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（由应用程序提供）：个人护理产品（PCP）是适用于身体的非处方产品（例如，头发颜色，洗发水，护发素，皮肤乳液，除臭剂，晒太阳，润肤露，唇膏，化妆，指甲油等）。每天，平均消费者使用10种化妆品，总计126种成分，大多数未在标签上列出。 Peer- reviewed papers report that ingestion or abuse of chemicals having estrogenic and/or androgenic activity (EA**/AnA**) by mammals (including humans) can likely cause various adverse health effects including uterine dysfunction, higher rates of some cancers, reduced sperm count, and abnormal brain maturation, disorders of attention, motivation, emotional, cognitive development, and changes in aggressive behavior and sexual 方向。这些不良反应有时可能以非常低的（皮摩尔至纳摩尔）浓度发生，尤其是在胎儿或发育中的哺乳动物上。认证（CCI）的同行评审论文和初步数据表明，PCP通常包含内分泌干扰化学物质（EDC），最常见的是可以口服或吸收的EA **/ana **。流行病学研究表明，这种产品可能会引起严重的不良健康影响。尽管政府机构和非政府组织已承认宽度ea **/ana **是引起关注的原因，但在美国和国际市场上的PCP尚未进行EA **/ana **的测试。 NIH/NIEHS渴望敏感和准确的测定，例如CCI在化妆品和其他物质或产品中检测EA **/ANA **的测定法。最后，目前没有商业或其他实体向弱势群体（例如怀孕的母亲，少年）或ea **/ana ** - 有限的化妆品公式对利基人群的特殊需求（例如，后者后女性）。上面概述的给定考虑因素，CCI在此阶段I SBIR应用中具有很高的科学，社交和商业优点，以表明使用其新颖，敏感和准确的体外评估来量化用于制定PCP的化学物质的水平。 CCI使用此IP与化妆品公司（4倍自然）合作，将使用有关化学物质的EA **/ana **的此类数据，以表明它可以使自己可行的可行的EA **/ANA ** - 免费的PCP - 可供孕妇，婴儿和/或无法检测到的EA ** ** ** ** ** ** ** ************ ********** ** ** ****** ** ** ** ** ** ** ** ** ****** ** ** ** ** ** ****** ** ** ** ** ******** ** ** ****** ** ** ** ** ** **** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ** ****** ** ** ** ** ** **。 CCI将使用4X Natural的IP来确保EA **/ANA ** - 免费PCP也没有金属，甲醛释放，过敏性或皮肤辐射的物质以及没有良好的EA **/ANA ************ ******** ******的消费者。与大多数其他商业实体，法规机构和消费者组使用的当前模型相比，CCI消除PCP中所有EA **/ANA **的方法是一种范式转移，这些模型通常会一次消除具有EA **/ANA **的化学物质。 CCI的小说模特达到了NIEHS的目标，即“为EDC制定创新的预防策略。