NOAELbased

NOAELbased refers to a methodology for determining safe exposure levels of substances, particularly in toxicology and risk assessment. NOAEL stands for No Observed Adverse Effect Level. The NOAEL is the highest dose of a substance administered in a study that causes no statistically or biologically significant adverse effects when compared to a control group.

The NOAELbased approach utilizes this identified NOAEL to derive acceptable exposure limits. This is typically achieved by applying uncertainty factors, also known as safety factors, to the NOAEL. These factors are used to account for various uncertainties, such as extrapolating from animal studies to humans, variations within the human population, and the duration of exposure.

For example, a regulatory agency might divide the NOAEL by a factor of 100 to account for interspecies variation and intraspecies variability, resulting in a reference dose or acceptable daily intake. This derived value represents a level of exposure that is considered unlikely to cause adverse health effects in the general population over a lifetime. NOAELbased approaches are fundamental in establishing guidelines for pharmaceuticals, food additives, environmental contaminants, and occupational exposures. The principle is to identify a level of exposure below which no harm is expected, even considering potential sensitivities.