EFFECT OF POLYOXYETHYLENE‐8‐MONOSTEARATE (MYRJ 45) ON LIVER FUNCTION IN PATIENTS CONVALESCING FROM HEPATIC DISORDERS^a

Abstract

Manuscript received Nay 26, 195B) Ti1 recent years synthetic emulsifiers of the polyoxyethrlene type have found a wide range of uses in the food and pharmaceutical industries (8,9). Such emulsifiers also have been administered to patients with steatorrheas of various kinds in an attempt to promote intestinal absorption of fat and fat-soluble vitamins ( 4 ) .The toxicology of some of these partial ester emulsifying agents, such as polyoxyethylene-20-sorbitan monooleate (TWEEN" 8 0 ) and polyoxyethylene-8-monostearate (MYRJ" 45) , has been studied extensively in experimental animals and human subjects (2, 3, 5, 6). Kranitz et al. have reported that the oral administration of TWEEN 80 in doses of 4.5 to 6.0 g. per day to more than 100 human subjects for periods up to four pears was unattended by clinical evidence of damage to liver, kidneys or heinatopoietic system ( 5 ) . Preston and associates have found a similar absence of toxic effects of sorbitan monostearate (SPAN" 60) polyoxyethylene-20-sorbitan monostearate (TWEEN 60) and of MYRJ 45 in relatively short-term studies involving administration of these substances to infants and children (10).Studies on certain polyoxyethyleiie stearates, including MYRJ 45, were reviewed i n 1953 by the Food Protection Committee of the Food and Nutrition Board of the National Research Council (11). This report concluded from the then available evidence that the safety of MYRJ 45 for use in foods had not been fully established owing principally to the findings of urinary calculi and mild liver changes in rats and hamsters fed high dietary levels for prolonged periods. This report further emphasized that no evidence of gross or microscopic pathology attributable to MYRJ 45 was found in other species. Recent reports of work originally presented in 1952 (1, 7) indicates adverse effects of MYRJ 45 in hamsters, particularly at 25% level in synthetic diets, including diarrhea, genitourinary bleeding and increased mortality.Reports of other studies, however, have described chronic feeding experiments with rats in which bread containing 15% of polyoxyethylene monostearate (MYRJ 45) on a flour basis (10.25 per cent as fed in the diet) (2, 3 ) or purified diets containing up to 207% (6) induced no specific pathology. The latter report concluded on the basis of both nutritional and histopathologic evidence "that no reasonable doubt exists concerning

THE RESPONSE OF HAMSTERS TO A NATURAL‐TYPE DIET CONTAINING EMULSIFIERSa

“…No diarrhea was observed in these animals nor was there any indication of hematuria. Absence of pathology after feeding Myrj 45 at abnormally high levels for prolonged periods of time confirmed studies by others with rats, cats, and humans (1,2,3,7,8,12,13,14,20). Eagle and Poling ( 4 ) present their pathological findings in terms of per cent, a procedure'that can be somewhat misleading when groups are as small (7 to 10) as those examined.…”

“…With the wide acceptance by the food industry of polyoxyethylene (8) stearate (Myrj 45) and other surface-active, partial fatty acid esters as emulsifying agents, considerable attention has been directed t o the study of the nutritional value and safety of these compounds (1,2,3,7,8,12,13,14,20). Although most studies emphasize the innocuous effects of Myrj 45 when ingested in experimental diets at extremely exaggerated dosage levels, Schweigert e t al.…”