Mona Oser

Toxicologic studies of petrolatum in mice and rats

Abstract The present studies were undertaken as a basis for determining the status of food grade petrolatum as a food additive under the terms of the Food Additives Amendment of 1958. The investigations of the petrolatum included 2-year rat feeding studies and single subcutaneous injections in mice followed by observation over an 18-month period. Previous work and the considerations leading to regulatory interest in the potential carcinogenicity of paraffin hydrocarbons have been reviewed in the extensive report on the toxicity of petroleum waxes by Shubik et al. (1962). Three specific color grades of petrolatum which met either USP XVI or NF XI (White or Yellow Petrolatum) were selected to represent the range of degrees of decolorization of petrolatum commonly used as direct food additives, or which may be incorporated in foods as an indirect additive, incidental to its use in processing.

Carcinogenicity study of carbarsone

A study is described in which diets containing 500 and 1000 ppm of carbarsone (p-ureidobenzene-arsonic acid) were fed to large groups of rats for 104 weeks, and 2000 ppm for 72 weeks followed by a 32-week withdrawal period. The lower dosages caused no changes in growth or efficiency of food utilization, and no deviation from normal hematologic, blood chemical, and urine parameters, or in tissue morphology. The 2000-ppm dose depressed growth and caused marked intestinal inflammatory reactions with the sequelae eventually resulting in death. When this highest dose was withdrawn from the diet of surviving rats at 72 weeks, they recovered completely. There were no indications of a carcinogenic potential of this compound at any dosage. Acute experiments in dogs given carbarsone in massive intragastric doses showed that two-thirds of the urinary arsenic excretion was in the form of arsanilic acid and one-third as the original compound.