Nutritional Studies on Rats on Diets Containing High Levels of Partial Ester Emulsifiers

Oser, Bernard L.; Oser, Mona

doi:10.1093/jn/61.1.149

Cited by 35 publications

(13 citation statements)

References 3 publications

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“…Data on efficiency of caloric utilisation (the weight gain per 100 cal. consumed) did not reveal any significant differences in F 0 –F 3 (Oser and Oser, ). The initial generation and presumably also the succeeding generations (limited documentation) showed no effect at any dose level (Oser and Oser, ).…”

Section: Assessmentmentioning

confidence: 85%

“…The authors reported an increased organ weight for these affected livers. Chronic glomerular nephritis was not found in controls but in 3/8 rats of the mid‐dose group and in 3/10 high‐dose group (Oser and Oser, ). Although this long‐term feeding study has several limitations (insufficient reporting, low number of animals, limited histopathology and organ weight data, no statistical analysis, infection of the respiratory tract in all groups), the results suggested treatment related effects in the liver at the highest dose tested and in the kidney at the mid‐ and high‐dose tested.…”

Section: Assessmentmentioning

confidence: 98%

“…The initial generation and presumably also the succeeding generations (limited documentation) showed no effect at any dose level (Oser and Oser, ). Neither the percentage of survival at week 104 nor the mean survival time of F 0 was influenced by the treatment (Oser and Oser, ). No deviation from the normal range was found at any dose in blood analysis.…”

Section: Assessmentmentioning

confidence: 99%

“…In a long‐term feeding study (Oser and Oser, ,b, ,b) sorbitan monostearate was fed ad libitum at concentrations of 0%, 5%, 10%, and 20% in the basal diet (equivalent to 0, 2,220, 4,500 and 9,000 mg/kg bw per day in male and to 0, 2,900, 5,800 and 11,600 mg/kg bw per day in female) to groups of 12 male and 20 female Wistar rats for 2 years. In Oser and Oser (), effects on reproduction and lactation were reported. Other endpoints are documented in Section 3.5.5.…”

Section: Assessmentmentioning

confidence: 99%

See 3 more Smart Citations

Re‐evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives

Mortensen¹,

Aguilar²,

Crebelli³

et al. 2017

EFS2

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The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives. The Scientific Committee on Food (SCF) allocated an acceptable daily intake (ADI) of 25 mg/kg body weight (bw) per day for E 491, E 492 and E 495 singly or in combination; and a separate group ADI for E 493 and E 494 singly or in combination of 5 mg/kg bw per day calculated as sorbitan monolaurate in 1974. The Panel noted that after oral administration sorbitan monostearate can be either hydrolysed to its fatty acid moiety and the corresponding anhydrides of sorbitol and excreted via urine or exhaled as CO 2 or excreted intact in the faeces. The Panel considered that sorbitan esters did not raise concern for genotoxicity. Based on the no observed adverse effect level (NOAEL) of 2,600 mg sorbitan monostearate/kg bw per day, taking into account the ratio between the molecular weight of sorbitan monostearate (430.62 g/mol) and sorbitan (164.16 g/mol), and applying an uncertainty factor of 100, the Panel derived a group ADI of 10 mg/kg bw per day expressed as sorbitan for sorbitan esters (E 491-495) singly or in combination. This group ADI of 10 mg sorbitan/kg bw per day is equivalent to 26 mg sorbitan monostearate/kg bw per day. The Panel concluded that the exposure at the mean and the 95th percentile level, using non-brand-loyal scenario, did not exceed the ADI in any of the population groups. The Panel on the request for an amendment of specifications regarding the removal of 'congealing range' concluded that it could be eventually replaced by another identification parameter such as melting point.

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Section: Assessmentmentioning

confidence: 85%

Section: Assessmentmentioning

confidence: 98%

Section: Assessmentmentioning

confidence: 99%

Section: Assessmentmentioning

confidence: 99%

See 2 more Smart Citations

Re‐evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives

Mortensen¹,

Aguilar²,

Crebelli³

et al. 2017

EFS2

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“…As defined by Oser and Oser (), there are four primary variables of interest in a reproduction study. First, there is the fertility index, which may be defined as the percentage of attempted matings (i.e., each female housed with a male) that resulted in pregnancy; pregnancy is determined by a method such as the presence of implantation sites in the female.…”

Section: Applicationsmentioning

confidence: 99%

Statistical Approaches to the Design of Toxicology Studies

Gad

1999

CP Toxicology

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Differing hepatotoxicity and lethality after subacute trichloroethylene exposure in aqueous or corn oil gavage vehicles in B6C3F1 Mice

Merrick

Robinson

Condie

1989

J of Applied Toxicology

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Subacute toxicity of trichloroethylene (TCE) was evaluated in male and female B6C3F1 mice using corn oil or aqueous gavage vehicles. Mice received oral doses of TCE five times a week for 4 weeks at 600, 1200 and 2400 mg/kg/day for males and 450, 900 and 1800 mg/kg/day for females. Vehicle control mice were dosed with either corn oil or a 20% aqueous solution of Emulphor. A dose-related increase in lethality occurred in male and female mice receiving TCE in Emulphor but not corn oil during the first week of treatment. Lethality was consistent with central nervous system depressant effects of TCE. After 4 weeks of exposure, body weights were not altered by TCE but liver/body weight ratios were uniformly increased by TCE administered in either vehicle in both sexes. Only male mice treated with TCE in corn oil, however, sustained elevations in serum enzyme levels, accompanied by liver histopathology. TCE in corn oil produced inflammation-associated focal necrosis in 30-40% of the male mice, with increasing severity from low to high dose. Lipid accumulation, as indicated by Oil-Red O staining, was most prevalent in male mice treated with TCE in corn oil but also occurred to a lesser degree in animals receiving either gavage vehicle alone. This study indicates that the type of oral gavage vehicle is an important factor in determining the nature of TCE toxicity.

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Nutritional Studies on Rats on Diets Containing High Levels of Partial Ester Emulsifiers

Cited by 35 publications

References 3 publications

Re‐evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives

Re‐evaluation of sorbitan monostearate (E 491), sorbitan tristearate (E 492), sorbitan monolaurate (E 493), sorbitan monooleate (E 494) and sorbitan monopalmitate (E 495) when used as food additives

Statistical Approaches to the Design of Toxicology Studies

Differing hepatotoxicity and lethality after subacute trichloroethylene exposure in aqueous or corn oil gavage vehicles in B6C3F1 Mice

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