efsa-opinion-chromium-food-drinking-water
efsa-opinion-chromium-food-drinking-water efsa-opinion-chromium-food-drinking-water
Chromium in food and bottled water LVM E2---- log-logist -- -- logistic -- -- 0.00 0.10 0.20 0 1 2 3 4 5 6 7 LVM H3---- 0 1 2 3 4 5 6 7 0.00 0.10 0.20 0 1 2 3 4 5 6 7 one-stage -- -- 0.00 0.10 0.20 0 1 2 3 4 5 6 7 two-stage -- -- 0.00 0.10 0.20 0.00 0.10 0.20 Weibull -- -- 0.00 0.10 0.20 0 1 2 3 4 5 6 7 log-prob -- -- 0.00 0.10 0.20 0 1 2 3 4 5 6 7 0.00 0.10 0.20 0.00 0.10 0.20 0 1 2 3 4 5 6 7 probit -- -- 0.00 0.10 0.20 0 1 2 3 4 5 6 7 gamma -- -- 0 1 2 3 4 5 6 7 0 1 2 3 4 5 6 7 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 15:23 01/20 2014 BMDL BMD 0 2 4 6 8 10 b) Result of BMDS when pooling the data of males and female for the quantal linear model Figure J3: Fit of all models used in PROAST to the dose-response data on the incidence of squamous cell carcinoma or papilloma in oral mucosa or tongue in rats. Note that the models denoted LVM E2 and H3 are not recommended by EFSA (2009c). dose EFSA Journal 2014;12(3):3595 230
Chromium in food and bottled water Table J4: Squamous cell carcinoma of the oral mucosa in male 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. The p-value of 1 indicates that the model is saturated and its fit equals to a fit of the full model fulfilling therefore the acceptance criterion trivially. Models Restriction N of parameters Minus Loglikelihood P- value Accepte d BMD 10 (mg/kg b.w. per day) BMDL 10 (mg/kg b.w. per day) Full model na 5 18.22 – – – – Null (reduced) model na 1 28.26 - - - - Probit na 2 18.22 1 yes 5.80 4.91 LogProbit none 2 18.22 1 yes 5.74 4.38 Logistic na 2 18.22 1 yes 5.85 4.11 LogLogistic none 2 18.22 1 yes 5.82 4.57 Quantal-Linear na 1 20.91 0.25 yes 7.45 4.07 Multistage Cancer na 1 19.09 0.79 yes 5.70 4.21 Multistage none 1 19.09 0.78 yes 5.70 4.21 Weibull none 2 18.22 1 yes 5.83 4.61 Gamma none 1 18.22 1 yes 5.72 4.51 na: not applicable, b.w: body weight. Quantal Linear Model with 0.95 Confidence Level 0.3 Quantal Linear BMD Lower Bound 0.25 0.2 Fraction Affected 0.15 0.1 0.05 0 BMDL BMD 11:48 06/10 2013 0 2 4 6 8 10 12 14 dose Figure J4: Fit of the quantal-linear model to the dose-response data of squamous cell carcinoma of the oral mucosa in male rats EFSA Journal 2014;12(3):3595 231
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Chromium in <strong>food</strong> and bottled <strong>water</strong><br />
Table J4: Squamous cell carcinoma of the oral mucosa in male rats. The benchmark dose (BMD 10 ) and<br />
the 95 % benchmark dose lower confidence limit (BMDL 10 ) values are given for a BMR of 10 % extra<br />
risk with characteristics of the model fit. The model with lowest BMDL 10 is highlighted in bold. The<br />
p-value of 1 indicates that the model is saturated and its fit equals to a fit of the full model fulfilling<br />
therefore the acceptance criterion trivially.<br />
Models<br />
Restriction<br />
N of<br />
parameters<br />
Minus<br />
Loglikelihood<br />
P-<br />
value<br />
Accepte<br />
d<br />
BMD 10<br />
(mg/kg<br />
b.w. per<br />
day)<br />
BMDL 10<br />
(mg/kg<br />
b.w. per<br />
day)<br />
Full model na 5 18.22 – – – –<br />
Null (reduced) model na 1 28.26 - - - -<br />
Probit na 2 18.22 1 yes 5.80 4.91<br />
LogProbit none 2 18.22 1 yes 5.74 4.38<br />
Logistic na 2 18.22 1 yes 5.85 4.11<br />
LogLogistic none 2 18.22 1 yes 5.82 4.57<br />
Quantal-Linear na 1 20.91 0.25 yes 7.45 4.07<br />
Multistage Cancer na 1 19.09 0.79 yes 5.70 4.21<br />
Multistage none 1 19.09 0.78 yes 5.70 4.21<br />
Weibull none 2 18.22 1 yes 5.83 4.61<br />
Gamma none 1 18.22 1 yes 5.72 4.51<br />
na: not applicable, b.w: body weight.<br />
Quantal Linear Model with 0.95 Confidence Level<br />
0.3<br />
Quantal Linear<br />
BMD Lower Bound<br />
0.25<br />
0.2<br />
Fraction Affected<br />
0.15<br />
0.1<br />
0.05<br />
0<br />
BMDL<br />
BMD<br />
11:48 06/10 2013<br />
0 2 4 6 8 10 12 14<br />
dose<br />
Figure J4: Fit of the quantal-linear model to the dose-response data of squamous cell carcinoma of the<br />
oral mucosa in male rats<br />
EFSA Journal 2014;12(3):3595 231
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