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Examples
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This dose is generally referred to as NOAEL (no observed adverse effect level).
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This TDI was based on the findings of several toxicity studies in rats, which together had yielded a specific NOAEL (no-observed-adverse-effect level, or the highest dose at which an adverse effect is not seen).
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"Dilution of toxicants is not a solution, even when all the science is in and we have a NOAEL for sensitive end points," she says.
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The NOAEL, LOAEL, NOEL, and LOEL have great importance in the conduct of risk assessments.
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When a NOAEL is not available, a 'lowest observed adverse effect level' (LOAEL) can be used to calculate the RfD.
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Thus the uncertainty factors are: 10 for human variability; 10 for an animal study; 10 for less than chronic exposure; and 10 for use of an LOAEL instead of a NOAEL.
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For example, the NOAEL or LOAEL for derivation of a 10-day HA would be obtained from an animal toxicity test of approximately 10 days duration (routinely 7-14 day toxicity studies).
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As in the case of RfDs, the product of uncertainty factors multiplied together is divided into the NOAEL or LOAEL to derive the MRL.
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Any toxic effect might be used for the NOAEL/LOAEL so long as it is the most sensitive toxic effect and considered likely to occur in humans.
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In determining the ADIs, RfDs or MRLs, the NOAEL is divided by safety factors (uncertainty factors) in order to provide a margin of safety for allowable human exposure.
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