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Cited by 397Genetically Modified Organisms ResearchPesticide Exposure and ToxicityAgricultural safety and regulations

RETRACTED: Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize

Open access
Séralini, Gilles-Eric, Clair, Emilie, Mesnage, Robin, Gress, Steeve, Defarge, Nicolas, Malatesta, Manuela, Hennequin, Didier, de Vendômois, Joël Spiroux·2012·Food and Chemical Toxicology
DOI 10.1016/j.fct.2012.08.005
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Abstract

This article has been retracted: please see Elsevier Policy on Article Withdrawal (http://www.elsevier.com/locate/withdrawalpolicy). The journal Food and Chemical Toxicology retracts the article “Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize,” which was published in this journal in November 2012. This retraction comes after a thorough and time-consuming analysis of the published article and the data it reports, along with an investigation into the peer-review behind the article. The Editor in-Chief deferred making any public statements regarding this article until this investigation was complete, and the authors were notified of the findings. Very shortly after the publication of this article, the journal received Letters to the Editor expressing concerns about the validity of the findings it described, the proper use of animals, and even allegations of fraud. Many of these letters called upon the editors of the journal to retract the paper. According to the journal’s standard practice, these letters, as well as the letters in support of the findings, were published along with a response from the authors.1 Due to the nature of the concerns raised about this paper, the Editor-in-Chief examined all aspects of the peer review process and requested permission from the corresponding author to review the raw data. The request to view raw data is not often made; however, it is in accordance with the journal’s policy that authors of submitted manuscripts must be willing to provide the original data if so requested.2 The corresponding author agreed and supplied all material that was requested by the Editor-in-Chief. The Editor-in-Chief wishes to acknowledge the co-operation of the corresponding author in this matter, and commends him for his commitment to the scientific process. Unequivocally, the Editor-in-Chief found no evidence of fraud or intentional misrepresentation of the data. However, there is a legitimate cause for concern regarding both the number of animals in each study group and the particular strain selected. The low number of animals had been identified as a cause for concern during the initial review process, but the peer review decision ultimately weighed that the work still had merit despite this limitation. A more in-depth look at the raw data revealed that no definitive conclusions can be reached with this small sample size regarding the role of either NK603 or glyphosate in regards to overall mortality or tumor incidence. Given the known high incidence of tumors in the Sprague–Dawley rat, normal variability cannot be excluded as the cause of the higher mortality and incidence observed in the treated groups. Ultimately, the results presented (while not incorrect) are inconclusive, and therefore do not reach the threshold of publication for Food and Chemical Toxicology. The peer review process is not perfect, but it does work. The journal is committed to getting the peer-review process right, and at times, expediency might be sacrificed for being as thorough as possible. The time-consuming nature is, at times, required in fairness to both the authors and readers. Likewise, the Letters to the Editor, both pro and con, serve as a post-publication peer-review. The back and forth between the readers and the author has a useful and valuable place in our scientific dialog. The Editor-in-Chief again commends the corresponding author for his willingness and openness in participating in this dialog. The retraction is only on the inconclusiveness of this one paper. The journal’s editorial policy will continue to review all manuscripts no matter how controversial they may be. The editorial board will continue to use this case as a reminder to be as diligent as possible in the peer review process.

AI snapshot

Written from the paper’s full text.

TL;DR

This 2012 *Food and Chemical Toxicology* paper reports a 2-year rat feeding study of Roundup-tolerant NK603 GM maize and Roundup, claiming increased mortality, tumors, and liver/kidney pathology. The provided bibliographic record marks the article as RETRACTED.

Key findings

  • In females, all treated groups died 2–3 times more than controls and more rapidly; up to 50% of males and 70% of females died in some GM-maize groups, versus 30% of control males and 20% of control females dying spontaneously before mean survival time.
  • Treated males had liver congestions and necrosis 2.5–5.5 times more frequently than controls, and marked/severe kidney nephropathies were generally 1.3–2.3 greater; males presented 4 times more large palpable tumors than controls, occurring up to 600 days earlier.
  • By the 24th month, 50–80% of treated females had developed tumors in all treated groups, with up to 3 tumors per animal, versus 30% of controls; the pituitary was the second most affected organ in females, generally around 2 times more affected than controls.
  • For all treatments and both sexes, 76% of altered biochemical parameters were kidney related; ferulic acid was decreased in GM and GM + R diets by 16–30%, and caffeic acid by 21–53%, compared with control diet.

Methods

  • Two-year life-long feeding study in 100 male and 100 female Sprague-Dawley rats, randomly assigned into 10 equivalent groups per sex: one control, six groups fed 11%, 22%, or 33% NK603 GM maize with or without Roundup application, and three groups given Roundup in drinking water at 0.1 ppb, 0.09%, or 0.5%.
  • Animals were monitored twice weekly; blood and urine were sampled 11 times over 24 months, with 31 blood parameters and 16 urine parameters assessed, plus histology of up to 34 organs/tissues and transmission electron microscopy of liver, kidney, and tumors.
  • Biochemical data were analyzed by multivariate methods including principal component analysis and orthogonal partial least-squares discriminant analysis (OPLS-DA), with discriminant variables selected at 99% confidence and models required to meet R²(Y) ≥ 80% and Q²(Y) ≥ 60%.

Limitations

  • The paper states that all data cannot be shown in one report, that the total chemical composition of the GM maize cannot be measured in detail, that substantial equivalence is insufficient to highlight unknown toxins, and that other mutagenic/metabolic effects cannot be excluded; it calls for further transcriptomic, proteomic, metabolomic, reproductive, and multigenerational studies.
  • Evident from the provided record: the article is retracted (title).
  • Evident from the text: group sizes were 10 animals per group per sex, and biochemical analysis was performed at month 15 because that was the last sampling time when most animals were still alive, with treated groups at 90% males and 94% females alive.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1016/j.fct.2012.08.005This paper is marked retracted.

Cites

52 of 52 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 51 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    For all treatments and both sexes, 76% of the altered parameters were kidney related.

    “for all treatments and both sexes, 76% of the altered parameters were kidney related”
    Quote in the paperSubstantial claim
  • Findingown data

    Marked and severe kidney nephropathies were generally 1.3-2.3 greater in treated groups.

    “Marked and severe kidney nephropathies were also generally 1.3-2.3greater.”
    Quote in the paperSubstantial claim
  • Findingown data

    The mortality difference was visible in 3 male groups fed GMOs.

    “This difference was visible in 3 male groups fed GMOs.”
    Quote in the paperSubstantial claim
  • Findingown data

    Biochemistry data confirmed very significant kidney chronic deficiencies.

    “Biochemistry data confirmed very significant kidney chronic deficiencies”
    Quote in the paperSubstantial claim
  • Findingown data

    The pituitary was the second most disabled organ in females.

    “the pituitary was the second most disabled organ”
    Quote in the paperNot a substantial claim
  • May combine two claims. 47
  • Classified as probably not a substantial claim. 16

  • May combine two claims.

    Findingown data

    In female rats, all treated groups died 2-3 times more than controls and more rapidly.

    “In females, all treated groups died 2-3 times more than controls, and more rapidly.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Females developed large mammary tumors almost always more often than and before controls.

    “Females developed large mammary tumors almost always more often than and before controls”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Males presented 4 times more large palpable tumors than controls, which occurred up to 600 days earlier.

    “Males presented 4 times more large palpable tumors than controls which occurred up to 600 days earlier.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Metastases were observed in only 2 cases; one in a group fed with 11% GM maize, and another in the highest dose of R treatment group.

    “Metastases were observed in only 2 cases; one in a group fed with 11% GM maize, and another in the highest dose of R treatment group.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Up to 14 months, no animals in the control groups showed any signs of tumors whilst 10-30% of treated females per group developed tumors, with the exception of one group (33% GMO + R).

    “Up to 14 months, no animals in the control groups showed any signs of tumors whilst 10-30% of treated females per group developed tumors, with the exception of one group (33% GMO + R).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Control male animals survived on average 624 ± 21 days, whilst females lived for 701 ± 20 days during the experiment.

    “Control male animals survived on average 624 ± 21 days, whilst females lived for 701 ± 20, during the experiment”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The maximum difference in males was 5 times more deaths during the 17th month in the 11% GM maize group, and in females 6 times greater mortality during the 21st month on the 22% GM maize diet with and without R.

    “The maximum difference in males was 5 times more deaths occurring during the 17th month in the group consuming 11% GM maize, and in females 6 times greater mortality during the 21st month on the 22% GM maize diet with and without R.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    In GM maize treated males (with or without R), 87% of discriminant variables were kidney related, but the disrupted profiles were less obvious because of advanced chronic nephropathies and deaths.

    “In GM maize treated males (with or without R), 87% of discriminant variables were kidney related, but the disrupted profiles were less obvious because of advanced chronic nephropathies and deaths.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    In female animals, the largest tumors were in total 5 times more frequent than in males after 2 years, with 93% being mammary tumors.

    “In female animals, the largest tumors were in total 5 times more frequent than in males after 2 years, with 93% being mammary tumors.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The R treatment groups showed the greatest rates of tumor incidence with 80% of animals affected with up to 3 tumors for one female, in each group.

    “The R treatment groups showed the greatest rates of tumor incidence with 80% of animals affected with up to 3 tumors for one female, in each group.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    At the end of the experiment, internal non-palpable tumors were added, and their sums were lower in males than in females.

    “At the end of the experiment, internal non-palpable tumors were added, and their sums were lower in males than in females.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Tumors began to reach a large size on average 94 days before in treated females, and up to 600 days earlier in 2 male groups eating the GM maize (11 and 22% with or without R).

    “Tumors began to reach a large size on average 94 days before in treated females, and up to 600 days earlier in 2 male groups eating the GM maize (11 and 22% with or without R).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Before mean survival time, 30% of control males and 20% of control females died spontaneously, while up to 50% of males and 70% of females died in some groups on diets containing the GM maize.

    “Before this period, 30% control males (three in total) and 20% females (only two) died spontaneously, while up to 50% males and 70% females died in some groups on diets containing the GM maize (Fig. 1).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The growths were rarely equal but almost always more frequent than in controls for all treated groups, often 2-3 times more in both sexes.

    “They were rarely equal but almost always more frequent than in controls for all treated groups, often 2-3 times more in both sexes.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The largest palpable growths (above a diameter of 17.5 mm in females and 20 mm in males) were found to be in 95% of cases non-regressive tumors, and were not infectious nodules.

    “The largest palpable growths (above a diameter of 17.5 mm in females and 20 mm in males) were found to be in 95% of cases non-regressive tumors, and were not infectious nodules.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Transmission electron microscopic observations of liver samples confirmed changes for all treated groups in relation to glycogen dispersion or appearance in lakes, increase of residual bodies and enlargement of cristae in mitochondria.

    “Transmission electron microscopic observations of liver samples confirmed changes for all treated groups in relation to glycogen dispersion or appearance in lakes, increase of residual bodies and enlargement of cristae in mitochondria (Fig. 4).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The first female death occurred in the 22% GM maize feeding group and resulted from a mammary fibroadenoma 246 days before the first control.

    “The first female death occurred in the 22% GM maize feeding group and resulted from a mammary fibroadenoma 246 days before the first control.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    In the GMO + R group at the highest dose, the smooth endoplasmic reticulum was drastically increased and nucleoli decreased in size, becoming more compact.

    “In the GMO + R group (at the highest dose) the smooth endoplasmic reticulum was drastically increased and nucleoli decreased in size, becoming more compact.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    There was no rejection by the animals of the diet with or without GMOs, nor any major difference in body weight.

    “There was no rejection by the animals of the diet with or without GMOs, nor any major difference in the body weight.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    For the different corns and diets, the study of the standard chemical composition revealed no particular difference; they were classified as substantially equivalent, except for transgene DNA quantification.

    “For the different corns and diets, the study of the standard chemical composition revealed no particular difference; this is why they were classified as substantially equivalent, except for transgene DNA quantification.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Females were more sensitive to the presence of R in drinking water than males, as evidenced by a shorter lifespan.

    “Females were more sensitive to the presence of R in drinking water than males, as evidenced by a shorter lifespan.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    These growths progressively increased in size and number, but not proportionally to the treatment dose over the course of the experiment.

    “These growths progressively increased in size and number, but not proportionally to the treatment dose over the course of the experiment (Fig. 2).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    By the beginning of the 24th month, 50-80% of female animals had developed tumors in all treated groups, with up to 3 tumors per animal, whereas only 30% of controls were affected.

    “By the beginning of the 24th month, 50-80% of female animals had developed tumors in all treated groups, with up to 3 tumors per animal, whereas only 30% of controls were affected.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Ions (Na, Cl) or urea increased in urine.

    “Ions (Na, Cl) or urea increased in urine.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The general causes of death were linked mostly to large mammary tumors in females, and other organic problems in males.

    “The general causes of death represented in histogram format (Fig. 1) are linked mostly to large mammary tumors in females, and other organic problems in males.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The rate of mortality was not proportional to the treatment dose, reaching a threshold at the lowest (11%) or intermediate (22%) amounts of GM maize in the diet, with or without R application.

    “However, the rate of mortality was not proportional to the treatment dose, reaching a threshold at the lowest (11%) or intermediate (22%) amounts of GM maize in the equilibrated diet, with or without the R application on the plant.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingreasoning

    The observed effects of NK603 and R are not additive and reached a threshold.

    “This explanation also corresponds to the fact that the observed effects of NK603 and R are not additive and reached a threshold.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Our data show that most observed effects in this study were not proportional to the dose of the treatment, non-monotonic and with a threshold effect.

    “Our data show that, as is often the case for hormonal diseases, most observed effects in this study were not proportional to the dose of the treatment (GM maize with and without R application; R alone), non-monotonic and with a threshold effect (Vandenberg et al., 2012).”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites Vandenberg et al., 2012 source

      Not checked in the free run.

  • May combine two claims.

    Findingcitation

    All treatments in both sexes enhanced large tumor incidence by 2-3-fold in comparison to controls, and also the number of mammary tumors in comparison to the same Harlan Sprague Dawley strain, and overall around 3-fold in comparison to the largest study with 1329 Sprague Dawley female rats.

    “All treatments in both sexes enhanced large tumor incidence by 2-3-fold in com- parison to our controls but also for the number of mammary tumors in comparison to the same Harlan Sprague Dawley strain (Brix et al., 2005), and overall around 3-fold in comparison to the largest study with 1329 Sprague Dawley female rats (Chandra et al., 1992).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites Brix et al., 2005 source

      Not checked in the free run.

    • cites Chandra et al., 1992 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    Mammary tumors in male rats occurred far less frequently than in females.

    “As expected, mammary tumors in males occurred far less frequently than in females.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingcitation

    Males on average died before females, except for some female treatment groups.

    “males on average died before females, except for some female treatment groups.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    The lifespan of the control group of animals corresponded to the mean rat lifespan.

    “The lifespan of the control group of animals corresponded to the mean rat lifespan”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In our study the tumors developed considerably faster than the controls, even though the majority of tumors were observed after 18 months.

    “In our study the tumors also developed considerably faster than the controls, even though the majority of tumors were observed after 18 months.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingreasoning

    In the groups of animals fed NK603 without R application, enhanced tumor incidence and mortality rates were observed, similar to other groups.

    “Interestingly, in the groups of animals fed with the NK603 without R application, similar effects with respect to enhanced tumor incidence and mortality rates were observed.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The largest tumors were palpable during the experiment and numbered from 20 mm in diameter for males and 17.5 mm for females.

    “The largest tumors were palpable during the experiment and numbered from 20 mm in diameter for males and 17.5 mm for females.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The significant biochemical disturbances and physiological failures documented in this work confirm the pathological effects of these GMO and R treatments in both sexes, with different amplitudes.

    “Altogether, the significant biochemical disturbances and physiological failures documented in this work confirm the pathological effects of these GMO and R treatments in both sexes, with different amplitudes.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Findingnone given

    Pituitary dysfunctions include adenomas, hyperplasias and hypertrophies.

    “Pituitary dysfunctions include adenomas, hyperplasias and hypertrophies.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    Profiles evidence kidney ion leakages and sex hormonal imbalance versus controls.

    “Profiles evidence kidney ion leakages and sex hormonal imbalance versus controls.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    In the present investigation, ultrastructural analysis revealed evidence of impediments in transcription and other defects in cell nuclear structure that were comparable in both sexes and dose-dependent in hepatocytes in all treatments.

    “In the present investigation, deeper analysis at an ultrastructural level revealed evidence of impediments in transcription and other defects in cell nuclear structure that were comparable in both sexes, and dose-dependent in hepatocytes in all treatments.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Roundup concentrations in the range of 10^3 times below the MRL induced endocrine disturbances in human cells and toxic effects thereafter, including in vivo.

    “it has been demonstrated that R concentrations in the range of 10 3 times below the MRL induced endocrine disturbances in human cells (Gasnier et al., 2009) and toxic effects thereafter (Benachour and Seralini, 2009), including in vivo (Romano et al., 2012).”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites Gasnier et al., 2009 source

      Not checked in the free run.

    • cites Benachour and Seralini, 2009

      Not checked in the free run.

    • cites Romano et al., 2012 source

      Not checked in the free run.

  • May combine two claims.

    Interpretationnone given

    All results were hormone and sex dependent, and the pathological profiles were comparable.

    “All results were hormone and sex dependent, and the pathological profiles were comparable.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Premisecitation

    Significant disturbances have been found in GMO subchronic toxicity studies and may be interpreted differently.

    “significant disturbances have been found and may be interpreted differently (Séralini et al., 2009;Spiroux de Vendômois et al., 2010)”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites Séralini et al., 2009 source

      Not checked in the free run.

    • cites Spiroux de Vendômois et al., 2010 source

      Not checked in the free run.

  • May combine two claims.

    Interpretationreasoning

    These results can be explained by the non linear endocrine-disrupting effects of Roundup, but also by the overexpression of the transgene in the GMO and its metabolic consequences.

    “These results can be explained by the non linear endocrine-disrupting effects of Roundup, but also by the overexpression of the transgene in the GMO and its metabolic consequences.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Detailed analyses have revealed alterations in kidney and liver functions that may be signs of early chronic diet intoxication, possibly explained at least in part by pesticide residues in GM feed.

    “Detailed analyses have revealed alterations in kidney and liver functions that may be the signs of early chronic diet intoxication, possibly explained at least in part by pesticide residues in the GM feed (Séralini et al., 2007;Spiroux de Vendômois et al., 2009).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites Séralini et al., 2007 source

      Not checked in the free run.

    • cites Spiroux de Vendômois et al., 2009 source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    Only OPLS-DA models with an explained variance R2(Y) >=80% and a cross-validated predictive ability Q2(Y) >=60% were used for selection of discriminant variables, when their regression coefficients were significant at 99% confidence level.

    “Only models with an explained variance R 2 (Y) P 80%, and a cross-validated predictive ability Q 2 (Y) P 60%, were used for selection of the discriminant variables (Fig. 5A), when their regression coefficients were significant at 99% confidence level.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductown data

    All feed formulations consisted of balanced diets, chemically measured as substantially equivalent except for the transgene, with no contaminating pesticides over standard limits.

    “All feed formulations consisted in balanced diets, chemically measured as substantially equivalent except for the transgene, with no contaminating pesticides over standard limits.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).

    Study design and conductnone given

    Anesthesia did not impact animal health.

    “It was first demonstrated that anesthesia did not impact animal health.”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Premisecitation

    Many authors have strongly emphasized the necessity of studying the potential toxic effects of total chemical mixtures rather than single components.

    “many authors in the field have strongly emphasized the necessity of studying the potential toxic effects of total chemical mixtures rather than single components (Cox and Surgan, 2006;Mesnage et al., 2010;Monosson, 2005).”
    Quote in the paperSubstantial claim0 of 3 sources checked
    • cites Cox and Surgan, 2006

      Not checked in the free run.

    • cites Mesnage et al., 2010

      Not checked in the free run.

    • cites Monosson, 2005 source

      Not checked in the free run.

  • Classified as probably not a substantial claim.

    Study design and conductnone given

    After acclimatization, 100 male and 100 female animals were randomly assigned on a weight basis into 10 equivalent groups.

    “After 20 days of acclimatization, 100 male and 100 female animals were randomly assigned on a weight basis into 10 equivalent groups.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductnone given

    The experimental protocol was conducted in accordance with the regulations of the authors' ethics in an animal care unit authorized by the French Ministries of Agriculture and Research.

    “The experimental protocol was conducted in accordance with the regulations of our ethics in an animal care unit authorized by the French Ministries of Agriculture and Research (Agreement Number A35-288-1).”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductnone given

    The GM maize and its nearest isogenic non-transgenic control were grown under similar normal conditions, in the same location, spaced at a sufficient distance to avoid cross-contamination.

    “These two types of maize were grown under similar normal conditions, in the same location, spaced at a sufficient distance to avoid cross-contamination.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductown data

    Statistical analysis was performed on the results obtained from samples taken at the 15th month time point, as this was the last sampling time when most animals were still alive (in treated groups 90% males, 94% females, and 100% controls).

    “For biochemical measurements in rats, statistical analysis was performed on the results obtained from samples taken at the 15th month time point, as this was the last sampling time when most animals were still alive (in treated groups 90% males, 94% females, and 100% controls).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationnone given

    The observed effects correspond to levels likely to arise from consumption or environmental exposure, such as either 11% GM maize in food, or 50 ng/L of glyphosate in R-formulation as can be found in some contaminated drinking tap waters, and which fall within authorized limits.

    “This corresponds to levels likely to arise from consumption or environmental exposure, such as either 11% GM maize in food, or 50 ng/L of glyphosate in R-formulation as can be found in some contaminated drinking tap waters, and which fall within authorized limits.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    The EPSPS enzyme drives the first step of aromatic amino acid biosynthesis in the plant shikimate pathway.

    “This enzyme is known to drive the first step of aromatic amino acid biosynthesis in the plant shikimate pathway; in addition estrogenic isoflavones and their glycosides are also products of this pathway (Duke et al., 2003).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites Duke et al., 2003 source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    R has been shown to disrupt aromatase which synthesizes estrogens, but also to interfere with estrogen and androgen receptors in cells.

    “R has been shown to disrupt aromatase which synthesizes estrogens (Richard et al., 2005), but to also interfere with estrogen and androgen receptors in cells (Gasnier et al., 2009).”
    Quote in the paperSubstantial claim0 of 2 sources checked
    • cites Richard et al., 2005 source

      Not checked in the free run.

    • cites Gasnier et al., 2009 source

      Not checked in the free run.

  • May combine two claims.

    Interpretationreasoning

    The similar pathological profiles provoked by the GM maize containing R residues may thus be explained at least by R residues themselves, knowing that the medium dose of the R treatment corresponds to acceptable levels of this pesticide residues in GMOs.

    “The similar pathological profiles provoked by the GM maize containing R residues may thus be explained at least by R residues themselves, knowing that the medium dose of the R treatment corresponds to acceptable levels of this pesticide residues in GMOs.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationcitation

    Other possible causes of observed pathogenic effects may be due to disturbed gene expression resulting from transgene insertional, general mutagenic or metabolic effects.

    “Other possible causes of observed pathogenic effects may be due to disturbed gene expression resulting from the transgene insertional, general mutagenic or metabolic effects (Latham et al., 2006;Wilson et al., 2006) as has been shown for MON810 GM maize (Rosati et al., 2008).”
    Quote in the paperNot a substantial claim0 of 3 sources checked
    • cites Latham et al., 2006 source

      Not checked in the free run.

    • cites Wilson et al., 2006 source

      Not checked in the free run.

    • cites Rosati et al., 2008 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Premisecitation

    It was previously known that glyphosate consumption in water above authorized limits may provoke hepatic and kidney failures.

    “In conclusion, it was previously known that glyphosate consumption in water above authorized limits may provoke hepatic and kidney failures (EPA).”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites EPA

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Interpretationcitation

    A consequent disruption of general metabolism in the GMO cannot be excluded, which could lead to production of other potentially active compounds such as miRNAs or leukotoxin diols.

    “A consequent disruption of general metabolism in the GMO cannot be excluded, which could lead, for example, to the production of other potentially active compounds such as miRNAs (Zhang et al., 2012) or leukotoxin diols (Markaverich et al., 2005).”
    Quote in the paperNot a substantial claim0 of 2 sources checked
    • cites Zhang et al., 2012 source

      Not checked in the free run.

    • cites Markaverich et al., 2005 source

      Not checked in the free run.

  • Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based).

    Interpretationnone given

    Other mutagenic and metabolic effects of the edible GMO cannot be excluded.

    “Other mutagenic and metabolic effects of the edible GMO cannot be excluded.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationreasoning

    The lesser effect on liver function in female animals may be due to their physiology being better adapted to estrogen metabolism.

    “The observation that liver function in female animals is less affected may be due to their physiology being better adapted to estrogen metabolism.”
    Quote in the paperNot a substantial claim
61 of 61

  • The paper relies on this without support.

    No regulatory authority requests mandatory chronic animal feeding studies to be performed for edible GMOs and formulated pesticides.

    “Currently, no regulatory authority requests mandatory chronic animal feeding studies to be performed for edible GMOs and formulated pesticides.”

  • The paper relies on this without support.

    None of the prior long-term and multi-generational animal feeding trials included a detailed follow-up of the animals with up to 11 blood and urine samples over 2 years, and none investigated the NK603 R-tolerant maize.

    “However, none of these studies have included a detailed followup of the animals with up to 11 blood and urine samples over 2 years, and none has investigated the NK603 R-tolerant maize.”

  • The paper relies on this without support.

    This report describes the first life-long rodent (rat) feeding study investigating possible toxic effects rising from an R-tolerant GM maize (NK603) and a complete commercial formulation of R herbicide.

    “This report describes the first life-long rodent (rat) feeding study investigating possible toxic effects rising from an R-tolerant GM maize (NK603) and a complete commercial formulation of Rherbicide.”

  • The paper relies on this without support.

    The variety of GM maize used in this study was judged by industry and regulators as substantially equivalent to the corresponding non-GM closest isogenic line.

    “This is despite the fact that the variety of GM maize used is this study was judged by industry and regulators as being substantially equivalent to the corresponding non-GM closest isogenic line.”

  • The paper relies on this without support.

    The total chemical composition of the GM maize cannot be measured in detail.

    “As the total chemical composition of the GM maize cannot be measured in details, the use of substantial equivalence is insufficient to highlight potential unknown toxins and therefore cannot replace long-term animal feeding trials for GMOs.”

  • The paper relies on this without support.

    The modified EPSPS is not inhibited by glyphosate, unlike the wild enzyme.

    “The modified EPSPS is not inhibited by glyphosate by contrast to the wild enzyme.”
6 of 6

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Male large-tumor frequency is reported as both fourfold and twofold

    Major

    The abstract says males had four times more large palpable tumors than controls, while the results say these tumors were, by the end of the experiment, twice as frequent on average.

1 of 1

Cites

1 retracted

Flagged first, then by citations

Research works printed but not linked: 2

  1. Cox, 2004, Herbicide factsheet – Glyphosate, J. pestic. reform, 24, 10
  2. Mesnage, 2010, Roundup in Genetically modified crops: Regulation and toxicity in mammals, Theorie in der Ökologie, 16, 31

Cited by

Sorted by citations

Related

Authors
Séralini, G.-E., Clair, E., Mesnage, R., Gress, S., Defarge, N., Malatesta, M., Hennequin, D., & de Vendômois, J. S.
Affiliations
  • Centre National de la Recherche Scientifique (FR)
  • University of Verona (IT)
  • Aliments Bioprocédés Toxicologie Environnements (FR)
ORCID
Venue
Food and Chemical Toxicology
Publisher
Elsevier BV
Published
2012-11
Volume
50
Issue
11
Pages
4221-4231
ISSN
0278-6915 (ISSN-L)
DOI
10.1016/j.fct.2012.08.005
OpenAlex
W2112857091
Semantic Scholar
c5bdef32a996dcc904f07fd1f670c2d527c1001a
Cited by
397
References
52
Citations by year
2026: 4 · 2025: 5 · 2024: 9 · 2023: 12 · 2022: 31 · 2021: 30 · 2020: 22 · 2019: 21 · 2018: 35 · 2017: 25 · 2016: 25 · 2015: 49 · 2014: 52 · 2013: 55 · 2012: 21
Type
retraction
Language
en
Status
Retracted
Update notices
Open access
Licence
Locations
  • Food and Chemical Toxicology (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • INFM-OAR (INFN Catania) (submittedVersion, cc-by-nc-nd)
Topics
  • Life Sciences › Agricultural and Biological Sciences › Plant Science › Genetically Modified Organisms Research
  • Life Sciences › Agricultural and Biological Sciences › Plant Science › Pesticide Exposure and Toxicity
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
Keywords
Roundup, glyphosate, chronic toxicity, Sprague-Dawley rats, tumor incidence, mortality, sample size, animal welfare, peer review, data validity, data falsification, data misrepresentation
MeSH terms
Glyphosate, Animals, Carcinogens, Zea mays, Dose-Response Relationship, Drug, Female, Glycine, Herbicides, Kidney, Liver, Male, Necrosis, Pituitary Gland, Mammary Neoplasms, Animal, Survival Rate, Rats, Sprague-Dawley, Plants, Genetically Modified, Toxicity Tests, Chronic, Microscopy, Electron, Transmission, Endocrine Disruptors

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-10.

Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-10.

Statistics and arithmetic are recomputed, not judged.

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