In vivo mutagenicity studies with iodinated glycerol azeo

• Published in: Mutation research. Genetic toxicology and environmental mutagenesis 1997-12, Vol.395 (1), p.29-36
• Main Authors: McGee, J.H, San Sebastian, Juan R, Sofia, R.Duane
• Format: Article
• Language: English
• Subjects: Biological and medical sciences; Bone marrow chromosomal aberration assay; Drug toxicity and drugs side effects treatment; Hepatocyte repair assay; In vitro; In vivo; Iodinated glycerol azeo; Medical sciences; Miscellaneous (drug allergy, mutagens, teratogens...); Pharmacology. Drug treatments; Sister chromatid exchange
• ISSN: 1383-5718; 1879-3592
• DOI: 10.1016/S1383-5718(97)00139-3

Previous studies have shown that iodinated glycerol azeo is positive in a number of in vitro mutagenicity assays including the Ames assay (TA100; TA1535), mouse lymphoma assay, Chinese hamster ovary (cytogenetic) assay and in one in vivo study, the sex-linked-recessive-lethal assay in Drosophila. Prior studies have also shown that the drug is negative in the mouse micronucleus assay. We now report that the drug is also negative for mutagenic activity in a number of other in vivo tests. Single intraperitoneal doses of 25, 125 and 250 mg/kg were without effect in the rat bone marrow chromosomal aberration assay. Single oral doses of 30, 75, 150 and 300 were negative in the rat hepatocyte DNA-repair assay. Single intraperitoneal doses of 30 and 100 mg/kg were without effect in the sister chromatid exchange (SCE) assay in the mouse. Statistically significant effects were seen at 200 and 300 mg/kg in the initial SCE assay and at 300 and 350 mg/kg in the confirmatory SCE assay. The rationale for considering the SCE results to be anomalous and thus not relative to the overall safety evaluation of the drug is presented.