One of the major reasons for studying chemical kinetics is to use measurements of the macroscopic properties of a system, Safety of 5,5-Dimethyloxazolidine-2,4-dione, such as the rate of change in the concentration of reactants or products with time.In a article, mentioned the application of 695-53-4, Name is 5,5-Dimethyloxazolidine-2,4-dione, molecular formula is C5H7NO3
Analysis of exposure margins in developmental toxicity studies for detection of human teratogens
The draft Step 2 ICH S5(R3) guideline includes an exposure-based endpoint as an option for selecting the high-dose in reproductive and developmental toxicity studies. To help determine an appropriate exposure margin for embryofetal developmental toxicity testing, a retrospective analysis was undertaken to determine what threshold would have been sufficient to detect hazards to embryofetal development in rats and rabbits for 18 known and 4 presumed human teratogens. The analysis showed that using a high dose that provided at least a 6-fold exposure margin in the developmental toxicity studies would have been sufficient to detect the teratogenic hazard with relevance for humans for all these therapeutics. With regards to human risk assessment practices for developmental toxicity, the analysis showed that, after excluding lenalidomide and pomalidomide data in rats, all available AUC margins at the NOAEL for the induction of malformations or embryofetal lethality were <4-fold of the exposure at the MRHD for all 22 therapeutics. These data support the proposed general approach of increased level of concern for human risk when exposure margins of the NOAEL to the MRHD are <10-fold, reduced concern when the exposure margins are 10- to 25-fold, and minimal concern when the exposure margin is > 25-fold.
Sometimes chemists are able to propose two or more mechanisms that are consistent with the available data. Safety of 5,5-Dimethyloxazolidine-2,4-dione, If a proposed mechanism predicts the wrong experimental rate law, however, the mechanism must be incorrect.Welcome to check out more blogs about 695-53-4, in my other articles.
Reference:
Oxazolidine – Wikipedia,
Oxazolidine | C3H1339NO – PubChem