A two-generation reproductive toxicity study of the high-intensity sweetener advantame in CD rats

Otabe, Akira; Fujieda, Takeshi; Masuyama, Takeshi

doi:10.1016/j.fct.2011.07.002

Cited by 17 publications

(22 citation statements)

References 8 publications

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“…The effect of vehicle, MEBF, and sildenafil on sperm count, production, and defects was studied as described elsewhere [17–19]. The rats were sacrificed, left caudal epididymis were collected, and contents were transferred to 30 mL of saline solution containing 0.05% triton-X and 0.01% merthiolate (STM solution) in a beaker.…”

Section: Methodsmentioning

confidence: 99%

“…The present study is an attempt to identify a possible mechanism of action for the reported efficacy of the plant. In addition, effect of herbal extract was also studied on sexual activity [1, 8, 9], sperm count/characteristics [17–19], and ratio of smooth muscle:collagen level in rat penile tissue [20–23] of young (5 months) and aged rats (24 months). …”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Erectogenic and Aphrodisiac Effects ofButea frondosaKoenig ex Roxb. in Rats: Involvement of Enzyme Inhibition

Goswami

Inamdar

Pandre

et al. 2013

Evidence-Based Complementary and Alternative Medicine

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Butea frondosa Koenig ex Roxb. (BF) is traditionally used to manage male sexual disorders including erectile dysfunction (ED). Methanol extract of BF (bark) inhibited Rho-kinase 2 (ROCK-II) enzyme activity in vitro with an IC50 of 20.29 ± 1.83 μg/mL. The relaxant effect of methanol extract of BF (MEBF) was studied on phenylephrine precontracted corpus cavernosum smooth muscle (CCSM) isolated from young rats. The effect of MEBF treatment on sexual behaviour of both young (5 month) and aged (24 month) rats was also studied in addition to the influence on smooth muscle, collagen (collagen-I and -III) level in penis, and sperm characteristics of young and aged rats. MEBF relaxed CCSM up to 21.77 ± 2.57% and increased sexual behavior of young and aged rats. This increase in sexual function could be attributed to ROCK-II inhibition and increase in ratio of smooth muscle to collagen level in rat penile tissue. Increased sperm production and decreased defective sperms in young and aged rats corroborate the usefulness of Butea frondosa in male infertility in addition to ED.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Erectogenic and Aphrodisiac Effects ofButea frondosaKoenig ex Roxb. in Rats: Involvement of Enzyme Inhibition

Goswami

Inamdar

Pandre

et al. 2013

Evidence-Based Complementary and Alternative Medicine

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show abstract

“…Most have been approved for use as a food additive and, as such, have undergone a premarket approval process in accordance with stipulations made by Additional information regarding NNSs can be found in previously published review articles. 10,21,22,38,43,[51][52][53][54][55][56][57][58][59][60][61]…”

Section: Sweeteners and Nnssmentioning

confidence: 99%

“…1 Reviews and investigative studies discussing and evaluating the safety of NNSs, including sucralose, 19 have been published. Studies investigating the potential toxic effects of NNSs have been performed in animals [55][56][57][58] and humans. 51,59 Results from these more recent studies have concluded that there are no potential teratogenic effects or negative effects of NNS use on weight or development in animals.…”

Section: Safety and Nns Usementioning

confidence: 99%

The Use of Nonnutritive Sweeteners in Children

2019

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The prevalence of nonnutritive sweeteners (NNSs) in the food supply has increased over time. Not only are more children and adolescents consuming NNSs, but they are also consuming a larger quantity of NNSs in the absence of strong scientific evidence to refute or support the safety of these agents. This policy statement from the American Academy of Pediatrics is intended to provide the pediatric provider with a review of (1) previous steps taken for approved use of NNSs, (2) existing data regarding the safety of NNS use in the general pediatric population, (3) what is known regarding the potential benefits and/or adverse effects of NNS use in children and adolescents, (4) identified gaps in existing knowledge and potential areas of future research, and (5) suggested talking points that pediatricians may use when discussing NNS use with families This document is copyrighted and is property of the American Academy of Pediatrics and its Board of Directors. All authors have filed conflict of interest statements with the American Academy of Pediatrics. Any conflicts have been resolved through a process approved by the Board of Directors. The American Academy of Pediatrics has neither solicited nor accepted any commercial involvement in the development of the content of this publication. The guidance in this statement does not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate. All policy statements from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed, revised, or retired at or before that time.

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“…The results based on the two-generation reproduction toxicity study (report AJO/203, 2004) provided in the application dossier were published by Otabe et al (2011e).…”

Section: Reproductive and Developmental Toxicitymentioning

confidence: 99%

Scientific Opinion on the safety of advantame for the proposed uses as a food additive

2013

EFS2

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The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of advantame as a sweetener for use in the food categories specified in the dossier. Advantame is stable under normal storage conditions. The Panel noted that there is an indication of advantame instability in acidic beverages and thermally treated foods. Metabolism and toxicokinetics of advantame and its main metabolite, ANS9801-acid, have been studied in mice, rats, rabbits, dogs and humans. Advantame is rapidly but poorly absorbed and the main excretion route is via faeces. The Panel concluded that advantame does not raised concern with regards to genotoxicity and carcinogenicity. The critical effect observed in animal studies was maternal toxicity (gastrointestinal disturbances) in the prenatal developmental toxicity study in rabbits. The NOAEL for this effect was 500 mg advantame/kg bw/day. Advantame was well tolerated in single or repeated doses up to 0.5 mg/kg bw/day by normo-glycemic or diabetic subjects. The Panel established an ADI of 5 mg/kg bw/day based on the application of a 100-fold uncertainty factor to the NOAEL of 500 mg/kg bw/day for maternal toxicity from the prenatal developmental toxicity study in the rabbit. Conservative estimates of advantame exposure for high level adults and children consumers were below the ADI for the proposed use levels

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A two-generation reproductive toxicity study of the high-intensity sweetener advantame in CD rats

Cited by 17 publications

References 8 publications

Erectogenic and Aphrodisiac Effects ofButea frondosaKoenig ex Roxb. in Rats: Involvement of Enzyme Inhibition

Erectogenic and Aphrodisiac Effects ofButea frondosaKoenig ex Roxb. in Rats: Involvement of Enzyme Inhibition

The Use of Nonnutritive Sweeteners in Children

Scientific Opinion on the safety of advantame for the proposed uses as a food additive

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