Effects of feeding emulsifiers on reproduction of C57BL/6 mice

Paschall, Homer Donald

doi:10.31274/rtd-180816-1994

Cited by 1 publication

(2 citation statements)

References 14 publications

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“…New data were found in the literature search in the databases Toxline, Medline and SciFinder. However, the relevance of these new studies (Paschall, 1964;Enright et al, 2010) is limited.…”

Section: 25mentioning

confidence: 99%

“…In the feeding study by Paschall (1964), three generations of male and female C57BL/6 mice (number of animals unknown) were given, continuously, a diet containing 0 or 10 % polysorbate 20 or 10 % polysorbate 60 (equivalent to 0 or 5 g/kg bw/day; higher doses expected in pregnant females and in the post-weaning period of 10 g/kg bw/day). Four matings were performed in the F0 and F1 generations and three matings in the F2 generation.…”

Section: 25mentioning

confidence: 99%

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Scientific Opinion on the re‐evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives

Panel¹

2015

EFS2

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The Panel on Food Additives and Nutrient Sources added to Food (ANS) re-evaluated the safety of polysorbate 20 (E 432), polysorbate 80 (E 433), polysorbate 40 (E 434), polysorbate 60 (E 435) and polysorbate 65 (E 436) as food additives. The Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) derived an Acceptable Daily Intake (ADI) of 25 mg/kg body weight (bw)/day (group ADI for polysorbates 20, 40, 60, 65 and 80) and the Scientific Committee on Food (SCF) derived a group ADI of 10 mg/kg bw/day. Small amounts of polyoxyethylene sorbitans are absorbed. Similar toxicokinetics would be expected for all polysorbates based on their similarities in structure and metabolic fate. The acute toxicity is very low. There is no concern regarding genotoxicity, carcinogenicity or developmental toxicity. From a limited number of studies, there is no indication of reproductive toxicity. The Panel considered the long-term carcinogenicity study in rats with a No Observed Adverse Effect Level (NOAEL) equivalent to 2 500 mg/kg bw/day -consistent with the NOAEL defined in subchronic studies -as the key study and allocated a group ADI of 25 mg/kg bw/day using an uncertainty factor of 100. The estimated exposure of toddlers at the highest level in non-brand loyal scenario remains very close to the ADI (24.5 mg/kg bw/day). The Panel is aware that for three food categories no reported uses have been obtained and that other dietary sources of exposure to polysorbates could not been considered in this opinion and therefore more data (usage and analytical data) are needed to decrease uncertainties in the refined exposure assessment scenario used. 20, 40, 60, 65 and 80 (SCF, 1985). The basis was a No Observed Effect Level (NOEL) equivalent to 1 460 mg/kg bw/day in the diet in the 90-day study in rats with polyoxyethylene sorbitan monostearate (polysorbate 60) (BIBRA, 1981; cited in SCF, 1985). A higher group ADI value of 0-25 mg/kg bw/day was allocated by the Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA, 1974a, b).The Panel was not provided with a newly submitted dossier and based its evaluation on previous evaluations and reviews, additional literature that has become available since then and data available following a public call for data. The Panel noted that not all original studies on which previous evaluations were based were available for re-evaluation by the Panel. Specifications for the polysorbates have been defined in Commission Regulation (EU) No 231/2012 and by JECFA (JECFA, 2006a).The Panel considered the evaluation of polysorbates (E 432-E 436) as a group in one opinion because of their similarities in structure and metabolic fate. These additives are hydrolysed to oxyethylene sorbitans and the relevant fatty acids, the latter being normal constituents of the diet. From the toxicological data as described in this opinion, there is ...

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“…New data were found in the literature search in the databases Toxline, Medline and SciFinder. However, the relevance of these new studies (Paschall, 1964;Enright et al, 2010) is limited.…”

Section: 25mentioning

confidence: 99%

Section: 25mentioning

confidence: 99%