Lack of in vivo and in vitro genotoxicity with the nonsteroid, antiinflammatory agent sodium meclofenamate

1984 ◽  
Vol 4 (4) ◽  
pp. 329-340 ◽  
Author(s):  
Melvin L. Kropko ◽  
J. E. Fitzgerald ◽  
Felix A. De la Iglesia
2012 ◽  
Vol 48 (3) ◽  
pp. 461-467 ◽  
Author(s):  
Camila Martins Güez ◽  
Emily Pansera Waczuk ◽  
Karina Braccini Pereira ◽  
Marcus Vinícius Morini Querol ◽  
João Batista Teixeira da Rocha ◽  
...  

The use of plants as a source of palliative or cure for pathological conditions is quite common worldwide. Xanthium spinosum (Asteraceae), popularly known in Brazil as 'espinho de carneiro', is an annual weed from South America, which has been used by empiric medicine to treat neoplasias. Owing to the extensive use of the above-mentioned plant and to the lack of reports about the real effects of its infusion, current study evaluated the genotoxic potential of its aqueous extract at concentrations 0.02 g L-1, 0.1 g L-1 and 0.2 g L-1 by fish micronucleus test and by comet human leukocytes assay. The micronucleus test featured at least 50 cells with micronuclei to every 2,000 cells scored, as a mutagenic parameter. The comet assay was used as a parameter for assessing the level of cell damage and the damage index. Since no significant changes in strain cells exposed to the aqueous extract in the comet and micronucleus assays were reported, it seems that no genotoxicity evidence is extant at the concentrations and in the assays performed.


1986 ◽  
Vol 171 (2-3) ◽  
pp. 157-163 ◽  
Author(s):  
G. Krishna ◽  
J. Nath ◽  
L. Soler ◽  
T. Ong

2021 ◽  
Vol 11 (21) ◽  
pp. 10257
Author(s):  
Young-Jae Song ◽  
Dong-Gu Kim ◽  
Jeonghoon Lee ◽  
Wonnam Kim ◽  
Hyo-Jin An ◽  
...  

The various species that comprise the genus Glycyrrhiza (Licorice) have long been used as oriental herbal medicines in Asian countries. Wongam (WG), which is a new variety of Glycyrrhiza, was developed in Korea to overcome the limitations of low productivity, environmental restrictions, and an insufficient presence of glycyrrhizic acid and liquiritigenin. In this study, we evaluated WG extract’s genotoxicity through an in vitro bacterial reverse mutation (AMES) test, an in vitro chromosome aberration test, and an in vivo mouse bone marrow micronucleus test. In the AMES test, WG extract at concentrations of up to 5000 µg/plate showed no genotoxicity regardless of S9 mix. No chromosome aberrations appeared after 6 h in 1400 µg/mL WG extract regardless of S9 mix or in 1100 µg/mL WG extract after 24 h without S9 mix. Nor was there a significant increase in the number of micronucleated polychromatic erythrocytes to total erythrocytes up to 5000 mg/kg/day for 2 days detected in the micronucleus test. These results confirm that WG extract is safe for use as an herbal medicine, as it precipitates no detectable genotoxic effects.


1982 ◽  
Vol 4 (5) ◽  
pp. 605-619 ◽  
Author(s):  
S. De Flora ◽  
P. Zanacchi ◽  
C. Bennicelli ◽  
A. Camoirano ◽  
M. Cavanna ◽  
...  

Author(s):  
J.E. Sinsheimer ◽  
B.H. Hooberman ◽  
S.K. Das ◽  
M.D. Brezzell ◽  
Z. You

Mutagenesis ◽  
2020 ◽  
Author(s):  
Stefan Pfuhler ◽  
Ralph Pirow ◽  
Thomas R Downs ◽  
Andrea Haase ◽  
Nicola Hewitt ◽  
...  

Abstract As part of the safety assessment process, all industrial sectors employ genotoxicity test batteries, starting with well-established in vitro assays. However, these batteries have limited predictive capacity for the in vivo situation, which may result in unnecessary follow-up in vivo testing or the loss of promising substances where animal tests are prohibited or not desired. To address this, a project involving regulators, academia and industry was established to develop and validate in vitro human skin-based genotoxicity assays for topically exposed substances, such as cosmetics ingredients. Here, we describe the validation of the 3D reconstructed skin (RS) Comet assay. In this multicenter study, chemicals were applied topically three times to the skin over 48 h. Isolated keratinocytes and fibroblasts were transferred to slides before electrophoresis and the resulting comet formation was recorded as % tail DNA. Before decoding, results of the validation exercise for 32 substances were evaluated by an independent statistician. There was a high predictive capacity of this assay when compared to in vivo outcomes, with a sensitivity of 77 (80)%, a specificity of 88 (97)% and an overall accuracy of 83 (92)%. The numbers reflect the calls of the performing laboratories in the coded phase, whereas those in parenthesis reflect calls according to the agreed evaluation criteria. Intra- and inter-laboratory reproducibility was also very good, with a concordance of 93 and 88%, respectively. These results generated with the Phenion® Full-Thickness skin model demonstrate its suitability for this assay, with reproducibly low background DNA damage and sufficient metabolic capacity to activate pro-mutagens. The validation outcome supports the use of the RS Comet assay to follow up positive results from standard in vitro genotoxicity assays when the expected route of exposure is dermal. Based on the available data, the assay was accepted recently into the OECD test guideline development program.


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