Studies on Brown FK. IV. Cytopathic effects of Brown FK on cardiac and skeletal muscle in the rat

Grasso, P.; Muir, A L; Golberg, L.; Batstone, Elizabeth

doi:10.1016/0015-6264(68)90076-x

Cited by 14 publications

(1 citation statement)

References 32 publications

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“…As described by the authors, progressive deposition of pigment, described as lipofuscin, in cardiac and skeletal muscles was the principal pathological feature during weeks 3-12. In animals receiving Brown FK by gavage, myopathy and fibrillolysis of the cardiac and skeletal muscles was also noted, accompanied by a moderate increase in acid phosphatase activity and a loss of phosphorylase activity (Grasso et al, 1968b).…”

Section: Studies In Ratsmentioning

confidence: 99%

Scientific Opinion on the re‐evaluation of Brown FK (E 154) as a food additive

Aguilar¹,

Charrondière²,

Dusemund³

et al. 2010

EFS2

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The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion re-evaluating the safety of Brown FK (E 154). Brown FK is a food colouring substance permitted only in kippers at a maximum concentration of 20 mg/kg, which has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the EU Scientific Committee for Food (SCF) in 1983. The SCF established an Acceptable Daily Intake (ADI) of 0.15 mg/kg body weight (bw)/day. JECFA withdrew their temporary ADI of 0.075 mg/kg bw/day for Brown FK at their latest evaluation in 1987, as the toxicological data were considered inadequate. The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations, additional literature that became available since then and the data available following a public call for data. The Panel calculated an anticipated refined dietary exposure to Brown FK for European children ranging from 0.03 to 0.07 mg/kg bw/day in average, and from 0.03 to 0.14 mg/kg bw/day at the 95th percentile. For the adult population the anticipated mean dietary exposure ranged from 0.002 to 0.07 mg/kg bw/day, and from 0.007 to 0.14 mg/kg bw/day at the 95th percentile. The Panel noted uncertainties surrounding the NOAELs reported for Brown FK in a chronic toxicity study and a carcinogenicity study in rats. It also noted the treatmentrelated changes occurring at the highest dose level in the latter study and that, as reported by JECFA, histopathological examination of the lower groups had not been carried out. The Panel considered, in line with JECFA, that this examination should have been carried out. The Panel considers therefore that it is unable to conclude on the safety of Brown FK given the deficiencies in the available toxicity database on the colour. KEY WORDSBrown FK, E 154, CAS Registry Number 8062-14-4, food colouring substance, sodium 4-(2,4-diaminophenylazo)benzenesulphonate, sodium 4-(4,6-diamino-m-tolylazo)benzenesulphonate, disodium 4,4'- Brown FK (E 154) is a multi-component mixture of mono-, di-and tri-azo dyes authorised as a food additive in the EU and previously evaluated by both the EU Scientific Committee for Food (SCF) in 1984 and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1977(JECFA) in , 1978(JECFA) in , 1985(JECFA) in , 1986(JECFA) in and 1987 Brown FK is described as consisting of a mixture of sodium 4-(2,4-diaminophenylazo) benzenesulphonate (component I), sodium 4-(4,6-diamino-m-tolylazo)benzenesulphonate (component II), disodium 4,4'-(4,6-diamino-1,3-phenylenebisazo)dibenzenesulphonate (component III), disodium 4,4'-(2,4-diamino-1,3-phenylenebisazo)dibenzenesulphonate (component IV), disodium 4,4'-(2,4-diamino-5-methyl-1,3-phenylenebisazo)dibenzenesulphonate (component V) and trisodium 4,4',4"-(2,4-diaminobenzene-1,3,5-trisazo)tribenzenesulphonate (component VI), together with subsidiary colouring matters and with water, sodium chloride and/or sodium sulphate as the principal uncoloured components.Th...

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Section: Studies In Ratsmentioning

confidence: 99%