Delayed effects of neonatal exposure to Tween 80 on female reproductive organs in rats

Gajdová, M.; Jakubovský, J; Války, J

doi:10.1016/0278-6915(93)90092-d

Cited by 20 publications

(13 citation statements)

References 7 publications

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“…PEG is not known to be metabolized in humans; it is absorbed minimally and rapidly excreted in feces with no known confirmed toxicity [24]. However, Gajdova et al [25] reported that Tween 80 with PEG Mn = 350 g/mol as an active ingredient has the potential to behave as a hormone/estrogen active agent. Neonatal exposure of female rats to PEG 350 significantly accelerated their sexual maturation, prolonged the estrous cycle, and induced persistent vaginal estrus and squamous cell metaplasia of the epithelial lining of the uterus.…”

Section: Introductionmentioning

confidence: 98%

Delayed adverse effects of neonatal exposure to polymeric nanoparticle poly(ethylene glycol)-block-polylactide methyl ether on hypothalamic–pituitary–ovarian axis development and function in Wistar rats

Rollerová

Jurčovičová

Mlynarčíková

et al. 2015

Reproductive Toxicology

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Section: Introductionmentioning

confidence: 98%

Delayed adverse effects of neonatal exposure to polymeric nanoparticle poly(ethylene glycol)-block-polylactide methyl ether on hypothalamic–pituitary–ovarian axis development and function in Wistar rats

Rollerová

Jurčovičová

Mlynarčíková

et al. 2015

Reproductive Toxicology

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“…In addition, several studies using the parenteral application route are available (Kocher-Becker et al, 1981;Ockenfels et al, 1982;Gajdova et al, 1993;Naya et al, 1999); however, this route has low relevance to human exposure and therefore the studies are not presented in detail.…”

Section: Developmental Toxicity Studiesmentioning

confidence: 99%

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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“…When used as an adjuvant for antitumor drugs such as adriamycin, increased drug toxicity has been demonstrated (Casazza et al 1978). Much like DBP, Tween 80 may also have an estrogenic activity in mammals (Gajdova et al 1993). Classical toxicity tests, which employ single chemical compounds and cellular biosensors such as enzymes and organelles, reproduce only part of the interaction of toxicant and organism and frequently do not take into account the bioavailability of the chemical or the possibility of synergistic/ antagonistic effects between chemicals contained in complex mixtures.…”

Section: Introductionmentioning

confidence: 99%

Dibutylphthalate and Tween 80 alter ultrastructure inCandida albicans: implications for peroxisome proliferation

et al. 2009

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Phthalates are ubiquitous environmental pollutants associated with endocrine disruption and peroxisome proliferation in experimental animals. In yeasts exposed to environmental chemicals, including phthalates, alterations in cell growth, cellular morphology, and H2O2 detoxification occur. Nutrient availability also influences diverse cellular processes. Differences in responses to environmental stress between Candida albicans and the model yeast, Saccharomyces cerevesiae, have been reported. In this study, we chose C. albicans as an alternate model for testing estrogen-like chemicals because of its high affinity estrogen-binding protein and, in contrast to S. cerevesiae, estrogens are not growth inhibitory for C. albicans. Cultures were grown in either yeast nitrogen dextrose (YND; phosphate limiting) or YNDP (YND plus 100 mmol/L inorganic phosphate). For chemical testing, 0.5% dibutylphthalate (DBP), 0.05% Tween 80, or a combination of the two (DBPT) were incorporated in growth media to investigate the effects of these estrogenic agents on cell proliferation, morphology, and catalase demonstration. We observed significant differences in cell growth related to DBP and changes in cell wall thickness related to both Tween 80 and phosphate. We describe ultrastructural changes including detachment of the outer yeast cell wall layer and presence of putative peroxisomes. Our findings support the proposal that C. albicans may be particularly suitable for use in studies involving cellular responses associated with exposure to estrogenic chemicals contained in complex mixtures.

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Delayed effects of neonatal exposure to Tween 80 on female reproductive organs in rats

Cited by 20 publications

References 7 publications

Delayed adverse effects of neonatal exposure to polymeric nanoparticle poly(ethylene glycol)-block-polylactide methyl ether on hypothalamic–pituitary–ovarian axis development and function in Wistar rats

Delayed adverse effects of neonatal exposure to polymeric nanoparticle poly(ethylene glycol)-block-polylactide methyl ether on hypothalamic–pituitary–ovarian axis development and function in Wistar rats

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

Dibutylphthalate and Tween 80 alter ultrastructure inCandida albicans: implications for peroxisome proliferation

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