Maxwell Gavin, Aleksic Maja, Aptula Aynur, Carmichael Paul, Fentem Julia, Gilmour Nicola, Mackay Cameron, Pease Camilla, Pendlington Ruth, Reynolds Fiona, Scott Daniel, Warner Guy, Westmoreland Carl
Unilever Safety & Environmental Assurance Centre (SEAC), Sharnbrook, Bedfordshire, UK.
Altern Lab Anim. 2008 Nov;36(5):557-68. doi: 10.1177/026119290803600511.
Allergic Contact Dermatitis (ACD; chemical-induced skin sensitisation) represents a key consumer safety endpoint for the cosmetics industry. At present, animal tests (predominantly the mouse Local Lymph Node Assay) are used to generate skin sensitisation hazard data for use in consumer safety risk assessments. An animal testing ban on chemicals to be used in cosmetics will come into effect in the European Union (EU) from March 2009. This animal testing ban is also linked to an EU marketing ban on products containing any ingredients that have been subsequently tested in animals, from March 2009 or March 2013, depending on the toxicological endpoint of concern. Consequently, the testing of cosmetic ingredients in animals for their potential to induce skin sensitisation will be subject to an EU marketing ban, from March 2013 onwards. Our conceptual framework and strategy to deliver a non-animal approach to consumer safety risk assessment can be summarised as an evaluation of new technologies (e.g. 'omics', informatics), leading to the development of new non-animal (in silico and in vitro) predictive models for the generation and interpretation of new forms of hazard characterisation data, followed by the development of new risk assessment approaches to integrate these new forms of data and information in the context of human exposure. Following the principles of the conceptual framework, we have been investigating existing and developing new technologies, models and approaches, in order to explore the feasibility of delivering consumer safety risk assessment decisions in the absence of new animal data. We present here our progress in implementing this conceptual framework, with the skin sensitisation endpoint used as a case study.
过敏性接触性皮炎（ACD；化学诱导的皮肤致敏）是化妆品行业关键的消费者安全终点。目前，动物试验（主要是小鼠局部淋巴结试验）用于生成皮肤致敏危害数据，以用于消费者安全风险评估。自2009年3月起，欧盟将实施一项针对用于化妆品的化学品的动物试验禁令。这项动物试验禁令还与欧盟对含有任何随后在动物身上进行过试验的成分的产品的市场销售禁令相关联，根据所关注的毒理学终点不同，该禁令将于2009年3月或2013年3月起生效。因此，自2013年3月起，对化妆品成分进行动物皮肤致敏潜力测试将面临欧盟市场销售禁令。我们用于提供非动物方法进行消费者安全风险评估的概念框架和策略可概括为对新技术（如“组学”、信息学）的评估，从而开发新的非动物（计算机模拟和体外）预测模型，用于生成和解释新形式的危害特征数据，随后开发新的风险评估方法，以便在人类接触的背景下整合这些新形式的数据和信息。遵循概念框架的原则，我们一直在研究现有技术并开发新技术、模型和方法，以探索在没有新的动物数据的情况下做出消费者安全风险评估决策的可行性。我们在此展示我们在实施这一概念框架方面取得的进展，以皮肤致敏终点作为案例研究。
