Estrogen Free Polymer Formulations for Food Packaging and Baby Products

描述（由申请人提供）：最近的科学调查表明，塑料通常会将内分泌干扰物（EDCs）浸入环境中。内分泌干扰物以各种方式干扰激素，最常见的是雌激素，并可能对许多行为和生理过程产生显著的不良影响，如精子计数，子宫和卵巢功能，攻击行为和性取向。艾德效应（激动或拮抗）有时在极低浓度（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（包括人类）。目前聚合物制剂中内分泌干扰物的普遍存在及其生物学效应保证了无雌激素（EA）活性的塑料产品的开发，特别是用于包装食品或制造婴儿产品的塑料。为了满足这一需求，Plastipure（PPi）正在提交第一阶段SBIR授权，以确认开发聚合物配方以制造不释放具有EA的化学品但仍具有许多有利特性的塑料是可行的，例如微波性，抗紫外线和水分，类似于目前市售的配方。PPi建议使用非常敏感的体外试验，以确认由PPi配方生产的塑料产品在暴露于塑料在正常使用过程中通常经历的不利条件（即热，水分，紫外线）之前或之后不会释放具有EA的化学品。其次，PPi计划确定3-5种不含雌激素的抗氧化剂，这些抗氧化剂可用于其他配方，以生产具有各种物理特性的不含EA的塑料。如果这些第一阶段的可行性研究是成功的，PPi应该有唯一已知的配方，可以使各种各样的塑料产品，不浸出化学品具有EA。然后，这些配方将被授权给塑料制造商，他们将生产不含EA的消费品，如食品容器和婴儿奶瓶。鉴于人们越来越关注自己和孩子的健康，以及大型和小型零售公司对PPi的要求，不含EA的塑料产品应该具有很高的商业潜力。公共卫生相关性：最近的科学调查表明，许多用于制造塑料的化学品会渗入环境中，并且是最常表现出雌激素活性（EA）的内分泌干扰物化学品（EDCs）。具有EA的EDC引起各种病症，例如子宫功能障碍或精子计数减少和异常脑成熟，导致病理学，例如学习障碍、注意力障碍、动机障碍、情绪障碍、认知发育障碍以及攻击性行为和性取向的改变。鉴于具有EA的EDCs对哺乳动物（包括人类）的这种不利影响，PPi确认开发用于食品包装和婴儿产品的不含EA的塑料制剂是可行的具有很高的科学、社会和商业价值。

DESCRIPTION (provided by applicant): Recent scientific investigations have shown that plastics often leach endocrine disruptor chemicals (EDCs) into the environment. EDCs interfere in various ways with hormones, most commonly estrogens, and can have significant adverse effects on many behavioral and physiological processes such as sperm counts, uterine and ovarian functions, aggressive behaviors, and sexual orientation. ED effects (agonistic or antagonistic) sometimes occur at very low (picomolar to nanomolar) concentrations, especially on fetal or developing mammals (including humans). The prevalence of EDCs in current polymer formulations and their biological effects warrant the development of plastic products free of estrogenic (EA) activity, especially for plastics used to package foodstuffs or to make baby products. In order to meet this need, Plastipure (PPi) is submitting a Phase I SBIR grant to confirm that it is feasible to develop polymer formulations to make plastics that do not release chemicals having EA but that still possess many advantageous characteristics, such as microwavability, resistance to UV light and moisture, similar to current commercially available formulations. PPi proposes to use very sensitive in vitro assays to confirm that plastic products produced from PPi's formulations do not release chemicals having EA before or after exposure to adverse conditions commonly experienced by plastics during normal use (i.e. heat, moisture, UV light). Secondly, PPi plans to identify 3-5 estrogenic free antioxidants that can be utilized in additional formulations to produce EA-free plastics with very diverse physical characteristics. If these Phase I feasibility studies are successful, PPi should have the only known formulations that can make a wide variety of plastic products that do not leach chemicals having EA. These formulations would then be licensed to plastic manufacturers who would then produce EA-free consumer products, such as food containers and baby bottles. 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: Recent scientific investigations have shown that many chemicals used to manufacture plastics leach into the environment and are endocrine disruptor chemicals (EDCs) that most commonly exhibit estrogenic activity (EA). EDC having EA cause various disorders such as uterine dysfunction or reduced sperm count and abnormal brain maturation leading to pathologies such as learning disabilities, disorders of attention, motivation, emotion, cognitive development, and changes in aggressive behavior and sexual orientation. Given such adverse effects of EDCs having EA on mammals (including humans) there is high scientific, societal, and commercial merit for PPi to confirm that it is feasible to develop EA-free plastic formulations for food packaging and baby products.