efsa-opinion-chromium-food-drinking-water
efsa-opinion-chromium-food-drinking-water efsa-opinion-chromium-food-drinking-water
Chromium in food and bottled water 0.6 Quantal Linear Model with 0.95 Confidence Level Quantal Linear BMD Lower Bound 0.5 0.4 Fraction Affected 0.3 0.2 0.1 0 BMDL BMD 16:05 01/20 2014 0 1 2 3 4 5 6 dose Figure J7: Fit of the Quantal Linear model to the dose-response data on epithelial carcinoma or adenoma combined in the duodenum, jejunum or ileum in male mice Table J8: Epithelial carcinoma or adenoma combined in the duodenum, jejunum or ileum in female 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 85.19 – – – – Null (reduced) model na 1 116.32 - - - - BMDL 10 (mg/kg b.w. per day) Probit na 2 94.88 < 10-3 no 2.30 2.51 LogProbit none 3 86.88 0.34 yes 1.19 0.70 Logistic na 2 95.78 < 10-3 no 3.26 2.72 LogLogistic none 3 87.22 0.25 yes 1.19 0.66 Quantal-Linear na 1 87.75 0.27 yes 1.30 1.02 Multistage Cancer na 1 87.75 0.27 yes 1.30 1.02 Multistage none 3 87.14 0.27 yes 1.00 0.67 Weibull none 3 87.64 0.18 yes 1.15 0.61 Gamma none 3 87.69 0.17 yes 1.18 0.61 na: not applicable; b.w.: body weight. EFSA Journal 2014;12(3):3595 236
Chromium in food and bottled water Weibull Model with 0.95 Confidence Level 0.6 Weibull BMD Lower Bound 0.5 0.4 Fraction Affected 0.3 0.2 0.1 0 16:23 01/20 2014 BMDL BMD 0 1 2 3 4 5 6 7 8 9 dose Figure J8: Fit of the Weibull model to the dose-response data on carcinoma or adenoma in the duodenum, jejunum or ileum female mice Table J9: Epithelial carcinoma or adenoma in the duodenum, jejunum or ileum in male and female mice combined. 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 selected model based on the model selection used in PROAST is highlighted in bold. Models N of parameters Loglikelihood Accepted BMD 10 (mg/kg b.w. per day) BMDL 10 (mg/kg b.w. per day) BMDU 10 (mg/kg b.w. per day) null 1 -216.49 – – – – full 10 -168.64 - - - - one-stage 2 -172.72 yes 1.41 1.15 1.77 two-stage 3 -172.72 yes 1.41 1.15 1.75 log-logist 3 -172.72 yes 1.56 1.04 2.22 Weibull 3 -172.65 yes 1.53 1.00 2.21 log-prob 3 -171.96 yes 1.60 1.06 2.27 Gamma 3 -172.6 yes 1.56 1.02 2.25 Logistic 2 -179.62 No 3.10 2.71 - probit 2 -178.22 No 2.86 2.50 - b.w.: body weight. EFSA Journal 2014;12(3):3595 237
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Chromium in <strong>food</strong> and bottled <strong>water</strong><br />
Weibull Model with 0.95 Confidence Level<br />
0.6<br />
Weibull<br />
BMD Lower Bound<br />
0.5<br />
0.4<br />
Fraction Affected<br />
0.3<br />
0.2<br />
0.1<br />
0<br />
16:23 01/20 2014<br />
BMDL BMD<br />
0 1 2 3 4 5 6 7 8 9<br />
dose<br />
Figure J8: Fit of the Weibull model to the dose-response data on carcinoma or adenoma in the<br />
duodenum, jejunum or ileum female mice<br />
Table J9: Epithelial carcinoma or adenoma in the duodenum, jejunum or ileum in male and female<br />
mice combined. The benchmark dose (BMD 10 ) and the 95 % benchmark dose lower confidence limit<br />
(BMDL 10 ) values are given for a BMR of 10 % extra risk with characteristics of the model fit. The<br />
selected model based on the model selection used in PROAST is highlighted in bold.<br />
Models<br />
N of<br />
parameters<br />
Loglikelihood<br />
Accepted<br />
BMD 10<br />
(mg/kg b.w.<br />
per day)<br />
BMDL 10<br />
(mg/kg b.w.<br />
per day)<br />
BMDU 10<br />
(mg/kg b.w.<br />
per day)<br />
null 1 -216.49 – – – –<br />
full 10 -168.64 - - - -<br />
one-stage 2 -172.72 yes 1.41 1.15 1.77<br />
two-stage 3 -172.72 yes 1.41 1.15 1.75<br />
log-logist 3 -172.72 yes 1.56 1.04 2.22<br />
Weibull 3 -172.65 yes 1.53 1.00 2.21<br />
log-prob 3 -171.96 yes 1.60 1.06 2.27<br />
Gamma 3 -172.6 yes 1.56 1.02 2.25<br />
Logistic 2 -179.62 No 3.10 2.71 -<br />
probit 2 -178.22 No 2.86 2.50 -<br />
b.w.: body weight.<br />
EFSA Journal 2014;12(3):3595 237