A Hard and Clear, Estrogen-Free Replacement for Bisphenol-A Based Polycarbonates

描述（由申请人提供）：许多科学研究表明，聚碳酸酯（PC）塑料可浸出双酚A (BPA)，这是用于制造PC和其他塑料制品的数百种具有雌激素活性（EA）或抗雌激素活性的化学物质之一。含有EA或抗EA的化学物质会对许多行为和生理过程产生显著的不利影响，如精子数量、子宫和卵巢功能、攻击行为和某些类型的癌症。这些不良反应有时发生在非常低的浓度（皮摩尔到纳摩尔），特别是对胎儿或发育中的哺乳动物（包括人类）。PC塑料坚硬透明，常用于制作婴儿奶瓶、水瓶和其他含有食品的产品。PPi的数据显示，目前市面上还没有不含ea的PC替代品，包括那些标榜不含双酚a和/或邻苯二甲酸盐的替代品。为了满足这种商业和健康相关的需求，Plastipure （PPi）正在提交I期SBIR授权，以确认开发不释放具有EA或抗EA（无EA）的化学物质的树脂是可行的，并且可以直接替代具有许多优势特性的PC树脂，例如坚硬、透明、可微波、耐紫外线和防潮。PPi还建议确认由这些无ea树脂制造的塑料产品在热、湿、紫外线和微波辐射的常用应力之前和之后都保持无ea。PPi将使用非常敏感、可重复和准确的体外测定来确认这些树脂或塑料制品中没有可检测到EA的化学物质释放。一旦这些第一阶段的可行性研究成功完成，PPi应该是唯一已知的硬而清晰的PC塑料替代品，不会浸出BPA，邻苯二甲酸盐或任何其他含有EA的化学物质。PPi的PC树脂的无EA替代品将被授权给塑料制造商，他们将生产无EA的消费品，如食品容器和婴儿奶瓶。另外，PPi也可以转包，以自己的标签生产一些此类产品。鉴于个人对自己和孩子的福祉日益关注，以及大小零售公司对生产者的要求，无ea塑料产品应该具有很高的商业潜力。

DESCRIPTION (provided by applicant): Many scientific investigations have shown that polycarbonate (PC) plastics leach bisphenol- A (BPA), one of many hundreds of chemicals having estrogenic activity (EA) or anti-EA used to manufacture PC and other plastic products. Chemicals having EA or anti-EA 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. These adverse effects sometimes occur at very low (picomolar to nanomolar) concentrations, especially on fetal or developing mammals (including humans). PC plastics are hard and clear and often used to make baby bottles or water bottles and other products that contain foodstuffs. PPi's data show that no EA-Free PC substitute is currently commercially available, including those marketed as BPA and/or phthalate free. In order to meet this commercial and health-related need, Plastipure (PPi) is submitting a Phase I SBIR grant to confirm that it is feasible to develop resins that do not release chemicals having EA or anti-EA (EA-Free) and that directly substitute for PC resins that have many advantageous characteristics, e.g., hard, clear, microwavable and resistant to UV light and moisture. PPi also proposes to confirm that plastic products manufactured from these EA-Free resins remain EA-free before and after common-use stresses of heat, moisture, UV and micrewave radiation. PPi will use very sensitive, reproducible and accurate in vitro assays to confirm that no chemicals having detectable EA are released from these resins or plastic products. Once these Phase I feasibility studies are successfully completed, PPi should have the only known hard and clear replacement for PC plastics that do not leach BPA, phthalates, or any other chemicals having EA. PPi's EA-Free substitutes for PC resins would then be licensed to plastic manufacturers who would then produce EA-free consumer products, such as food containers and baby bottles. Alternatively, PPi may subcontract to have some such products manufactured under its own label. Given the increasing concern of individuals for their and their children's well-being and PPi's requests from large and small retail firms, EA-free plastic products should have high commercial potential. PUBLIC HEALTH RELEVANCE: Many scientific investigations have shown that polycarbonate (PC) plastics leach bisphenol-A (BPA), one of many hundreds of chemicals having estrogenic activity (EA) or anti-EA used to manufacture PC and other plastic products. Chemicals having EA or anti-EA 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. These adverse effects sometimes occur at very low (picomolar to nanomolar) concentrations, especially on fetal or developing mammals (including humans). Given such adverse effects of chemicals having EA and anti-EA on mammals (including humans), there is high scientific, societal, and commercial merit for PPi to develop EA-/Anti-EA-Free plastic resins and products that are direct substitutes for PC resins and products, especially water bottles, food containers and baby products.