Heinemeyer Gerhard, Hahn Axel
Federal Institute for Risk Assessment (BfR), Thielallee 88-92, D-14195 Berlin, Germany.
Toxicol Appl Pharmacol. 2005 Sep 1;207(2 Suppl):636-44. doi: 10.1016/j.taap.2005.02.026.
Product information databases are important prerequisites for providing data to poison centers (PC) to give adequate advice in cases of poisonings and for preparation of statistics as annual reports. For risk assessment measures, they can help for exposure assessments and for priority setting. A product database is a set of information of product and substance names, compositions, and uses of products. Data are provided due to national regulations as well as to national and international agreements between industry, international associations, e.g. the European Association of Poison Centres and Clinical Toxicologists (EAPCCT), and clinical toxicology institutions. They have different contents, i.e. complete formulations, frame formulations, and material safety data sheets. For definite identification of products, the product name should be readily taken from the labels and must be similar to the names provided by electronic media as databases. Products should be classified according to their use. The first system that has been prepared for that purpose is the ATC classification for pharmaceuticals. For chemicals, several systems e.g. the WHO-IPCS classification code, exist; the EU technical guidance document for risk assessment of chemicals is mentioning use categories, and they are used on national levels as well. For risk assessment purposes, statistics of poisonings and other health hazards are important as well as information about exposure. Linking cases of poisonings with product data enables risk assessors to perform statistical evaluations about health effects due to product use categories which can be compared to product compositions. If products are categorized by their use, information about use characteristics, such as frequencies and durations, can be derived. Hence, product categories can be taken to characterize scenarios and thus help for model estimations of exposure and respective doses.
产品信息数据库是向中毒控制中心（PC）提供数据的重要前提条件，以便在中毒病例中提供充分的建议，并用于编制年度报告等统计数据。对于风险评估措施，它们有助于进行暴露评估和确定优先事项。产品数据库是一组关于产品和物质名称、成分及产品用途的信息。数据是根据国家法规以及行业、国际协会（如欧洲中毒控制中心和临床毒理学家协会（EAPCCT））与临床毒理学机构之间的国家和国际协议提供的。它们有不同的内容，即完整配方、框架配方和材料安全数据表。为了准确识别产品，产品名称应易于从标签中获取，并且必须与电子媒体（如数据库）提供的名称相似。产品应根据其用途进行分类。为此目的编制的第一个系统是药品的解剖学治疗学及化学分类系统（ATC）。对于化学品，存在多种系统，例如世界卫生组织国际化学品安全规划署（WHO-IPCS）分类代码；欧盟化学品风险评估技术指导文件提到了使用类别，并且它们也在国家层面使用。出于风险评估目的，中毒及其他健康危害的统计数据以及暴露信息同样重要。将中毒病例与产品数据相联系，使风险评估人员能够对因产品使用类别导致的健康影响进行统计评估，并可与产品成分进行比较。如果按用途对产品进行分类，就可以得出有关使用特征（如频率和持续时间）的信息。因此，可以利用产品类别来描述场景，从而有助于对暴露和相应剂量进行模型估计。
