efsa-opinion-chromium-food-drinking-water
efsa-opinion-chromium-food-drinking-water efsa-opinion-chromium-food-drinking-water
Chromium in food and bottled water Table J5: Squamous cell carcinoma of the oral mucosa in female rats. 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 34.74 – – – – Null (reduced) model na 1 51.09 - - - - BMDL 10 (mg/kg b.w. per day) Probit na 2 35.83 0.54 yes 5.19 4.34 LogProbit none 2 34.92 0.95 yes 4.16 3.00 Logistic na 2 36.10 0.44 yes 5.48 4.66 LogLogistic none 2 35.05 0.89 yes 4.41 3.17 Quantal-Linear na 1 36.96 0.35 yes 3.95 2.58 Multistage Cancer na 1 35.08 0.96 yes 4.50 3.46 Multistage none 2 35.02 0.91 yes 4.55 3.49 Weibull none 2 35.08 0.88 yes 4.49 3.24 Gamma none 2 35.03 0.90 yes 4.36 3.21 na: not applicable, b.w.: body weight 0.4 0.35 Quantal Linear Model with 0.95 Confidence Level Quantal Linear BMD Lower Bound 0.3 0.25 Fraction Affected 0.2 0.15 0.1 0.05 0 BMDL BMD 11:49 06/10 2013 0 1 2 3 4 5 6 7 8 9 dose Figure J5: Fit of the quantal-linear model to the dose-response data on squamous cell carcinoma of the oral mucosa in female rats EFSA Journal 2014;12(3):3595 232
Chromium in food and bottled water Table J6: Squamous cell carcinoma of the oral mucosa in male and female rats combined using PROAST 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 -80.77 – – – – full 10 -53.09 - - - - one-stage 2 -58.89 yes 5.09 3.57 7.62 two-stage 3 -58.89 yes 5.09 3.57 7.62 log-logist 3 -54.56 yes 5.01 4.11 5.96 Weibull 3 -54.56 yes 5.07 4.18 5.98 log-prob 3 -54.49 yes 4.80 3.90 5.85 gamma 3 -54.54 yes 4.96 4.09 5.93 logistic 2 -55.50 yes 5.67 5.01 6.27 probit 2 -55.17 yes 5.45 4.83 - b.w.: body weight. EFSA Journal 2014;12(3):3595 233
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Chromium in <strong>food</strong> and bottled <strong>water</strong><br />
Table J5: Squamous cell carcinoma of the oral mucosa in female rats. The benchmark dose (BMD 10 )<br />
and the 95 % benchmark dose lower confidence limit (BMDL 10 ) values are given for a BMR of 10 %<br />
extra risk with characteristics of the model fit. The model with lowest BMDL 10 is highlighted in bold.<br />
Models<br />
Restriction<br />
N of<br />
parameters<br />
Minus<br />
Loglikelihood<br />
P-<br />
value<br />
Accepted<br />
BMD 10<br />
(mg/kg<br />
b.w. per<br />
day)<br />
Full model na 5 34.74 – – – –<br />
Null (reduced) model na 1 51.09 - - - -<br />
BMDL 10<br />
(mg/kg<br />
b.w. per<br />
day)<br />
Probit na 2 35.83 0.54 yes 5.19 4.34<br />
LogProbit none 2 34.92 0.95 yes 4.16 3.00<br />
Logistic na 2 36.10 0.44 yes 5.48 4.66<br />
LogLogistic none 2 35.05 0.89 yes 4.41 3.17<br />
Quantal-Linear na 1 36.96 0.35 yes 3.95 2.58<br />
Multistage Cancer na 1 35.08 0.96 yes 4.50 3.46<br />
Multistage none 2 35.02 0.91 yes 4.55 3.49<br />
Weibull none 2 35.08 0.88 yes 4.49 3.24<br />
Gamma none 2 35.03 0.90 yes 4.36 3.21<br />
na: not applicable, b.w.: body weight<br />
0.4<br />
0.35<br />
Quantal Linear Model with 0.95 Confidence Level<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 />
BMDL<br />
BMD<br />
11:49 06/10 2013<br />
0 1 2 3 4 5 6 7 8 9<br />
dose<br />
Figure J5: Fit of the quantal-linear model to the dose-response data on squamous cell carcinoma of the<br />
oral mucosa in female rats<br />
EFSA Journal 2014;12(3):3595 232
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