Citric Acid Cross-Linking of a Polysaccharide-Based Hydrogel of Plant Origin: A Preliminary Study on Toxicity Evaluation using Rat as Model Animal

Abstract

The regulatory approval of the active pharmaceutical ingredients and their excipient presupposes the development of safety assessment of these substances. The study of acute oral and dermal toxicity of a cross-linked hydrogel made by the esterification of Artemisia vulgaris seed mucilage and citric acid was achieved by following the directives and guidelines 420 and 402 of the OECD. For toxicity studies, rat was taken as the model animal and the rats were divided into four different groups. The animals (rats) in group A were not subjected to hydrogel and used as a control. Whereas the other groups, i.e. B, C and D of were treated with hydrogel dose of 0.05, 0.3 and 2 g/kg of the bodyweight, and were treated as the test groups. The behavior of all animals was observed, food consumption, water intake, allergic reactions, mortality rate, and all other side effects were noted in 14 days. All the observed animals survived without any serious behavior and physiological defects. It was also found that the biochemical analysis and hematological tests were found to be consistent and comparable after 14 days of the treatment in both groups of animals, control and treated. The internal organs of animals (the major ones) were removed in order to establish the weight of the organs. The accumulated results of acute oral experiments showed that the produced hydrogel is harmless and non-toxic when taken orally.