Six-month toxicity study of butylated hydroxyanisole in beagle dogs

Tobe, Masuo; Furuya, Tuyoshi; Kawasaki, Yasushi; Naito, Katsushi; Sekita, Kiyoshi; Matsumoto, Kiyoshi; Ochiai, Toshiaki; Usui, Akio; Kokubo, Takeshi; Kanno, Jun; Hayashi, Yuzo

doi:10.1016/0278-6915(86)90310-8

Cited by 33 publications

(6 citation statements)

References 4 publications

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“…Investigation of the mitotic index in the squamous epithelium of the distal oesophagus showed no changes. The data showed no histopathological effects after 6 months of exposure to BHA in the diet in the stomach, oesophagus, duodenum or liver of beagle dogs (Tobe et al, 1986).…”

Section: Dogsmentioning

confidence: 75%

Scientific Opinion on the re-evaluation of butylated hydroxyanisole - BHA (E 320) as a food additive

2011

EFSA Journal

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The Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers a scientific opinion re‐evaluating the safety of butylated hydroxyanisole (BHA) (E 320). BHA is a synthetic antioxidant authorised as a food additive in the EU that was previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) several times, the latest in 1989 and the EU Scientific Committee for Food (SCF) in 1989. Both committees established an ADI of 0.5 mg/kg bw/day, with that of the SCF being classified as temporary. Both ADIs were based on proliferative changes in the rat forestomach. 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 an EFSA public call for data. The Panel concluded that BHA does not raise concern with respect to genotoxicity. A large number of long‐term toxicity and carcinogenicity studies with BHA have been performed, demonstrating proliferative changes in the forestomach with BMDL10 values in the rat of 115 and 83 mg/kg bw/day. The Panel concluded that the present database does give reason to revise the ADI. The Panel considered that forestomach hyperplasia in rodents may no longer be relevant for human risk assessment. Based on a NOAEL of 100 mg/kg bw/day for growth retardation, increased mortality and behavioural effects in rat pups at higher dose levels, and using an uncertainty factor of 100 the Panel established an ADI of 1.0 mg/kg bw/day. This NOAEL also covers the BMDL10 values for forestomach hyperplasia observed in the rat. The Panel also concluded that at the current levels of use refined intake estimates are generally below the ADI of 1.0 mg/kg bw/day.

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Section: Dogsmentioning

confidence: 75%

Scientific Opinion on the re-evaluation of butylated hydroxyanisole - BHA (E 320) as a food additive

2011

EFSA Journal

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“…In addition, the vehicle-treated group of females showed a tendency to decrease in body weight from approximately 14 days. In all groups, increment and reduction tendencies were also observed, and these changes were observed [ 59 – 62 ]. The changes in body weights were probably the result of irritation of the alimentary tract [ 61 ].…”

Section: Discussionmentioning

confidence: 99%

Preclinical Safety of the Root Extract of Polygala tenuifolia Willdenow in Sprague‐Dawley Rats and Beagle Dogs

Shin

Won²,

Ha³

et al. 2014

Evidence-Based Complementary and Alternative Medicine

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The root of Polygala tenuifolia Willdenow has been used for the treatment of insomnia, depression, and amnesia. However, the toxicological properties of the herb have been overlooked, because it has been used for a long time for various purposes. In this study, we evaluated the preclinical safety of the root extract in rats and beagle dogs. First, the acute oral toxicity was tested in both rats and dogs. In the rats, only one female of 2 g/kg died, but no treatment-related death or clinical and gross findings were observed after the administration. No toxicological changes or mortalities related to the test substance were also observed after the administration in the dogs. Although vomiting, discoloration, or hemorrhage was found in some dogs, there were no serious abnormalities. Second, the subchronic toxicity was investigated in the rats. Two animals were found dead in the female group of 1,000 mg/kg/day, but there were no abnormal findings associated with the test substance. There also were no adverse effects on the clinical signs, body weight, and hematological and biochemical findings. Therefore, our results showed that the acute or subchronic toxicity of the root extract of Polygala tenuifolia might not be toxic to rats and dogs.

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“…The mitotic index in the lower oesophagus was unchanged. 210 Guinea pigs, given 1000 mg/kg bw/day by gavage for 4 weeks showed no changes in the stomach or lower oesophagus.145 A study in the pig produced equivocal results. BHA was given to pregnant pigs in doses of 0, 50, 200 or 400 mg/kg bw/day from mating to day 110 of pregnancy.…”

Section: Short-term Studiesmentioning

confidence: 91%