Chronic Toxicity of Bread Additives to Rats

Graham, W. Donald; Teed, H; Grice, H. C.

doi:10.1111/j.2042-7158.1954.tb10983.x

Cited by 42 publications

(16 citation statements)

References 10 publications

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“…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.…”

Section: Discussionsupporting

confidence: 84%

THE RESPONSE OF HAMSTERS TO A NATURAL‐TYPE DIET CONTAINING EMULSIFIERS^a

Oser¹,

Oser²

1957

Journal of Food Science

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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. (23,27), employing purified diets, reported some deleterious effects in hamsters. The hamster is a relative newcomer among experimental animals for prolonged nutritional studies and much remains to be elucidated of its nutritional requirements and normal physiology ( 5 ) . I n addition, it is known t o be less uniform in its responses than the rat and is subject to many transmissible diseases (18, 22, 28). It therefore seemed of interest t o reevaluate the hamster response to high levels of Myrj 45 under conditions where the basal diet consisted of natural rather than "purified" ingredients. Although the results of these studies were largely negative insofar as demonstrating toxicity was concerned, it seemed warranted to record our observations because of the recent publication (4,19) of apparently contradictory findings which were originally reported a t the Ice Cream Hearings (25) before the Administrator of the Federal Security Agency in 1952.The basic composition of the diet fed in our hamster experiments is the same as that used in long-term studies of the nutritional effects of a large series of emulsifiers in rats ( 1 5 ) . It was formulated t o resemble the American dietary in respect to the proportions of protein, fat, and carbohydrate present and the proportions of protein and fat derived from animal and vegetable sources, while a t the same time satisfying the known nutritional requirements of either rats or hamsters. The test materials were incorporated at the expense of the wheat and corn mixture in the ratio in which the latter appear in the diet (i.e., 2 : l ) .Two studies were conducted. In the first, diets including equivalent levels of Myrj 45 (polyoxyethylene (8) monostearate) were compared with those containing a hydrogenated vegetable oil (Primex), diglycerides and monoglycerides from meat fats and vegetable fats (sold commercially as "Esterine"), and cottonseed oil monoglyceride ("Myverol 18-85"). The test materials were fed at graded dietary levels ( 0 , 5, 10, and 15%) in successive periods of 2 or 4 weeks' duration, the levels being the same for all materials a t any given period.Because of the observation of increased kidney weights and somewhat lower weight gains in the Myrj 45 hamsters compared with those fed "This investigation was supported by a grant from the Atlas Powder Company, Wilmington, Delaware. 273

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Section: Discussionsupporting

confidence: 84%

THE RESPONSE OF HAMSTERS TO A NATURAL‐TYPE DIET CONTAINING EMULSIFIERS^a

Oser¹,

Oser²

1957

Journal of Food Science

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“…In treated females, a low incidence of renal tubular degeneration and glomerulonephritis was observed (Graham et al, 1954as reported in CIR, 1974. Some animals were necropsied at weeks 13 and 26 and at study termination.…”

Section: The Ntp Concluded: "Under the Conditions Of This Bioassay Pmentioning

confidence: 62%

Scientific Opinion on the re‐evaluation of propyl gallate (E 310) as a food additive

2014

EFS2

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The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion reevaluating the safety of propyl gallate (E 310). Propyl gallate is an antioxidant authorised as a food additive in the EU. In 1976, the SCF established a group ADI of 0-0.2 mg/kg bw for three gallates (propyl, octyl, dodecyl). JECFA in its last evaluation in 1996 allocated an ADI only to propyl gallate of 0-1.4 mg/kg bw and did not establish ADIs for octyl and dodecyl gallate. The Panel considered that no substantial new toxicological data have emerged since this last evaluation. The Panel concluded that the 90-day toxicity study in rats was the key study for the evaluation of propyl gallate considering the uncertainties and lack of a NOAEL in the carcinogenicity database on propyl gallate. Based on the NOAEL of 135 mg propyl gallate/kg bw/day of this study and taking account of the Opinion of the Scientific Committee of EFSA on Default values, the Panel concluded that an uncertainty factor of 300 should be applied for extrapolation from a subchronic to chronic data and due to the limitations in the reproductive toxicity database and derived an ADI of 0.5 mg/kg bw/day for propyl gallate.The Panel also concluded that there was no longer a basis for the present group ADI and that propyl, octyl and dodecyl gallates should be evaluated separately and the present group ADI should be withdrawn. The high level of exposure exceeded the ADI in adults and the elderly. However, given the conservatism of the exposure assessment, the Panel concluded that the use of propyl gallate as food additive at the current uses and use levels is not of safety concern.

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“…Propionic acid and its calcium, potassium and sodium salts are authorised as food additives in the EU in accordance with Annex II to Regulation ( normal constituent of foods, and despite only one chronic toxicity study (1-year) being available (Graham et al, 1954), allocated an acceptable daily intake (ADI) for man "not limited"…”

Section: Information On Existing Authorisations and Evaluationsmentioning

confidence: 99%

Scientific Opinion on the re-evaluation of propionic acid (E 280), sodium propionate (E 281), calcium propionate (E 282) and potassium propionate (E 283) as food additives

Panel¹

2014

EFSA Journal

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The EFSA ANS Panel provides a scientific opinion re-evaluating the safety of propionic acid (E 280), sodium propionate (E 281), calcium propionate (E 282) and potassium propionate (E 283) which are authorised as food additives in the EU and have been previously evaluated by the SCF and JECFA. JECFA allocated an ADI "not limited". The SCF concluded that potassium propionate could be added to the list of preservatives and established an ADI "not specified". Propionates are naturally occurring substances in the normal diet. The Panel considered that forestomach hyperplasia reported in long-term studies in rodents is not a relevant endpoint for humans because humans lack this organ. Based on the reported presence of reversible diffuse epithelial hyperplasia in the oesophagus the LOAEL for a 90-day study in dogs was considered by the Panel to be 1 % propionic acid in the diet and the NOAEL to be 0.3 % propionic acid in the diet. The Panel considered that there is no concern with respect to genotoxicity and carcinogenicity. The Panel concluded that the present database did not allow allocation of an ADI for propionic acid -propionates. The overall mean and 95 th percentile exposures to propionic acid -propionates resulting from their use as food additives (major contributor to exposure) ranged from 0.7-21.1 and 3.6-40.8 mg/kg bw/day, respectively. The Panel noted that the concentration provoking site of contact effect in the 90-day study in dogs (1 % propionic acid in the diet) is a factor of three higher than the concentration of propionic acid -propionates in food at the highest permitted level and concluded that for food as consumed, there would not be a safety concern from the maximum concentrations of propionic acid and its salts at their currently authorised uses and use levels as food additives. The JECFA allocated an acceptable daily intake (ADI) "not limited" for propionic acid and its sodium, potassium and calcium salts considering that propionate is a normal intermediary metabolite and a normal constituent of foods (JECFA, 1974).In 1974, the SCF concluded that potassium propionate could be added to the list of preservatives permitted to be used in food (SCF, 1975). In 1990, the SCF concluded that there were no adverse health consequences to man from the present uses of propionic acid as a food additive (SCF, 1992). However, the SCF expressed the need to assess comparative studies with other short chain fatty acids and their salts. The SCF established an ADI "not specified".Currently, propionic acid -propionates (E 280-283) are authorised food additives in the EU with maximal permitted levels (MPLs) ranging from 1000 to 3000 mg/kg in foods.Propionates are naturally occurring substances in the normal diet. Propionic acid is produced by certain bacteria and occurs in various food and feed stuffs as a result of microbial production.The absorption of short chain fatty acids, including propionate, by the gastrointestinal has been studied both in rats and in humans. The absorption has been described to occ...

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Chronic Toxicity of Bread Additives to Rats

Cited by 42 publications

References 10 publications

THE RESPONSE OF HAMSTERS TO A NATURAL‐TYPE DIET CONTAINING EMULSIFIERS^a

THE RESPONSE OF HAMSTERS TO A NATURAL‐TYPE DIET CONTAINING EMULSIFIERS^a

Scientific Opinion on the re‐evaluation of propyl gallate (E 310) as a food additive

Scientific Opinion on the re-evaluation of propionic acid (E 280), sodium propionate (E 281), calcium propionate (E 282) and potassium propionate (E 283) as food additives

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Chronic Toxicity of Bread Additives to Rats

Cited by 42 publications

References 10 publications

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

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

Scientific Opinion on the re‐evaluation of propyl gallate (E 310) as a food additive

Scientific Opinion on the re-evaluation of propionic acid (E 280), sodium propionate (E 281), calcium propionate (E 282) and potassium propionate (E 283) as food additives

Contact Info

Product

Resources

About

THE RESPONSE OF HAMSTERS TO A NATURAL‐TYPE DIET CONTAINING EMULSIFIERS^a

THE RESPONSE OF HAMSTERS TO A NATURAL‐TYPE DIET CONTAINING EMULSIFIERS^a