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Improved method for selection of the NOAEL.

Research paper by E J EJ Calabrese, L A LA Baldwin

Indexed on: 01 Feb '94Published on: 01 Feb '94Published in: Regulatory Toxicology and Pharmacology



Abstract

The paper proposes that the NOAEL be defined as the highest dosage tested that is statistically significantly different from the control group while also being statistically significantly different from the LOAEL. This new definition requires that the NOAEL be defined from two points of reference rather than the current approach (i.e., single point of reference) in which the NOAEL represents only the highest dosage not statistically significantly different from the control group. This proposal is necessary in order to differentiate NOAELs which are statistically distinguishable from the LOAEL. Under the new regime only those satisfying both criteria would be designated a true NOAEL while those satisfying only one criteria (i.e., not statistically significant different from the control group) would be designated a "quasi" NOAEL and handled differently (i.e., via an uncertainty factor) for risk assessment purposes.