Goater, TO; Griffiths, D; Mcelligott, TF; Swan, AAB
The paper is a summary of unpublished reports 1962-65 by the Armour Pharmaceutical Co., Illinois and by Imperial Chemical Industries, Cheshire. Polyoxyethylene tallow amine is N, N-bis(2-hydroxy-ethyl) alkyl(C14-C18)amine in which the alkyl part is of tetradecyl 3, hexadecyl 26, oleyl 40 and octadecyl groups 31%. It is used as an antistatic and to coat film or paper. From tests with solvents it was thought that a maximum of 1 ppm would migrate into food packed in the film or paper. For groups of 10 female Holtzman rats weighing 115 to 130 g given a single dose by stomach tube the acute LD50 was 1.85 g per kg [bodyweight]. For the analogues Ethomeen C/15, S/12, S/15, T/15 and T/60, respectively, the acute LD50 was 0.75, 1.5, 1.0, 0.5 to 0.6 and over 2 g per kg. Minimum lethal daily dose of C/15 for guineapigs given it for 8 days was 500 mg per kg. Young adult Alderley Park Wistar rats, specific pathogen-free, were given stock powdered diet freely alone or with 170, 500, 1500 or 4500 ppm polyoxy-ethylene tallow amine for 90 days. Values in blood and urine, weight or organs and body and histological changes were noted. There was no effect with 500 ppm or less. Beagle dogs were given a diet with none or 13, 40 or 120 mg per kg bodyweight daily for 90 days; there was no effect with 13 mg per kg or less, equivalent to about 500 ppm in diet for a dog of 12 kg.The undiluted substance caused reddening and scab on the shaven skin of rats. One drop instantly irritated a rabbit's eye, with opaque cornea and iritis in 24 h and sloughing conjunctiva in 48 h. With 0.1 and 10% aqueous solution or suspension Ethomeen T/60 caused no irritation, S/12 irreversibly damaged the eyeball and the other 3 analogues gave moderate inflammation for several days. It was concluded that polyoxyethylene tallow amine was safe for use in food wrappings but that there should be special precautions against contact with skin or eyes during handling.-M. S.