Oral toxicity and bacterial mutagenicity studies with a spunbond polyethylene and polyethylene terephthalate polymer...

Spunbond, nonwoven fabrics consisting of polyethylene and polyethylene terephthalate, which meet food contact requirements, may be used as pouch materials for products containing food and/or flavor ingredients that are held in the mouth. In these situations ingestion may occur, resulting in exposure to the fabric and potentially antimony, a catalyst used in polyethylene terephthalate. To assess potential adverse effects when such a material is ingested, a 13 week dietary study in Sprague-Dawley CD rats and a Salmonella reverse mutation assay were conducted. Ground fabric was dosed at target concentrations of 0.5%, 2.5%, and 5% in the dietary study. Antimony trioxide in the polyethylene terephthalate was used to determine the test material concentration in the diet and was also assessed for bioavailability. Detectable levels of antimony were found in 2/20 blood samples of control rats, and in 20/20 high-dose group rats. No toxicologically relevant treatment related effects were observed in any of end points evaluated in the feeding study. In the mutagenicity assay, ground fabric was extracted in phosphate buffered saline or dimethysulfoxide and tested in Salmonella strains TA98, TA100, TA102, TA1535, and TA1537 with and without S9 activation. No mutagenic response was observed at any dose level tested. These results demonstrate that repeated daily ingestion of a spunbond, nonwoven polymer fabric consisting of polyethylene and polyethylene terephthalate for up to 13 weeks is well tolerated in rats, with no apparent target-organ toxicity at dietary levels up to 5%, and that fabric extracts are not mutagenic in a bacterial reverse mutation assay.