A Nonanimal Test Method to Determine the Ocular Safety of Consumer Products and Chemicals: Commercialization

确定消费品和化学品眼部安全性的非动物测试方法：商业化

• 批准号: 10696247
• 负责人: Stewart Lebrun
• 金额: $ 16.8万
• 依托单位: LEBRUN LABS, LLC
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-03-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10696247
• 关键词: Address; Animal Cruelty; Animal Testing; Animal Welfare; Animals; Applications Grants; Area; Businesses; Cell Culture Techniques; Chemicals; Classification; Code; Complex; Consumer Product Safety; Corrosion; Corrosives; Cosmetics; Custom; Detection; Development; Diagnostic Reagent Kits; Dissection; Ensure; Environment; Ethics; European Union; Evaluation; Eye; Funding; Funding Opportunities; Government; Government Agencies; Grant; Hour; Image; India; Industry; Injections; Interagency Coordinating Committee on the Validation of Alternative Methods; International; Irritants; Israel; Label; Laboratories; Laws; Legal patent; Lesion; Life; Manufacturer; Marketing; Methods; Molds; Movement; NIH Program Announcements; National Institute of Environmental Health Sciences; National Toxicology Program; Oryctolagus cuniculus; Outsourcing; Performance; Phase; Plumbing; Population; Privatization; Process; Production; Recording of previous events; Reliability of Results; Safety; Sales; Self Care; Shipping; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Specific qualifier value; Standardization; Statutes and Laws; System; Techniques; Testing; Time; Tissues; Toxicology; Training; Work; Writing; blind; chemical standard; commercialization; commercialization readiness; consumer product; cost effective; design; experience; hazard; improved; irritation; manufacture; manufacturing process; manufacturing test; packaging material; personal care products; pressure; prevent; programs; prototype; quality assurance; response; retinal toxicity; safety testing; skills; working group

ABSTRACT The phase I and II Small Business Innovation Research (SBIR) applications, from which this application is a continuation, was in response to the National Institute of Environmental Health Sciences’ solicitation for “Improved Test Systems for Prioritization and Safety Evaluation.” Specifically, the application was written to address the need for a nonanimal ocular safety test to differentiate ocular nonirritant substances from irritant and corrosive substances. Ocular safety tests have routinely been conducted on live animals with a time to results of up to 21 days and are considered by many to be inhumane. Recent government legislation and consumer pressure are directed at reducing or eliminating the use of live animals for the routine testing of consumer products and cosmetics. However, limited options exist for nonanimal testing. Currently, accepted nonanimal test methods require the advanced purchase (up to three weeks) of live tissues and a technician skilled in aseptic technique; additionally, such tests do not have a long shelf life or misclassify ocular corrosives as nonirritants, are time intensive, and require other advanced laboratory techniques including cell culture or dissection and subjective interpretation of ocular lesions. The subject of this proposal is the production of a rapid, irritancy-predictive, quantitative, standardized test kit with a one-year shelf life to provide standardized results more accurately and with higher sensitivity than any other available nonanimal ocular irritation test. Using chemicals selected and coded by a government agency [National Toxicology Program (NTP)’s Interagency Center for the Evaluation of Alternative Toxicological Methods] and evaluated by representatives from other U.S. governmental agencies (NTP’s Interagency Coordinating Committee on the Validation of Alternative Methods Ocular Toxicology Working Group] during the prior SBIR grants, it was demonstrated that the test kit has a transferability of 92%, according to results from a blind transferability study. Overall, for the detection of nonirritants, out of the 90 chemicals evaluated, no false-negative results were obtained (100% sensitivity) using the Globally Harmonized System of Classification and Labelling of Chemicals. The overall sensitivity and accuracy outperformed all other available nonanimal ocular irritation test methods. In addition to the test being rapid and shelf stable, test kit performance for the detection of nonirritant compounds was excellent. A major new development for the OptiSafe test is that it is now moving towards international regulatory acceptance. International regulatory acceptance is anticipated to greatly expand OptiSafe sales, if the product can be effectively manufactured to meet the need, the subject of this grant application. The scope of the SBIR/STTR Commercialization Readiness Pilot (CRP) Program, as provided on the funding opportunity announcement, includes “technical assistance associated with manufacturing.” The aims of this application are to seek technical assistance to improve manufacturing of the test kit, including a complex part manufacturing process and packaging so that the kit can be shipped without damage domestically and internationally to meet the worldwide need for an accurate, shelf-stable nonanimal eye irritation test. An accurate, rapid, stable, nonanimal eye safety test kit represents a significant business opportunity in the current market of consumer products and cosmetics and will make a needed solution available to both private industry and regulatory agencies.

摘要 第一阶段和第二阶段的小企业创新研究（SBIR）应用程序，从该应用程序是一个 继续，是为了响应国家环境健康科学研究所的邀请， “改进的优先级和安全评估测试系统。具体来说，申请书是写给 解决了非动物眼部安全性试验的需求，以区分眼部非刺激性物质和刺激性物质 和腐蚀性物质。眼部安全性测试已常规地在活体动物上进行， 结果长达21天，许多人认为这是不人道的。最近的政府立法和 消费者的压力是针对减少或消除使用活的动物进行例行测试， 消费品和化妆品。然而，非动物试验的选择有限。目前，接受 非动物测试方法需要提前购买（最多三周）活组织和技术人员 精通无菌技术;此外，此类测试的保质期不长或对眼部腐蚀剂进行错误分类 无刺激性，是时间密集型的，需要其他先进的实验室技术，包括细胞培养或 眼部病变的解剖和主观解释。本提案的主题是制作一个 快速、刺激性预测、定量、标准化检测试剂盒，有效期为一年， 结果更准确，灵敏度更高，比任何其他可用的非动物眼刺激试验。 使用由政府机构选择和编码的化学品[国家毒理学计划（NTP）的 替代毒理学方法评价机构间中心]，并由代表进行评价 来自其他美国政府机构（NTP的机构间协调委员会， 替代方法眼部毒理学工作组]在之前的SBIR赠款期间，证明了 根据一项盲法转移性研究的结果，该试剂盒的转移性为92%。总的来说， 检测无刺激性，在评价的90种化学品中，未获得假阴性结果（100% 使用《全球化学品统一分类和标签制度》（《全球统一制度》），整体 灵敏度和准确度优于所有其他可用的非动物眼刺激试验方法。除了 该试验快速且贮存稳定，用于检测无刺激性化合物的试剂盒性能 好极了 OptiSafe测试的一个重大新进展是，它现在正朝着国际监管方向发展。 验收国际监管机构的认可预计将大大扩大OptiSafe的销售，如果产品 可以有效地制造，以满足需要，这一补助金申请的主题。 SBIR/STTR商业化准备试点（CRP）计划的范围，如资金提供的 机会公告，包括“与制造相关的技术援助”。其目的是 申请是为了寻求技术援助，以改善生产的检测试剂盒，包括一个复杂的部分 制造过程和包装，以便试剂盒可以在国内运输而不会损坏， 以满足全球对准确、货架稳定的非动物眼刺激试验的需求。 准确、快速、稳定的非动物眼安全检测试剂盒代表了一个重要的商业机会， 目前的消费品和化妆品市场，并将提供所需的解决方案，以私人 行业和监管机构。

项目成果

Expansion of the application domain of a macromolecular ocular irritation test (OptiSafe™).

• DOI: 10.1016/j.tiv.2022.105515
• 发表时间: 2023-02
• 期刊: Toxicology in vitro : an international journal published in association with BIBRA
• 作者: Lebrun S;Chavez S;Nguyen L;Chan R
• 通讯作者: Chan R