Final Report on the Safety Assessment of Polyethylene1

Abstract

Polyethylene is an ethylene polymer used for a variety of purposes in cosmetics as an abrasive, adhesive, binder or bulking agent, an emulsion stabilizer, a film former, an oral care agent, and as a nonaqueous viscosity-increasing agent. Polyethylene is also used in food packaging materials and medical products, including prosthetics. The molecular weight of Polyethylene as used in cosmetics varies over a wide range. The lowest reported molecular weight is 198 Daltons and the highest is 150,000. In any given polymer preparation, there can be a broad range of molecular weights. Cellular and tissue responses to Polyethylene, determined as part of implant biocompatibility testing, include fibrous connective tissue build-up around the implant material that varies as a function of the physical form of the implant material. Specific assays for osteoblast proliferation and collagen synthesis demonstrated a reduction as a function of exposure to Polyethylene particles that is inversely related to particle size. The effect of Polyurethane particles on monocyte-derived macrophages, however, had a stimulatory effect, prolonging the survival of these cells in culture. The LD50 for Polyethylene, with an average molecular weight of 450, in rats was > 2000 mg/kg. For Polyethylene with an average molecular weight of 655, the LD50 was > 5.0 g/kg. Toxicity testing in rats shows no adverse effects at Polyethylene (molecular weight not given) doses of 7.95 g/kg or at 1.25%, 2.50%, or 5.00% in feed for 90 days. Dermal irritation studies on rabbits in which 0.5 g of Polyethylene (average molecular weight of 450) was administered in 0.5ml of water caused no irritation or corrosive effects; Polyethylene with an average molecular weight of 655 was a mild irritant. Polyethylene (average molecular weight of 450) did not cause dermal sensitization in guinea pigs tested with 50% Polyethylene ( w/w ) in a rachis oil BP. Polyethylene, with a molecular weight of 450 and a molecular weight of 655, was a mild irritant when tested as a solid material in the eyes of rabbits. Rabbit eyes treated with a solution containing 13% Polyethylene beads produced minimal irritation and no corneal abrasions. No genotoxicity was found in bacterial assays. No chemical carcinogenicity has been seen in implantation studies, although particles from Polyethylene implants can induce so-called solid-state carcinogenicity, which is a physical reaction to an implanted material. Occupational case reports of ocular irritation and systemic sclerosis in workers exposed to Polyethylene have been difficult to interpret because such workers are also exposed to other irritants. Clinical testing of intrauterine devices made of Polyethylene failed to conclusively identify statistically significant adverse effects, although squamous metaplasia was observed. The Cosmetic Ingredient Review (CIR) Expert Panel did not expect significant dermal absorption and systemic exposure to large Polyethylene polymers used in cosmetics. The Panel was concerned that information on impurities, including residual catalyst and reactants from the polymerization process, was not available. The Panel considered that the monomer unit in Polyethylene polymerization is ethylene. In the United States, ethylene is 99.9% pure. The other 0.1% includes ethane, propylene, carbon dioxide, carbon monoxide, sulfur, hydrogen, acetylene, water, and oxygen. The Panel believed that the concentration of these impurities in any final polymer would be so low as to not raise toxicity issues. Safety tests of cosmetic-grade Polyethylene have consistently failed to identify any toxicity associated with residual catalyst. Although it was reported that one process used to cross-link Polyethylene with an organic peroxide, this process is not currently used. In addition, cosmetic-grade Polyethylene is not expected to contain toxic hexanes. The Panel was concerned that the only genotoxicity data available was nonmammalian, but taking this information in concert with the absence of any chemical car-cinogenicity in implant studies suggests no genotoxic mechanism for carcinogenicity. The solid-state carcinogenicity effect was not seen as relevant for Polyethylene as used in cosmetics. The available data support the conclusion that Polyethylene is safe for use in cosmetic formulations in the practices of use and concentrations described.