title: Human exposures to monomers resulting from consumer contact with polymers.
abstract: Many consumer products are composed completely, or in part, of polymeric materials. Direct or indirect human contact results in potential exposures to monomers as a result of migrations of trace amounts from the polymeric matrix into foods, into the skin or other bodily surfaces. Typically, residual monomer levels in these polymers are <100 p.p.m., and represent exposures well below those observable in traditional toxicity testing. These product applications thus require alternative methods for evaluating health risks relating to monomer exposures. A typical approach includes: (a) assessment of potential human contacts for specific polymer uses; (b) utilization of data from toxicity testing of pure monomers, e.g. cancer bioassay results; and (c) mathematical risk assessment methods. Exposure potentials are measured in one of two analytical procedures: (1) migration of monomer from polymer into a simulant solvent (e.g. alcohol, acidic water, vegetable oil) appropriate for the intended use of the product (e.g. beer cans, food jars, packaging adhesive, dairy hose); or (2) total monomer content of the polymer, providing worse-case values for migratable monomer. Application of toxicity data typically involves NOEL or benchmark values for non-cancer endpoints, or tumorigenicity potencies for monomers demonstrated to be carcinogens. Risk assessments provide exposure 'safety margin' ratios between levels that: (1) are projected to be safe according to toxicity information, and (2) are potential monomer exposures posed by the intended use of the consumer product. This paper includes an example of a health risk assessment for a chewing gum polymer for which exposures to trace levels of butadiene monomer occur.
authors.affiliation: The Goodyear Tire & Rubber Co., 1485 East Archwood Avenue, Akron, OH 44306, USA. apleber@goodyear.com
authors.forename: A P
authors.initials: AP
authors.lastname: Leber
mesh_terms: D002070:Butadienes / Q000032:analysis / Q000633:toxicity; D002638:Chewing Gum / Q000032:analysis / Q000633:toxicity; D004781:Environmental Exposure; D004782:Environmental Health; D005506:Food Contamination / Q000032:analysis; D006801:Humans; D019055:No-Observed-Adverse-Effect Level; D011108:Polymers / Q000737:chemistry / Q000633:toxicity*; D018570:Risk Assessment; D012449:Safety
chemical_list: D002070:Butadienes; D002638:Chewing Gum; D011108:Polymers; C031763:1,3-butadiene