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

描述(申请人提供)：许多科学研究表明，聚碳酸酯(PC)塑料会浸出双酚A(BPA)，这是用于制造PC和其他塑料产品的数百种具有雌激素活性(EA)或抗EA的化学物质之一。含有EA或抗EA的化学物质可以对许多行为和生理过程产生显著的不利影响，如精子计数、子宫和卵巢功能、攻击行为和某些类型的癌症。这些不良影响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塑料坚硬而透明，经常用于制造婴儿奶瓶或水瓶以及其他含有食品的产品。PPI的数据显示，目前还没有商业上可用的不含EA的PC替代品，包括那些市场上销售的不含BPA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，PlattiPure(PPI)正在提交一期SBIR赠款，以确认开发不释放含有EA或抗EA(不含EA)的化学物质的树脂是可行的，并直接替代具有许多优势特性的PC树脂，例如，硬、透明、可微波和抗紫外线和潮湿。PPI还建议确认，由这些不含EA的树脂制造的塑料产品在常见的热、湿、紫外线和微波辐射压力前后保持不含EA。PPI将使用非常敏感、可重复和准确的体外测试来确认这些树脂或塑料产品中没有释放出含有可检测到的EA的化学物质。一旦这些第一阶段可行性研究成功完成，PPI应该拥有唯一已知的硬质和明确的PC塑料替代品，不会渗出BPA、邻苯二甲酸盐或任何其他含有EA的化学品。PPI的PC树脂不含EA的替代品将被授权给塑料制造商，然后这些制造商将生产不含EA的消费产品，如食品容器和婴儿奶瓶。或者，PPI可以将一些这样的产品转包到自己的品牌下生产。鉴于个人日益关注自己和孩子的福祉，以及大小零售公司对PPI的要求，不含EA的塑料产品应该具有很高的商业潜力。 与公众健康相关：许多科学调查表明，聚碳酸酯(PC)塑料会浸出双酚A(BPA)，这是用于制造PC和其他塑料产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的化学物质可以对许多行为和生理过程产生显著的不利影响，如精子计数、子宫和卵巢功能、攻击行为和某些类型的癌症。这些不良影响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)。鉴于含有EA和抗EA的化学品对哺乳动物(包括人类)的不利影响，PPI开发不含EA/抗EA的塑料树脂和产品，直接替代PC树脂和产品，特别是水瓶、食品容器和婴儿产品，具有很高的科学、社会和商业价值。

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.