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

基本信息

  • 批准号:
    10546635
  • 负责人:
  • 金额:
    $ 12.8万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 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

项目摘要

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小型企业创新研究(SBIR)应用程序,本应用程序是从这些应用程序 继续,是应国家环境健康科学研究所的邀请 “改进了优先排序和安全评估的测试系统。”具体地说,该应用程序被写入 解决非动物眼部安全测试的需要,以区分眼部非刺激性物质和刺激性物质 和腐蚀性物质。眼睛安全测试通常在活体动物身上进行,有时间 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 消费者的压力是为了减少或取消使用活动物进行常规测试 消费品和化妆品。然而,非动物试验的选择有限。目前,已接受 非动物试验方法需要预先购买活组织(最多三周)和一名技术人员 精通无菌技术;此外,这种测试不会有很长的保质期,也不会错误地对眼睛腐蚀性物质进行分类 作为非刺激性物质,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。这项提议的主题是制作一份 快速、刺激性-预测性、定量、标准化检测试剂盒,具有一年的保质期,提供标准化 结果比任何其他可用的非动物眼刺激试验更准确,灵敏度更高。 使用政府机构挑选和编码的化学品[国家毒理学计划]S 替代毒理学方法评估机构间中心],并由代表进行评估 来自其他美国政府机构(NTP的机构间协调委员会关于验证 替代方法眼毒理学工作组]在先前的SBIR资助期间,证明了 根据一项盲目可转移性研究的结果,该检测试剂盒的可转移性为92%。总体而言, 检测无刺激性,在评估的90种化学物质中,没有获得假阴性结果(100% 敏感性)使用全球化学品统一分类和标签制度。整体而言 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……之外 该检测快速且货架稳定,检测非刺激性化合物的试剂盒性能为 好极了。 OptiSafe测试的一个重大新发展是,它现在正在走向国际监管 接受。如果产品获得国际监管机构的认可,预计将极大地扩大OptiSafe的销售 可以有效地制造,以满足需要,这项拨款申请的主题。 资金规定的SBIR/STTR商业化准备试验(CRP)计划的范围 商机公告,包括“与制造相关的技术援助”。这样做的目的是 申请是寻求技术援助,以改进检测试剂盒的制造,包括复杂的部件 制造过程和包装,以使套件可以运输而不会损坏国内和 在国际上,以满足全球对准确、货架稳定的非动物眼刺激测试的需求。 准确、快速、稳定的非动物眼部安全检测试剂盒代表着在 目前的消费品和化妆品市场,并将提供所需的解决方案,这两个私人 行业和监管机构。

项目成果

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Stewart Lebrun其他文献

Stewart Lebrun的其他文献

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{{ truncateString('Stewart Lebrun', 18)}}的其他基金

IVD EIT a Nonanimal Kit and Service for the Detection of Ocular Irritants: Phase II
IVD EIT 用于检测眼部刺激物的非动物试剂盒和服务:第二阶段
  • 批准号:
    10699287
  • 财政年份:
    2023
  • 资助金额:
    $ 12.8万
  • 项目类别:
IVD EIT: A Nonanimal Kit and Service for the Detection of Reversible Ocular Irritants
IVD EIT:用于检测可逆眼部刺激物的非动物试剂盒和服务
  • 批准号:
    10007220
  • 财政年份:
    2020
  • 资助金额:
    $ 12.8万
  • 项目类别:
Non-Animal Test Method To Determine The Ocular Safety Of Consumer Products and Chemicals
确定消费品和化学品的眼部安全性的非动物测试方法
  • 批准号:
    8906576
  • 财政年份:
    2015
  • 资助金额:
    $ 12.8万
  • 项目类别:
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
  • 财政年份:
    2015
  • 资助金额:
    $ 12.8万
  • 项目类别:
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