Subchronic feeding study of high oleic acid soybeans (Event DP-3Ø5423-1) in Sprague–Dawley rats

Delaney, Bryan; Appenzeller, Laura M.; Munley, Susan M.; Hoban, Denise; Sykes, Greg P.; Malley, Linda A.; Sanders, C.

doi:10.1016/j.fct.2008.10.003

Cited by 56 publications

(34 citation statements)

References 47 publications

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“…The increases in body weight and food consumption in mid- and high-dose male groups were different from those of the female groups. In other toxicity studies using oleic acid, there were no treatment-related changes in body weight or food consumption for any of the groups (15). Therefore, the changes in body weight and food consumption are not considered related to the treatment, and will necessitate further study of the longterm results.…”

Section: Resultsmentioning

confidence: 95%

Evaluation of Genotoxicity and 28-day Oral Dose Toxicity on Freeze-dried Powder of Tenebrio molitor Larvae (Yellow Mealworm)

Han¹,

Yun²,

Kim³

et al. 2014

Toxicological Research

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The larval form of Tenebrio molitor (T. molitor) has been eaten in many countries and provides benefits as a new food source of protein for humans. However, no information exists regarding its safety for humans. The objective of the present study was to evaluate the genotoxicity and repeated dose oral toxicity of the freeze-dried powder of T. molitor larvae. The genotoxic potential was evaluated by a standard battery testing: bacterial reverse mutation test, in vitro chromosome aberration test, and in vivo micronucleus test. To assess the repeated dose toxicity, the powder was administered once daily by oral gavage to Sprague-Dawley (SD) rats at dose levels of 0, 300, 1000 and 3000 mg/kg/day for 28 days. The parameters which were applied to the study were mortality, clinical signs, body and organ weights, food consumption, ophthalmology, urinalysis, hematology, serum chemistry, gross findings and histopathologic examination. The freezedried powder of T. molitor larvae was not mutagenic or clastogenic based on results of in vitro and in vivo genotoxicity assays. Furthermore, no treatment-related changes or findings were observed in any parameters in rats after 28 days oral administration. In conclusion, the freeze-dried powder of T. molitor larvae was considered to be non-genotoxic and the NOAEL (No Observed Adverse Effect Level) was determined to be 3000 mg/kg/day in both sexes of SD rats under our experimental conditions.

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Section: Resultsmentioning

confidence: 95%

Evaluation of Genotoxicity and 28-day Oral Dose Toxicity on Freeze-dried Powder of Tenebrio molitor Larvae (Yellow Mealworm)

Han¹,

Yun²,

Kim³

et al. 2014

Toxicological Research

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“…gonad weight, fecundity, fertility, gonadal histopathology) of female [23-26,46,47,85-96] and male [23-26,46,47,50,51,85,87,89-96] reproduction in animal feeding studies.…”

Section: Introductionmentioning

confidence: 99%

GMOs in animal agriculture: time to consider both costs and benefits in regulatory evaluations

Eenennaam

2013

J Animal Sci Biotechnol

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In 2012, genetically engineered (GE) crops were grown by 17.3 million farmers on over 170 million hectares. Over 70% of harvested GE biomass is fed to food producing animals, making them the major consumers of GE crops for the past 15 plus years. Prior to commercialization, GE crops go through an extensive regulatory evaluation. Over one hundred regulatory submissions have shown compositional equivalence, and comparable levels of safety, between GE crops and their conventional counterparts. One component of regulatory compliance is whole GE food/feed animal feeding studies. Both regulatory studies and independent peer-reviewed studies have shown that GE crops can be safely used in animal feed, and rDNA fragments have never been detected in products (e.g. milk, meat, eggs) derived from animals that consumed GE feed. Despite the fact that the scientific weight of evidence from these hundreds of studies have not revealed unique risks associated with GE feed, some groups are calling for more animal feeding studies, including long-term rodent studies and studies in target livestock species for the approval of GE crops. It is an opportune time to review the results of such studies as have been done to date to evaluate the value of the additional information obtained. Requiring long-term and target animal feeding studies would sharply increase regulatory compliance costs and prolong the regulatory process associated with the commercialization of GE crops. Such costs may impede the development of feed crops with enhanced nutritional characteristics and durability, particularly in the local varieties in small and poor developing countries. More generally it is time for regulatory evaluations to more explicitly consider both the reasonable and unique risks and benefits associated with the use of both GE plants and animals in agricultural systems, and weigh them against those associated with existing systems, and those of regulatory inaction. This would represent a shift away from a GE evaluation process that currently focuses only on risk assessment and identifying ever diminishing marginal hazards, to a regulatory approach that more objectively evaluates and communicates the likely impact of approving a new GE plant or animal on agricultural production systems.

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“…Long-term and multigenerational feeding studies Long-term feeding studies. In a 90-day or 13-weeks feeding studies on rats, several groups have reported that there were no effects on male reproductive organs such as testes, epididymides and prostate in rodents compared with rats receiving non-GM food in long-term study when the diet was treated with different GM foods (Hammond et al, 2006;MacKenzie et al, 2007;Schroder et al, 2007;Appenzeller et al, 2008Appenzeller et al, , 2009aAppenzeller et al, and 2009bDelaney et al, 2008b;Healy et al, 2008;He et al, 2008 and No apparent differences in percentages of testicular cell populations (haploid, diploid and tetraploid).…”

Section: Velimirov Et Al (2008)mentioning

confidence: 99%

“…In the 90-day or 13-week feeding studies in rats, no statistical difference was uncovered in either the relative body and ovary weight of rats fed transgenic corns (Hammond et al, 2006;Healy et al, 2008), maize (MacKenzie et al, 2007;He et al, 2009;Appenzeller et al, 2009a and2009b), rice (Schroder et al, 2007) or soybeans (Appenzeller et al, 2008;Delaney et al, 2008b); and there were no histopathologic lesions in ovaries from rats fed DAS-59122-7 maize (Cry34Ab1 and Cry35Ab1 proteins; He et al, 2008). Furthermore, Malley et al (2007) reported higher mean uterus weight during the estrous stage of rats fed maize DAS-59122-7 (Cry34Ab1 and Cry35Ab1 proteins) or 5002B (commercial rodent diets) v. the 33R77 group (non-transgenic reference maize grain), 091 group (non-transgenic nearisogenic maize grain) or 5002A (commercial rodent diets); however, this might be due to the fact that the proportion of rats in proestrus and estrus in the 59122 and 5002B groups was greater than that in the 5002A, 091 and 33R77 maize grain groups, in which a greater proportion of rats were in metestrus and diestrus.…”

Section: Introductionmentioning

confidence: 99%

Do genetically modified crops affect animal reproduction? A review of the ongoing debate

Zhang

Shi

2011

Animal

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In the past few years, genetically modified (GM) crops aimed at producing food/feed that became part of the regular agriculture in many areas of the world. However, we are uncertain whether GM food and feed can exert potential adverse effects on humans or animals. Of importance, the reproductive toxicology of GM crops has been studied using a number of methods, and by feeding GM crops to a number species of animals to ensure the safety assessment of GM food and feed. It appears that there are no adverse effects of GM crops on many species of animals in acute and short-term feeding studies, but serious debates of effects of long-term and multigenerational feeding studies remain. The aims of this review are to focus on the latest (last 3 to 4 years) findings and debates on reproduction of male and female animals after feeding daily diets containing the GM crops, and to present the possible mechanism(s) to explain their influences.

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Subchronic feeding study of high oleic acid soybeans (Event DP-3Ø5423-1) in Sprague–Dawley rats

Cited by 56 publications

References 47 publications

Evaluation of Genotoxicity and 28-day Oral Dose Toxicity on Freeze-dried Powder of Tenebrio molitor Larvae (Yellow Mealworm)

Evaluation of Genotoxicity and 28-day Oral Dose Toxicity on Freeze-dried Powder of Tenebrio molitor Larvae (Yellow Mealworm)

GMOs in animal agriculture: time to consider both costs and benefits in regulatory evaluations

Do genetically modified crops affect animal reproduction? A review of the ongoing debate

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