[Pharmacology and toxicology of etofenamate. 2]

1. Since the anti-inflammatory effect of 2-(2-hydroxyethoxy)-ethyl-N-(a,a,a-trifluoro-m-tolyl)anthranilate (etofenamate, TVX 485, Rheumon Gel) is occasionally stronger than that of flufenamic acid and as its toxicity is in the same range as that of the latter, a wider therapeutic margin may be expected for etofenamate in therapeutic use of Rheumon gel. 2. In subchronic oral administration, rats tolerated 22 mg/kg and dogs 100 mg/kg without any signs of toxicity. Sub-chronic cutaneous administration of Rheumon gel in pigs (2 g/kg) likewise showed no signs of toxicity. Thus, an adequate safety factor would seem to exist, bearing in mind the comparative daily dose in man of approx. 0.3 g gel/kg body weight. In histological tests oedema of kidney papillas or degeneration of papillas, respectively, could not be seen. 3. In the dose range tested, etofenamate shows no signs of teratogenic or fetotoxic effects in either rats or rabbits. 4. The evidence of the cutaneous absorption of etofenamate from Rheumon gel could be demonstrated by the biological effect in animal experiments.