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144 results on '"D. Marzin"'

1. Fighting enteropathogenic E coli with algal polysaccharides

Author: M. Gallissot, M. Suarez, M. Berri, P. Nyvall-Collen, M. Porter, and D. Marzin
Published: 2022
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2. The microbial PhIP metabolite 7-hydroxy-5-methyl-3-phenyl-6,7,8,9-tetrahydropyrido[3′,2′:4,5]imidazo[1,2-a]pyrimidin-5-ium chloride (PhIP-M1) induces DNA damage, apoptosis and cell cycle arrest towards Caco-2 cells

Author: Lynn Vanhaecke, D. Marzin, Sofie Lust, Willy Verstraete, Lara Derycke, Frank Le Curieux, and Marc Bracke
Subjects: Programmed cell death, Cell Survival, DNA damage, Metabolite, Apoptosis, Biology, Toxicology, chemistry.chemical_compound, Humans, DAPI, Carcinogen, Cell Proliferation, Cell Cycle, Imidazoles, General Medicine, Cell cycle, Comet assay, Pyrimidines, chemistry, Biochemistry, Carcinogens, Comet Assay, Caco-2 Cells, DNA Damage, Mutagens
Abstract: 7-Hydroxy-5-methyl-3-phenyl-6,7,8,9-tetrahydropyrido[3',2':4,5]imidazo[1,2-a]pyrimidin-5-ium chloride (PhIP-M1) is a newly identified intestinal microbial metabolite from the food carcinogen 2-amino-1-methyl-6-phenylimidazo[4,5-b]pyridine (PhIP). Although the mutagenic potential of the endogenous N-hydroxy PhIP derivate has been reported, the risks associated with PhIP-M1 have not yet been explored. In this work, the cytotoxic and genotoxic effects originating from PhIP-M1 were assessed in the epithelial intestinal Caco-2 cell line. PhIP-M1 significantly decreased in a time- and dose-dependent manner mitochondrial dehydrogenase activity and protein synthesis, with IC50 values of, respectively, 180+/-39.4 and 173+/-20.3 microM after 24h, and 33.8+/-3.5 and 37.3+/-10.9 microM after 72 h. Apoptosis within the concentration ranges of cytotoxicity was confirmed by morphological examination, DAPI nuclear staining and annexin V staining. PhIP-M1 provoked cell cycle arrest, characterized by a significant increase in the number of nucleoids in the G2/M phase. A dose-dependent increase in DNA damage, as quantified by the alkaline comet assay, was observed after 3h in the 50-200 microM range. Because these PhIP-M1-induced genomic and cellular events may contribute to the carcinogenicity of PhIP, the potency of the colon microbiota to bioactivate PhIP must be included in future risk assessments.
Published: 2008
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3. La notion de seuil en mutagenèse : implications pour l’évaluation du risque mutagène et cancérogène

Author: D. Marzin
Subjects: Pharmacology, Threshold dose, Philosophy, Pharmaceutical Science, Humanities
Abstract: Resume Pendant longtemps, il a ete admis qu’il n’existait pas de seuil en mutagenese : un produit etait ou non mutagene, ce qui signifie que, quelle que soit la dose, il existait toujours un risque puisque, au moins theoriquement, une molecule pouvait reagir avec une base et provoquer ainsi une mutation. Cependant depuis ces dernieres annees, des travaux ont montre que pour certains mecanismes d’action mutagene, il etait possible de demontrer un seuil essentiellement dans le cas de produits ne reagissant pas directement avec l’ADN. Il existe differents types de seuils et le simple seuil statistique apparait comme etant insuffisant en terme d’evaluation du risque, il faut que l’on puisse etablir un seuil biologique reposant sur des mecanismes coherents avec un seuil. Parmi ces mecanismes, on peut retenir comme etant parfaitement demontre a seuil : les effets des aneugenes, les effets des inhibiteurs des topoisomerases, les inhibiteurs d’ADN polymerases, les produits provoquant une inhibition de la fidelite de la replication de l’ADN ou certains produits dont le metabolisme est different a faible et forte dose. En revanche, pour certains mecanismes, la demonstration d’un seuil est moins bien etablie, c’est le cas des produits induisant des desequilibres des pools de nucleotides ou les produits provoquant une inhibition de la reparation de l’ADN. Dans certains cas, des mecanismes impliquant des systemes existant de facon redondante dans la cellule, tels que la reparation de l’ADN des lesions oxydatives, laissent penser que des seuils pourraient exister. Certains auteurs tentent meme de demontrer qu’il existerait un seuil pour les agents alkylants. Si la plupart des seuils ont ete demontres in vitro , il a pu etre demontre egalement in vivo que certains mecanismes tels que les perturbations physiologiques comme l’hypo ou l’hyperthermie induisant des micronoyaux dans la moelle de rongeurs presentaient un seuil. L’utilisation d’une dose seuil pour l’evaluation du risque implique de retenir le marqueur le plus sensible, par exemple la non-disjonction dans le cas des aneugenes, afin d’eliminer les facteurs confondants comme l’apoptose et de prendre en compte les differences de sensibilite entre espece, mais aussi de demontrer que, si ce mecanisme a seuil existe, il est le seul a l’origine des effets mutagenes observes. La demonstration de tels seuils presente un interet particulier pour l’evaluation du risque pour l’homme des produits mutagenes et des cancerogenes genotoxiques.
Published: 2007
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4. Genotoxic activity of chlorohydroxyfuranones in the microscale micronucleus test on mouse lymphoma cells and the unscheduled DNA synthesis assay in rat hepatocytes

Author: Fabrice Nesslany, Frank Le Curieux, Leif Kronberg, D. Marzin, and Tony Munter
Subjects: Male, Lymphoma, Cell Survival, Health, Toxicology and Mutagenesis, DNA Fragmentation, Biology, Toxicology, medicine.disease_cause, Mice, Tumor Cells, Cultured, Genetics, CHFS, medicine, Animals, Furans, Genetics (clinical), Micronucleus Tests, Dose-Response Relationship, Drug, Mutagenicity Tests, In vitro toxicology, DNA, Molecular biology, Rats, Inbred F344, Rats, medicine.anatomical_structure, Liver, Cell culture, Hepatocyte, Micronucleus test, DNA fragmentation, Micronucleus, Genotoxicity, Mutagens
Abstract: Chlorohydroxyfuranones (CHFs) are mutagenic disinfection by-products found in chlorine-treated drinking water. In the current study, the genotoxicity of four CHFs, 3,4-dichloro-5-hydroxy-2(5H)-furanone (MCA), 3-chloro-4-methyl-5-hydroxy-2(5H)-furanone (MCF), 3-chloro-4-(chloromethyl)-5-hydroxy-2(5H)-furanone (CMCF) and 3-chloro-4-(dichloromethyl)-5-hydroxy-2(5H)-furanone (MX), was determined. Two in vitro assays, the microscale micronucleus assay on L5178Y mouse lymphoma cells and the unscheduled DNA synthesis assay on a hepatocyte primary culture from Fisher F344 rats, were carried out. All four CHFs demonstrated genotoxic effects in both assays. In the two systems used, CMCF was the most genotoxic compound, followed by MCA, MX and MCF, respectively. This work was the first study of the DNA damaging properties of all four CHFs in two in vitro genotoxicity tests. These new data expand the range of genetic damages induced by this group of compounds.
Published: 1999
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5. [Untitled]

Author: D. Marzin
Subjects: Genetics, Chemical compound, DNA damage, Health, Toxicology and Mutagenesis, Mutagen, Cell Biology, Computational biology, Gene mutation, Biology, Toxicology, medicine.disease_cause, Comet assay, chemistry.chemical_compound, chemistry, Micronucleus test, medicine, DNA microarray, Genotoxicity
Abstract: New developments in mutagenic risk assessment have appeared in the past few years. New methods have been developed such as in vitro micronucleus assay for chromosomal alterations, comet assay for primary DNA damage, use of transgenic animals to detect in vivo gene mutations, and fluorescent in situ hybridization method to detect aneuploidy. Other new methods will be developed in the few next years, including the use of DNA chips and the use of molecular biological methods. Several micromethods have been developed to test a great number of chemical compounds. New concepts have appeared concerning interpretation of data, and particularly of thresholds especially in the case of aneugens; in some cases metabolic or mechanistic thresholds were demonstrated. Genotoxic studies are best integrated into toxicological testing: for example, some genotoxicity tests can be integrated into subacute toxicology; interpretation of data includes metabolism; and toxicokinetic data relate to other toxicological studies. Conversely, genotoxicity data can be used to interpret toxicology studies.
Published: 1999
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6. Comparison of Different Genotoxic Tests for Biological Monitoring of Coke Oven Workers. Preliminary Results

Author: F. Klein, J.M. Haguenoer, M. De Meo, D. Marzin, G. Dumesnil, A. Pfohl-Leszkowicz, and Y. Grosse
Subjects: Coke oven, Polymers and Plastics, Chemistry, Organic Chemistry, technology, industry, and agriculture, 32p postlabelling, Sister chromatid exchange, Coke, Contamination, complex mixtures, Toxicology, Environmental chemistry, Biomonitoring, Materials Chemistry, Micronucleus, Carcinogen
Abstract: Chemical by-products of coke production are classified by IARC as carcinogenic in humans. Polycylic aromatic hydrocarbons (PAH) are the main compounds involved in carcinogenic and mutagenic activities of coke oven smokes, but many other compounds are present in emissions and could be involved in these activities. PAH analysis of the atmosphere indicated external contamination, but is not sufficient to evaluate the risk for exposed workers. The aim of this study was to evaluate relationship between atmospheric analysis of PAH and genotoxic markers in coke oven workers'white cells compared to controls. One hundred fifty-five exposed workers'samples were analyzed. They were selected in 5 coke production sites using a complete questionnaire allowing one to exclude all confounding factors. Two equal groups of smokers and nonsmokers were analysed. Analysis of chromosomal aberrations (CA), sister chromatid exchange (SCE), micronucleus (MN) and DNA-adduct formation using 32P-postlabelling were performed ...
Published: 1996
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7. [Notion of threshold in mutagenesis: implications for mutagenic and carcinogenic risk assessment]

Author: D, Marzin
Subjects: Carcinogenicity Tests, Endpoint Determination, Mutagenicity Tests, Carcinogens, Humans, Risk Assessment, Mutagens
Abstract: During years, it has been widely admitted in the scientific community that there was no threshold in mutagenesis: a compound was or not a mutagen. The meaning of such a proposition was that a risk existed at all exposure level, because, at least theoretically, one molecule is sufficient to cause the formation of a DNA adduct which is able to induce a mutation. However, works carried out in the last few years have shown that in the case of some specific mechanisms of mutagenesis, a threshold could be demonstrated essentially in the case of compounds that do not react directly with DNA. Several types of thresholds exist, and the simple statistical threshold is not sufficient in terms of risk assessment. A biological threshold that is consistent with a mechanism of action of the mutagen should be established. Amongst these mechanisms, we can mention some mechanism with a demonstrated threshold: effects of aneugens, effects of topoisomerases inhibitors, effects of DNA polymerases inhibitors, effects of compounds with a different metabolism at high doses compared to low doses. On the contrary, for some mechanisms, the demonstration of the mechanism is suspected, but not totally demonstrated. It is the case of compounds which induce nucleotides pool imbalance or compounds which are DNA repair inhibitors. In some cases, when a redundancy exists in the repair of damages, like oxidative DNA damage, a threshold is suspected. Some authors even recently proposed the possibility of a threshold in the case of alkylating agents. The majority of mutagenic thresholds were demonstrated in vitro, however some mechanisms were demonstrated in vivo, for example in the case of micronucleus induction by hypo or hyperthermia in rodents bone marrow. The use of threshold in risk assessment requires the use of the most sensitive endpoint for example, non disjunction in the case of aneugens, confusing factors like apoptosis should be eliminated and species sensitivities should be taken into account. A very important point to consider is to demonstrate that the mechanism with threshold was really thee only one involved in the mutagenic effect. The demonstration of such thresholds is of particular interest for human risk assessment in the case of mutagens and of genotoxic carcinogens.
Published: 2007

8. New approaches to estimating the mutagenic potential of chemicals

Author: D, Marzin
Subjects: Chromosome Aberrations, Mutagenicity Tests, Data Interpretation, Statistical, Animals, DNA Damage, Mutagens
Abstract: New developments in mutagenic risk assessment have appeared in the past few years. New methods have been developed such as in vitro micronucleus assay for chromosomal alterations, comet assay for primary DNA damage, use of transgenic animals to detect in vivo gene mutations, and fluorescent in situ hybridization method to detect aneuploidy. Other new methods will be developed in the few next years, including the use of DNA chips and the use of molecular biological methods. Several micromethods have been developed to test a great number of chemical compounds. New concepts have appeared concerning interpretation of data, and particularly of thresholds especially in the case of aneugens; in some cases metabolic or mechanistic thresholds were demonstrated. Genotoxic studies are best integrated into toxicological testing: for example, some genotoxicity tests can be integrated into subacute toxicology; interpretation of data includes metabolism; and toxicokinetic data relate to other toxicological studies. Conversely, genotoxicity data can be used to interpret toxicology studies.
Published: 2000

9. A micromethod for the in vitro micronucleus assay

Author: D. Marzin and Fabrice Nesslany
Subjects: Cytochalasin B, Health, Toxicology and Mutagenesis, Hamster, Mutagen, Biology, In Vitro Techniques, Toxicology, medicine.disease_cause, Sensitivity and Specificity, Cell Line, Clastogen, Mice, Cricetinae, Genetics, medicine, Animals, Cytotoxicity, Genetics (clinical), Biotransformation, Micronucleus Tests, Reproducibility of Results, Molecular biology, In vitro, Rats, Liver, Toxicity, Micronucleus test, Micronucleus, Mutagens
Abstract: A micromethod for the in vitro micronucleus assay was developed using L5178Y cells to enable the rapid screening of a large number of molecules. The method is quick, simple to perform and needs very small amounts of compound, i.e.
Published: 1999

10. Comparative genotoxicity of halogenated acetic acids found in drinking water

Author: F. le Curieux, F. Erb, D. Marzin, and S. Giller
Subjects: Salmonella typhimurium, Health, Toxicology and Mutagenesis, Dichloroacetic acid, Acetates, Toxicology, medicine.disease_cause, Microbiology, Ames test, chemistry.chemical_compound, Acetic acid, Water Supply, Genetics, medicine, Escherichia coli, Animals, Chloroacetates, Trichloroacetic acid, Trichloroacetic Acid, SOS Response, Genetics, Genetics (clinical), Chromatography, Micronucleus Tests, Dichloroacetic Acid, Mutagenicity Tests, Salamandridae, Hydrocarbons, Brominated, SOS chromotest, chemistry, Micronucleus test, Micronucleus, Genotoxicity, DNA Damage, Mutagens
Abstract: Three short-term assays (SOS chromotest, Ames fluctuation test and newt micronucleus test) were performed to detect the genotoxic activity of organohalides, compounds likely to be found in chlorinated and/or ozonated drinking water: monochloro-, dichloro- and trichloroacetic acids and mono-bromo-, dibromo- and tribromoacetic acids. With the SOS chromotest, only three of the chemicals studied (dichloroacetic acid, dibromo- and tribromoacetic acids) were found to induce primary DNA damage in Escherichia coli PQ 37. In the Ames fluctuation test, all the compounds except monochloroacetic acid showed mutagenic activity in Salmonella typhimurium strain TA100. In these two in vitro tests, a good correlation between increasing number of substituents and decreasing mutagenicity was observed. Namely, the toxicity of brominated and chlorinated acetic acids decreased when the number of substituents increased. The newt micronucleus test detected a weak clastogenic effect on the peripheral blood erythrocytes of Pleurodeles waltl larvae for trichloroacetic acid only.
Published: 1997

11. Use of the SOS chromotest, the Ames-fluctuation test and the newt micronucleus test to study the genotoxicity of four trihalomethanes

Author: F. Erb, Laury Gauthier, F. le Curieux, and D. Marzin
Subjects: Salmonella typhimurium, Erythrocytes, Health, Toxicology and Mutagenesis, Bromodichloromethane, Toxicology, medicine.disease_cause, Ames test, chemistry.chemical_compound, Clastogen, Structure-Activity Relationship, Pleurodeles, Genetics, medicine, Escherichia coli, Animals, SOS response, SOS Response, Genetics, Genetics (clinical), Chromatography, Micronucleus Tests, Dose-Response Relationship, Drug, Hydrocarbons, Halogenated, Mutagenicity Tests, Hydrocarbons, Brominated, SOS chromotest, chemistry, Micronucleus test, Chloroform, Bromoform, Genotoxicity, DNA Damage, Mutagens, Trihalomethanes
Abstract: Three short-term assays (the SOS chromotest, the Ames-fluctuation test and the newt micronucleus test) were carried out to evaluate the genotoxicity of four trihalomethanes (chloroform, bromodichloromethane, chlorodibromomethane and bromoform). With the SOS chromotest, all the chemicals studied except chloroform were found to induce primary DNA damage in Escherichia coli PQ37. In the Ames-fluctuation test, only bromoform showed mutagenic activity on Salmonella typhimurium strain TA100. The newt micronucleus assay detected a clastogenic effect on the peripheral blood erythrocytes of Pleurodeles waltl larvae for bromodichloromethane and bromoform. It appeared that the presence of bromine substituent(s) generally led to significant genotoxic activity. Moreover, the use of the metabolic system significantly increased the genotoxicity of the brominated trihalomethanes in the SOS chromotest. Unlike previous investigations in which the SOS chromotest was always the least interesting assay, this study exhibited the good efficiency of this in vitro test on E.coli for the detection of trihalomethanes with bromine substituents.
Published: 1995

12. Study of the genotoxic activity of six halogenated acetonitriles, using the SOS chromotest, the Ames-fluctuation test and the newt micronucleus test

Author: F. le Curieux, S. Giller, D. Marzin, Laury Gauthier, F. Erb, Centre National de la Recherche Scientifique - CNRS (FRANCE), Institut Pasteur (FRANCE), Université Toulouse III - Paul Sabatier - UT3 (FRANCE), and Université Lille 2, Droit et Santé (FRANCE)
Subjects: Pleurodeles, Acetonitriles, Toxicology, medicine.disease_cause, Bromine or chlorine substituent, Ames-fluctuation test, Ames test, SOS chromotest, Clastogen, Halogens, Sensitivity, Water Supply, Génétique des plantes, Genetics, medicine, polycyclic compounds, Animals, SOS response, SOS Response, Genetics, Chromatography, Micronucleus Tests, biology, Dose-Response Relationship, Drug, Chemistry, Mutagenicity Tests, biology.organism_classification, Halogenated acetonitrile, Newt micronucleus test, Micronucleus test, Chlorination by-product, Genotoxicity, Mutagens
Abstract: Three short-term assays (the SOS chromotest, the Ames-fluctuation test and the newt micronucleus test) were carried out to evaluate the genotoxicity of six halogenated acetonitriles identified in chlorinated waters (monochloro-, dichloro-, trichloro-, monobromo-, dibromo- and bromochloroacetonitrile). With the SOS chromotest, three of the chemicals studied (dichloro-, dibromo- and bromochloroacetonitrile) were found to induce primary DNA damage in Escherichia coli PQ37. In the Ames-fluctuation test, all the compounds except dibromoacetonitrile showed muta- genic activity on Salmonella typhimurium strain TA100. The newt micronucleus assay detected a clastogenic effect on the peripheral blood erythrocytes of Pleurodeles waltl larvae for all the six haloacetonitriles studied. Moreover, two structure-activity relationships were noted: (l) the genotoxic activity of haloacetonitriles containing bromine substituents appeared higher than the corresponding chlorinated acetonitriles and (2) the clastogenic activity of the chlorinated acetonitriles increased with the number of chlorine substituents.
Published: 1995

13. Study of the genotoxic activity of five chlorinated propanones using the SOS chromotest, the Ames-fluctuation test and the newt micronucleus test

Author: F. le Curieux, F. Erb, and D. Marzin
Subjects: Pleurodeles, Salmonella typhimurium, DNA damage, Toxicology, medicine.disease_cause, Ames test, Acetone, Clastogen, Water Supply, Genetics, medicine, Escherichia coli, Hydrocarbons, Chlorinated, Animals, SOS response, SOS Response, Genetics, Chromatography, Micronucleus Tests, biology, Chemistry, Mutagenicity Tests, biology.organism_classification, SOS chromotest, Allyl Compounds, Micronucleus test, Genotoxicity
Abstract: Three short-term assays (the SOS chromotest, the Ames-fluctuation test and the newt micronucleus test) were carried out to evaluate the genotoxicity of five chlorinated propanones identified in several chlorinated waters (monochloropropanone, 1,1-dichloropropanone, 1,3-dichloropropanone, 1,1,1-trichloropropanone and 1,1,3-trichloropropanone). In the SOS chromotest, all the compounds except monochloropropanone were found to induce primary DNA damage in Escherichia coli. With the fluctuation test, all five chloropropanones showed mutagenic activity on Salmonella typhimurium strain TA100. The newt micronucleus assay detected a clastogenic effect on the peripheral blood erythrocytes of Pleurodeles waltl larvae only for 1,3-dichloropropanone and 1,1,3-trichloropropanone. Moreover, two structure-activity relationships are noticeable: (1) chloropropanones with chlorine substituents on both carbon positions (1,3-DCP and 1,1,3-TCP) are by far more genotoxic than chloropropanones substituted only on one carbon position (1,1-DCP and 1,1,1-TCP); (2) the increase of the number of chlorine substituents decreases the mutagenic activity (fluctuation test) of the chlorinated propanones studied.
Published: 1994

14. Comparison of three short-term assays: results on seven chemicals. Potential contribution to the control of water genotoxicity

Author: F, Le Curieux, D, Marzin, and F, Erb
Subjects: Salmonella typhimurium, Mutagenicity Tests, Sodium Hypochlorite, Water Pollution, Salamandridae, Sensitivity and Specificity, 4-Nitroquinoline-1-oxide, Evaluation Studies as Topic, 2-Naphthylamine, Formaldehyde, Benzo(a)pyrene, Escherichia coli, Animals, Potassium Dichromate, Cyclophosphamide, DNA Damage, Environmental Monitoring, Mutagens
Abstract: Three short-term assays (the SOS chromotest, the Ames fluctuation test and the newt micronucleus test) were used to evaluate the genotoxicity of seven chemicals (4-nitroquinoline 1-oxide, potassium dichromate, formaldehyde, sodium hypochlorite, benzo[a]pyrene, cyclophosphamide and 2-naphthylamine). In the SOS chromotest, all seven compounds except sodium hypochlorite and cyclophosphamide were found to induce primary DNA damage in E. coli. With the Ames fluctuation test, all seven chemicals except sodium hypochlorite showed mutagenic activity on Salmonella typhimurium TA100, TA102 or TA98. The newt micronucleus assay detected a clastogenic effect of all seven compounds except formaldehyde on the peripheral blood erythrocytes of Pleurodeles waltl larvae. For each compound, the sensitivity of the tests was compared; (1) the SOS chromotest is the least sensitive assay in every case, (2) the Ames fluctuation test is the most sensitive assay for studied chemicals with direct genotoxic effect and (3) the newt micronucleus assay is the most sensitive test for tested compounds with indirect genotoxic activity. The potential contribution of these three tests in the monitoring of water genotoxicity is discussed.
Published: 1993

15. Trenbolone: application of the Ames test. Recent data

Author: D, Marzin
Subjects: Salmonella typhimurium, Anabolic Agents, Micronucleus Tests, Mutagenicity Tests, Cricetinae, Animals, Humans, CHO Cells, Trenbolone Acetate, Cell Line, HeLa Cells
Abstract: The mutagenicity of trenbolone, a synthetic androgen, was studied in a number of genotoxicity tests using in vitro and in vivo systems for gene mutations, chromosomal mutations and primary DNA damage demonstration. Only 2 tests were found to be positive or dubious: the in vitro micronucleus test in SHE cells (however, this test was negative in 2 other cell lines: C3H and CHO cells) and the Ames test for 1 of the 5 studies which found a positive result in TA 100 strain without metabolic activation. Repetition of this study with pure trenbolone showed no genotoxic activity; trenbolone was therefore considered to be devoid of genotoxic activity.
Published: 1991

16. Cellular uptake and biotransformation of arsenic V in transformed human cell lines HeLa S(3) and Hep G(2)

Author: F. Erb, D. Marzin, A. E. Peel, and A. Brice
Subjects: biology, Arsenate, chemistry.chemical_element, General Medicine, Methylation, Toxicology, biology.organism_classification, Molecular biology, In vitro, HeLa, Hep G2, chemistry.chemical_compound, chemistry, Biochemistry, Biotransformation, Cell culture, Arsenic
Abstract: The biotransformation of arsenate was studied in two human transformed cell lines (epithelial HeLa S(3) and hepatoma Hep G(2) cells) by the determination of several arsenic species both in the culture medium and in the cells. Arsenate reduction, which was observed in the two cell lines, was higher in Hep G(2) cells. Methylation appeared to be a minor pathway for HeLa cells, but was more important in the hepatoma cells.
Published: 1990

17. Repérage des expositions professionnelles aux solvants organiques dans l’industrie de la fabrication des colles et chaussures dans la ville de Sfax (Tunisie)

Author: P. Frimat, Moncef Khadhraoui, Imed Gargouri, D Marzin, Boubaker Elleuch, C. Nisse, A. Leroyer, and M. Larbi Masmoudi
Subjects: Public Health, Environmental and Occupational Health
Published: 2007
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18. Biological monitoring of coke oven workings using human lymphocytes

Author: A. Leszkowicz-Pfohl, F. Klein, J.M. Haguenoer, and D. Marzin
Subjects: Materials science, Coke oven, Metallurgy, Genetics, Toxicology
Published: 1996
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19. Potent genotoxic activity of benzo[a]pyrene coated onto hematite measured by unscheduled DNA synthesis in vivo in the rat.

Author: S. Garry, F. Nesslany, E.M. Aliouat, J-M. Haguenoer, and D. Marzin
Subjects: GENETIC toxicology, HYDROCARBONS, POLYCYCLIC aromatic compounds, LUNG cancer
Abstract: Since epidemiological studies have firmly implicated co-exposure to iron oxides and polycyclic aromatic hydrocarbons as a potential etiological factor involved in the excess mortality due to lung cancer in miners, experimental studies have been performed to investigate the role of iron particles in benzo[a]pyrene (B[a]P)-induced lung pathogenesis. In a previous study using the Comet assay in vivo in the rat, we demonstrated that iron particles enhanced B[a]P genotoxicity. To determine whether co-exposure (B[a]P/iron oxides) induces a real genotoxic activity or is only due to inhibition of DNA repair, the unscheduled DNA synthesis (UDS) assay was implemented in vivo in the rat. The UDS assay was used to measure DNA repair in two cell types (lung cells and hepatocytes) of OFA Sprague-Dawley rats, 24 h after endotracheal administration of a single dose of an iron oxide (hematite, Fe2O3) (0.75 mg), of B[a]P (0.75 mg) or of B[a]P (0.75 mg) coated on hematite particles (0.75 mg). No difference in UDS was observed in the two organs investigated in rats treated with iron oxide alone compared with control animals, while a significant increase in UDS was observed in lungs and liver of rats treated with B[a]P alone compared with control animals. The main finding was a significant increase in UDS observed in both lung and liver cells of rats treated with B[a]P coated on hematite when compared with those treated with B[a]P alone. The current study demonstrates (i) that iron particles did not inhibit UDS in lung cells and hepatocytes of OFA Sprague-Dawley treated rats with B[a]P coated on hematite and (ii) a potent genotoxic activity of co-exposure to B[a]P coated on hematite. Therefore, our data may contribute to explaining the excess mortality due to lung cancer in epidemiological studies and overall why exposure to B[a]P coated on Fe2O3 particles resulted in a higher tumor incidence in rodents compared with exposure to B[a]P alone. [ABSTRACT FROM AUTHOR]
Published: 2003
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20. Concentrations plasmatiques de l'imipramine et de la desmethylimipramine et effet anti-depresseur au cours d'un traitement control�

Author: R. Olivier-Martin, D. Marzin, E. Buschsenschutz, P. Pichot, and J. Boissier
Subjects: Pharmacology, Drug, media_common.quotation_subject, Therapeutic effect, Plasma levels, Drug interaction, Imipramine, Levomepromazine, Anesthesia, medicine, Antidepressant, Psychology, human activities, Depression (differential diagnoses), medicine.drug, media_common
Abstract: 24 depressed inpatients received a standardized treatment by imipramine, 6 among them receiving also levomepromazine. Plasma concentrations of imipramine and DMI were controlled weekly during the study, and standardized assessment of clinical state were made by a psychiatrist who was unaware of biochemical findings. Interaction between the antidepressant and neuroleptic metabolism is shown by a significant increase of DMI levels, though the clinical effect of the drug association could not be asserted. The therapeutic effect seems mainly dependant of etiology of depression. Endogeneous depressions improve more than other types. Among endogeneous depressions a significant correlation was found between the degree of clinical improvement after three weeks and DMI level, sum of imipramine + DMI level, but not with concentration of imipramine alone.
Published: 1975
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21. [Utilization of genotoxicity tests for biological surveillance of personnel exposure]

Author: D, Marzin
Subjects: Occupational Diseases, Mutagenicity Tests, Humans
Abstract: Monitoring of those staff exposed to products or atmospheres containing carcinogenic substances may be carried out using genetic toxicology tests. These tests may highlight primary DNA modifications, genetic or chromosomal mutations, detect mutagens at the urinary level or assess a global effect, expressed by a genotoxic effect. All these tests must be used taking into account exposure kinetics, the substance in question and exposure conditions.
Published: 1989

22. [Theory and practice of genetic toxicology tests. Tests on eukaryotes]

Author: D, Marzin
Subjects: Cell Nucleus, Chromosome Aberrations, DNA Repair, Mutagenicity Tests, Mutation, Animals, Chromosome Disorders, DNA, Chromosomes, Translocation, Genetic, Mutagens
Abstract: The search for a mutation prone activity on bacteria must be completed by tests on eucaryotes, in vitro as well as in vivo. Tests on eucaryotes enable to study agents inducing gene mutations [on yeats, cultures of mammal cells (V 79, L 5278 Y), lethal recessive mutation linked to the sex chromosome, on drosophils...], chromosomal mutations (metaphases analysis in vitro and in vivo, micronucleus, lethal dominance), the involvement of repair mechanisms of DNA (non-programmed DNA synthesis, exchange of sister chromatides...). One must well differentiate the tests usable routinely for a screening from the tests currently validated and routine tests. It is only at the completion of a set of tests on bacteria and eucaryotes cells that the potential mutation risk of a product for human health, may be ascertained.
Published: 1986

23. [Proposal for a strategy for research on mutagenic effects]

Author: D, Marzin and H, Vo Phi
Subjects: Genes, Mutagenicity Tests, Cells, Cultured, Chromosomes, Cell Line
Published: 1985

24. Mutagenicity of eight anthracycline derivatives in five strains of Salmonella typhimurium

Author: Jasmin C, R. Maral, D. Marzin, and Mathé G
Subjects: Salmonella typhimurium, endocrine system, Salmonella, Anthracycline, Naphthacenes, Daunorubicin, medicine.disease_cause, chemistry.chemical_compound, polycyclic compounds, medicine, Doxorubicin, Aclarubicin, Epirubicin, chemistry.chemical_classification, Antibiotics, Antineoplastic, Chemistry, Mutagenicity Tests, Zorubicin, fungi, Mutagenesis, food and beverages, Glycoside, Molecular biology, Oncology, Biochemistry, medicine.drug, Mutagens
Abstract: The mutagenicity of eight anthracycline derivatives, doxorubicin (adriamycin, ADM), daunorubicin (DNR), rubidazone (zorubicin), detorubicin (DTR), 4'-epi-adriamycin (4' epi-ADM), AD 32, N-leucyl daunorubicin (N-leu DNR) and aclacinomycin A, has been tested on Salmonella typhimurium TA 100, Ta 98, TA 1535, TA 1537 and TA 1538. All but aclacinomycin A were mutagenic. Adriamycin and daunorubicin were mutagenic in all five strains, but only at very high doses (40-100 micrograms/plate) in TA 1535 and 1537. TA 98 was the most sensitive strain. In general S9 mix (liver homogenate) increased the mutagenicity of the low doses of both compounds. Zorubicin, 4'-epi-adriamycin and detorubicin were mutagenic for TA 98 and TA 100 and slightly mutagenic in TA 1538. They were also activated by S9 mix. N-leu DNR and AD 32 were slightly but significantly mutagenic for TA 98 and TA 1538 and were also activated by S9 mix. Aclacinomycin A lacked mutagenic activity in the five strains even at cytotoxic doses, both in the presence and absence of S9 mix. The results with AD 32 N-leu DNR and aclacinomycin A strengthen the hypothesis according to which amino moiety of the anthracycline glycosides is essential for mutagenesis.
Published: 1983

25. Quantitative determination of dibekacin using radioimmunoassay, substrate-labelled fluorescent immunoassay and rate nephelometric inhibition immunoassay for tobramycin

Author: D. Duriez, A. Dewilde, D. Marzin, and P. Wattre
Subjects: Chromatography, medicine.diagnostic_test, Dibekacin, Chemistry, Radioimmunoassay, Substrate (chemistry), Fluorescent Antibody Technique, General Medicine, Cross Reactions, Quantitative determination, Kanamycin, Nephelometry and Turbidimetry, FLUORESCENT IMMUNOASSAY, Immunoassay, medicine, Tobramycin, Humans, Reagent Kits, Diagnostic, Nephelometry, medicine.drug
Abstract: Summary Radioimmunoassay, rate nephelometric inhibition immunoassay and substrate-labelled fluorescent immunoassay were employed for the quantitative determination of dibekacin in serum. The cross-reactivity of the antibody provided with each assay allowed the use of tobramycin assay procedures for measuring dibekacin concentrations. With radioimmunoassay and nephelometric immunoassay, a dibekacin calibration curve was required, whereas fluorescent immunoassay was directly suitable for dibekacin assay, with cross-reactivity of nearly 100%. This allows the purchase of one assay kit for testing two antibiotics and thus reduces the cost to medical laboratories.
Published: 1985

26. Participants

Author: D. Averbeck, N. Bichet, D. Bonneau, P.E. Bost, J. Cadet, L. Caillard, Y. Champey, I. Chouroulinkov, J.R. Claude, Y. Courtois, R. Cumming, A. Dayan, J. Dayan, F. Decloitre, M. Defais, J. Deregnaucourt, J.Y. Detaille, J. Drake, M. Estenne, M. Firth, B. Fleury, E. Fournier, N. Gerard, F. Guinot, B. Ingham, P. Janiaud, G. Jolles, L. Julou, D. Kirkland, P.E. Kramer, C. Lasne, G. Loiseau, C. Loquet, E. Lorge, P. Magd, F. Marano, D. Marzin, D. Papadopoulo, J. Pasquet, R. Rees, A. Rico, J. Roba, F. Roquet, C. Schlatter, R. Sebbag, M. Shahin, C. Silice, G. Siou, M. Teule, V. Thybaud, H. Tuchmann-Duplessis, B. Vannier, N. Weill, H. Wetzig, R. Woehrle, F. Würgler, and F. Zajdela
Published: 1989
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27. Aspects of cholesterol metabolism in normal and hypercholesterolemic Syrian hamsters. Influence of fenofibrate

Author: M O, Plancke, P, Olivier, V, Clavey, D, Marzin, and J C, Fruchart
Subjects: Cholesterol, Fenofibrate, Liver, Mesocricetus, Cricetinae, Lipoproteins, Hypercholesterolemia, Animals, Female, Propionates, Lipid Metabolism, Lipids, Triglycerides
Abstract: This study reports the short-term effects of fenofibrate in golden Syrian hamsters receiving a standard or cholesterol enriched (0.5%) diet. In chow fed control animals, the plasma cholesterol (132 mg/dl) was transported essentially by LDL (27%) and HDL (56%). Conversely, the bulk of triglycerides (114 mg/dl) circulated in VLDL (54%). One week of hypercholesterolemic diet increased plasma cholesterol (+80%) and it is reflected in a 3.3-fold increase in VLDL, 2.8-fold in IDL, 1.6-fold in LDL and 1.5-fold in HDL, accompanied by a rise in cholesterol hepatic level by a factor of 4.5. 15 days of treatment with fenofibrate (300 mg/kg/d) produced a decrease in free plasma cholesterol (-21%) without modification in total cholesterol level in chow fed animals. In liver, cholesterol was reduced by 27% and triglycerides were raised by 58%. In animals receiving the hypercholesterolemic diet, fenofibrate increased hepatic and plasmatic triglyceride levels (55 and 54%, respectively), although it slightly reduced plasma cholesterol levels and more markedly the hepatic cholesterol content (-55%). In chow fed animals, cholesterol biosynthesis was decreased by fenofibrate treatment by 40%. The effects of fenofibrate on triglyceride levels are in contrast to experiences in other animal species, including man, and indicate a hypersecretion of chylomicrons and/or a hypersecretion of VLDL, although the explanations are not yet obvious. The results concerning cholesterol metabolism indicate similarities between man and hamster.
Published: 1988

28. Ames test and trenbolone

Author: D. Marzin
Subjects: Salmonella typhimurium, Mutagenicity Tests, Chemistry, Health, Toxicology and Mutagenesis, Pharmacology toxicology, General Medicine, Trenbolone acetate, Toxicology, Ames test, chemistry.chemical_compound, Trenbolone, medicine, Trenbolone Acetate, Food science, Estrenes, Mutagenicity Test, Mutagens, medicine.drug
Published: 1989
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29. Comparative study of mutagenicity of nitrosourea and anthracyclic derivatives

Author: P. Ribaud, Jasmin C, G. Mathe, D. Marzin, and J.L. Imbach
Subjects: Nitrosourea, chemistry.chemical_compound, chemistry, Stereochemistry, Genetics, Toxicology
Published: 1981
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30. Biochemical toxicology: A practical approach

Author: D. Marzin
Subjects: Philosophy, General Medicine, Biochemistry, Classics
Published: 1988
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31. Effects of dietary marine sulphated polysaccharides (Algimun®) on growth performance, immune responses and disease resistance of juvenile gilthead seabream (Sparus aurata) to Photobacterium damselae subsp. piscicida.

Author: Güroy D, Güroy B, Bilen S, Terzi E, Kenanoğlu ON, García-Suárez M, Marzin D, Mantoğlu S, Karadal O, Şahin İ, and Kuşku H
Subjects: Animals, Dietary Carbohydrates, Disease Resistance, Photobacterium, Polysaccharides, Fish Diseases, Gram-Negative Bacterial Infections, Sea Bream
Abstract: The present study evaluated the effects of a dietary mix of marine sulphated polysaccharides, named Algimun® (AL), supplementation to gilthead seabream (Sparus aurata) juveniles in terms of growth performance, immune responses, and resistance against Photobacterium damselae subsp. piscicida. A total of 240 fish (initial mean weight of 6.00 ± 0.03 g) was randomly separated into 12 tanks (400 L, 20 fish per tank) distributed in four replicates. Fish were fed three experimental diets: a basal diet (Control), and a basal diet with two inclusion rates of Algimun® as 3 g/kg (AL0.3) and 5 g/kg (AL0.5) for 30 days before bacterial infection with P. damselae subsp. piscicida. After a 30-day feeding-period, growth performance was significantly improved in AL0.3 and AL0.5 groups compared to the control group (P < 0.05). AL0.3 and AL0.5 groups showed significantly higher lysozyme activity and myeloperoxidase activity when compared to the control group (P < 0.05). The gene expression of immune mediators (IL-1β, IL-6, IL-10, IL-18, TNF-α and COX-2) was significantly upregulated in the intestine, spleen and head kidney in AL0.3 and AL0.5 groups when compared to the control group (P < 0.05). Eight days post-challenge, the survival rate against P. damselae subsp. piscicida was numerically higher in fish within AL0.3 and AL0.5 groups compared to control (+20%). The study findings suggest that marine sulphated polysaccharides (Algimun®) could be used as an immunomodulator in gilthead seabream to support animal's health and boost resistance in case of disease outbreak., (Copyright © 2022 Elsevier Ltd. All rights reserved.)
Published: 2022
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32. Scientific Opinion on Flavouring Group Evaluation 7, Revision 6 (FGE.07Rev6): saturated and unsaturated aliphatic secondary alcohols, ketones and esters of secondary alcohols and saturated linear or branched-chain carboxylic acids from chemical group 5.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler PJ, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Manco M, Moldeus P, Passamonti S, Shah R, Waalkens-Berendsen I, Wölfle D, Wright M, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Nørby KK, Svendsen C, Vianello G, and Mennes W
Abstract: The EFSA Panel on Food Additives and Flavourings was requested to evaluate 55 flavouring substances assigned to the Flavouring Group Evaluation 07 (FGE.07), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Fifty-three substances have already been considered in FGE.07 and its revisions. This revision 6 includes two additional substances which have been cleared with respect to genotoxicity in FGE.201Rev2 (4-methyl-3-hepten-5-one [FL-no: 07.261]) and FGE.204Rev1 (non-2-en-4-one, [FL-no: 07.187]). The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC) and available data on metabolism and toxicity. The Panel concluded that none of the 55 substances gives rise to safety concerns at their levels of dietary intake, when estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate. Normal and maximum use levels were available for all flavouring substances. For 52 substances, including the newly included substances [FL-no: 07.187 and 07.261], their 'modified Theoretical Added Maximum Daily Intakes' (mTAMDIs) estimates were above the TTC for their structural classes (I and II). Therefore, for these 52 flavouring substances, more detailed data on uses and use levels should be provided to finalise their safety evaluations., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)
Published: 2022
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33. Scientific Opinion on Flavouring Group Evaluation 63, Revision 4 (FGE.63Rev4): consideration of aliphatic secondary saturated and unsaturated alcohols, ketones and related esters evaluated by JECFA (59th and 69th meetings) structurally related to flavouring substances evaluated by EFSA in FGE.07Rev6.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler PJ, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Manco M, Moldeus P, Passamonti S, Shah R, Waalkens-Berendsen I, Wölfle D, Wright M, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Nørby KK, Svendsen C, Vianello G, and Mennes W
Abstract: The EFSA Panel on Food Additives and Flavourings was requested to evaluate 43 flavouring substances assigned to the Flavouring Group Evaluation 63 (FGE.63), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty-nine substances have already been considered in FGE.63 and its revisions ([FL-no: 02.023, 02.099, 02.104, 02.136, 02.155, 02.252, 07.015, 07.069, 07.081, 07.099, 07.100, 07.101, 07.102, 07.114, 07.123, 07.151, 07.190, 07.240, 07.247, 07.249, 07.256, 09.281, 09.282, 09.657, 09.658, 09.923, 09.924, 09.925 and 09.936]). The remaining 14 flavouring substances have been cleared with respect to genotoxicity in FGE.204Rev1 ([FL-no: 02.102, 02.193, 07.044, 07.048, 07.082, 07.104, 07.105, 07.106, 07.107, 07.121, 07.139, 07.177, 07.188 and 07.244]) and they are considered in this revision 4 of FGE.63. The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC) and available data on metabolism and toxicity. The Panel concluded that none of these 43 substances gives rise to safety concerns at their levels of dietary intake, when estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate for 43 flavouring substances. However, for 14 of these flavouring substances in the present revision and for 10 of the substances in the previous revision (FGE.63Rev3), the 'modified Theoretical Added Maximum Daily Intakes' (mTAMDIs) values are equal to or above the TTCs for their structural classes (I and II). For 15 substances previously evaluated in FGE.63Rev3, use levels are still needed to calculate the mTAMDI estimates. Therefore, in total for 39 flavouring substances, more data on uses and use levels should be provided to finalise their safety evaluations., (© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.)
Published: 2022
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34. Scientific Opinion on Flavouring Group Evaluation 67, Revision 3 (FGE.67Rev3): consideration of 23 furan-substituted compounds evaluated by JECFA at the 55th, 65th, 69th and 86th meetings.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Manco M, Moldeus P, Passamonti S, Shah R, Waalkens-Berendsen I, Wölfle D, Wright M, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Carfì M, Vianello G, and Mennes W
Abstract: The Panel on Food Additives and Flavourings (FAF) was requested to consider the JECFA evaluations of 25 flavouring substances assigned to the Flavouring Group Evaluation 67 (FGE.67Rev3), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Eleven substances have already been considered in FGE.67 and its revisions (FGE.67Rev1 and FGE.67Rev2). During the current assessment, two substances were no longer supported by industry, therefore 12 candidate substances are evaluated in FGE.67Rev3. New genotoxicity and toxicity data are available for 2-pentylfuran [FL-no: 13.059] and 2-acetylfuran [FL-no: 13.054], which are representative substances of subgroup IV [FL-no: 13.069, 13.106, 13.148] and VI-B [FL-no: 13.045, 13.070, 13.083, 13.101, 13.105, 13.138, 13.163], respectively. Based on these data, the Panel concluded that the concern for genotoxicity is ruled out for both [FL-no: 13.054] and [FL-no: 13.059] and consequently for the substances that they represent. Since the candidate substances cannot be anticipated to be metabolised to innocuous products only, they were evaluated along the B-side of the Procedure. The Panel derived a NOAEL of 22.6 mg/kg bw per day and a BMDL of 8.51 mg/kg bw per day, for 2-acetylfuran and 2-pentylfuran, respectively. For all 12 substances sufficient margins of safety were calculated when based on the MSDI approach. Adequate specifications for the materials of commerce are available for all 23 flavouring substances. The Panel agrees with JECFA conclusions, for all 23 substances, 'No safety concern at estimated levels of intake as flavouring substances' based on the MSDI approach. For 18 substances [FL-no: 13.021, 13.022, 13.023, 13.024, 13.031, 13.045, 13.047, 13.054, 13.059, 13.074, 13.083, 13.101, 13.105, 13.106, 13.138, 13.148, 13.163 and 13.190], the mTAMDI intake estimates are above the threshold of toxicological concern (TTC) for their structural classes and more reliable data on uses and use levels are required to finalise their evaluation., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2021
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35. Scientific Opinion on Flavouring Group Evaluation 13 Revision 3 (FGE.13Rev3): furfuryl and furan derivatives with and without additional side-chain substituents and heteroatoms from chemical group 14.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Manco M, Moldeus P, Passamonti S, Shah R, Waalkens-Berendsen I, Wölfle D, Wright M, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Carfì M, Vianello G, and Mennes W
Abstract: The Panel on Food additives and Flavourings of the EFSA was requested to update Flavouring Group Evaluation 13 using the Procedure as outlined in Commission Regulation (EC) No 1565/2000, to include an evaluation of the flavouring substances 2-ethyl-5-methylfuran [FL-no: 13.125] and 2-octylfuran [FL-no: 13.162]. FGE.13 revision 3 (FGE.13Rev3) deals with 26 flavourings substances of which 24 have been already evaluated to be of no safety concern. For [FL-no: 13.125] and [FL-no: 13.162], a concern for genotoxicity was raised in FGE.13Rev1. This concern could be ruled out based on new genotoxicity data on supporting substances in FGE.67Rev3. Subsequently, [FL-no: 13.125 and 13.162] were evaluated, through a stepwise approach that integrates intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity, along the B-side of the Procedure, making use of a BMDL of 8.51 mg/kg body weight (bw) per day. The Panel derived this BMDL from an oral subchronic toxicity study with the supporting substance 2-pentylfuran [FL-no: 13.059]. Using this BMDL, for [FL-no: 13.125 and 13.162], adequate margins of safety were calculated based on the MSDI approach. The Panel concluded that the 26 candidate substances in FGE.13Rev3 do not give rise to safety concerns at their levels of dietary intake, when estimated on the basis of the MSDI approach. Adequate specifications for the materials of commerce have been provided for all 26 substances. Data on uses and use levels are needed for [FL-no: 13.130]. For 21 flavouring substances [FL-no: 13.011, 13.102, 13.108, 13.113, 13.114, 13.122, 13.125, 13.127, 13.129, 13.132, 13.133, 13.135, 13.136, 13.139, 13.141, 13.143, 13.146, 13.149, 13.162, 13.178 and 13.185], the mTAMDI intake estimates are above the TTC for their structural class and more reliable data on uses and use levels are required to finalise their evaluation., (© 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2021
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36. Scientific Opinion on Flavouring Group Evaluation 69, Revision 1 (FGE.69Rev1): consideration of aromatic substituted secondary alcohols, ketones and related esters evaluated by JECFA (57th meeting), structurally related to aromatic ketones from chemical group 21 evaluated by EFSA in FGE.16Rev2.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Manco M, Moldeus P, Passamonti S, Shah R, Waalkens-Berendsen I, Wölfle D, Wright M, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, and Mennes W
Abstract: The EFSA Panel on Food Additives and Flavourings was requested to evaluate 35 flavouring substances attributed to the Flavouring Group Evaluation 69 (FGE.69), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Thirty-two substances have already been considered in FGE.69 [FL-no: 02.033, 02.034, 02.036, 02.064, 02.065, 02.080, 07.004, 07.013, 07.022, 07.023, 07.025, 07.026, 07.028, 07.029, 07.032, 07.038, 07.040, 07.042, 07.070, 07.079, 07.086, 07.087, 09.144, 09.178, 09.179, 09.189, 09.200, 09.231, 09.249, 09.476, 09.486 and 09.501]. The remaining three substances [FL-no: 02.066, 07.024 and 07.027] have been cleared with respect to genotoxicity in FGE.215Rev1 and are considered in this revision FGE.69Rev1. The substances were evaluated through a stepwise approach, namely the Procedure, that integrates information on the structure-activity relationships, intake from current uses, Threshold of Toxicological Concern (TTC) and available data on metabolism and toxicity. The Panel considered that for 33 flavouring substances evaluated through the Procedure the specifications are adequate and the Panel agrees with JECFA conclusions 'No safety concern at estimated levels of intake as flavouring substances' when based on the MSDI approach. For two flavouring substances [FL-no: 07.038 and 07.042], there is insufficient information on their chemical identity to reach a final conclusion. For six substances [FL-no: 02.066, 07.013, 07.024, 07.028, 07.032 and 07.086], there is no concern when the exposure was estimated based on the 'modified Theoretical Added Maximum Daily Intake' (mTAMDI) approach. For 28 substances, use levels are needed to calculate the mTAMDI estimates in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation accordingly. For one substance [FL-no: 07.027], more reliable data on uses and use levels are required in order to finalise the safety evaluation., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2020
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37. Scientific Opinion on Flavouring Group Evaluation 91, Revision 3 (FGE.91Rev3): consideration of aliphatic, aromatic and α,β-unsaturated sulfides and thiols evaluated by JECFA (53rd, 61st, 68th and 76th meetings), structurally related to substances in FGE.08Rev5.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Manco M, Moldeus P, Oskarsson A, Passamonti S, Shah R, Waalkens-Berendsen I, Wölfle D, Wright M, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Vianello G, and Mennes W
Abstract: The EFSA Panel on Food Additives and Flavourings was requested to evaluate 49 flavouring substances assigned to the Flavouring Group Evaluation 91 (FGE.91), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Forty-four substances have been considered in FGE.91 and its revisions (FGE.91Rev1 and FEG.91Rev2). With regard to the remaining five flavouring substances considered in this revision 3 of FGE.91: two ([FL-no: 12.065 and 12.079]) have been cleared with respect to genotoxicity in FGE.201Rev2; two ([FL-no: 12.169 and 12.241]) were originally allocated to FGE.74Rev4 and one ([FL-no: 12.304]) to FGE.08Rev5. The Panel considered the flavouring substance [FL-no: 12.169] representative for the tertiary monothiols [FL-no: 12.038, 12.085, 12.137, 12.138, 12.145, 12.252, 12.259, 12.241 and 12.304]. The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of these 49 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. The specifications for the materials of commerce have also been considered and found adequate for all 49 flavouring substances. For five substances [FL-no: 12.077, 12.162, 12.265, 12.267 and 17.036], evaluated through the Procedure in FGE.91Rev2, no normal and maximum use levels are available. For 10 substances [FL-no: 12.065, 12.038, 12.079, 12.108, 12.139, 12.264, 12.274, 12.252, 12.284 and 12.304], the modified Theoretical Added Maximum Daily Intake (mTAMDI) intake estimates are above the TTC for their structural class. Therefore, for these 15 substances, more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2020
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38. Scientific Opinion on Flavouring Group Evaluation 72, Revision 2 (FGE.72Rev2): consideration of aliphatic, branched-chain saturated and unsaturated alcohols, aldehydes, acids and related esters evaluated by JECFA (61st, 68th and 69th meetings) and structurally related to flavouring substances in FGE.05Rev3.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Vianello G, and Mennes W
Abstract: The EFSA Panel on Food Additives and Flavourings was requested to evaluate 31 flavouring substances assigned to the Flavouring Group Evaluation 72 (FGE.72), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Twenty-three substances have already been considered in FGE.72 and FGE.72Rev1 ([FL-no: 02.011, 02.012, 02.027, 02.029, 02.058, 02.076, 02.109, 05.020, 05.021, 05.124, 05.148, 05.169, 08.036, 08.044, 08.047, 08.055, 08.064, 08.070, 08.079, 09.273, 09.408, 09.931 and 16.001]). The remaining eight flavouring substances have been cleared with respect to genotoxicity in FGE.200Rev1 ([FL-no: 05.114]) and FGE.201Rev2 ([FL-no: 02.174, 05.033, 05.090, 05.095, 05.105, 05.107 and 05.126]) and they are considered in this revision 2 of FGE.72. The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of these 31 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate for all 31 flavouring substances. For 21 substances, evaluated through the Procedure in the previous revision (FGE.72Rev1), no normal and maximum use levels are available. For four substances, the modified Theoretical Added Maximum Daily Intake (mTAMDI) intake estimates are equal to ([FL-no: 05.090]) or above ([FL-no: 05.107, 05.105, 05.033]) the TTC for their structural class. Therefore, for these 25 substances more detailed data on uses and use levels should be provided in order to refine their exposure assessments and to finalise their safety evaluations., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2020
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39. Scientific Opinion on Flavouring Group Evaluation 61 Revision 2 (FGE.61Rev2): consideration of aliphatic acetals evaluated by JECFA (57th, 63rd and 68th meetings) structurally related to acetals evaluated by EFSA in FGE.03Rev2.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Carfì M, Martino C, and Mennes W
Abstract: The EFSA Panel on Food Additives and Flavourings was requested to evaluate 12 flavouring substances attributed to the Flavouring Group Evaluation 61 (FGE.61), using the Procedure as outlined in the Commission Regulation (EC) No 1565/2000. Nine substances have already been considered in FGE.61 and FGE.61Rev1 [FL-no: 06.001, 06.004, 06.005, 06.008, 06.009, 06.015, 06.028, 06.037, 06.081]. The remaining three substances [FL-no: 06.025, 06.031 and 06.072] have been cleared with respect to genotoxicity in FGE.200Rev1 and are considered in this revision 2 of FGE.61. The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of the 12 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate. For nine flavouring substances [FL-no: 06.001, 06.004, 06.005, 06.008, 06.009, 06.015, 06.028, 06.037 and 06.081], use levels are still needed to calculate the modified Theoretical Added Maximum Daily Intake (mTAMDI) values in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation accordingly., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2020
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40. Scientific Opinion on Flavouring Group Evaluation 71 Revision 1 (FGE.71Rev1): consideration of aliphatic, linear, α,β-unsaturated alcohols, aldehydes, carboxylic acids, and related esters evaluated by JECFA (63rd and 69th meeting) structurally related to flavouring substances evaluated in FGE.05Rev3.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Martino C, and Mennes W
Abstract: The EFSA Panel on Food Additives and Flavourings was requested to evaluate 39 flavouring substances assigned to the Flavouring Group Evaluation 71 (FGE.71), using the Procedure in Commission Regulation (EC) No 1565/2000. Nine substances have already been considered in FGE.71 [FL-no: 08.054, 08.073, 08.123, 09.037, 09.156, 09.157, 05.158, 09.235, 09.239]. The remaining 30 substances [FL-no: 02.020, 02.050, 02.090, 02.112, 02.137, 02.156, 02.210, 05.037, 05.060, 05.070, 05.073, 05.076, 05.078, 05.102, 05.109, 05.150, 05.171, 05.179, 09.276, 09.277, 09.303, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.678 and 09.841] have been cleared with respect to genotoxicity in FGE.200Rev1 and they are considered in this revision. The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of the 39 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate, except for [FL-no: 08.073 and 09.235]. For these two substances, data on the composition of the stereoisomeric mixture should be requested. Normal and maximum use levels should be provided for nine flavouring substances [FL-no: 08.054, 08.073, 08.123, 09.037, 09.156, 09.157, 05.158, 09.235, 09.239]. For two flavouring substances [FL-no: 02.020 and 05.076], the 'modified Theoretical Added Maximum Daily Intake' (mTAMDI) estimates are above the TTC for their structural class I. Therefore, additional information on uses and use levels should be provided for these eleven substances in order to finalise their evaluation., (© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2020
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41. Scientific Opinion on Flavouring Group Evaluation 215 Revision 1 (FGE.215Rev1): seven α,β-unsaturated cinnamyl ketones from subgroup 3.2 of FGE.19.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Carfì M, and Mennes W
Abstract: The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of flavouring substances from subgroup 3.2 of FGE.19 in the Flavouring Group Evaluation 215, Revision 1 (FGE.215Rev1). In FGE.215, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the concern for genotoxicity could not be ruled out and requested in vivo data for the two representative substances 4-phenylbut-3-en-2-one [FL-no: 07.024] and 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030]. The Flavour Industry has provided additional genotoxicity studies for both representative substances [FL-no: 07.024] and [FL-no: 07.030]. Based on these new data, the Panel concluded that the concern for genotoxicity is ruled out for the representative substance [FL-no: 07.024] and for the structurally related substances 4-phenylbut-3-en-2-ol [FL-no: 02.066] and 3-methyl-4-phenylbut-3-en-2-one [FL-no: 07.027] which can accordingly be evaluated through the Procedure in FGE.69. For the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030], the Panel concluded that [FL-no: 07.030] is aneugenic in vitro . For such substances, there is currently no agreed follow-up strategy to finalise their safety assessment. The Panel is aware that the EFSA Scientific Committee is going to address this issue and a statement clarifying the assessment of in vitro aneugenic substances is under preparation. The Panel concluded therefore that, for the time being, the representative substance 1-(4-methoxyphenyl)pent-1-en-3-one [FL-no: 07.030] and the structurally related substances vanillylidene acetone [FL-no: 07.046] and 1-(4-methoxyphenyl)-4-methylpent-1-en-3-one [FL-no: 07.049] cannot be evaluated through the Procedure. The Panel further concluded that 4-(2,3,6-trimethylphenyl)but-3-en-2-one [FL-no: 07.206] is to be considered as a stand-alone substance due to the presence of the methyl groups, therefore, in vitro genotoxicity data were requested for [FL-no: 07.206]. Industry communicated that the evaluation of [FL-no: 07.206] is not supported any longer, therefore additional data were not submitted., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2019
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42. Scientific Opinion on Flavouring Group Evaluation 5, Revision 3 (FGE.05Rev3): Branched- and straight-chain unsaturated aldehydes, dienals, unsaturated and saturated carboxylic acids and related esters with saturated and unsaturated aliphatic alcohols and a phenylacetic acid related ester from chemical groups 1, 2, 3, 5 and 15.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Carfì M, Martino C, Vianello G, and Mennes W
Abstract: The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate 54 flavouring substances attributed to the Flavouring Group Evaluation 05 (FGE.05), using the Procedure as referred to in the Commission Regulation (EC) No 1565/2000. This Revision 3 includes 17 additional substances which have been cleared with respect to genotoxicity in FGE.200Rev1 ([FL-no: 02.192, 02.231, 05.072, 05.144, 05.184, 05.189, 05.190, 05.191, 05.195, 09.247, 09.400, 09.866, 09.948]) and in FGE.203Rev2 ([FL-no: 05.081, 05.186, 05.194, 05.196]). The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of the 54 substances gives rise to safety concern at their levels of dietary intake, estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate, except for 10 substances ([FL-no: 08.072, 08.083, 08.101, 08.119, 08.120, 09.181, 09.329, 09.335, 09.379 and 09.637]) for which quantitative figures on the composition of stereoisomeric mixtures are missing and for [FL-no: 09.578] complete specifications should be provided. Normal and maximum use levels were not available for [FL-no: 08.072, 08.083, 08.101, 08.119, 08.120, 09.287, 09.326 and 09.578]. Except for flavouring substances [FL-no: 05.072, 05.081, 05.186, 05.194, 05.196, 09.934 and 09.942], more reliable intake data should be requested for all the 46 flavouring substances, for which use levels were submitted, as their modified Theoretical Added Maximum Daily Intake (mTAMDI) exposure estimates are above the threshold of concern for structural classes I and II. This would include more reliable intake data and then, if required, additional toxicological data., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2019
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43. Scientific Opinion on Flavouring Group Evaluation 204 Revision 1 (FGE.204Rev1): consideration of genotoxicity data on representatives for 17 monounsaturated, aliphatic, α,β-unsaturated ketones and precursors from chemical subgroup 1.2.1 of FGE.19.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Carfì M, Vianello G, and Mennes W
Abstract: The Panel on Food Additives and Flavourings (FAF Panel) of the European Food Safety Authority was requested to evaluate the genotoxic potential of the flavouring substances from subgroup 1.2.1 of FGE.19 in the Flavouring Group Evaluation 204 (FGE.204). In the present revision of this FGE (FGE.204Rev1), the FAF Panel evaluated new data provided by Industry following a request from the former Panel on Food Contact materials, Enzymes, Flavourings and Processing Aids (CEF Panel). This request followed from positive results in an in vitro micronucleus test for clastogenicity and a negative result, but with no proof of bone marrow exposure, in an in vivo micronucleus assay for the representative substance 7-methyl-3-octenone-2 [FL-no: 07.177]. Subsequently, the Industry submitted an in vivo comet assay which was considered equivocal in the liver. The study was repeated confirming that 7-methyl-3-octenone-2 [FL-no: 07.177] did not induce primary DNA damage in the liver and duodenum. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for [FL-no: 07.177] and the 15 structurally related substances [FL-no: 02.102, 02.193, 07.044, 07.048, 07.082, 07.104, 07.105, 07.106, 07.107, 07.121, 07.139, 07.187, 07.188, 07.244, 07.258] which can be evaluated through the Procedure for flavouring substances., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2019
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44. Scientific Opinion on Flavouring Group Evaluation 70, Revision 1 (FGE.70Rev1): consideration of aliphatic, linear, α,β-unsaturated, di- and trienals and related alcohols, acids and esters evaluated by JECFA (61st-68th-69th meeting).

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Carfì M, Martino C, Vianello G, and Mennes W
Abstract: The EFSA Panel on Food Additives and Flavourings was requested to evaluate 29 flavouring substances attributed to the Flavouring Group Evaluation 70 (FGE.70), using the Procedure in Commission Regulation (EC) No 1565/2000. Seven substances have already been considered in FGE.70 [FL-no: 08.085, 09.194, 09.260, 09.300, 09.371, 09.639 and 09.840]. The remaining 22 substances [FL-no: 02.049, 05.058, 05.111, 05.120, 05.172, 09.947, 02.139, 02.153, 02.162, 02.188, 05.057, 05.064, 05.071, 05.084, 05.101, 05.108, 05.125, 05.127, 05.140, 05.141, 05.173 and 09.573] have been cleared with respect to genotoxicity in FGE.200Rev1 and FGE.203Rev2 and are considered in this revision. The substances were evaluated through a stepwise approach that integrates information on the structure-activity relationships, intake from current uses, toxicological threshold of concern (TTC), and available data on metabolism and toxicity. The Panel concluded that none of the 29 substances gives rise to safety concerns at their levels of dietary intake, estimated on the basis of the 'Maximised Survey-derived Daily Intake' (MSDI) approach. Besides the safety assessment of the flavouring substances, the specifications for the materials of commerce have also been considered and found adequate, except for [FL-no: 09.371 and 09.840]. For these two substances, data on the composition of the stereoisomeric mixture should be requested. Data on the identity and contents of secondary components should be requested for [FL no: 09.260]. Normal and maximum use levels should be provided for seven flavouring substances [FL-no: 08.085, 09.194, 09.260, 09.300, 09.371, 09.639 and 09.840]. For six flavouring substances [FL-no: 05.057, 05.058, 05.111, 05.120, 05.172 and 09.947] further information is required based on the comparison of the 'modified Theoretical Added Maximum Daily Intakes' (mTAMDIs) with the TTCs. This includes more reliable data on use and use levels and then, if required, additional toxicological data., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2019
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45. Scientific Opinion on Flavouring Group Evaluation 501 (FGE.501): Grill flavour concentrate (vegetable).

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Carfì M, Martino C, and Mennes W
Abstract: The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to deliver a scientific opinion on the implications for human health of the product Grill flavour concentrate (vegetable) [FL-no: 21.002] in the Flavouring Group Evaluation 501 (FGE.501), according to Regulation (EC) No 1331/2008 and Regulation (EC) No 1334/2008 of the European Parliament and of the Council. The product is derived from heat-treated canola oil and intended to be used as a food flavouring with grilled aroma in a wide variety of food categories. Information on manufacturing and compositional data was considered adequate to show the reproducibility of the production process. The chronic dietary exposure to the substance estimated using the added portions exposure technique (APET) was calculated to be 0.402 and 0.252 mg/person per day for a 60-kg adult and for a 15-kg child, respectively. Based on exposure estimate and the results from the repeated-dose toxicity studies, a sufficient margin of safety could be calculated. However, the Panel noted that for six constituents of the flavouring there is an indication for genotoxicity. Therefore, these six substances have to be further considered. Until these evaluations have been finalised the safety of Grill flavour concentrate (vegetable) cannot be fully assessed., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2019
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46. Scientific Opinion on Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3): Consideration of genotoxic potential for α,β-unsaturated alicyclic ketones and precursors from chemical subgroup 2.4 of FGE.19.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Carfì M, Vianello G, and Mennes W
Abstract: The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 5 flavouring substances in Flavouring Group Evaluation 210 Revision 3 (FGE.210Rev3). In FGE.210, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids concluded that the genotoxic potential could not be ruled out for any of the flavouring substances. In FGE.210Rev1, the concern for genotoxic potential has been ruled out for eight substances [FL-no: 02.105, 07.007, 07.009, 07.011, 07.036, 07.088, 07.091 and 07.170]. In FGE.210 Rev2, the concern for genotoxic potential has been ruled out for allyl α-ionone [FL-no: 07.061]. In the present revision of FGE 210 (FGE.210Rev3), additional in vitro and in vivo data on the representative substance α-damascone [FL-no: 07.134] are evaluated. To investigate equivocal and positive results observed in in vitro micronucleus studies, an in vivo combined micronucleus (bone marrow) and comet assay (liver and duodenum) was performed. α-Damascone did not induce micronuclei in bone marrow and no primary DNA damage in duodenum; however, an increase in primary DNA damage was observed in liver. This positive result was attributed by the applicant to a high level of peroxides in the sample tested. Therefore, the comet assay was repeated with a new sample of α-damascone, confirming the negative results observed in duodenum, but equivocal results were observed in liver. Two additional in vivo comet assays in liver were performed in order to clarify the potential impact of peroxides on the obtained results from the genotoxicity testing. However, the materials studied in these tests were not suitable to establish the potential role of peroxides in the genotoxicity of α-damascone. The Panel concluded that the concern for genotoxicity cannot be ruled out for α-damascone [FL-no: 07.134] and the four structurally related substances [FL-no: 07.130, 07.225, 07.226 and 07.231]., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2019
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47. Scientific Opinion on Flavouring Group Evaluation 217 Revision 2 (FGE.217Rev2), consideration of genotoxic potential for α,β-unsaturated ketones and precursors from chemical subgroup 4.1 of FGE.19: lactones.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Carfì M, Vianello G, and Mennes W
Abstract: The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 12 flavouring substances from subgroup 4.1 of FGE.19 in the Flavouring Group Evaluation 217 (FGE.217). Based on experimental data, in previous versions of this FGE (FGE.217 and FGE217Rev1), for 6-methylcoumarin [FL-no: 13.012] and 5-ethyl-3-hydroxy-4-methylfuran-2(5 H )-one [FL-no: 10.023] the concern for genotoxicity was ruled out. 6-Methylcoumarin was evaluated using the Procedure in FGE.80Rev1. For 5-ethyl-3-hydroxy-4-methylfuran-2(5 H )-one [FL-no: 10.023] and the structurally related substance 3-hydroxy-4,5-dimethylfuran-2(5 H )-one [FL-no: 10.030], no further EFSA considerations were needed because these substances were evaluated by JECFA before 2000. Also based on experimental data, in FGE217Rev1, the concern for genotoxicity could not be ruled out for furan-2(5 H )-one [FL-no: 10.066] and 3,4-dimethyl-5-pentylidenefuran-2(5 H )-one [FL-no: 10.042], which later substance represents the following flavourings: [FL-no: 10.034, 10.036, 10.043, 10.046, 10.054, 10.057, 10.060 and 10.170]. In the current revision of this FGE (FGE217Rev2), based on the results of additional genotoxicity studies, the FAF Panel concluded that [FL-no: 10.066] is genotoxic in vivo . Therefore, furan-2(5 H )-one [FL-no: 10.066] cannot be evaluated according to the Procedure. For [FL-no: 10.042] in order to rule out a concern for clastogenicity at site of first contact, the FAF Panel requests results from an in vivo comet assay in duodenum. In addition, [FL-no: 10.042] has also been identified as an aneugenic substance in vitro . Until the concern for clastogenicity at site of first contact for [FL-no: 10.042] and the concern for aneugenicity can be ruled out, this substance and [FL-no: 10.034, 10.036, 10.043, 10.046, 10.054, 10.057, 10.060 and 10.170] cannot be evaluated through the Procedure., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2019
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48. Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with α,β-unsaturation in ring/side-chain and precursors from chemical subgroup 2.2 of FGE.19.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gürtler R, Gundert-Remy U, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Carfì M, Kovalkovicova N, Martino C, Vianello G, and Mennes W
Abstract: The EFSA Panel on Food Additives and Flavourings was requested to evaluate the genotoxic potential of flavouring substances from subgroup 2.2 of FGE.19 in the Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3). In FGE.208Rev1, the Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) evaluated genotoxicity studies on the representative substance p -mentha-1,8-dien-7-al [FL-no: 05.117], which was found to be genotoxic in vivo . The Panel concluded that there was a potential safety concern for the nine substances in this FGE that were all represented by [FL-no: 05.177]. Consequently, substance [FL-no: 05.117], as well as four substances ([FL-no: 05.121, 09.272, 09.899 and 09.900]), no longer supported by industry were deleted from the Union List. In FGE.208Rev2, the Panel assessed genotoxicity studies submitted on five flavouring substances [FL-no: 02.060, 02.091, 05.106, 09.278 and 09.302] and concluded that the concern for genotoxicity could be ruled out for these substances, except from myrtenal [FL-no: 05.106] for which the available data were considered equivocal. Thus, industry provided additional genotoxicity studies (a bacterial reverse mutation assay and a combined in vivo bone marrow erythrocytes micronucleus test and Comet assay in liver and duodenum) for this substance which were evaluated in the present opinion, FGE.208Rev3. Based on these new data, the Panel concluded that the concern for genotoxicity could be ruled out for myrtenal [FL-no: 05.106]. Subsequently, this substance can be evaluated through the Procedure., (© 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2019
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49. Scientific Opinion on Flavouring Group Evaluation 200, Revision 1 (FGE.200 Rev.1): 74 α,β-unsaturated aliphatic aldehydes and precursors from chemical subgroup 1.1.1 of FGE.19.

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Husøy T, Mennes W, Moldeus P, Oskarsson A, Rainieri S, Shah R, Waalkens-Berendsen I, Wölfle D, Binderup ML, Bolognesi C, Marcon F, Marzin D, Mosesso P, Carfì M, Vianello G, and Gürtler R
Abstract: The Panel on Food Additives and Flavourings of the European Food Safety Authority was requested to evaluate the genotoxic potential of 74 flavouring substances from subgroup 1.1.1 of FGE.19 in the Flavouring Group Evaluation 200 Revision 1 (FGE.200 Rev1). In FGE.200, genotoxicity studies were provided for one representative substance, namely hex-2( trans )-enal [FL-no: 05.073], and for other two substances in the same subgroup, namely 2-dodecenal [FL-no: 05.037] and 2-nonenal [FL-no: 05.171]. The Panel concluded that the concern still remains with respect to genotoxicity for the substances of this subgroup and requested an in vivo Comet assay performed in duodenum and liver for hex-2( trans )-enal [FL-no: 05.073]. For the two other representative substances of subgroup 1.1.1 (nona-2( trans ),6( cis )-dienal [FL-no: 05.058] and oct-2-enal [FL-no: 05.060]), the Panel requested a combined in vivo Comet assay and micronucleus assay. These data have been provided and are evaluated in the present opinion FGE.200 Rev1. Industry submitted genotoxicity studies on trans -2-octenal [FL-no: 05.190], instead of oct-2-enal [FL-no: 05.060]. Based on the available data, the Panel concluded that the concern for genotoxicity can be ruled out for hex-2( trans )-enal [FL-no: 05.073], trans -2-octenal [FL-no: 05.190] and nona-2( trans ),6( cis )-dienal [FL-no: 05.058], therefore all the 74 substances [FL-no: 02.020, 02.049, 02.050, 02.090, 02.112, 02.137, 02.156, 02.192, 02.210, 02.231, 05.037, 05.058, 05.060, 05.070, 05.072, 05.073, 05.076, 05.078, 05.102, 05.109, 05.111, 05.114, 05.120, 05.144, 05.150, 05.171, 05.172, 05.179, 05.184, 05.189, 05.190, 05.191, 05.195, 06.025, 06.031, 06.072, 09.054, 09.097, 09.109, 09.119, 09.146, 09.233, 09.244, 09.247, 09.276, 09.277, 09.303, 09.312, 09.385, 09.394, 09.395, 09.396, 09.397, 09.398, 09.399, 09.400, 09.410, 09.411, 09.469, 09.482, 09.489, 09.492, 09.493, 09.498, 09.678, 09.701, 09.719, 09.741, 09.790, 09.841, 09.866, 09.947, 09.948, 13.004] can be evaluated through the Procedure for flavouring substances., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2018
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50. Scientific Opinion of Flavouring Group Evaluation 411 (FGE.411): 2-(4-methylphenoxy)- N -(1 H -pyrazol-3-yl)- N -(thiophen-2-ylmethyl)acetamide from chemical group 30 (miscellaneous substances).

Author: Younes M, Aquilina G, Castle L, Engel KH, Fowler P, Frutos Fernandez MJ, Fürst P, Gundert-Remy U, Gürtler R, Husøy T, Moldeus P, Oskarsson A, Rainieri S, Shah R, Waalkens-Berendsen I, Wölfle D, Benigni R, Binderup ML, Bolognesi C, Brimer L, Chipman K, Marcon F, Marzin D, Mosesso P, Mulder G, Svendsen C, van Benthem J, Anastassiadou M, Carfí M, and Mennes W
Abstract: EFSA was requested to deliver a scientific opinion on the implications for human health of the flavouring substance 2-(4-methylphenoxy)- N -(1 H -pyrazol-3-yl)- N -(thiophen-2-ylmethyl)acetamide [FL-no: 16.133], in the Flavouring Group Evaluation 411 (FGE.411), according to Regulation (EC) No 1331/2008 of the European Parliament and of the Council. The substance has not been reported to occur in natural source materials of botanical or animal origin. It is intended to be used as a flavouring substance in specific categories of food but not intended to be used in beverages, except for milk and dairy based beverages that are opaque. The chronic dietary exposure to the substance estimated using the added portions exposure technique (APET), is calculated to be 225 μg/person per day for a 60-kg adult and 142 μg/person per day for a 15-kg 3-year-old child. A 90-day oral gavage study in rats showed no adverse effects at doses up to 100 mg/kg body weight (bw) per day, providing an adequate margin of safety. Developmental toxicity was not observed in a study with rats at the dose levels up to 1,000 mg/kg bw per day. The Panel concluded that there is no safety concern for [FL-no: 16.133], when used as a flavouring substance at the estimated level of dietary exposure calculated using the APET approach and based on the recommended uses and use levels as specified in Appendix B. This conclusion does not apply for use in beverages where the substance can be subject to phototransformation., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)
Published: 2018
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