SAFER PERSONAL CARE PRODUCTS

更安全的个人护理产品

• 批准号: 8832229
• 负责人: Cathy Z Yang
• 金额: $ 15.1万
• 依托单位: CERTICHEM, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-22 至 2015-08-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8832229
• 关键词: Adolescent; Adopted; Adverse effects; Advertising; African American; Aggressive behavior; Agonist; American; Androgens; Attention; Biological Assay; Brain; Chemicals; Cognitive; Collaborations; Cosmetics; Data; Deodorants; Development; Disease; Drops; Drug Formulations; Emotions; Endocrine Disruptors; Epidemiologic Studies; Estrogens; Exposure to; Female; Fetus; Formaldehyde; Functional disorder; Goals; Government Agencies; Grant; Hair Dyes; Health; Human; In Vitro; Infant; Ingestion; International; Knowledge; Label; Laboratories; Learning Disabilities; Left; Lotion; MCF7 cell; Malignant Neoplasms; Mammals; Marketing; Measures; Modeling; Mothers; Motivation; Nail plate; National Institute of Environmental Health Sciences; National Toxicology Program; Paper; Parabens; Pathology; Peer Review; Phase; Phenols; Photons; Polishes; Population; Postmenopause; Pregnant Women; Prevention strategy; Regulation; Reporting; Self Care; Sex Orientation; Simulate; Skin; Small Business Innovation Research Grant; Soaps; Specific qualifier value; Sperm Count Procedure; Stress; Sunlight; Testing; Time; To specify; UV sensitive; United States National Institutes of Health; Vulnerable Populations; Woman; Work; absorption; estrogenic activity; fetal; in vitro Assay; in vivo; innovation; meetings; novel; phthalates; pregnant; public health relevance

 DESCRIPTION (provided by applicant): Personal care products (PCPs) are non-prescription products applied to the body (e.g., hair colorants, shampoos, conditioners, skin lotions, deodorants, suntan lotions, lipstick, makeups, nail polishes, etc.). Daily, the average consumer uses 10 cosmetic products, totaling 126 ingredients, most not listed on the label. Peer- reviewed papers report that ingestion or absorption of chemicals having estrogenic and/or androgenic activity (EA**/AnA**) by mammals (including humans) can possibly cause various adverse health effects including uterine dysfunction, higher rates of some cancers, reduced sperm count, and abnormal brain maturation, disorders of attention, motivation, emotion, cognitive development, and changes in aggressive behavior and sexual orientation. These adverse effects may sometimes occur at very low (picomolar to nanomolar) concentrations, especially on fetal or developing mammals. CertiChem's (CCi's) peer-reviewed papers and preliminary data show that PCPs often contain endocrine disrupting chemicals (EDCs), most-commonly having EA**/AnA** that can be orally ingested or absorbed through the skin. Epidemiological studies suggest that such products may be causing significant adverse health effects. Although government agencies and NGOs have acknowledged widespread EA**/AnA** exposure as a cause of concern, PCPs on the US and international markets are not yet required to undergo testing for EA**/AnA**. NIH/NIEHS desire sensitive and accurate assays such as those used by CCi to detect EA**/AnA** in cosmetics and other substances or products. Finally, no commercial or other entity is currently offering EA**/AnA**-free cosmetic formulations to vulnerable populations (e.g., pregnant mothers, juveniles) or EA**/AnA**-limited cosmetic formulations to niche populations with a special need (e.g., postmenopausal females). Given considerations outlined above, there is high scientific, societal, and commercial merit for CCi in this Phase I SBIR application to show that it is feasible to use its novel, sensitive and accurate in vitro assays to quantify the level of EA**/AnA** in chemicals used to formulate PCPs. Using this IP in collaboration with a cosmetics firm (4X Naturals), CCi will use such data on the EA**/AnA** of chemicals to show it is feasible to formulate a commercially viable EA**/ANA**- free PCP for use by pregnant mothers, infants, and/or juveniles that has no detectable EA**/AnA**. CCi will use 4x Natural's IP to insure that the EA**/ANA**-free PCP is also free of metallic, formaldehyde-releasing, allergenic, or skin-irritating substances as well as no or formulations having well-specified levels of EA**/AnA** for consumers in well-identified niche markets. CCi's approach to eliminate all EA**/AnA** in PCPs is a paradigm-shift compared to the current model used by most other commercial entities, regulatory agencies and consumer groups that typically eliminate chemicals having EA**/AnA** one at a time. CCi's novel model meets an NIEHS goal of "developing innovative prevention strategies" for EDC's.

 描述（由申请人提供）： 个人护理产品 (PCP) 是适用于身体的非处方产品（例如染发剂、洗发水、护发素、润肤露、除臭剂、防晒霜、口红、化妆品、指甲油等）消费者每天平均使用 10 种化妆品，总计 126 种成分，其中大多数未在标签上列出，同行评审论文报告称，摄入或吸收的化学物质具有以下性质。哺乳动物（包括人类）的雌激素和/或雄激素活性（EA**/AnA**）可能会导致各种不利的健康影响，包括子宫功能障碍、某些癌症的发病率较高、精子数量减少、大脑成熟异常、注意力障碍、动机、情绪、认知发展以及攻击行为和性取向的变化有时可能会在非常低的浓度（皮摩尔至纳摩尔）下发生，特别是对胎儿或发育中的哺乳动物。论文和初步数据显示，五氯苯酚通常含有内分泌干扰化学物质 (EDC)，最常见的是可口服或通过皮肤吸收的 EA**/AnA** 流行病学研究表明，此类产品可能对健康造成严重不利。尽管政府机构和非政府组织承认广泛的 EA**/AnA** 暴露令人担忧，但美国和国际市场上的 PCP 尚未被要求接受 EA**/AnA** 测试。 NIH/NIEHS 需要灵敏且准确的检测方法，例如 CCi 用于检测化妆品和其他物质或产品中的 EA**/AnA** 的检测方法。最后，目前没有商业或其他实体提供不含 EA**/AnA** 的检测方法。针对弱势人群（例如怀孕母亲、青少年）的化妆品配方或针对有特殊需要的利基人群（例如绝经后女性）的 EA**/AnA** 限制化妆品配方 鉴于上述考虑因素，存在较高的风险。 CCi 在第一阶段 SBIR 应用中的科学、社会和商业价值表明，使用其新颖、灵敏且准确的体外测定来量化用于配制 PCP 的化学品中 EA**/AnA** 的水平是可行的CCi 与化妆品公司 (4X Naturals) 合作使用该 IP，将利用化学品 EA**/AnA** 的此类数据来证明配制商业上可行的不含 EA**/ANA** 的产品是可行的。孕妇使用的 PCP未检测到 EA**/AnA** 的母亲、婴儿和/或青少年将使用 4x Natural 的 IP 来确保不含 EA**/ANA** 的 PCP 也不含金属、释放甲醛、 CCi 的方法是消除过敏性或皮肤刺激性物质，以及不含 EA**/AnA** 或具有明确水平的 EA**/AnA** 的配方。与大多数其他商业实体、监管机构和消费者团体当前使用的模型相比，PCP 中的 EA**/AnA** 是一种范式转变，这些模型通常一次消除一种含有 EA**/AnA** 的化学品。该模型满足 NIEHS 为 EDC“制定创新预防策略”的目标。