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）是应用于身体的非处方产品（例如，染发剂、洗发剂、调理剂、护肤液、润肤剂、防晒霜、唇膏、化妆品、指甲油等）。每天，消费者平均使用10种化妆品，总共126种成分，大多数都没有在标签上列出。同行评审的论文报道了哺乳动物（包括人类）摄入或吸收具有雌激素和/或雄激素活性的化学物质（EA**/AnA**）可能会引起各种不良的健康影响，包括子宫功能障碍、某些癌症的高发病率、精子计数减少和异常的脑成熟、注意力、动机、情感、认知发育障碍以及攻击性行为和性取向的改变.这些不良影响有时可能在非常低的浓度（皮摩尔至纳摩尔）下发生，尤其是对胎儿或发育中的哺乳动物。CertiChem（CCi）的同行评审论文和初步数据显示，PCP通常含有内分泌干扰物（EDCs），最常见的是可以口服或通过皮肤吸收的EA**/AnA**。流行病学研究表明，这类产品可能对健康造成重大不利影响。虽然政府机构和非政府组织已经承认广泛的EA**/AnA** 暴露是一个令人担忧的原因，但美国和国际市场上的PCP尚未被要求进行EA**/AnA** 检测。NIH/NIEHS需要灵敏和准确的测定，例如CCi用于检测化妆品和其他物质或产品中的EA**/AnA** 的测定。最后，目前没有商业或其他实体向弱势群体（例如，怀孕母亲、青少年）或EA**/AnA** 限制的化妆品配方，以满足具有特殊需求的利基人群（例如，绝经后女性）。鉴于上述考虑，CCi在I期SBIR应用中具有很高的科学、社会和商业价值，表明使用其新颖、灵敏和准确的体外测定来定量用于配制PCP的化学品中的EA**/AnA** 水平是可行的。CCi将与一家化妆品公司（4X Naturals）合作使用该知识产权，利用化学品EA**/AnA** 的此类数据，证明配制一种商业上可行的不含EA**/ANA** 的五氯苯酚供孕妇、婴儿和/或青少年使用是可行的，该五氯苯酚不含可检测到的EA**/AnA**。CCi将使用4x Natural的知识产权，以确保不含EA**/ANA** 的PCP也不含金属、甲醛释放、过敏或皮肤刺激性物质，以及不含或含有明确规定水平的EA**/AnA** 的配方，供明确确定的利基市场的消费者使用。CCi消除PCP中所有EA**/AnA** 的方法与大多数其他商业实体、监管机构和消费者团体使用的当前模式相比是一种范式转变，这些商业实体、监管机构和消费者团体通常一次消除一种具有EA**/AnA** 的化学品。CCi的新模型符合NIEHS为EDC“开发创新预防策略”的目标。