Nutritional Studies on Rats on Diets Containing High Levels of Partial Ester Emulsifiers I. General Plan and Procedures; Growth and Food Utilization

Oser, Bernard L.; Oser, Mona

doi:10.1093/jn/60.3.367

Cited by 55 publications

(16 citation statements)

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“…It did decrease rat reproduction at 20% of their oral intake. 48 It is not known whether some protection may be conferred by digestive processes to smaller loads of polysorbate 80 that is not present in the parenteral route of administration to young female rats. This research highlights 4 issues.…”

Section: Discussionmentioning

confidence: 99%

Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination

Little¹,

Ward

2014

Journal of Investigative Medicine High Impact Case Reports

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Three young women who developed premature ovarian insufficiency following quadrivalent human papillomavirus (HPV) vaccination presented to a general practitioner in rural New South Wales, Australia. The unrelated girls were aged 16, 16, and 18 years at diagnosis. Each had received HPV vaccinations prior to the onset of ovarian decline. Vaccinations had been administered in different regions of the state of New South Wales and the 3 girls lived in different towns in that state. Each had been prescribed the oral contraceptive pill to treat menstrual cycle abnormalities prior to investigation and diagnosis. Vaccine research does not present an ovary histology report of tested rats but does present a testicular histology report. Enduring ovarian capacity and duration of function following vaccination is unresearched in preclinical studies, clinical and postlicensure studies. Postmarketing surveillance does not accurately represent diagnoses in adverse event notifications and can neither represent unnotified cases nor compare incident statistics with vaccine course administration rates. The potential significance of a case series of adolescents with idiopathic premature ovarian insufficiency following HPV vaccination presenting to a general practice warrants further research. Preservation of reproductive health is a primary concern in the recipient target group. Since this group includes all prepubertal and pubertal young women, demonstration of ongoing, uncompromised safety for the ovary is urgently required. This matter needs to be resolved for the purposes of population health and public vaccine confidence.

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Section: Discussionmentioning

confidence: 99%

Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination

Little¹,

Ward

2014

Journal of Investigative Medicine High Impact Case Reports

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“…After administration of a single dose of 14 C‐sorbitan monostearate (labelled on the polyol moiety), 90% and 50% (oily and water emulsion form, respectively) of the emulsifier were hydrolysed to stearic acid and anhydrides of sorbitol that were extensively excreted (44% and 66%) in the urine; only a fraction of sorbitol anhydrides was oxidised to 14 CO 2 (14–24% of the administered radioactivity); very low amounts of radioactivity (˂ 0.1%) were measured in tissues; continuous administration (28 days) of the same labelled compound showed no accumulation of the additive in the fat (Wick and Joseph, , ). Similar studies performed with sorbitan 14 C‐monostearate (labelled on the fatty acid) showed that the stearate moiety had a coefficient of digestibility of 53.3%; fractionation of carcass fat showed that 14 C was incorporated into fatty acids, glycerol and non‐identified residues (Wick and Joseph, ; Oser and Oser, ).…”

Section: Assessmentmentioning

confidence: 75%

Safety for the environment of sorbitan monolaurate as a feed additive for all animal species

Additives¹,

Bampidis²,

Azimonti³

et al. 2020

EFS2

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The additive sorbitan monolaurate consists of sorbitol (and its anhydrides) esterified with fatty acids derived from coconut oil. It is currently authorised in the European Union and it is intended to be used as a technological additive (functional group of emulsifiers), in feedingstuffs for all animal species, at a maximum concentration of 85 mg/kg complete feed. In 2019, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of sorbitan monolaurate. Owing the lack of data, the FEEDAP Panel could not conclude on the safety of the additive for the environment. The applicant submitted new data (fate and degradation as well as ecotoxicity data) that were evaluated in the present opinion. The absorption, distribution, metabolism and excretion of structurally related compounds (sorbitan monostearate and sorbitan trioleate) indicate that the additive is expected to be partially metabolised. In addition, sorbitan monolaurate and some related compounds are readily biodegradable. The limited available data on the effects of sorbitan monolaurate in marine crustaceans and in marine sediment indicate that the ecotoxicity of the additive is low, in consistency with the very low acute toxicity of sorbitan esters. Overall, the FEEDAP Panel concludes that a risk of sorbitan monolaurate to terrestrial and aquatic environment is unlikely. Therefore, no safety concerns for the environment are expected from the use of the additive under assessment according to the established conditions of use.

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“…No deviation from the normal range was found at any dose in blood analysis. Urinalysis showed no difference with control (Oser and Oser, 1957a). Complete histopathology was performed only in two rats per sex at the high-dose group.…”

Section: Ratsmentioning

confidence: 89%

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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Nutritional Studies on Rats on Diets Containing High Levels of Partial Ester Emulsifiers I. General Plan and Procedures; Growth and Food Utilization

Cited by 55 publications

References 0 publications

Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination

Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination

Safety for the environment of sorbitan monolaurate as a feed additive for all animal species

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

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