efsa-opinion-chromium-food-drinking-water

Chromium in food and bottled water
Data Dose 0 0.38 0.91 2.4 5.9
Response 14/47 38/49 31/49 32/49 42/46
Models
Restriction
BMD
Minus
10 BMDL 10
N of
P-
(mg/kg (mg/kg
Loglikelihood
Accepted
parameters
value
b.w. per b.w. per
day) day)
Full model na 5 132.2 – – – –
Null (reduced) model na 1 154.8 - - - -
Probit na 2 142.8.2 < 10-4 no 0.56 0.43
LogProbit none 3 - - if
Logistic na 2 142.8 < 10-4 no 0.53 0.39
LogLogistic none 3 - - if
Quantal-Linear (QL) na 2 142.5.0 < 10-3 no 0.38 0.26
Multistage Cancer na same as QL
Multistage none 3 142.5.0 < 10-4 no 0.32 0.16
Weibull none 2 - - if
Gamma none 2 - - if
b.w.: body weight; na: not applicable, if: invalid fit;
Multistage Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL
1
Multistage
0.9
0.8
Fraction Affected
0.7
0.6
0.5
0.4
0.3
0.2
BMDL BMD
0.1
0 1 2 3 4 5 6
dose
11:18 01/21 2014
Figure J16: Fits of the Multistage model to the dose-response data on hystiocytic cellular infiltration in
the mesenteric lymph node in male mice.
J 2.5.
Hystiocytic cellular infiltration in mesenteric lymph nodes in female mice.
For the dose-response analysis of the incidence of hystiocytic cellular infiltration in mesenteric
lymph nodes in female mice three non-restricted models (log-probit, log-logistic and Weibull) showed
an acceptable fit (p > 0.05) which resulted in BMDL 10 values less than 10 -5 mg/kg b.w. per day. The fit
of the restricted models showed, as expected, higher BMDL 10 values (0.064 and 0.30 mg/kg b.w. per
day ) than the corresponding unrestricted models but their fit was not acceptable.
The graphs in Figure J17 show the fit of the log-logistic and the Weibull model, both for unrestricted
and restricted modeling.
EFSA Journal 2014;12(3):3595 248