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Cited by 864Pesticide Exposure and ToxicityAgricultural safety and regulationsCarcinogens and Genotoxicity Assessment

RETRACTED: Safety Evaluation and Risk Assessment of the Herbicide Roundup and Its Active Ingredient, Glyphosate, for Humans

Williams, Gary M., Kroes, Robert, Munro, Ian C.·2000·Regulatory Toxicology and Pharmacology
DOI 10.1006/rtph.1999.1371
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Abstract

Reviews on the safety of glyphosate and Roundup herbicide that have been conducted by several regulatory agencies and scientific institutions worldwide have concluded that there is no indication of any human health concern. Nevertheless, questions regarding their safety are periodically raised. This review was undertaken to produce a current and comprehensive safety evaluation and risk assessment for humans. It includes assessments of glyphosate, its major breakdown product [aminomethylphosphonic acid (AMPA)], its Roundup formulations, and the predominant surfactant [polyethoxylated tallow amine (POEA)] used in Roundup formulations worldwide. The studies evaluated in this review included those performed for regulatory purposes as well as published research reports. The oral absorption of glyphosate and AMPA is low, and both materials are eliminated essentially unmetabolized. Dermal penetration studies with Roundup showed very low absorption. Experimental evidence has shown that neither glyphosate nor AMPA bioaccumulates in any animal tissue. No significant toxicity occurred in acute, subchronic, and chronic studies. Direct ocular exposure to the concentrated Roundup formulation can result in transient irritation, while normal spray dilutions cause, at most, only minimal effects. The genotoxicity data for glyphosate and Roundup were assessed using a weight-of-evidence approach and standard evaluation criteria. There was no convincing evidence for direct DNA damage in vitro or in vivo, and it was concluded that Roundup and its components do not pose a risk for the production of heritable/somatic mutations in humans. Multiple lifetime feeding studies have failed to demonstrate any tumorigenic potential for glyphosate. Accordingly, it was concluded that glyphosate is noncarcinogenic. Glyphosate, AMPA, and POEA were not teratogenic or developmentally toxic. There were no effects on fertility or reproductive parameters in two multigeneration reproduction studies with glyphosate. Likewise there were no adverse effects in reproductive tissues from animals treated with glyphosate, AMPA, or POEA in chronic and/or subchronic studies. Results from standard studies with these materials also failed to show any effects indicative of endocrine modulation. Therefore, it is concluded that the use of Roundup herbicide does not result in adverse effects on development, reproduction, or endocrine systems in humans and other mammals. For purposes of risk assessment, no-observed-adverse-effect levels (NOAELs) were identified for all subchronic, chronic, developmental, and reproduction studies with glyphosate, AMPA, and POEA. Margins-of-exposure for chronic risk were calculated for each compound by dividing the lowest applicable NOAEL by worst-case estimates of chronic exposure. Acute risks were assessed by comparison of oral LD50 values to estimated maximum acute human exposure. It was concluded that, under present and expected conditions of use, Roundup herbicide does not pose a health risk to humans.

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Registry

Crossref · 10.1006/rtph.1999.1371This paper is marked retracted.

Cites

84 of 84 references verified0 citation errors · 0 not checkable

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  • Toxicity evaluation of herbicides is generally performed on mammalian physiology through the long-term study of only their active principle, rather than the formulation used in agriculture, as was the case for glyphosate.

    “toxicity evaluation of herbicides is generally performed on mammalian physiology through the long-term study of only their active principle, rather than the formulation used in agriculture, as was the case for glyphosate (Williams et al., 2000)”

    From RETRACTED: Long term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize (2012) · cites this paper as Williams et al., 2000

  • Evaluation of long-term toxicity of herbicides is generally performed on mammalian physiology employing only their active principle, rather than the complete formulations as used in agriculture.

    “Furthermore, evaluation of long-term toxicity of herbicides is generally performed on mammalian physiology employing only their active principle, rather than the complete formulations as used in agriculture.”

    From Republished study: long-term toxicity of a Roundup herbicide and a Roundup-tolerantgenetically modified maize (2014) · cites this paper as [17]

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Authors
Williams, G. M., Kroes, R., & Munro, I. C.
Affiliations
  • New York Medical College (US)
  • Utrecht University (NL)
  • Cantox Health Sciences International (CA)
Corresponding author
Munro, Ian C.
ORCID
Williams, Gary M.
Venue
Regulatory Toxicology and Pharmacology
Publisher
Elsevier BV
Published
2000-04
Volume
31
Issue
2
Pages
117-165
ISSN
0273-2300 (ISSN-L)
DOI
10.1006/rtph.1999.1371
OpenAlex
W2163656090
Cited by
864
References
84
Citations by year
2026: 18 · 2025: 28 · 2024: 43 · 2023: 53 · 2022: 49 · 2021: 58 · 2020: 62 · 2019: 50 · 2018: 56 · 2017: 48 · 2016: 46 · 2015: 43 · 2014: 40 · 2013: 41 · 2012: 30
FWCI
11.77
Type
journal article
Language
en
Status
Retracted
Update notices
Open access
closed
Licence
Locations
  • Regulatory Toxicology and Pharmacology (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Agricultural and Biological Sciences › Plant Science › Pesticide Exposure and Toxicity
  • Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Carcinogens and Genotoxicity Assessment
Keywords
glyphosate, Roundup, aminomethylphosphonic acid, herbicide safety, human health risk assessment, genotoxicity, carcinogenicity, reproductive toxicity, developmental toxicity, endocrine disruption, no-observed-adverse-effect level, margin of exposure, percutaneous absorption, bioaccumulation, retracted article
MeSH terms
Abnormalities, Drug-Induced, Glyphosate, Animals, Carcinogens, DNA Damage, Environmental Exposure, Female, Glycine, Herbicides, Humans, Male, Mutagens, Organophosphorus Compounds, Polyethylene Glycols, Reproduction, Safety, Risk Assessment, Toxicity Tests

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