Baby bottles that release no chemicals having estrogenic activity

婴儿奶瓶不释放具有雌激素活性的化学物质

• 批准号: 8239891
• 负责人: Stuart Yaniger
• 金额: $ 58.44万
• 依托单位: PLASTIPURE, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-03-21 至 2013-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8239891
• 关键词: Address; Adolescent; Adverse effects; Affect; Aggressive behavior; Awareness; Behavioral; Biological Process; Characteristics; Chemicals; Consumer Product Safety; Data; Devices; Drug Formulations; Equipment; Exhibits; Exposure to; Fetus; Food Packaging; Freezing; Funding; Grant; Health; Health Benefit; Heating; Human; Industry; Infant; Ingestion; Learning; Legal patent; Mammals; Marketing; Mechanics; Methods; Mission; Molds; National Institute of Environmental Health Sciences; Nipples; Obesity; Ovarian; Penetration; Phase; Physiological Processes; Plant Resins; Plastics; Platinum; Polymers; Positioning Attribute; Process; Property; Prostate; Puberty; Public Health; Report (document); Resistance; Safety; Silicones; Simulate; Specimen; Sperm Count Procedure; Sterilization; Stress; Structure; Sunlight; Technology; Testing; Time; Ultraviolet Rays; Vulnerable Populations; Work; base; bisphenol A; cancer type; chemical reaction; chemical release; commercialization; cost; design; disability; dosage; estrogenic activity; fetal; fitness; fluoromethyl 2,2-difluoro-1-(trifluoromethyl)vinyl ether; improved; innovation; manufacturing process; meetings; microwave electromagnetic radiation; novel; physical property; polycarbonate; polycarbonate plastic; prototype; public health relevance; seal; sperm function; success

DESCRIPTION (provided by applicant): In this Fast-Track application, PlastiPure (PPi) proposes to rapidly and completely develop for commercialization an EA-Free baby bottle to address an important public health problem: ingestion by infants of chemicals having estrogenic activity (EA) or anti-EA leaching from multiple components of baby bottles, including the bottle, anticolic devices, nipple, sealing rings, etc. Many scientific studies have shown that chemicals having EA or anti-EA can have significant adverse health effects on many biological processes such as sperm number and function, prostate size, uterine and ovarian functions, time to puberty, obesity, learning abilities, and some types of cancers. These adverse health effects sometimes occur at very low (pM-nM) concentrations, especially on fetal or developing mammals (including humans). Many scientific studies have also shown that bisphenol A (BPA) has EA and leaches from hard and clear polycarbonate (PC) plastics at nM-<M concentrations that have adverse health effects on fetal or juvenile mammals. PPi's studies show that almost all plastics, including BPA-free plastics and most components of all plastic baby bottles, release other chemicals having EA often at levels higher than PC plastics. PPi will use its unique and patented materials and manufacturing processes to produce baby bottles whose component parts do not release any chemical having EA or anti-EA, i.e., are EA-Free even when exposed to common-use stresses (UV light, microwaves, moist heat). In Phase I, PPi will confirm preliminary data that that it is feasible to develop EA-Free silicones to manufacture EA-Free nipples for baby bottles. In Phase II, PPi will confirm that it has EA-Free resins to make all other components of EA- Free baby bottles, including hard and clear resin substitutes for PC bottles, that meet or exceed fit-for-use tests and remain EA-Free, both as new bottles and after repeated test cycles simulating extended use. PPi's EA-Free baby bottles will be unique in the industry and provide significant health benefits to our most vulnerable populations: fetus, infants and juveniles. Because it has already developed most of the materials, PPi is uniquely positioned to begin work immediately and put advanced-technology, safer products on retail shelves within 21/2 years. As breakout products, EA-Free baby bottles will achieve rapid market penetration and raise consumer awareness about the safety of plastic products in general. The success of these baby bottles will allow PPi to introduce safer EA-Free plastics into a broad range of food packaging and consumer goods, greatly increasing overall consumer product safety. Using PPi's unique and patented EA-Free plastic materials and processing methods to produce EA-Free baby bottles directly and decisively fulfill NIEHS' (and PPi's) mission to "reduce the burden of human illness and disability." PUBLIC HEALTH RELEVANCE: PlastiPure (PPi) is addressing a public health problem [release of chemicals having estrogenic or anti-estrogenic activity (EA or anti-EA) ingested by infants using plastic baby bottles] by using its unique and patented materials and methods to produce baby bottles that do not release chemicals having EA or anti-EA. Chemicals having EA or anti- EA, even at very low dosages on fetal mammals, can have significant adverse effects on many behavioral and physiological processes such as sperm counts, uterine and ovarian functions, aggressive behaviors, and some types of cancers. EA-Free baby bottles decisively fulfill PPi's and NIEHS' mission of "reducing the burden of human illness and disability".

描述（由申请人提供）：在此快速通道申请中，PlastiPure（PPi）提议快速、全面地开发一种无EA奶瓶，以实现商业化，从而解决一个重要的公共卫生问题：婴儿摄入具有雌激素活性（EA）或从婴儿奶瓶的多个部件（包括奶瓶、防结肠装置、奶嘴、密封圈）浸出的抗EA化学品，许多科学研究已经表明，具有EA或抗EA的化学品可以对许多生物过程具有显著的不利健康影响，例如精子数量和功能、前列腺大小、子宫和卵巢功能、青春期时间、肥胖、学习能力和某些类型的癌症。这些不利的健康影响有时发生在非常低的浓度（pM-nM），特别是对胎儿或发育中的哺乳动物（包括人类）。 许多科学研究还表明，双酚A（BPA）具有EA，并从硬而透明的聚碳酸酯（PC）塑料中浸出，其浓度为nM-<M，对胎儿或幼年哺乳动物具有不利的健康影响。PPi的研究表明，几乎所有的塑料，包括不含BPA的塑料和所有塑料奶瓶的大多数组件，都会释放出比PC塑料更高水平的EA。 PPi将使用其独特的专利材料和制造工艺生产婴儿奶瓶，其组成部分不会释放任何具有EA或抗EA的化学物质，即，即使暴露于常用应力（紫外线、微波、湿热）下也不含EA。在第一阶段，PPi将确认初步数据，即开发不含EA的有机硅来生产婴儿奶瓶用不含EA的奶嘴是可行的。在第二阶段，PPi将确认其拥有不含EA的树脂，以制造不含EA的婴儿奶瓶的所有其他组件，包括PC奶瓶的硬质和透明树脂替代品，这些树脂符合或超过适合使用的测试，并保持不含EA，无论是作为新奶瓶还是在模拟长期使用的重复测试周期后。 PPi的无EA婴儿奶瓶将在行业中独树一帜，并为我们最脆弱的人群提供显著的健康益处：胎儿，婴儿和青少年。由于PPi已经开发了大部分材料，因此它具有独特的优势，可以立即开始工作，并在21/2年内将先进技术、更安全的产品投放零售货架。作为突破性产品，无EA婴儿奶瓶将实现快速的市场渗透，并提高消费者对塑料产品安全性的认识。这些婴儿奶瓶的成功将使PPi能够将更安全的无EA塑料引入到广泛的食品包装和消费品中，大大提高消费品的整体安全性。 使用PPi独特的专利EA-Free塑料材料和加工方法生产EA-Free婴儿奶瓶，直接并决定性地履行NIEHS（和PPi）的使命“减轻人类疾病和残疾的负担”。" 公共卫生关系：PlastiPure（PPi）正在解决一个公共卫生问题[释放具有雌激素或抗雌激素活性（EA或抗EA）的化学品，由婴儿使用塑料奶瓶摄入]通过使用其独特的专利材料和方法，生产婴儿奶瓶，不释放具有EA或抗EA的化学品。具有EA或抗EA的化学品，即使在胎儿哺乳动物上以非常低的剂量，也可以对许多行为和生理过程具有显著的不利影响，例如精子计数、子宫和卵巢功能、攻击性行为和某些类型的癌症。EA-Free婴儿奶瓶决定性地实现了PPi和NIEHS“减轻人类疾病和残疾负担”的使命。