JaCVAM-organized international validation study of the in vivo rodent alkaline comet assay for detection of genotoxic carcinogens: II. Summary of definitive validation study results

Uno, Yoshifumi; Kojima, Hajime; Omori, Takashi; Corvi, Raffaella; Honma, Masamitu; Schechtman, Leonard M.; Tice, Raymond R.; Burlinson, Brian; Escobar, Patricia; Kraynak, Andrew R.; Nakagawa, Yukari; Nakajima, Masahiro; Pant, Kamala; Asano, Naoki; Lovell, David P.; Morita, Takeshi; Ohno, Yasuo; Hayashi, Makoto

doi:10.1016/j.mrgentox.2015.04.010

Cited by 69 publications

(50 citation statements)

References 53 publications

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“…It presents several significant advantages over other commonly used genotoxicity assays. This assay has previously been formally validated in order to represent the standardised protocol with acceptability by international regulatory agencies (9).…”

mentioning

confidence: 99%

Sevoflurane and isoflurane genotoxicity in kidney cells of mice

Brozović

Oršolić

Rozgaj

et al. 2017

Archives of Industrial Hygiene and Toxicology

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The aim of this study was to evaluate the DNA damage and repair in kidney cells of Swiss albino mice after repeated exposure to sevoflurane and isoflurane and compare their detrimental effects. We used the alkaline comet assay to establish the genetic damage and measured three parameters: tail length, tail moment, and tail intensity of comets. These parameters were measured immediately after exposure to the above mentioned inhalation anaesthetics, two hours, six hours, and 24 hours later and were compared with the control group. Mean values of all three parameters were significantly higher in experimental groups compared to the control group. DNA damage in kidney cells of mice exposed to sevoflurane increased continuously before it reached its peak 24 hours after exposure. Isoflurane induced the highest DNA damage two hours after exposure. Levels of DNA damage recorded 24 h after cessation of exposure to both tested compounds suggest that sevoflurane was slightly more genotoxic than isoflurane to kidney cells of mice. According to these results, the currently used volatile anaesthetics sevoflurane and isoflurane are able to damage DNA in kidney cells of mice. Such findings suggest a possibility for similar outcomes in humans and that fact must be taken into account in everyday clinical practice.

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confidence: 99%

Sevoflurane and isoflurane genotoxicity in kidney cells of mice

Brozović

Oršolić

Rozgaj

et al. 2017

Archives of Industrial Hygiene and Toxicology

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“…The study was conducted in accordance with the validation study protocol version 14.2 [7]. The following are the details of this study.…”

Section: Methodsmentioning

confidence: 99%

Combination comet/micronucleus assay validation performed by BioReliance under the JaCVAM initiative

Pant

Krsmanovic

Bruce

et al. 2015

Mutation Research/Genetic Toxicology and Environmental Mutagene

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“…The data are obtained from the Phase 4-2 validation study [2]. Briefly, the validation study was conducted in 14 laboratories, and 40 test chemicals were examined, which included 19 genotoxic carcinogens, 6 genotoxic non-carcinogens, 7 non-genotoxic carcinogens, and 8 non-genotoxic non-carcinogens [2,17].…”

Section: Data Sourcementioning

confidence: 99%

“…The data from the JaCVAM-organized international validation study of the in vivo rat alkaline comet assay were reported and analyzed statistically using the simple means of % tail DNA for the 100 cells scored per individual rat [1,2]. After submission of the validation package to OECD, it was requested that the data should be re-analyzed based on the mean of the 2 medians for the 50 cells scored per each of two slides.…”

Section: Introductionmentioning

confidence: 99%

“…Due to TG 489, the individual laboratory reports of the main validation study (Phase 4-2) from most of the participating laboratories were revised and described using their own statistical approach based on using medians (and means) [4][5][6][7][8][9][10][11][12][13][14][15][16]. Also, we separately re-analyzed the Phase 4-2 data based on the median based approach in the same manner as the original statistical analysis of the JaCVAM-organized validation study as reported by Uno et al [2] in order to compare the sensitivity/specificity using the simple mean approach with the median based approach.…”

Section: Introductionmentioning

confidence: 99%

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