efsa-opinion-chromium-food-drinking-water
efsa-opinion-chromium-food-drinking-water efsa-opinion-chromium-food-drinking-water
Chromium in food and bottled water a) Result of PROAST for all models Quantal Linear Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL 0.4 0.35 Quantal Linear BMD Lower Bound 0.3 0.25 Fraction Affected 0.2 0.15 0.1 0.05 0 15:42 01/20 2014 BMDL 0 2 4 6 8 10 12 b) Result of BMDS when pooling the data of males and female for the quantal linear model Figure J6: Fit of all models used in Proast tto the dose-response data on the incidence of squamous cell carcinoma in oral mucosa in rats. Note that the models denoted LVM E2 and H3 are not recommended by EFSA (2009c). BMD dose EFSA Journal 2014;12(3):3595 234
J.1.2. mice Chromium in food and bottled water BMD analysis of eptithelial cell neoplastic lesion in the small intestine in male and female The CONTAM Panel identified one data set reported by NTP (NTP 2007, 2008), Stout et al. (2009), and Witt et al. (2013) on the neoplastic effects of SDD in duodenum, jenunum and ileum combined in male and female mice as suitable for DR assessment of Cr(VI). This Section informs on the details of the analysis at first for male and females separately using BMDS software and then on the result of the analysis when combining males and females using PROAST software. We start with the evaluation of the carcinoma or adenoma data and report then also the evaluations of the carcinoma data only following the order of the results reported in Table 20 in Section 7.5.1, see also the comment in Section J1.1 above. Table J7: Epithelial carcinoma or adenoma in the duodenum, jejunum or ileum in male mice. The benchmark dose (BMD 10 ) and the 95 % benchmark dose lower confidence limit (BMDL 10 ) values are given for a BMR of 10 % extra risk with characteristics of the model fit. The model with lowest BMDL 10 is highlighted in bold. Models Restriction N of parameters Minus Loglikelihood P- value Accepted BMD 10 (mg/kg b.w. per day) Full model na 5 78.55 – – – – Null (reduced) model na 1 97.54 - - - - BMDL 10 (mg/kg b.w. per day) Probit na 2 79.14 0.76 yes 2.60 2.17 LogProbit none 3 79.12 0.56 yes 2.36 1.19 Logistic na 2 79.28 0.69 yes 2.82 2.36 LogLogistic none 3 79.10 0.57 yes 2.30 1.14 Quantal-Linear na 2 79.74 0.50 yes 1.48 1.08 Multistage Cancer na 3 79.04 0.61 yes 2.22 1.18 Multistage none 3 79.04 0.61 yes 2.22 1.15 Weibull none 3 79.09 0.58 yes 2.26 1.11 Gamma none 2 79.11 0.57 yes 2.29 1.10 b.w.: body weight; na: not applicable EFSA Journal 2014;12(3):3595 235
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Chromium in <strong>food</strong> and bottled <strong>water</strong><br />
a) Result of PROAST for all models<br />
Quantal Linear Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL<br />
0.4<br />
0.35<br />
Quantal Linear<br />
BMD Lower Bound<br />
0.3<br />
0.25<br />
Fraction Affected<br />
0.2<br />
0.15<br />
0.1<br />
0.05<br />
0<br />
15:42 01/20 2014<br />
BMDL<br />
0 2 4 6 8 10 12<br />
b) Result of BMDS when pooling the data of males and female for the quantal linear model<br />
Figure J6: Fit of all models used in Proast tto the dose-response data on the incidence of squamous cell<br />
carcinoma in oral mucosa in rats. Note that the models denoted LVM E2 and H3 are not recommended<br />
by EFSA (2009c).<br />
BMD<br />
dose<br />
EFSA Journal 2014;12(3):3595 234
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