Annual Report of preparatory activities for the evaluation of toxicity studies supporting the GM food/feed safety assessment, performed during the period 28/11/2018 to 5/12/2019

Nonoxynols are chemically stable ethoxylated alkylphenols which are chemically foaming and solubilizing agents. Estimates of the acute oral LD50s of nine of the Nonoxynols (-2 to 15) range from 0.62 to 7.4 g/kg in several animal species. Acute dermal toxicity studies in rabbits produced an LD50 range of 1.8 ml/kg to 4.4 g/kg. Skin irritation tests on rabbits indicated that Nonoxynols are nonirritating to moderately irritating. Nonoxynol compounds with short ethoxylated chains are generally severe ocular irritants, whereas long-chained Nonoxynols are only slightly irritating to the rabbit eye. No evidence of carcinogenicity was observed when Nonoxynol-4 and 9 were fed to both dogs and rats. A mutagenicity study of these two compounds by the Ames test was negative. Undiluted Nonoxynol-4 and 9 were nonirritating and nonsensitizing in clinical studies. A 50% solution of Nonoxynol-15 and/or Nonoxynol-50 produced no irritation or sensitization when tested on 168 subjects, nor was there evidence of phototoxicity when tested on a subset of this population. It is concluded that Nonoxynols 2, 4, 8, 9, 10, 12, 14, 15, 30, 40, and 50 are safe as cosmetic ingredients.

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Safety assessment of the aqueous extract of the flowers of Nymphaea lotus Linn (Nymphaeaceae): Acute, neuro- and subchronic oral toxicity studies in albinos Wistar rats

Journal of Complementary and Integrative Medicine ◽

10.1515/jcim-2016-0046 ◽

2017 ◽

Vol 14 (2) ◽

Cited By ~ 1

Author(s):

Mireille Kameni Poumeni ◽

Danielle Claude Bilanda ◽

Paul Désiré Dzeufiet Djomeni ◽

Yolande Sandrine Mengue Ngadena ◽

Marguerite Francine Mballa ◽

...

Keyword(s):

Aqueous Extract ◽

Safety Assessment ◽

Wistar Rats ◽

Behavioral Changes ◽

Oral Toxicity ◽

Supplementary Food ◽

Toxicity Studies ◽

Dose Dependent

AbstractBackgroundLinn (MethodsAqueous extract ofResultsOur findings indicate dose-dependent elevation of nitrites contents in the flowers aqueous extract ofConclusionsdo not possesses neurotoxicity but is able to induce behavioral changes in rats. Therefore, the application of this plant as either drug or supplementary food should be carefully considered.

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Exploitation of molecular profiling techniques for GM food safety assessment

Current Opinion in Biotechnology ◽

10.1016/s0958-1669(03)00021-1 ◽

2003 ◽

Vol 14 (2) ◽

pp. 238-243 ◽

Cited By ~ 83

Author(s):

Harry A Kuiper ◽

Esther J Kok ◽

Karl-Heinz Engel

Keyword(s):

Food Safety ◽

Safety Assessment ◽

Molecular Profiling ◽

Gm Food ◽

Profiling Techniques

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Safety Assessment of Lactobacillus helveticus KLDS1.8701 Based on Whole Genome Sequencing and Oral Toxicity Studies

Toxins ◽

10.3390/toxins9100301 ◽

2017 ◽

Vol 9 (10) ◽

pp. 301 ◽

Cited By ~ 9

Author(s):

Bailiang Li ◽

Da Jin ◽

Smith Etareri Evivie ◽

Na Li ◽

Fenfen Yan ◽

...

Keyword(s):

Whole Genome Sequencing ◽

Genome Sequencing ◽

Safety Assessment ◽

Lactobacillus Helveticus ◽

Whole Genome ◽

Oral Toxicity ◽

Toxicity Studies

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Safety assessment of the methanol extract of the stem bark of Amphimas pterocarpoides Harms: Acute and subchronic oral toxicity studies in Wistar rats

Toxicology Reports ◽

10.1016/j.toxrep.2014.10.003 ◽

2014 ◽

Vol 1 ◽

pp. 877-884 ◽

Cited By ~ 11

Author(s):

Job Tchoumtchoua ◽

Oumarou Riepouo Mouchili ◽

Sylvin Benjamin Ateba ◽

Stéphane Zingue ◽

Maria Halabalaki ◽

...

Keyword(s):

Safety Assessment ◽

Wistar Rats ◽

Methanol Extract ◽

Stem Bark ◽

Oral Toxicity ◽

Toxicity Studies

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Preliminary safety assessment of Yarrowia lipolytica extracellular lipase: Results of acute and 28-day repeated dose oral toxicity studies in rats

Food and Chemical Toxicology ◽

10.1016/j.fct.2010.05.077 ◽

2010 ◽

Vol 48 (8-9) ◽

pp. 2393-2400 ◽

Cited By ~ 13

Author(s):

Saoussen Turki ◽

Zeineb Jabloun ◽

Ghada Mrabet ◽

Ammar Marouani ◽

Philippe Thonart ◽

...

Keyword(s):

Yarrowia Lipolytica ◽

Safety Assessment ◽

Repeated Dose ◽

Extracellular Lipase ◽

Oral Toxicity ◽

Toxicity Studies ◽

Dose Oral

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Food and feed safety assessment of RNAi plants and products.

RNAi for plant improvement and protection ◽

10.1079/9781789248890.0013 ◽

2021 ◽

pp. 131-153

Author(s):

Hanspeter Naegeli ◽

Gijs Klete ◽

Antje Dietz-Pfeilstetter

Keyword(s):

Risk Assessment ◽

Recombinant Proteins ◽

Safety Assessment ◽

Plant Metabolism ◽

Specific Effects ◽

Food And Feed ◽

Feed Safety ◽

Interfering Rna ◽

Data Requirements ◽

Food And Feed Safety

Abstract This paper evaluates the potential hazards of food and feed derived from RNAi plants including: adverse changes of plant metabolism; mechanisms and potential for non-target gene silencing in humans and livestock, including gut microbiome; bioinformatics tools for predictionof off-target sequences of interfering RNA; the possible non-specific effects of dsRNA and siRNA in mammals; and the comparison of data requirements for safety assessment of food and feed from RNAi plants and from plants expressing recombinant proteins. It also discusses exposure and RNAi-specific risk assessment.

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