efsa-opinion-chromium-food-drinking-water

efsa-opinion-chromium-food-drinking-water efsa-opinion-chromium-food-drinking-water

damienvanherp
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16.04.2014 Views

Chromium in food and bottled water Table J11: Epithelial carcinoma in the duodenum, jejunum or ileum carcinoma 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) BMDL 10 (mg/kg b.w. per day) Full model na 5 44.90 – – – – Null (reduced) model na 1 51.05 - - - - Probit na 2 46.24 0.44 yes 7.46 5.63 LogProbit none 3 45.82 0.40 yes 6.29 3.59 Logistic na 3 46.31 0.42 yes 7.66 5.96 LogLogistic none 2 45.90 0.36 yes 6.51 3.80 Quantal-Linear na 2 45.94 0.55 yes 6.60 3.93 Multistage Cancer na 3 45.94 0.35 yes 6.63 3.94 Multistage yes 3 45.94 0.36 yes 6.63 3.12 Weibull none 3 45.91 0.36 yes 6.57 3.87 Gamma none 3 45.91 0.36 yes 6.56 3.89 na: not applicable Multistage Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL 0.3 Multistage 0.25 0.2 Fraction Affected 0.15 0.1 0.05 0 BMDL BMD 16:46 08/01 2013 0 1 2 3 4 5 6 7 8 9 dose Figure J11: Fit of the Multistage model to the dose-response data on epithelial carcinoma in the duodenum, jejunum or ileum in female mice EFSA Journal 2014;12(3):3595 240

Chromium in food and bottled water Table J12: Epithelial carcinoma in the duodenum, jejunum or ileum carcinoma 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. Numerical results of the fit of the probit model were inconsistent. 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 -96.29 – – – – full 10 -85.80 - - - - one-stage 2 -88.05 yes 6.34 4.16 11.5 two-stage 3 -88.05 yes 6.34 4.16 11.5 log-logist 3 -88.02 yes 6.36 3.94 16.5 Weibull 3 -88.02 yes 6.37 3.98 16.2 log-prob 3 -88.03 yes 6.38 3.81 18.5 gamma 3 -88.02 yes 6.38 4.00 15.9 logistic 2 -88.02 yes 7.32 5.90 10.7 probit - - - - - - b.w.: body weight. EFSA Journal 2014;12(3):3595 241

Chromium in <strong>food</strong> and bottled <strong>water</strong><br />

Table J12: Epithelial carcinoma in the duodenum, jejunum or ileum carcinoma 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. Numerical results<br />

of the fit of the probit model were inconsistent.<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 -96.29 – – – –<br />

full 10 -85.80 - - - -<br />

one-stage 2 -88.05 yes 6.34 4.16 11.5<br />

two-stage 3 -88.05 yes 6.34 4.16 11.5<br />

log-logist 3 -88.02 yes 6.36 3.94 16.5<br />

Weibull 3 -88.02 yes 6.37 3.98 16.2<br />

log-prob 3 -88.03 yes 6.38 3.81 18.5<br />

gamma 3 -88.02 yes 6.38 4.00 15.9<br />

logistic 2 -88.02 yes 7.32 5.90 10.7<br />

probit - - - - - -<br />

b.w.: body weight.<br />

EFSA Journal 2014;12(3):3595 241

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