New guideline reduces animal testing and protects from allergies caused by chemicals
ECHA has published advice to registrants on how to reliably combine different sources of alternative data when assessing skin sensitisation of chemicals. This reduces the need to test on animals, while protecting people from allergies. The advice is based on a recent OECD guideline.
Helsinki, 13 October 2021 – The OECD guideline informs REACH registrants on how to reliably combine different sources of non-animal data on skin sensitisation properties of their substances. It will help companies to reduce animal testing while ensuring that people are protected from allergies caused by chemicals.  
ECHA has now published advice on how to use the guideline and advance the use of non-animal test methods. This is the first guideline outlining how to use in silico tools (using computer simulation) such as the QSAR Toolbox to assess skin sensitisation.
Mike Rasenberg, ECHA’s Director for Hazard Assessment says: “This is an important milestone for advancing the use of alternative methods to assess chemical hazards. With the new guideline, we make sure that this approach can be used to protect people against skin sensitisation, without the need to conduct tests on animals. ECHA contributed significantly to its development in close cooperation with the OECD, Joint Research Centre and other organisations.”
The guideline contains defined approaches for assessing whether a substance is a skin sensitiser, and categorising whether the sensitisation is strong or moderate. This categorisation is especially important, as REACH requires skin sensitisation potency to be assessed. If the defined approach results in a conclusion on skin sensitisation and potency, it can replace the currently used in vivo method Local Lymph Node Assay, reducing testing on animals.
Using the guideline helps registrants who have already submitted in chemico or in vitro data in their registrations but are uncertain whether this data is accepted by regulators. ECHA encourages those registrants to check whether they can use the defined approaches for their substances to make conclusive predictions and update their dossiers accordingly. If registrants cannot make conclusive predictions, they may need to generate new data or use a weight of evidence approach. The guideline also helps registrants select the most suitable tests to generate new data for substances.

Background
Since 2017, REACH requires registrants to use in vitro methods (tests outside a living organism, usually involving isolated tissues, organs or cells) to provide data on skin sensitisation.
From information in ECHA’s Classification and Labelling Inventory, there are over 14 000 substances on the EU market with some indication of a skin sensitising concern.  Allergic contact dermatitis is a common occupational and environmental health issue. Many skin sensitising chemicals are already restricted under REACH.

新的指导方针减少了动物试验，防止化学物质引起的过敏
ECHA已经向注册者发布了关于在评估化学品皮肤致敏性时如何可靠地结合不同来源的替代数据的建议。这减少了在动物身上进行试验的需要，同时保护人们不过敏。该建议是基于经合组织最近的指导方针。
赫尔辛基，2021年10月13日—经合组织指南向REACH注册人提供了如何可靠地结合其物质皮肤致敏特性的不同非动物数据来源的信息。它将帮助公司减少动物试验，同时确保人们免受化学物质引起的过敏。
ECHA现已就如何使用该指南和促进非动物试验方法的使用发表了建议。这是第一个指南概述如何使用硅工具(使用计算机模拟)，如QSAR工具箱来评估皮肤过敏。
ECHA危险评估主任Mike Rasenberg说:“这是推进使用替代方法评估化学危害的一个重要里程碑。有了新的指导方针，我们可以确保这种方法可以用于保护人们免受皮肤过敏，而无需在动物身上进行试验。ECHA与经合组织、联合研究中心和其他组织密切合作，为其发展做出了重大贡献。”
该指南包含了确定的方法，用于评估一种物质是否是皮肤致敏剂，并对其致敏程度是强是弱进行分类。这种分类尤其重要，因为REACH要求对皮肤敏感的效力进行评估。如果定义的方法在皮肤致敏和效力方面得出结论，它可以取代目前使用的活体方法局部淋巴结试验，减少动物试验。
使用该指南有助于已在注册中提交化学或体外数据但不确定该数据是否被监管机构接受的注册者。ECHA鼓励这些注册人检查他们是否可以使用其物质的定义方法进行结论性预测，并相应地更新他们的档案。如果登记者不能做出结论性的预测，他们可能需要生成新的数据或使用证据权重方法。该指南还帮助注册人选择最合适的试验，以产生物质的新数据。
背景
自2017年以来，REACH要求注册者使用体外方法(活体体外测试，通常涉及分离的组织、器官或细胞)来提供皮肤敏感的数据。
根据欧洲化学品管理局分类和标签清单中的信息，在欧盟市场上有超过14000种物质表明存在皮肤敏感问题。过敏性接触性皮炎是常见的职业和环境卫生问题。REACH已经限制了许多皮肤敏感的化学物质。

更多信息请点击：https://echa.europa.eu/-/new-guideline-reduces-animal-testing-and-protects-from-allergies-caused-by-chemicals 

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