efsa-opinion-chromium-food-drinking-water

Chromium in food and bottled water
a) b)
Log-Logistic Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL
1
Log-Logistic
BMD Lower Bound
Log-Logistic Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL
1
Log-Logistic
BMD Lower Bound
0.8
0.8
Fraction Affected
0.6
0.4
Fraction Affected
0.6
0.4
0.2
0.2
0
BMDLBMD
0
BMDL BMD
11:36 01/21 2014
0 1 2 3 4 5 6 7 8 9
0 1 2 3 4 5 6 7 8 9
dose
dose
11:34 01/21 2014
c) d)
Weibull Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL
Weibull Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL
1
Weibull
BMD Lower Bound
1
Weibull
BMD Lower Bound
0.8
0.8
Fraction Affected
0.6
0.4
Fraction Affected
0.6
0.4
0.2
0.2
0
BMDLBMD
0
BMDL BMD
11:41 01/21 2014
0 1 2 3 4 5 6 7 8 9
dose
11:42 01/21 2014
0 1 2 3 4 5 6 7 8 9
dose
Figure J17: Fits of the unrestricted log-logistic model (a), restricted log-logistic model (b), unrestricted
Weibull model (c) and restricted Weibull model (d) to the dose-response data on hystiocytic cellular
infiltration in the mesenteric lymph node in female mice.
J 2.6.
Hystiocytic cellular infiltration in liver in female mice.
For the dose-response analysis of the incidence of hystiocytic cellular infiltration in liver in female mice
all non-restricted models, except the probit and logistic model showed an acceptable fit (p > 0.05) which
resulted in BMDL 10 values ranging between 0.058 and 0.011 mg/kg b.w. per day.
The graphs in Figure J18 show the fit of the Gamma model, both for unrestricted and restricted
modeling. The fit of the restricted model showed as expected higher BMDL 10 values, for the Gamma
and the Weibull model the BMDL 10 values were 0.29 and 0.35 mg/kg b.w. per day, respectivele with
acceptable fits (p = 0.07 and 0.08, respectively.
A BMDL 10 = 0.011 mg/kg b.w. per day was used to characterize these data.
Using a different modelling approach not following EFSA (2009) ATSDR reported a BMDL 10 of
0.12 mg/kg b.w. per day (ATSDR, 2012).
EFSA Journal 2014;12(3):3595 250