Chronic oral toxicity studies of di-n-hexyl azelate in rats and dogs

Hodge, Harold C.; Maynard, Elliott A.; Downs, William L.; L, Salerno; Packer, James T.

doi:10.1016/0041-008x(62)90063-7

Cited by 4 publications

(7 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In an older study, groups of 50 male and 50 female rats (strain not specified) were dosed via diet with 0%, 1%, 5% or 20% of hydroxypropyl methyl cellulose (equivalent to 0, 500, 2,500 or 10,000 mg/kg bw per day). Also in this study, apart from a decrease in body weights of high‐dosed males, no other significant adverse findings were reported and there was no indication of a carcinogenic effect (Hodge et al., ).…”

Section: Discussionmentioning

confidence: 46%

“…In groups of six rabbits (approximately 6 months old and with a body weight of 1.8 kg) dosed via diet with 0%, 10% or 25% of HPMC (equivalent to 0, 3,000 or 7,500 mg/kg bw per day) over 30 days, no adverse effects concerning body weights, urine analysis, haematology, organ weights and histological examination were reported (Hodge et al, 1950).…”

Section: Rabbitsmentioning

confidence: 99%

“…Two dogs (body weights of 11 and 13 kg) were dosed with 25 or 50 g/day, respectively, of HPMC over 30 days (Hodge et al, 1950). In the higher dose animal, effects such as diarrhoea, slight weight loss and slight depression in RBC count were noted, while the lower dose in the other animal was well tolerated.…”

Section: Dogsmentioning

confidence: 99%

“…In a 2-year study, four groups of 50 male and 50 female rats (strain not specified) were dosed via diet with 0%, 1%, 5% or 20% of HPMC (equivalent to 0, 500, 2,500 or 10,000 mg/kg bw per day) (Hodge et al, 1950). In males dosed with 20%, a slight retardation of body weight gain (about 30 g less compared to the other dose groups) was seen during the first year (weights taken weekly).…”

Section: Ratsmentioning

confidence: 99%

“…In a study with weanling rats (no further data), groups of 10 male and 10 female rats were dosed via diet with 0%, 2%, 10% or 25% of HPMC (equivalent to 0, 2,400, 12,000 or 30,000 mg/kg bw per day) over 30 days (Hodge et al, 1950). The highest dose level caused diarrhoea and a decrease in body weights; three of 10 males and six of 10 females died.…”

Section: Ratsmentioning

confidence: 99%

See 4 more Smart Citations

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

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

confidence: 46%

Section: Rabbitsmentioning

confidence: 99%

Section: Dogsmentioning

confidence: 99%

Section: Ratsmentioning

confidence: 99%

Section: Ratsmentioning

confidence: 99%

See 3 more Smart Citations