Toxikologische Beurteilung von Saccharosecarbonsäureestern auf der Grundlage subchronischer Fütterungsversuche mit Ratten 1. Mitt. Wirkung von Saccharosefettsäurepolyester

Lewerenz, H. J.; Mieth, G.; Bleyl, D. W. R.; Plass, R.; Schliemann,

doi:10.1002/food.19910350517

Cited by 4 publications

(3 citation statements)

References 13 publications

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“…Data from dietary reproductive studies were available for microcrystalline cellulose, powdered cellulose and sodium carboxy methyl cellulose, (Documentation provided to EFSA n. 41, Lewerenz et al., ; referred to by SCF, ; Bieri et al., ; Fritz and Becker, ).…”

Section: Discussionmentioning

confidence: 99%

“…A combined one‐generation reproductive/chronic toxicity study was performed in rats (Lewerenz et al., ; referred to by SCF, ) (Lewerenz et al., ; referred to by SCF, ), in which males and females of the F1 generation were fed microcrystalline cellulose (90% of particles < 20 μm) at 0 (control), 30, 100 or 200 g/kg diet (equivalent to 0, 1,500, 5,000 or 10,000 mg/kg bw per day), for up to 2 years (data from secondary sources, no further details available). The treatment induced some growth depression of the F1 rats at the top dose during the early growth phase only.…”

Section: Biological and Toxicological Datamentioning

confidence: 99%

“…An unpublished, combined, one‐generation reproduction/chronic toxicity study in rats with microcrystalline cellulose (90% of particles < 20 μm) in the diet at levels of 0 (control), 30, 100 or 200 g/kg diet (equivalent to 0, 1,500, 5,000 or 10,000 mg/kg bw per day) (Lewerenz et al., , ; referred to by SCF, ) revealed no effects on reproductive parameters (no details reported). Due to the limited reporting and low number of animals involved, the Panel considered this study inadequate for risk assessment.…”

Section: Biological and Toxicological Datamentioning

confidence: 99%

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Re‐evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives

Younes¹,

Aggett²,

Aguilar³

et al. 2018

EFS2

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Following a request from the European Commission, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to deliver a scientific opinion re-evaluating the safety of microcrystalline cellulose (E 460(i)), powdered cellulose (E 460(ii)), methyl cellulose (E 461), ethyl cellulose (E 462), hydroxypropyl cellulose (E 463), hydroxypropyl methyl cellulose (E 464), ethyl methyl cellulose (E 465), sodium carboxy methyl cellulose (E 466), enzymatically hydrolysed carboxy methyl cellulose (E 469) and cross-linked carboxy methyl cellulose (E 468) as food additives. The Joint FAO/WHO Expert Committee on Food Additives (JECFA) and the Scientific Committee on Food (SCF) established an acceptable daily intake (ADI) 'not specified' for unmodified and modified celluloses. Celluloses are not absorbed and are excreted intact in the faeces; in addition, microcrystalline cellulose, powdered and modified celluloses could be fermented by the intestinal flora in animals and humans. Specific toxicity data were not always available for all the celluloses evaluated in the present opinion and for all endpoints. Given their structural, physicochemical and biological similarities, the Panel considered it possible to readacross between all the celluloses. The acute toxicity of celluloses was low and there was no genotoxic concern. Short-term and subchronic dietary toxicity studies performed with E 460(i), E 461, E 462, E 463, E 464, E 466 and E 469 at levels up to 10% did not indicate specific treatment related adverse effects. In chronic toxicity studies performed with E 460(i), E 461, E 463, E 464, E 465 and E 466, the no observed adverse effect level (NOAEL) values reported ranged up to 9,000 mg/kg body weight (bw) per day. No carcinogenic properties were detected for microcrystalline cellulose and modified celluloses. Adverse effects on reproductive performance or developmental effects were not observed with celluloses at doses greater than 1,000 mg/kg bw by gavage (often the highest dose tested). The combined exposure to celluloses (E 460-466, E 468 and E 469) at 95th percentile of the refined (brand-loyal) exposure assessment for the general population was up to 506 mg/kg bw per day. The Panel concluded that there was no need for a numerical ADI and that there would be no safety concern at the reported uses and use levels for the unmodified and modified celluloses (E 460(i); E 460(ii); E 461-466; E 468 and E 469). The Panel considered an indicative total exposure of around 660-900 mg/kg bw per day for microcrystalline, powdered and modified celluloses.

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Section: Discussionmentioning

confidence: 99%

Section: Biological and Toxicological Datamentioning

confidence: 99%

Section: Biological and Toxicological Datamentioning

confidence: 99%

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Re‐evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives

Younes¹,

Aggett²,

Aguilar³

et al. 2018

EFS2

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Toxikologische Beurteilung von Saccharosecarbonsäureestern auf der Grundlage subchronischer Fütterungsversuche mit Ratten 2. Mitt. Wirkung von Sucroacetoglyceriden

Lewerenz

Mieth

Bleyl

et al. 1991

Nahrung

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Groups of male and female rats received a sucroacetoglycerides containing product (SAG) for 3 months at dietary levels of 0, 2.5, 5 and 10%. Food consumption was initially increased in females at all SAG-levels. After two weeks significant increases in food intake were observed in males and females fed 10% SAG throughout the feeding period. The serum analysis revealed significantly elevated activity in serum alkaline phosphatase at the highest SAG-level in males and females after 6 weeks and in females after 13 weeks. Histological changes related to the SAG-feeding were noted in the intestinal lymph nodes of male and female animals fed 10% SAG. The no-adverse effect level established in this subchronic feeding study was 5% SAG in the diet of rats, equivalent to a daily intake of 3.6 g/kg body weight in males and 4.0 g/kg in females.

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Akalorische Lipide – Entwicklungstrends und Probleme ihrer Applikation als Fettaustauschstoffe

Mieth¹

1992

Fett Wiss. Technol.

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Die Entwicklung niedrig energetischer Lebensmittel ist ein aktueller Trend der Lebensmittelindustrie hinsichtlich einer Einschränkung des Konsums an fett‐ und cholesterolreichen Produkten, die bekanntlich Risikofaktoren für Fettsucht und Gefäßkrankheiten darstellen. In diesem Zusammenhang wird die Applikation von Fettaustauschstoffen in Form konfektionierter verdaulicher Proteine und Polysaccharide mit hohem Wasserbindungsvermögen bereits praktiziert, wogegen für den Einsatz maßgeschneiderter akalorischer Lipide auf Basis von Estern und Ethern von Polyalkoholen und Polysäuren mit fettähnlicher Funktionalität die gesetzlichen Voraussetzungen noch ausstehen. Diese Übersichtsarbeit informiert allgemein über Möglichkeiten und Einschränkungen der Verwendung verschiedenartiger Klassen von Pseudofetten als Austauschstoffe für natürliche Fette. Am Beispiel von Zuckerestern werden weiterhin der Fortschritt und Ausblick für derartige Lebensmittel‐Zusatzstoffe dargelegt.

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Toxikologische Beurteilung von Saccharosecarbonsäureestern auf der Grundlage subchronischer Fütterungsversuche mit Ratten 1. Mitt. Wirkung von Saccharosefettsäurepolyester

Cited by 4 publications

References 13 publications

Re‐evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives

Re‐evaluation of celluloses E 460(i), E 460(ii), E 461, E 462, E 463, E 464, E 465, E 466, E 468 and E 469 as food additives

Toxikologische Beurteilung von Saccharosecarbonsäureestern auf der Grundlage subchronischer Fütterungsversuche mit Ratten 2. Mitt. Wirkung von Sucroacetoglyceriden

Akalorische Lipide – Entwicklungstrends und Probleme ihrer Applikation als Fettaustauschstoffe

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