Safety of fluralaner oral solution, a novel systemic poultry red mite treatment, for chicken breeders' reproductive performances.

BACKGROUND: Poultry mites are the most significant pest affecting production systems in the chicken egg-laying industry, altering the health condition of the birds, and causing stress, mortality and decline of egg quality impacting economic performance. Fluralaner is a novel systemic parasiticide that is effective against poultry mites (Dermanyssus gallinae, Ornithonyssus sylviarum) in chickens after oral administration. The evaluation of the safety of this new product in breeder chickens is particularly relevant because poultry mite infestation affects long cycle production systems, such as layers and breeders farms, for which the productivity heavily depends on the health of the reproductive function. This study was designed to investigate the safety for reproductive performances of fluralaner in male and female chickens at 3 times the recommended dose (1.5 instead of 0.5 mg/kg body weight) and 2 times the recommended duration (4 administrations instead of 2 administrations, with a 7 day interval between administrations). METHODS: This randomized, parallel-group, blinded study included 432 Bovans brown parent stock chickens (48 males and 384 females, 17-week old). Birds were randomly assigned to 16 pens (three males and 24 females per pen), and then each pen assigned to one of the two treatment groups (8 pens, i.e. 216 birds per group). Fluralaner was administered via drinking water on a total of four occasions 7 days apart, at daily doses of 1.5 mg fluralaner/kg body weight, equivalent to 3 times the recommended dose of fluralaner per administration and 2 times the recommended number of administrations. Birds supplied with non-medicated drinking water served as controls. The treatments were given at time of peak egg production in the bird's life: i.e. at 30 to 34 week of age. During that period, all adult chickens were clinically observed. The reproductive performances were carefully monitored including the number of eggs laid, egg weight, fertility and hatchability. Furthermore, the health and viability (up to 14 days of life) of randomly selected chicks was also monitored. RESULTS: There were no clinical findings related to fluralaner treatment. There were no statistically significant differences between the reproductive performances of treated and control groups, nor in their progeny chickens viability. CONCLUSIONS: Oral administration of fluralaner was well tolerated by breeder chickens with a safety margin of approximately 3-fold obtained. Fluralaner had no effect on the egg number, weight and fertility, and no effect on egg hatchability or chick viability. Based on these results, a safe use of the new mite treatment proposed with fluralaner administered via drinking water is expected in layer and breeder field industrial conditions.

Safety of fluralaner oral solution, a novel systemic antiparasitic treatment for chickens, in laying hens after oral administration via drinking water.

BACKGROUND: Poultry mites are the most significant pest affecting production systems in the egg-laying industry. Fluralaner is a novel systemic insecticide and acaricide that is effective against poultry mites (Dermanyssus gallinae, Ornithonyssus sylviarum) in chickens after oral administration. This study investigated the safety of oral administration of a 1% solution of fluralaner in drinking water to laying hens at the recommended treatment dose and at multiples of this dose. METHODS: One hundred-twenty healthy 28-week-old laying hens, weighing 1.4-2.1 kg at first administration, were included in the study, and allocated to 4 treatment groups of 30 hens each receiving daily doses of 0, 0.5, 1.5 and 2.5 mg fluralaner/kg body weight, equivalent to 0, 1, 3, and 5 times the recommended dose of fluralaner. The product was administered via drinking water on a total of six occasions, as 3-day treatment periods twice with an interval of 4 days with no treatment (treatment on days 1, 2, 3 and 8, 9, 10), representing 3 times the recommended number of administrations. Hens supplied with non-medicated drinking water served as controls. During the study, all hens were clinically observed, and their health was carefully monitored including body weight, food and water consumption, hematology, clinical chemistry, and withdrawal reflex test. Eggs laid over the study were evaluated for main characteristics (e.g. weight, shape, strength, shell thickness and soundness, albumen height, yolk color, Haugh unit and presence of blood and/or meat spots). Following euthanasia of the hens at the end of the second treatment period (day 11) or 18 days later (day 29), complete gross post-mortem examination, including organ weight determination, and histopathological examination of multiple tissues were conducted. RESULTS: There were no clinical findings related to fluralaner treatment. Statistically significant differences between the treated groups and the control group were observed for some clinical pathology parameters; none of these findings were considered to be of clinical nor zootechnical relevance. Organ weights, gross post mortem and histopathological examinations did not reveal any finding associated with treatment with fluralaner. CONCLUSIONS: Oral administration of fluralaner via drinking water at the recommended treatment dose (0.5 mg/kg body weight twice at 1-week interval), is well tolerated and has a high safety margin up to an overall dose of 15 times the recommended one (5 times the daily dose given 3 times the number of days) in healthy adult laying hens. Based on the present results, the use of the new mite treatment based on fluralaner administered via drinking water is expected to be safe for laying hens under industrial conditions, and to have no negative impact on their egg quality and production.