Replacement Ocular Battery (ROBatt)

描述(由申请者提供)：该赠款项目的目标是开发和预验证替换眼球电池(ROBatt)，这是一种分级测试策略，由四种替代眼刺激测试组成，将取代使用Draize兔眼测试的监管强制急性眼刺激测试。ROBATT包括牛角膜不透明和通透性分析(BCOP)、使用10天受精卵的绒毛尿囊膜血管分析(CAMVA)、猪角膜可逆性分析(PorCORA)和猪共焦分析(PorFocal)。这种分级策略遵循决策树，允许对可能的眼刺激进行彻底的询问。虽然建议使用四种检测方法，但大多数情况下，根据刺激程度的不同，只使用两到三种检测方法。ROBatt项目的具体目标是使用欧洲化学品生态毒理学和毒理学中心(ECETOC)数据库中列出的至少50种化学品来验证决策树变量，包括腐蚀性(EEC R41，GHS/EPA Cat 1)、严重(EEC R36，GHS Cal 2，HMIS2)和中等(EPA Cat。HMIS2)、轻度(HMIS1)和无刺激性(EPA Cat 4，HMIS0)。该项目的长期目标是将ROBatt测试策略提交给iCCVAM/ECVAM，以考虑作为Draize兔眼测试的独立替代方案。ROBatt测试战略的验证和接受将通过用四种可靠的替代测试取代兔子，大大减少用于消费品、化学品和原材料毒理学评估的兔子的数量。 与公共健康相关：随着新的化学品和产品配方的推出，眼睛刺激测试对于确保足够的公共健康安全水平具有极其重要的意义。在大多数情况下，这些安全评估是使用Draize兔子眼睛测试进行的，导致每年有数千只兔子用于测试。自上世纪80年代以来，人们一直在讨论替代方案，但没有得到监管机构的任何明显接受。

DESCRIPTION (provided by applicant): The objective of this grant project is the development and pre-validation of the Replacement Ocular Battery (ROBatt), a tiered testing strategy consisting of a battery of four alternative ocular irritancy assays, which will replace regulatory mandated acute ocular irritation testing using the Draize Rabbit Eye test. ROBatt consists of the Bovine Corneal Opacity and Permeability Assay (BCOP), the Chorioallantoic Membrane Vascular Assay using 10-day fertile chicken eggs (CAMVA), the Porcine Corneal Reversibility Assay (PorCORA) and the Porcine Confocal Assay (PorFocal). This tiered strategy follows a decision tree that allows for a thorough interrogation of possible ocular irritants. Although four assays are recommended, in most cases only two or three will be used depending on the degree of irritation. The Specific Aim of the ROBatt project is to validate the decision tree variables using at least 50 chemicals listed in the European Center for Ecotoxicology and Toxicology of Chemicals (ECETOC) data bank, including Corrosive (EEC R41, GHS/EPA Cat 1), Severe (EEC R36, GHS CaL 2, HMIS 2), Moderate (EPA Cat. 3, HMIS 2), Mild (HMIS 1) and Non-irritating (EPA Cat 4, HMIS 0). The long-term project goal is to submit the ROBatt testing strategy to iCCVAM/ECVAM for consideration as a standalone alternative to the Draize Rabbit Eye test. Validation and acceptance of the ROBatt testing strategy will significantly reduce the number of rabbits used in the toxicological assessment of consumer products, chemicals and raw materials by replacing rabbits with four robust alternative assays. PUBLIC HEALTH RELEVANCE: Ocular irritation testing is extremely relevant to assuring adequate safety levels of public health as new formulations of chemicals and products are introduced. In most cases, these safety assessments are performed using the Draize Rabbit Eye test, resulting in thousands of rabbits used in testing every year. Alternatives have been discussed since the 80s without any appreciable acceptance from regulators.