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EC number: 206-354-4
CAS number: 330-54-1
For calculation of the DNELs the assessment factors (AF) of the
ECETOC Technical report no. 86 "Derivation of assessment factors for
human health" (2003) were applied. The AF used from the ECETOC Technical
report no. 86 for the DNEL calculation for Diuron differ in
two points from the AF recommended in the "Guidance on information
requirements and chemical safety assessment Chapter R.8:
Characterisation of dose[concentration]-response for human health",
ECHA, May 2008. The AF for remaining differences is 1 instead of 2.5 and
the AF for intraspecies differences for worker is 3 instead of 5. The AF
from the ECETOC Technical report no. 86 were used because there is
evidence that association between intra- and inter-species assessment
factors is conservative and that the inclusion of a remaining difference
factor is unnecessary. ECETOC (2003) analyzed the available data of
Freireich et al. (1966), Schein et al. (1979), and Watanabe et al.
(1992) and concluded that apart from allometric scaling there is the
likelihood of additional variability around the extrapolated dose or
predicted NOAEL in humans. However, this additional variability is
probably due not only to possible differences in biological sensitivity
between species, but also to intraspecies differences. Apart from these
aspects, one also has to consider the different endpoints (maximum
tolerated dose – MTD - versus toxic dose low - TDL) used for the
evaluation of human and animal data. Thus, it is evident that the
comparison of ‘toxic doses’ across species is actually a comparison
between doses that cause ‘dose-limiting’ toxicity (MTDH) in a sensitive
subpopulation of humans (health-compromised, cancer patients) at one
extreme and lethality in 10% of the population of otherwise assumed
healthy animals (lethal dose - LD10) at the other. This will
overestimate the sensitivity of humans in relation to other species, but
to an extent which is (largely) unquantifiable. As a consequence, the
adjustment of interspecies AF to account for the differences noted in
such analyses is not scientifically justified. Therefore, although
residual interspecies variability may remain following allometric
scaling, this is largely accounted for in the default assessment factor
proposed for intraspecies variability reflecting the inherent
interdependency of inter- and intraspecies factors (ECETOC, 2003). For
this total (inter- and intraspecies) variability, ECETOC proposed an
overall factor of 3 for the workplace and of 5 for the general
population. Therefore, a separate residual AF for interspecies is
unnecessary because it is already accounted for by the intraspecies
assessment factor (Calabrese, 1985; Hattis et al, 1987).
Calabrese, E.J. (1985). Uncertainty factors and interindividual
variation. Regul Toxicol Pharmacol 5:190-196. ECETOC
(2003). Derivation of Assessment Factors for Human Health Risk
Assessment. Technical Report No.86. European Centre for Ecotoxicology
and Toxicology of Chemicals, Brussels, Belgium.
Freireich, E (1966). Quantitative Comparison of Toxicity of
anticancer agents in mouse, rat, hamster, dog, monkey, and man. Canc
Chemotherap Res 50: 219-245.
Hattis, D. et al. (1987). Human variability in susceptibility to
toxic chemicals: a preliminary analysis of pharmacokinetic data from
normal volunteers. Risk Anal 7:415 - 426.
Schein, P. et al. (1979). The evaluation of anticancer drugs in
dogs and monkeys for the prediction of qualitative toxicities in humans.
Clin Pharmacol Therap 11: 3-40. Watanabe, K. et al. (1992).
Interspecies extrapolation: a re-examination of acute toxicity data.Risk
Anal 12: 301-310.
DNELs for general population do not have to be calculated, because there
is no consumer exposure to Diuron.
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