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This factor uses a default
factor of 10 in the risk
assessment to account
for intraspecies variability.
Or a Chemical Specific
Adjustment Factor (CSAF)
can be calculated
to replace the default:
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This factor is an
adjustment from
subchronic studies to
chronic and addresses
the potential that
adverse effects may
occur at lower doses as
the exposure duration
increases (e.g., from a
short duration to a
chronic duration).
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This factor accounts for
additional uncertainties
outside the PoD such as
severity of effects, lack of
data (reproductive and
developmental toxicity) or
quality of data. EMA
(2014) suggests a factor
(1-10) may be applied in
cases of severe toxicity
(e.g. non-genotoxic
carcinogenicity, severe
neurotoxicity or teratogenicity).
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This factor addresses
uncertainty in those
circumstances when a
NOAEL is not available
in the critical study for
the HBEL calculation.
The F5 is applied to a
LOAEL with the
purpose of estimating
a NOAEL
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This factor is used
when limited data is
available on the
compound being
assessed and there is
uncertainty around
whether the critical
effect can be
determined from a
small number of
toxicity studies
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