Toxicity assay in repeated doses of Dermatophagoides siboney allergen extract in mice

► We assessed the toxicity of a Dermatophagoides siboney allergen extract in mice. ► 166.6UB of the allergen extract was administered subcutaneously for 28days. ► Repeated dosing of the allergen extract did not cause significant toxic effects. ► The D. siboney allergen extract appears to be safe for human use. Allergen extracts are used for hyposensitivity and immunotherapy treatments, reducing significantly clinical symptoms of allergic diseases. Because of its wide use in immunoallergen therapy, we evaluated the Dermatophagoides siboney allergen extract to establish the potential toxicity following repeated subcutaneous dosing in Cenp:NMRI mice. Animals were randomly distributed into two groups, control (vehicle) and treated (166.6UB/animal), and they were observed daily for clinical signs of toxicity following treatment. Body weight was weekly measured. At the end of the study, blood samples were collected for hematology and serum chemistry analysis and animals were euthanized for gross necropsy and histological examination of tissues. There were not significant differences in body weight or hematology parameters between control and treated animals. Differences were noted in uric acid, blood urea nitrogen and glucose; however, these alterations were not considered to be of biologic relevance. Pathology evaluations demonstrated hemorrhagic and inflammatory lesions at the administration site in both experimental groups. We conclude that repeated dosing of 166.6UB did not cause significant toxic effects in the mouse model.