T/SHSOT 005-2022 The integrated testing and evaluation method for eye irritation based on BCOP and CAMVA
T/SHSOT 005-2022 The integrated testing and evaluation method for eye irritation based on BCOP and CAMVA
Basic Information
Scope
Scope: This document specifies the procedures, methods, and reporting requirements for integrated testing based on CAMVA and BCOP. This document applies to cosmetic raw materials and products, chemicals, pesticides, disinfection products, and other items that may come into contact with the eyes, for the accurate classification and identification of ocular irritation and the assessment of potential hazards. Main technical content: 5.1 General elements 5.1.1 Classification of IATA module methods The methods integrated in the IATA scheme are divided into two categories: regulatory methods (DA) and judgmental methods (JBA). When using these methods, it is important to distinguish between them and clearly define the toxicological endpoints and usage scenarios being addressed, as these factors will determine the uncertainty of the methods and their acceptable levels, the selection of methods (components), and the manner of evidence integration. 5.1.2 Information sources for IATA IATA, as a method, should integrate and weigh all relevant existing and available evidence, and guide the generation of targeted new data as needed to support regulatory decisions regarding potential hazards and risks. Data in IATA methods may include different sources of information, such as computer models, classification methods, and cross-reference methods, in vitro methods, and in vivo tests. This includes experimentally obtained or predicted data, existing or newly generated data. It also includes physical and chemical tests, animal experiments, and human clinical trials, as well as new technological methods (NAM), such as in vitro methods and computer-based methods. In vitro methods can be classified according to their biological basis, such as those based on cell culture systems (e.g., cell-based assays and reconstructed human tissue assays), or according to their technical implementation or underlying supporting technologies (e.g., high-throughput screening, high-content screen