门、大学、科研院所和企业等多方参与的国家毒理学产学研联盟，扩大转化毒理学研究，使更多的技术成果转化为实际产品，直接服务于社会经济建设和人类健康事业。
Toxicology
Toxicology is the science that studies the adverse effects of chemical, physical, or biological agents on living organisms and the ecosystem, including the prevention, treatment of amelioration of such adverse effects. As an integrated discipline, toxicology has the characteristics of multivariate and integration, involves basic academic research, application research and development, and management service. Entering the 21st century, toxicology has already become an important scientific resource and technical power for maintaining environment friendly and ecological balance, protecting life safety and health living, maintaining social economic sustainable development, and promoting social civilization and progress.
1. Outline of the development of toxicology in China
Toxicology has a long development history same as the development history of the traditional Chinese medicine in China. As early as the ancient period of firestorm monarch Yan Emperor, there is record about that Shennong tasted a hundred grasses, met 70 toxicants and poisonings on one day. The modern toxicology science started from 1950's in China; it has been experiencing a rapid development stage from the mid 1990's. At the present, a number of new technology theories and branch disciplines have emerged in toxicology academic system, such as toxicological genomics, poisoning metabonomics, poisoning and dynamics, nanotoxicology. There are three main fields within toxicology, i.e., descriptive toxicology, mechanistic toxicology, and regulatory toxicology. Up to now, there have developed various specialty subdisciplines under toxicology in China, they are industrial toxicology, food toxicology, drug addiction toxicology, clinical toxicology, biochemistry and molecular toxicology, feed toxicology, genetic toxicology, immunotoxicology, reproductive toxicology, environmental toxicology, ecotoxicology, biotoxin toxicology, analytical toxicology, veterinary toxicology, military toxicology, radiotoxicology, regulatory toxicology, intoxication and remedy, medicine toxicology, neurotoxicology, and Nanotoxicology.
In recent years, the strength of toxicology science and technology has been in rapid growing, the scope of scientific research, teaching and management is constantly expanding. Along with the increasing of budget invested in the field of toxicology, the ability of innovation in toxicology has boosted in China. On the one hand, toxicological basic research level is raising and the international impact is steadily increasing. On the other hand, the applied technologies and platforms of toxicology have been rapidly developed for the analytical testing and risk evaluation of chemicals including environmental pollutants, residues in all kinds of products, and medicines. The toxicology achievements have played an irreplaceable role in the evaluation of safety and risk management of exogenous environmental pollutants, industrial chemicals, medicine, food, cosmetics, health-related products, and new materials, such as nanomaterials, etc. Especially in recent years, the knowledge and
technologies of toxicology have been successfully applied to the emergency disposal and medical rescue for the prevention against the potential public emergencies of radiological, chemical, biological events, to the security of the 2008 Olympic Games in Beijing and the 2010 World Expo in Shanghai, to perform the international conventions for drug control, and to process the left chemical toxic agents by Japanese, major events of environmental pollution, etc.
2. The main progress and achievement of toxicology in China
2.1 The progress of toxicological basic research
The basic research level of toxicology is constantly upgrading in China. The quantity and quality of research articles published in international journals with good reputation by Chinese toxicologists increase year after year, and now it reaches nearly 400 SCI papers per year.
For the target organs toxicity and mechanism, in addition to the application of the traditional experimental models and methods for the research of target organs toxicities in vivo and in vitro, it also adopts and establishes a series of advanced target-organ toxicology research models and methods in recent years. The toxic characteristics, strength, and reversible mechanisms of target organs toxicities have been widely studied and elucidated in the animal models or in vitro cultured primary tissue cells for various exogenous chemicals, including industrial chemicals, environmental pollutants, food contaminants and biological products, Chinese and western medicines, and new materials.
For the Environmental-endocrine Disrupting Chemicals (EDCs), the increasing research data indicate that various human diseases of reproductive system are related to the exposure of exogenous chemicals or drugs. With the research strategies for the combination of in vitro study and whole animal study, laboratorial experimental study
and population cohort study in site, Chinese investigators have systematically studied the features and related mechanisms of reproductive toxicity of multiple EDCs. It has been proved that a number of EDCs, especially some of the persistent organic pollutants (POPs), led to broad reproductive disorders, including sexual differentiation abnormalities, genital deformity, sperm defect, sexual abnormalities, birth defect, dead fetus, and spontaneous abortion. These studied have provided important data for the risk evaluation and population intervention research of the reproductive toxicity.
Biomarker is one of the important fields in the toxicology research. In recent years, Chinese investigators have found multiple biomarkers (contact markers or effective markers) related to the exposures of a number of chemicals or toxicants. For example, 1- itrogen-6-ethylene (deoxidizing) adenine was revealed as the contact biomarker for evaluating the occupational exposure level of workers to vinyl chloride. Chinese and American investigators jointly initiated a cooperative project of molecular epidemiology study on occupational benzene exposure workers; the project aims to elucidate the complex relationship between the benzene exposure and the early changes of metabolic products and hematology index. Their data have played a direct role for promoting the Occupational Health & Safety Administration, USA to decrease the occupational benzene exposure limitation to 1ppm level. Chinese investigators also found the body contact markers or effect markers for the interaction between human and chemicals. The technology of gene analysis has also been broadly employed to the susceptibility studies of the environmental pollutants and chemicals in China.
Oxidative stress damage is a major mechanism of the acute and chronic injuries induced by a wide range of chemicals, radiation, and biological factors. In recent years, Chinese investigators have made a great progress in this field. A series of advanced platforms of oxidative stress and antioxidant research have been established. The oxidative stress damage and its mechanisms have been elucidated for some
chemicals. A theory of antioxidant compound chain has been proposed. Antioxidant compounds and their activities have been screened and evaluated using the traditional Chinese medicines and nature compounds.
For the DNA damage repair, a series of progresses have been achieved in the area of DNA damage repair and cellular responses. The involvement and mechanisms of multiple DNA repair genes have been elucidated on the cellular responses to various chemicals and ionizing radiation. It has been revealed that DNA-PK complex regulates the mitotic progressing and spindle stability in response to ionizing radiation, and plays a “cross-talk” role between the pathways of DNA repair and mitotic checkpoint. Apak (ATM and p53-associated KZNF protein) has been demonstrated as a negative regulator of p53-mediated apoptosis and it displays the dual role of ATM in p53 regulation after the induction of DNA damage. Axin has been found to be a critical determinant in p53-dependent tumor suppression in which Pirh2 and Tip60 have different roles in triggering cell-cycle arrest or apoptosis depending on the severity of genotoxic stress. JWA, an oxidative DNA damage responsive gene, was shown as a novel regulator of XRCC1 in the base excision repair protein complex to facilitate the repair of DNA single-strand breaks. A series of papers based on above results have been published in the journals of Nature Cell Biology, Cancer Research, Oncogene, JBC, and Nucleic Acids Research.
Epigenetic is a rapidly growing research field that focuses on the heritable alterations in gene expression caused by mechanisms other than changes in DNA sequence. Recently, the epigenetic effect induced by environmental factors has become an exciting topic in the toxicology field in China. The association of epigenetic changes and the genomic instability during the progressing of carcinogenesis induced by chemicals, such as the crystallization type NiS and BaP, and ionizing radiation has been broadly studied. Epigenetic silencing of MGMT was observed in NiS-treated cells, and which is associated with DNA hypermethylation, histone modifications, and DNMT1 upregulation. Nano-particle SiO (2) was also
demonstrated to induce a global hypoacetylation implying a global epigenetic response, which includes consequential decreased levels of DNMT1, DNMT3a, and methyl-CpG binding protein 2 (MBD2). The bystander effect and genomic instability induced by ionizing radiation has also been considered as an epigenetic effect. The gap junction and oxidative stress and ROS, for example NO, were demonstrated responding to bystander effect.
2.2 The progress of applied toxicology research
In recent years, Chinese toxicologists have made remarkable achievements on the construction of toxicological platforms and technologies which meet the social needs for safety aspects of domestic environment, food, pharmaceutical and occupational issues.
In the area of environmental safety maintenance, the achievements reflected on the detection of environmental pollutants, determination of the metabolic, general toxicity and mechanism in vitro and animal experiments, and risk evaluation. The achievements also include the assessment methods and measures for early detection and early prevention of human toxicity effects for environmental pollutants. The research areas include the atmospheric environment toxicology, soil environment toxicology, and water toxicology, etc.
Toxicology achievements promote occupational safety. The main goal is to understand the health hazards of industrial chemicals, and prevent and control the occupational disease. In recent years, a great progress has been made on the neurotoxic effects and mechanism of lead, organic solvent, polymer compounds, and so on, as well as the corresponding biological markers of exposures. Multiple toxic effective markers and susceptibility markers have been found in the biomarker studies of occupational contact workers.
In the food safety aspects, Chinese government and administrative authorities have recently issued a series of administrative laws or regulation standards based on the fundamental data of food toxicology studies. For example, they include “the safety evaluation and toxicological testing requirements of food containers and packaging materials”, “the safety evaluation procedures for new resource food”, and “the safety detection of 90 days fed rats for the transgenic plants and their food products”. A series of food safety monitoring, warning, and evaluating methods and platforms have been constructed, which have greatly improved the technology level of food safety evaluation and monitoring, and it results in that the field gradually connects and matches with the international practices.
Toxicology plays an irreplaceable role in the guarantee for drug safety. In recent years, much more efforts have been made on the toxicology research and safety supervision of western medicines and traditional Chinese medicines. It has been strengthened on the administration of animal experiments, construction and management of professional drug toxicology research organization. Many progresses have been made on the establishment and application of toxicity pathological diagnosis technology and other new technologies and methods on drugs toxicology research. Up to the year of 2010, 39 GLP centers for drug toxicology research and safety evaluation have been authorized by SFDA. The drug toxicology research and safety evaluation in China has been gradually connected and matched with the international standardization and management system.
The toxicology and safety evaluation of new materials and products, especially the nanomaterials becomes a new research field, and progresses rapidly in China, which even led to the establishment of nanotoxicology, a new specialty subdiscipline of toxicology. The nanotoxicology research in China reaches at the international advanced level in many aspects.
2.3 The progress of regulatory toxicology research
Regulatory toxicology is a rapidly growing and developing field of toxicology in China. In recent years, a series of policies, law, and regulatory in regard to the management of domestic public health and the environmental and ecological protection have been issued, and most of these documents are largely formulated on the basis of the basic scientific data, and the theories achieved through the solid toxicology research.
A series of tests guiding principles and standard procedures have been issued and implemented for the purposes of toxicology research and risk management of food, medicines, and chemicals. Among them, the internationalization of the standardization and management with respect to the experimental animals is the guarantee for the domestic GLP laboratory to connect with the international practice. All sorts of relevant regulations and documents have been formulated and issued, including the experimental animal classification, raise management, and environmental conditions and facilities for animal experiments, etc. The principles involving replacement, reduction, and implementation of animal use and animal welfare have been strengthened.
According to the international practices, domestic GLP centers have also established their own Institutional Animal Care and Use Committees (IACUC), and execute ethical censorship of animal testing. By the year of 2010, 27 agencies / centers have passed the certification of the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) in China. Following the practice of SFDA-authorized GLP on the toxicology research and safety evaluation of drugs, the National Ministry of Agriculture has launched the construction and evaluation of GLP centers for chemicals in the year of 2008. In the year of 2009, the National Ministry of Environment Protection has promulgated a list of authorized agencies for new chemicals registration and testing.
For the execution of global chemicals unified classification and labeling or Global Harmonized System (GHS), the General Administration of Quality Supervision, Inspection, and Quarantine of China released a series standards (GB20576-2006 and GB20602-2006) in the late year of 2006, which link to the chemicals classification, warning labels, and warming illustrate safety norms. On this basis, the specification and chemical risk evaluation norm have been issued in the year of 2008.
Toxicology is developing very fast in recent years in China, and currently is still in a period of expansive development. It has also been facing the great challenges. In order to meet the rapidly growing needs of national public health, environment safety, economic development, and social stability, toxicology discipline should continue to expand its fields, and construct its perfective science system. It is necessary to establish the Chinese National Toxicology Program (CNTP), and create a national toxicology innovation atmosphere. To pay equal attention to both basis research and application research should be further emphasized. It is suggested to establish a national toxicology industry league with the participators coming from related government agencies, universities, scientific research institutions, and enterprises in order to expand the translation research of toxicology.