Genotoxicity assessment: opportunities, challenges and perspectives for quantitative evaluations of dose–response data

Menz, Jakob; Götz, Mario E.; Gündel, Ulrike; Gürtler, Rainer; Herrmann, Kristin; Hessel-Pras, Stefanie; Kneuer, Carsten; Kolrep, Franziska; Nitzsche, Dana; Pabel, Ulrike; Sachse, Benjamin; Schmeisser, Sebastian; Schumacher, David M.; Schwerdtle, Tanja; Tralau, Tewes; Zellmer, Sebastian; Schäfer, Bernd

doi:10.1007/s00204-023-03553-w

Cited by 17 publications

(7 citation statements)

References 132 publications

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“…For a quantitative interpretation of genotoxicity and mutagenicity data, reference points are missing, like a benchmark dose. The dose–response relationship still needs to be evaluated (Menz et al, 2023 ). Therefore, it is difficult to quantitatively assess the genotoxicity and mutagenicity of the investigated river systems.…”

Section: Discussionmentioning

confidence: 99%

Ecotoxicological evaluation of surface waters in Northern Namibia

Faulstich,

Wollenweber,

Reinhardt-Imjela

et al. 2024

Environ Monit Assess

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The increasing pressure on freshwater systems due to intensive anthropogenic use is a big challenge in central-northern Namibia and its catchment areas, the Kunene and the Kavango Rivers, and the Cuvelai-Etosha Basin, that provide water for more than 1 million people. So far, there is no comprehensive knowledge about the ecological status and only few knowledge about the water quality. Therefore, it is crucial to learn about the state of the ecosystem and the ecological effects of pollutants to ensure the safe use of these resources. The surface waters of the three systems were sampled, and three bioassays were applied on three trophic levels: algae, daphnia, and zebrafish embryos. Additionally, in vitro assays were performed to analyze mutagenicity (Ames fluctuation), dioxin-like potential (micro-EROD), and estrogenicity (YES) by mechanism-specific effects. The results show that acute toxicity to fish embryos and daphnia has mainly been detected at all sites in the three catchment areas. The systems differ significantly from each other, with the sites in the Iishana system showing the highest acute toxicity. At the cellular level, only weak effects were identified, although these were stronger in the Iishana system than in the two perennial systems. Algae growth was not inhibited, and no cytotoxic effects could be detected in any of the samples. Mutagenic effects and an estrogenic potential were detected at three sites in the Iishana system. These findings are critical in water resource management as the effects can adversely impact the health of aquatic ecosystems and the organisms within them.

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Section: Discussionmentioning

confidence: 99%

Ecotoxicological evaluation of surface waters in Northern Namibia

Faulstich,

Wollenweber,

Reinhardt-Imjela

et al. 2024

Environ Monit Assess

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“…The Panel recognises ongoing developments to include dose-response modelling and derivation of benchmark dose levels in risk assessment strategies for such substances. (Menz et al, 2023). However, the techniques, as applied by the applicant (e.g.…”

Section: Genotoxicity Assessment Of the Individual Componentsmentioning

confidence: 99%

Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product

Younes,

Aquilina,

Castle

et al. 2023

EFS2

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The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product SmoKEz C-10 (SF-005), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. SmoKEz C-10 is obtained by pyrolysis of maple, oak, hickory, ash, birch, beech and cherry woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.01 to 5.1 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 18.1 mg/kg bw per day at the 95th percentile. The Panel concluded that five components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan-2(5H)-one and benzene-1,2-diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 lg/kg bw per day for DNA-reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity.

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“…Therefore, the Panel did not follow the NOAEL‐approach suggested by the applicant. The Panel recognises ongoing developments to include dose–response modelling and derivation of benchmark dose levels in risk assessment strategies for such substances (Menz et al., 2023). However, the techniques as applied by the applicant (e.g.…”

Section: Assessmentmentioning

confidence: 99%

Scientific opinion on the renewal of the authorisation of Zesti Smoke Code 10 (SF‐002) as a smoke flavouring Primary Product

Younes,

Aquilina,

Castle

et al. 2023

EFS2

Self Cite

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The EFSA Panel on Food Additives and Flavourings (FAF) was requested to evaluate the safety of the smoke flavouring Primary Product Zesti Smoke Code 10 (SF-002), for which a renewal application was submitted in accordance with Article 12(1) of Regulation (EC) No 2065/2003. This opinion refers to the assessment of data submitted on chemical characterisation, dietary exposure and genotoxicity of the Primary Product. Zesti Smoke Code 10 is obtained by pyrolysis of hickory and oak woods. Given the limitations of the quantification approach employed by the applicant, the Panel could not judge whether the applied methods meet the legal quality criterion that at least 80% of the volatile fraction shall be identified and quantified. At the maximum proposed use levels, dietary exposure estimates calculated with DietEx ranged from 0.02 to 4.6 mg/kg body weight (bw) per day at the mean and from no dietary exposure to 13.0 mg/kg bw per day at the 95th percentile. The Panel concluded that four components in the Primary Product raise a potential concern for genotoxicity. In addition, a potential concern for genotoxicity was identified for the unidentified part of the mixture. The Primary Product contains furan-2(5H)-one and benzene-1,2-diol, for which a concern for genotoxicity was identified in vivo upon oral administration. Considering that the exposure estimates for these two components are above the threshold of toxicological concern (TTC) of 0.0025 lg/kg bw per day for DNA-reactive mutagens and/or carcinogens, the Panel concluded that the Primary Product raises concern with respect to genotoxicity.

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Genotoxicity assessment: opportunities, challenges and perspectives for quantitative evaluations of dose–response data

Cited by 17 publications

References 132 publications

Ecotoxicological evaluation of surface waters in Northern Namibia

Ecotoxicological evaluation of surface waters in Northern Namibia

Scientific opinion on the renewal of the authorisation of SmokEz C‐10 (SF‐005) as a smoke flavouring Primary Product

Scientific opinion on the renewal of the authorisation of Zesti Smoke Code 10 (SF‐002) as a smoke flavouring Primary Product

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