Human Data.

(A) Human Data. If the hazard is ascertained from human data, a safety factor of ten will be applied to the lowest No Observed Effect Level (NOEL) seen among the relevant studies. If no NOEL can be determined, a safety factor of 100 will be applied to the Lowest Observed Effect Level (LOEL). Both the NOEL and LOEL are defined in terms of daily dose level.


16 CFR § 1500.135

Scoping language

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