Evaluation of vinyl laurate in a battery of in vitro and in vivo tests for genotoxicity

• Published in: Regulatory toxicology and pharmacology 2015-06, Vol.72 (1), p.77-84
• Main Authors: van Acker, Frédérique, Messinger, Horst, Bär, Albert
• Format: Article
• Language: English
• Subjects: Acetaldehyde; Ames test; Animals; CAS 2146-71-6; Cell Line; Chewing Gum - toxicity; CHO Cells; Chromosome aberration; Chromosome Aberrations - drug effects; Clastogenicity; Cricetulus; DNA Damage - drug effects; HPRT mutation assay; Laurates - toxicity; Male; Mice; Micronucleus test; Micronucleus Tests - methods; Mutagenicity; Mutagenicity Tests - methods; Mutagens - toxicity; Mutation - drug effects; Polymers - toxicity; Polyvinyls - toxicity; Toxicity Tests - methods; Vinyl laurate
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1016/j.yrtph.2014.09.016

•Vinyl laurate was not mutagenic in the bacterial reverse mutation (Ames) test.•Vinyl laurate was not mutagenic in L5178Y cells (HPRT test) mutation.•Vinyl laurate gave an equivocal response in the in vivo chromosome aberration test.•Vinyl laurate was not clastogenic in the mouse bone marrow micronucleus test. Vinyl laurate is a potential residual monomer in chewing gum base formulated with polyvinyl acetate vinyl laurate copolymer (PVAcVL). The genotoxic potential of vinyl laurate was examined in a battery of in vitro and in vivo genotoxicity tests. Vinyl laurate was not mutagenic in Ames tests. In addition, it was not mutagenic in the HPRT mutation assay in L5178Y cells. An in vitro mammalian chromosome aberration assay performed in CHO cells was equivocal. Vinyl laurate and/or its metabolites were not clastogenic in the mouse bone marrow micronucleus test. Kinetic data indicate that VL is metabolised to acetaldehyde and lauric acid. Both metabolites are well known and have been studied previously. Model calculations show, that any exposure to acetaldehyde from the consumption of PVAcVL containing chewing gum will remain far below levels of acetaldehyde exposure from food in which acetaldehyde occurs naturally. Direct exposure to VL will primarily be at the site of entry. The lack of toxicity in a 90-day repeated dose toxicity test, performed with VL doses up to approximately 3000 times higher than the maximal VL intake from the consumption of a typical piece of chewing gum, demonstrates a high safety margin.