Studies on the toxicity and metabolism of ?-apo-8?-carotenal in dogs

Bagdon, Robert E.; Impellizzeri, Charles W.; Osadca, M

doi:10.1016/0041-008x(62)90031-5

Cited by 13 publications

(14 citation statements)

References 7 publications

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“…The extreme safety of APO was demonstrated by Bagdon et al (50) in dogs, by Ferrando (266) and Schärer and Studer (700a) in rats, and by Marusich et al (534) in poultry. It is approved for use as a food color in the United States and most other countries (62,66,69,106,626).…”

Section: ß-Apo-8'-carotenal For Yolk Pigmentationmentioning

confidence: 91%

Oxycarotenoids in Poultry Feeds

Marusich¹,

Bauernfeind²

1981

Carotenoids as Colorants and Vitamin a Precursors

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Section: ß-Apo-8'-carotenal For Yolk Pigmentationmentioning

confidence: 91%

Oxycarotenoids in Poultry Feeds

Marusich¹,

Bauernfeind²

1981

Carotenoids as Colorants and Vitamin a Precursors

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“…No significant compound-related effects were noted regarding general health, post mortem pathological lesions, peripheral blood picture, liver function, serum enzymes, blood urea levels or organ weights (Bagdon et al, 1962). Microscopic examination revealed pigmentation of the adipose tissue, kidney and adrenal cortex.…”

Section: Short-term and Subchronic Toxicitymentioning

confidence: 82%

“…Values of β-apo-8'carotenal levels in other tissue were variable. Microscopic examination revealed pigmentation of the adipose tissue, kidney and adrenal cortex (Bagdon et al, 1962). The Panel noted that although the authors concluded that the content of vitamin A in the kidneys of β-apo-8'-carotenal treated dogs was 3 to 5-fold higher than in the kidneys of the control animals, close evaluation of the study results does not seem to support this conclusion.…”

Section: Absorption Distribution Metabolism and Excretionmentioning

confidence: 92%

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Scientific Opinion on the re‐evaluation of β‐apo‐8’‐carotenal (E 160e) as a food additive

2012

EFS2

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Suggested citation: EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the reevaluation of β-apo-8'-carotenal (E 160e) as a food additive. ABSTRACTThe Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion reevaluating the safety of β-apo-8'-carotenal (E 160e) as a food additive in the EU. β-Apo-8'-carotenal was previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1974 and the EU Scientific Committee for Food (SCF) in 1975 and 2000. Both committees established an Acceptable Daily Intake (ADI) of 0-5 mg/kg bw/day, which was withdrawn by the SCF in 2000. The Panel concluded that the available in vitro and in vivo genotoxicity studies do not give reason for concern with respect to genotoxicity. Upon a public call for data two subchronic toxicity studies in rats performed according to OECD guidelines and under GLP became available for evaluation. Based on the 13-week study the Panel established that based on increased incidence of eosinophilic droplets in the kidneys the LOAEL was 10 mg β-apo-8'-carotenal active ingredient/kg bw/day. Upon a public call for data two additional studies on reproductive and developmental toxicity became available revealing a NOAEL of 500 mg/kg bw/day, the highest dose level tested. Overall, the Panel concluded that the present database on β-apo-8'-carotenal provides a basis to revise the ADI. The Panel concluded that based on the LOAEL of 10 mg/kg bw/day from the 13 week study in rats and an uncertainty factor of 200, an ADI for β-apo-8'-carotenal of 0.05 mg/kg bw/day can be established. Exposure estimates at Tier 3 indicate that the newly set ADI is reached for adults on average and exceeded by adults at the 95 th percentile and by children on average and at the 95 th /97.5 th percentile.

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“…A rat liver enzyme which catalyzes the oxidation and reduction of retinal to vitamin A acid and alcohol, respectively, is inhibited by p-chloromercuribenzoate, arsenite, and a number of chelating agents; inactivated enzyme is reactivated by Fe++ or when dialyzed, by FAD (19,20) . .B-8'-Apocarotenal, a homologue of vitamin A aldehyde, which is widely distributed in natural material (21), is converted into the corresponding carotenoic acid in rats, chicks, and dogs (22,23,24) and differs in this respect from vitamin A aldehyde from which an in vivo conversion into vitamin A acid could not be demonstrated (16).…”

mentioning

confidence: 96%