No-observed-adverse-effect level
View article: Risk to human health related to the presence of perfluoroalkyl substances in food
Risk to human health related to the presence of perfluoroalkyl substances in food Open
The European Commission asked EFSA for a scientific evaluation on the risks to human health related to the presence of perfluoroalkyl substances (PFASs) in food. Based on several similar effects in animals, toxicokinetics and observed conc…
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Update on the Health Effects of Bisphenol A: Overwhelming Evidence of Harm Open
In 1997, the first in vivo bisphenol A (BPA) study by endocrinologists reported that feeding BPA to pregnant mice induced adverse reproductive effects in male offspring at the low dose of 2 µg/kg/day. Since then, thousands of studies have …
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Re-evaluation of titanium dioxide (E 171) as a food additive Open
The present Opinion deals with the re-evaluation of the safety of titanium dioxide (TiO 2 , E 171) when used as a food additive.From the available data on absorption, distribution and excretion, the EFSA Panel on Food Additives and Nutrien…
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Organ burden and pulmonary toxicity of nano-sized copper (II) oxide particles after short-term inhalation exposure Open
A 5-d, 6-h/day exposure equivalent to an aerosol of agglomerated CuO NPs resulted in a dose-dependent toxicity in rats, which almost completely resolved during a 3-week post-exposure period.
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Re‐evaluation of carrageenan (E 407) and processed Eucheuma seaweed (E 407a) as food additives Open
The present opinion deals with the re-evaluation of the safety of food-grade carrageenan (E 407) and processes Eucheuma seaweed (E 407a) used as food additives. Because of the structural similarities, the Panel concluded that processed Euc…
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Toxicity of the main electronic cigarette components, propylene glycol, glycerin, and nicotine, in Sprague-Dawley rats in a 90-day OECD inhalation study complemented by molecular endpoints Open
While the toxicity of the main constituents of electronic cigarette (ECIG) liquids, nicotine, propylene glycol (PG), and vegetable glycerin (VG), has been assessed individually in separate studies, limited data on the inhalation toxicity o…
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Re‐evaluation of glutamic acid (E 620), sodium glutamate (E 621), potassium glutamate (E 622), calcium glutamate (E 623), ammonium glutamate (E 624) and magnesium glutamate (E 625) as food additives Open
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of glutamic acid-glutamates (E 620-625) when used as food additives. Glutamate is absorbed in the intestine an…
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Safety of nisin (E 234) as a food additive in the light of new toxicological data and the proposed extension of use Open
The present scientific opinion deals with the evaluation of the safety of nisin (E 234) in the light of new toxicological data and with the proposed extension of use in unripened cheese and heat-treated meat products. Nisin (E 234) is curr…
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Safety assessment of Withania somnifera extract standardized for Withaferin A: Acute and sub-acute toxicity study Open
Based on this study, the no-observed-adverse-effect-level of WSE is 2000 mg/kg body weight, the highest level tested.
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Safety assessment of a standardized polyphenolic extract of clove buds: Subchronic toxicity and mutagenicity studies Open
Despite the various reports on the toxicity of clove oil and its major component eugenol, systematic evaluations on the safety of polyphenolic extracts of clove buds have not been reported. Considering the health beneficial pharmacological…
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Risk Assessment of Triclosan, a Cosmetic Preservative Open
Triclosan (TCS) is an antimicrobial compound used in consumer products. The purpose of current study was to examine toxicology and risk assessment of TCS based on available data. Acute toxicities of oral, transdermal and inhalation routes …
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Mixed “Antiandrogenic” Chemicals at Low Individual Doses Produce Reproductive Tract Malformations in the Male Rat Open
Biomonitoring efforts have clearly shown that all humans are exposed to chemical mixtures. Of concern is whether or not exposure to mixtures during pregnancy contributes to congenital abnormalities in children even when each chemical is at…
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Acute Oral Toxicity of Tetrodotoxin in Mice: Determination of Lethal Dose 50 (LD50) and No Observed Adverse Effect Level (NOAEL) Open
Tetrodotoxin (TTX) is starting to appear in molluscs from the European waters and is a hazard to seafood consumers. This toxin blocks sodium channels resulting in neuromuscular paralysis and even death. As a part of the risk assessment pro…
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Toxicological Evaluation of β-Caryophyllene Oil Open
In a subchronic toxicity study, administration of β-caryophyllene (BCP) oil by oral gavage to Wistar rats at dosages of 0, 150, 450, or 700 mg/kg/d for 90 days, including a 21-day recovery period, did not produce any significant toxicologi…
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Evaluation of Iron Oxide Nanoparticles Toxicity on Liver Cells of BALB/c Rats Open
Based on our results, the administration of Fe3O4-NPs causes dose dependent adverse effects on liver.
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Health Effects of Naphthalene Exposure: A Systematic Evidence Map and Analysis of Potential Considerations for Dose–Response Evaluation Open
Although both epidemiological and animal studies of naphthalene provide weight of evidence for hazard identification, the available animal studies appear more suitable for reference value derivation. PBPK models and mechanistic and toxicok…
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Analysis of public oral toxicity data from REACH registrations 2008-2014 Open
The European Chemicals Agency, ECHA, made available a total of 13,832 oral toxicity studies for 8,568 substances up to December 2014. 75% of studies were from the retired OECD Test Guideline 401 (11% TG 420, 11% TG 423 and 1.5% TG 425). Co…
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Assessment of information as regards the toxicity of fumonisins for pigs, poultry and horses Open
In 2018, the EFSA Panel on Contaminants in the Food Chain (CONTAM) adopted a Scientific Opinion on the risks for animal health related to the presence of fumonisins, their modified forms and hidden forms in feed. A no observed adverse effe…
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Re‐evaluation of β‐cyclodextrin (E 459) as a food additive Open
The EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re‐evaluating the safety of β‐cyclodextrin (E 459) as a food additive. β‐Cyclodextrin is a non‐reducing cyclic oligosaccharide consisti…
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Improved effect of pumpkin seed oil against the bisphenol-A adverse effects in male mice Open
The present study was conducted to evaluate the ameliorative role of pumpkin seed oil (PSO) against potential adverse effects of bisphenol-A (BPA) in male mice. BPA was administered to the mice orally at a dose of 50 mg/kg body weight once…
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Re‐evaluation of polyglycerol polyricinoleate (E 476) as a food additive Open
The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion re-evaluating the safety of polyglycerol polyricinoleate (PGPR, E 476) used as a food additive. In 1978, the Scientific Committee for Food (…
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Safety evaluation of syringic acid: subacute oral toxicity studies in Wistar rats Open
Syringic acid (SA) is a phenolic acid and have been investigated for diverse pharmacological activities, but the safety and/or mechanism of toxicity is still lacking in the literature. Subacute toxicity studies will add value to its pharma…
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Relationship between magnitude of body weight effects and exposure duration in mammalian toxicology studies and implications for ecotoxicological risk assessment Open
For regulatory approval of pesticides in the EU, an ecotoxicological risk assessment has to be conducted including an assessment of long-term effects on mammals. For this assessment, toxicity studies are considered which are conducted with…
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Toxicological evaluation of a saponin-rich standardized extract of fenugreek seeds (FenuSMART®): Acute, sub-chronic and genotoxicity studies Open
The present study investigated the safety of a saponin-rich standardized extract of fenugreek seeds (FenuSMART®; FHE), that has been clinically shown to be effective in ameliorating the postmenopausal discomforts and establishing hormonal …
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Acute Toxicity and Ecological Risk Assessment of Benzophenone and N,N-Diethyl-3 Methylbenzamide in Personal Care Products Open
Benzophenone (BP) and N,N-diethyl-3-methylbenzamide (DEET) are two chemicals often used in personal care products (PCPs). There is a lack of systematic ecotoxicological evaluations about the two chemicals to aquatic organisms. In the prese…
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Comparison of the developmental/reproductive toxicity and hepatotoxicity of phthalate esters in rats using an open toxicity data source Open
Phthalate esters (PEs) are widely used as plasticizers in various kinds of plastic products. Some PEs have been known to induce developmental and reproductive toxicity (DART) as well as hepatotoxicity in laboratory animals. In some cases o…
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An Evaluation of the Genotoxicity and Subchronic Oral Toxicity of Synthetic Curcumin Open
A battery of toxicological studies was conducted in accordance with international guidelines to investigate the genotoxicity and repeated-dose oral toxicity in rats of synthetic curcumin (VEAMIN 99, >99% purity). There was no evidence of m…
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Oral toxicity of titanium dioxide P25 at repeated dose 28-day and 90-day in rats Open
Background Nanotechnology is indispensable to many different applications. Although nanoparticles have been widely used in, for example, cosmetics, sunscreen, food packaging, and medications, they may pose human safety risks associated wit…
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The margin of internal exposure (MOIE) concept for dermal risk assessment based on oral toxicity data – A case study with caffeine Open
Route-to-route extrapolation is a common part of human risk assessment. Data from oral animal toxicity studies are commonly used to assess the safety of various but specific human dermal exposure scenarios. Using theoretical examples of va…
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Flaws in design, execution and interpretation limit CLARITY‐BPA’s value for risk assessments of bisphenol A Open
The Consortium Linking Academic and Regulatory Insights on BPA Toxicity (CLARITY‐BPA) involved the Food and Drug Administration, the National Toxicology Program and 14 academic investigators funded by the National Institute of Environmenta…