Phase II year
2009
(last award dollars: 2010)
Phase II Amount
$1,207,230
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 or next-most commonly androgens, 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) and androgenic (AnA) 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 II SBIR grant to develop for commercialization polymer formulations to make plastics that do not release chemicals having EA and AnA but that still possess many advantageous characteristics, such as microwavability, resistance to UV light and moisture and physical properties similar to current commercially available formulations. PPi proposes to confirm that PPi's EA-Free formulations are also AnA-Free and have equivalent physical properties and thermal stability as compared to current commercial formulations. Secondly, PPi plans to identify a set of EA- and AnA-Free chemicals (e.g. colorants, clarifiers and antistats) that could be incorporated during the conversion or finishing processes that could be used with our resins to produce EA-Free and AnA-Free products. Finally, PPi plans to develop at least one next-generation EA-Free and AnA-Free PE or PP which utilize antioxidants and other additives that do not contain chemical moieties that could degrade or otherwise react to produce chemicals which exhibit EA or AnA. If these Phase II development 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 or AnA. These formulations would then be licensed to plastic manufacturers who would then produce EA-Free and AnA-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 and AnA-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) or next-most commonly exhibit androgenic activity (AnA). EDCs having EA and/or AnA 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 and AnA on mammals (including humans); there is high scientific, societal, and commercial merit for PPi to develop EA-Free and AnA-Free plastic formulations, especially for food packaging and baby products.
Public Health Relevance Statement: 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) or next-most commonly exhibit androgenic activity (AnA). EDCs having EA and/or AnA 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 and AnA on mammals (including humans); there is high scientific, societal, and commercial merit for PPi to develop EA-Free and AnA-Free plastic formulations, especially for food packaging and baby products.
Project Terms: 0-6 weeks old; 4,4' isopropylidinediphenol; Actinic Rays; Adhesives; Adverse effects; Advertising; Aggression; Aggressive behavior; Androgenic Agents; Androgenic Compounds; Androgens; Antioxidants; Assay; Attention; Australia; Behavioral; Bioassay; Biologic Assays; Biological; Biological Assay; Brain; Canada; Characteristics; Chemicals; Chemotherapy-Hormones/Steroids; China; Client; Clinical Trials, Phase I; Cognitive; Country; Data; Development; Disease; Disorder; Drug Formulations; Dysfunction; Early-Stage Clinical Trials; Electromagnetic, Microwave; Emotions; Encephalon; Encephalons; Endocrine; Endocrine Disrupter; Endocrine Disrupting Chemicals; Endocrine Disruptors; Endocrine Gland Secretion; Endocrine disrupting agent; Environment; Estrogenic Agents; Estrogenic Compounds; Estrogens; Ethene Homopolymers; Ethylene Homopolymers; Ethylene Polymers; Evaluation; Exhibits; Exposure to; Figs; Figs - dietary; Food; Food Container; Food Packaging; Formulation; Formulations, Drug; Functional disorder; Fungi, Filamentous; Goals; Government; Grant; Health; Heat Stress; Heat Stress Disorders; Heat Stress Syndromes; Heating; Hormones; Human; Human, General; Individual; Infant, Newborn; Injection of therapeutic agent; Injections; Ink; Investigation; Japan; Knowledge; Learning Disabilities; Learning disability; Legal patent; Letters; Licensing; Mainland China; Mammalia; Mammals; Mammals, General; Man (Taxonomy); Man, Modern; Manufacturer; Manufacturer Name; Marketing; Methods; Microwaves; Molds; Molecular Weight; Motivation; National Institute of Environmental Health Sciences; Nervous System, Brain; Newborn Infant; Newborns; Organism-Level Process; Organismal Process; Orientation, Sexual; Ovarian; Patents; Pathology; Persons; Phase; Phase 1 Clinical Trials; Phase I Clinical Trials; Phase I Study; Physiologic Processes; Physiological Processes; Physiopathology; Plant Resins; Plasticizers; Plastics; Polyethylenes; Polymers; Polypropylenes; Powder dose form; Powders; Pressure; Pressure- physical agent; Prevalence; Procedures; Process; Progress Reports; Propene Polymers; Propylene Polymers; Protocol; Protocols documentation; Publishing; Reporter Genes; Reporting; Resins, Plant; Resistance; Robotics; SBIR; SBIRS (R43/44); SIS; Sampling; Sex Orientation; Sister; Small Business Innovation Research; Small Business Innovation Research Grant; Solvents; Sperm Count; Sperm Count Procedure; Sperm Numbers; Stress; Sun/Ultra-Violet Rays; Testing; Therapeutic Androgen; Therapeutic Estrogen; Therapeutic Hormone; Toy; Treatment Side Effects; UV radiation; Ultraviolet Rays; Validation; anti-oxidant; bisphenol A; catalyst; chemical release; child well being; commercialization; consumer product; diphenylolpropane; disease/disorder; endocrine disrupting compound; estrogenic activity; experience; fetal; in vitro Assay; manufacturing process; medical schools; meetings; microwave electromagnetic radiation; microwave radiation; monomer; newborn human (0-6 weeks); next generation; pathophysiology; phase 1 study; phase 1 trial; phase I trial; phthalates; physical property; pressure; protocol, phase I; public health relevance; resin; resistant; side effect; social; theories; therapy adverse effect; treatment adverse effect; ultraviolet light; ultraviolet radiation
