In Vitro Assay for Chemical Allergens

化学过敏原的体外测定

• 批准号: 7682900
• 负责人: Seyoum Ayehunie
• 金额: $ 21.37万
• 依托单位: MATTEK CORPORATION
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-06-01 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7682900
• 关键词: Allergens; Allergic; Allergic Contact Dermatitis; Animal Experiments; Animal Model; Animal Welfare; Animals; Antigen-Presenting Cells; Biological Assay; Biological Markers; Biological Models; Blinded; Case Study; Cavia; Cell surface; Cells; Characteristics; Chemicals; Communities; Cosmetics; Dendritic Cells; Developed Countries; Drug Formulations; Economics; Epidermis; Evaluation; Exposure to; Food Preservatives; Goals; Haptens; Hazard Assessment; Health; Household Products; Human; Hygiene; Hypersensitivity; In Vitro; Industry; Interleukin-6; International; Laboratories; Laboratory Animals; Langerhans cell; Local Lymph Node Assay; Marketing; Materials Testing; Measurable; Metals; Methods; Modeling; Mus; Occupational; Ointments; Patch Tests; Pattern; Perfume; Pharmacologic Substance; Phase; Process; Regulation; Reproducibility; Research; Risk; Screening procedure; Sensitivity and Specificity; Skin; System; Testing; Textiles; Topical application; Training; Uncertainty; Up-Regulation; Validation; Variant; assay development; base; chemical allergen; cost; cytokine; good laboratory practice; hazard; improved; in vitro Assay; in vitro testing; in vivo; occupational hazard; research study; response; tool; validation studies

Allergic contact dermatitis (ACD) is one of the most common and costly health problems in industrialized countries. Currently, more than 100,000 chemicals are in commercial use and another 2,000 new chemicals and numerous new-product formulations are tested or marketed every year. All of these materials must be screened for allergenicity. During Phase I, a human dendritic cell based assay was developed which gives sensitive and specific responses to allergens. The non-optimized assay is approximately a factor of 10 less expensive than current animal based tests. In addition, the assay avoids animal welfare issues and uncertainty related to species extrapolation. During Phase II, thedatabase of materials tested will be expanded and the in vitro assay method and prediction model will be finalized. The reproducibility of the assay will be assessed and, after demonstration of interlaboratory transferability, a multi-lab GLP validation study will be performed. Finally, an optimized assay kit which further enhances the economic advantages of the in vitro method will be developed. Allergic contact dermatitis, in vitro testing, plasmacytoid DC. A predictive test system for assessing the allergic contact dermatitis potential of chemicals will have far reaching application in industries involved in cosmetic, personal hygiene and topical pharmaceutical products. Evaluation of allergenicity is important to minimize the hazards of occupational and public exposure to chemicals and products. The proposed human cell based assay will provide a sensitive and specific method of allergen screening without the use of laboratory animals and at a reduced cost.

过敏性接触性皮炎（ACD）是一种最常见和昂贵的健康问题， 工业化国家。目前，超过100，000种化学品用于商业用途， 另有2,000种新化学品和许多新产品配方正在测试或上市 每年所有这些材料都必须进行过敏性筛查。 在I期期间，开发了基于人树突状细胞的测定法，其提供灵敏的 和对过敏原的特异性反应非优化的检测试剂盒大约低10倍 比目前的动物实验更昂贵。此外，该测定还避免了动物福利问题 和物种外推的不确定性。在第二阶段， 将扩大和体外测定方法和预测模型将最终确定。的 将评估测定的重现性，并在实验室间证明后， 可转移性，将进行多实验室GLP验证研究。最后，优化的检测试剂盒 其进一步增强了体外方法的经济优势。 变应性接触性皮炎，体外试验，浆细胞样树突状细胞。用于评估化学品的过敏性接触性皮炎可能性的预测性测试系统将具有 广泛应用于化妆品、个人卫生和局部制药等行业 产品.过敏原性评价对减少职业性和公众性危害具有重要意义 接触化学品和产品。所提出的基于人细胞的测定将提供灵敏且 在不使用实验室动物的情况下以降低的成本进行过敏原筛选的特定方法。