Two recently approved in vivo Genotoxicity test guidelines
ثبت نشده
چکیده
A. TITLE OF THE TEST GUIDELINES (YEAR OF ORIGINAL ADOPTION, YEAR OF UPDATE) Transgenic rodent (TGR) somatic and germ cell gene mutation assays, EU: B.58, OECD: 488 (2011, 2013) In vivo mammalian alkaline comet assay, EU: none at present, OECD: 489 (2014) Note: the latest version of the OECD test guideline (TG) should always be used independent of whether it is published in the EU Test Method Regulation or not.
منابع مشابه
Undetactable levels of genotoxicity of SiO2 nanoparticles in in vitro and in vivo tests
BACKGROUND Silica dioxide (SiO2) has been used in various industrial products, including paints and coatings, plastics, synthetic rubbers, and adhesives. Several studies have investigated the genotoxic effects of SiO2; however, the results remain controversial due to variations in the evaluation methods applied in determining its physicochemical properties. Thus, well characterized chemicals an...
متن کاملGenotoxicity assessment of Elaeagnus angustifolia L. fruit extract (senjed) nanocapsule by in vitro and in vivo methods
Background: Although initial studies on Elaeagnus Angustifolia L. Fruit Extract (Senjed) Nanocapsule showed its efficacy in osteoporosis in rat model as well as its significant role in elevating the serum calcium levels, there is no study on its possible genotixic potentials which is necessary for developing all nanopharmaceuticals. Objective: This study aimed to evaluate the genotoxicity of Se...
متن کاملGenotoxicity studies OF p-dimethylaminoazobenzene (DAB).
The potential genotoxicity of the rodent liver carcinogen p-dimethylaminoazobenzene (DAB) was evaluated in compliance with the guidelines for genotoxicity studies of drugs (Notification No. 1604, Nov. 1, 1999, Ministry of Health and Welfare, Japan) and the OECD guidelines for testing chemicals. DAB was clearly positive in both the bacterial reverse mutation test (Ames test) and in vitro chromos...
متن کاملGenotoxicity Assessment of Erythritol by Using Short-term Assay
Erythritol is a sugar alcohol that is widely used as a natural sugar substitute. Thus, the safety of its usage is very important. In the present study, short-term genotoxicity assays were conducted to evaluate the potential genotoxic effects of erythritol. According to the OECD test guidelines, the maximum test dose was 5,000 μg/plate in bacterial reverse mutation tests, 5,000 μg/ml in cell-bas...
متن کاملCombining the in vivo comet and micronucleus assays: a practical approach to genotoxicity testing and data interpretation
Despite regulatory directives requiring the reduction of animal use in safety testing, recent modifications to genotoxicity testing guidelines now propose the use of two in vivo genotoxicity assays as a follow-up to an in vitro positive (International Conference on Harmonization Consensus Draft Guidance S2[R1] released March, 2008). To address both goals, the in vivo comet and micronucleus (MN)...
متن کامل