Abstract The EFSA Panel on Food Contact Materials (FCM) was requested by the European Commission to re‐evaluate the potential genotoxicity of styrene after oral exposure and its safety for use in plastic FCM with a specific migration limit (SML) of 40 μg/kg food.
EFSA Panel on Food Contact Materials (FCM) +18 more
wiley +1 more source
Linking environmental carcinogen exposure to TP53 mutations in human tumours using the human TP53 knock-in (Hupki) mouse model [PDF]
TP53 is one of the most commonly mutated genes in human tumours. Variations in the types and frequencies of mutations at different tumour sites suggest that they may provide clues to the identity of the causative mutagenic agent.
Arlt, Volker M. +2 more
core +2 more sources
Integrated In Vivo Genotoxicity Assessment of Procarbazine Hydrochloride Demonstrates Induction of Pig‐a and LacZ Mutations, and Micronuclei, in MutaMouse Hematopoietic Cells [PDF]
Procarbazine hydrochloride (PCH) is a DNA‐reactive hematopoietic carcinogen with potent and well‐characterized clastogenic activity. However, there is a paucity of in vivo mutagenesis data for PCH, and in vitro assays often fail to detect the genotoxic effects of PCH due to the complexity of its metabolic activation. We comprehensively evaluated the in
Clotilde Maurice +3 more
openaire +2 more sources
Abstract Styrene has been shown to induce lung tumors in mice, but not in rats. The current study investigated the potential role of genotoxicity as an initial key event in the mode of action for styrene‐induced lung tumors in mice. Transgenic male B6C3F1 Big Blue® mice were treated by oral gavage for 28 consecutive days with 0 (corn oil), 75, 150, or ...
B. Bhaskar Gollapudi +2 more
wiley +1 more source
Deriving safe limits for N-nitroso-bisoprolol by error-corrected next-generation sequencing (ecNGS) and benchmark dose (BMD) analysis, integrated with QM modeling and CYP-docking analysis [PDF]
N-nitroso-bisoprolol (NBP) is a nitrosamine drug substance-related impurity (NDSRI) of bisoprolol, which is used to treat cardiac diseases since decades. To investigate the mutagenic potential of NBP, in vitro methods such as Enhanced Ames Test (EAT) and
George Johnson
core +1 more source
Abstract The present opinion is the follow‐up of the conclusions and recommendations of the Scientific Opinion on the re‐evaluation of silicon dioxide (E 551) as a food additive relevant to the safety assessment for all age groups. In addition, the risk assessment of silicon dioxide (E 551) for its use in food for infants below 16 weeks of age is ...
EFSA Panel on Food Additives and Flavourings (FAF) +53 more
wiley +1 more source
Protocol for risk assessment of “other substances”. The Norwegian Scientific Committee for Food and Environment [PDF]
publishedVersio
Alexander, Jan +8 more
core +4 more sources
Quantitative relationships between lacZ mutant frequency and DNA adduct frequency in Muta™Mouse tissues and cultured cells exposed to 3-nitrobenzanthrone [PDF]
The frequency of stable DNA adducts in a target tissue can be used to assess biologically effective dose; however, the utility of the metric in a risk assessment context depends on the likelihood that the DNA damage will be manifested as mutation ...
Arlt, Volker M +3 more
core +2 more sources
Abstract The detection of N‐nitrosamines in drug products has raised global regulatory interest in recent years due to the carcinogenic potential of some nitrosamines in animals and a need to identify a testing strategy has emerged. Ideally, methods used would allow for the use of quantitative analysis of dose–response data from in vivo genotoxicity ...
Shaofei Zhang +6 more
wiley +1 more source
Statistical analysis of lacZ mutant frequency data from MutaTMMouse mutagenicity assays [PDF]
Transgenic mouse assays have provided an unprecedented opportunity to study mutagenesis in diverse rodent tissues. In this article data from MutaMouse mutagenicity assays based on the Escherichia coli gene lacZ were analyzed systematically using liver and bone marrow as potential target tissues.
K Y, Fung, G R, Douglas, D, Krewski
openaire +2 more sources

