Multi-Level Safety Studies of Anti Fel d 1 IgY Ingredient in Cat Food.

Ray A. Matulka,David Corley,Larry Thompson

doi:10.3389/fvets.2019.00477

Abstract

Chickens exposed to antigens produce IgY antibodies, similar in structure to mammalian IgG. Hens exposed with an allergen produced by cats (Fel d 1) results in production of anti-Fel d 1 specific IgY (AFD1), which is naturally concentrated in egg yolk. A chicken egg product ingredient containing AFD1 was evaluated for safety in a 26-week randomized, controlled, blinded tolerance study in cats and in vitro for mutagenic and genotoxic effects. The in vivo study was conducted with groups fed kibble containing 0, 7, 39, or 66 ppm AFD1. Parameters examined included: clinical observations, body weights, food consumption, serum chemistry, hematology, blood coagulation, urinalyses, and mortality and morbidity checks. AFD1 was evaluated for potential mutagenic effects utilizing the bacterial reverse mutation assay at concentrations of up to 2.78 ppm and for potential structural chromosomal aberrations at up to 3 ppm using human peripheral blood lymphocytes (HPBL). After 6-months of feeding to cats, there were no significant differences between control and any test groups in any parameters analyzed. No significant increases in mutations or chromosomal aberrations were observed in tests with or without metabolic activation (S9). These studies show AFD1 was well-tolerated in cats at levels tested and does not induce mutagenic or chromosomal aberrations under study conditions.

Highlights

Pet ownership has been steady or increasing in the United States and worldwide, with cats being the second-most frequent household pet
This novel approach to reducing allergenic Fel d 1 exposure by use of anti-Fel d 1 specific IgY (AFD1) was recently evaluated in a 10-week feeding period in which cats consumed a food containing the anti-Fel d 1 IgY-containing AFD1 ingredient [9]
The AFD1 ingredient is in a unique category: while IgYcontaining egg products have been frequently included in cats’ diets for many years, a commercially-produced egg yolk product containing antibodies directed toward the Fel d 1 protein has not been previously marketed and the daily effect of binding the secreted Fel d 1 protein is currently unknown

Summary

INTRODUCTION

Pet ownership has been steady or increasing in the United States and worldwide, with cats being the second-most frequent household pet. Active Fel d 1 is a potent allergen, Fel d 1 bound by AFD1 is unable to bind to IgE and is not recognized as an allergen by the sensitized human This novel approach to reducing allergenic Fel d 1 exposure by use of AFD1 was recently evaluated in a 10-week feeding period in which cats consumed a food containing the anti-Fel d 1 IgY-containing AFD1 ingredient [9]. The AFD1 ingredient is in a unique category: while IgYcontaining egg products have been frequently included in cats’ diets for many years, a commercially-produced egg yolk product containing antibodies directed toward the Fel d 1 protein has not been previously marketed and the daily effect of binding the secreted Fel d 1 protein is currently unknown. Reported in this paper are the results of a 26-week multilevel tolerance study in cats and evaluation of the potential for genotoxicity by the ingredient using standard in vitro methods

MATERIALS AND METHODS

RESULTS AND DISCUSSION

CONCLUSIONS

ETHICS STATEMENT