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    An immunotoxicity screening study on Salmeterol in rats

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    Authors
    van Loveren H
    de Jong WH
    van de Vliet H
    Verlaan B
    de la Fonteyne-Blankestijn LJ
    Hoejenbos-Spithout HHM
    de Waal EJ
    Type
    Report
    Language
    en
    
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    Title
    An immunotoxicity screening study on Salmeterol in rats
    Translated Title
    Een immunotoxiteits screeningsstudie van Salmeterol in ratten
    Publiekssamenvatting
    Salmeterol, een lang werkzame Beta2-adrenoreceptor agonist, werd bestudeerd in een 28-daagse toxiciteitstest in de Wistar rat. Aandacht werd daarbij geschonken aan parameters voor immunotoxiciteit. Het doel was verder bij te dragen in de validatie van deze immunotoxiciteitstesten voor geneesmiddelen. Mannelijke ratten werden oraal behandeld met 0, 0.2, 2 of 20 mg Salmeterol/kg lichaamsgewicht per dag. Gedurende de loop van het experiment bleek dat de hoogste dosering die was gekozen te hoog was. Om deze reden werd de hoogste dosering teruggebracht tot 10 mg/kg/dag, vanaf dag 9 van de behandeling. Lichaamsgewicht en beenmergcellulariteit werden door de behandeling niet beinvloed. Ook hematologische parameters waren niet veranderd in de behandelde dieren, behalve de aantallen bloedplaatjes, die in alle doseringsgroepen significant verlaagd waren. Ook de gewichten van de levers waren in alle doseringsgroepen afgenomen. Het thymusgewicht was afgenomen in de groepen die waren behandeld met 2 en met 20/10 mg/kg/dag. Er werden geen (histo)pathologische lesies waargenomen in (niet)lymfoide organen, die te relateren waren aan de behandeling. Serum immunoglobuline G spiegels waren toegenomen in de groepen behandeld met 2 en 10/20 mg/kg/dag. Percentages B cellen in de milt waren afgenomen in alle doseringsgroepen. De gegevens van deze studie geven aan dat het panel van immunotoxiciteitstesten zoals hier gebruikt om Salmeterol te onderzoeken in staat is om geringe immunotoxische potentie zoals die uit de literatuur naar voren komt te identificeren. Verder onderzoek zal moeten aangeven wat de functionele consequenties van deze geringe immunotoxiciteit van Salmeterol zijn.<br>
    Salmeterol, a long-acting Beta2-adrenoreceptor agonist, was studied in a 28-day repeated dose toxicity test in Wistar rats. Attention was paid to immunotoxicity screening parameters incorporated in the study protocol. The aim of this study was to further validate these assays for pharmaceuticals. Male rats were orally treated with 0, 0.2, 2 and 20 mg salmeterol/kg body weight/day. During the course of the study, it appeared that the highest dose level used was too high, and the animals tried to resist intubation, leading to intubation errors and intercurrent death of some of them. Therefore, the magnitude of the dose was lowered to 10 mg/kg/day at day 9 of treatment. Body weight and bone marrow cellularity were not affected, neither were hematological parameters, except for platelet counts that were decreased at all dose levels. Also liver weights were decreased at all dose levels tested. Absolute thymic weights were decreased at the 2 and 20/10 mg/kg/day dose levels. No treatment-related (histo)pathological lesions were seen in (non)lymphoid organs. Serum immunoglobulin G at the 2 and 10/20 mg/kg/day dose level. Numbers of B cells in the spleen were decreased at all dose levels tested. The data indicate that the panel of tests used in this study to examine salmeterol is able to detect the reported low immunotoxic potential. Further research is needed to elucidate whether salmeterol interferes with immune responses in rats upon antigenic challenge.<br>
    Publisher
    Rijksinstituut voor Volksgezondheid en Milieu RIVM
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