An Evaluation of Genotoxicity Tests With Aquateric® Aqueous Enteric Coating

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Abstract
The genotoxic potential of Aquateric® Aqueous Enteric Coating was evaluated in the Ames test, the mouse lymphoma mutation assay, and the mouse micronucleus test. Aquateric was not mu-tagenic when tested in Salmonella typhimurium cell strains TA98, TA100, TA1535, TA1537, TA1538, with or without metabolic activation. A mouse lymphoma assay was conducted at concentrations ranging from 116 to 2000 μg/ml and 116 to 1250 μg/ml in the absence and presence of metabolic activation, respectively. No increased mutant frequencies were noted for any concentration tested. Aquateric was tested in the mouse micronucleus assay at a single oral dose of 7200 mg/kg Aquateric (equivalent to 5000 mg/kg cellulose acetate phthalate, the major ingredient) and bone marrow was harvested at 24, 48, and 72 hours after treatment. There was no significant increase in the number of mouse bone marrow mi-cronucleated polychromatic erythrocytes in Aquateric-treated animals at any of the harvest times. Based on the negative results in the Ames test, the mouse lymphoma mutation assay, and the mouse micronucleus test, it was concluded that Aquateric is not genotoxic.

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