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 J2: Squamous cell carcinoma or papilloma in oral mucosa or tongue 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) BMDL 10 (mg/kg b.w. per day) Full model na 5 44.55 – – – – Null (reduced) model - 1 56.74 - - - - Probit na 2 45.72 0.50 yes 4.92 4.01 LogProbit none 3 45.43 0.41 yes 4.58 3.20 Logistic na 2 45.67 0.52 yes 5.17 4.31 LogLogistic none 2 45.50 0.39 yes 4.87 3.34 Quantal-Linear na 2 47.22 0.15 yes 4.11 2.61 Multistage Cancer na 2 45.57 0.50 yes 4.73 3.52 Multistage none 2 45.36 0.44 yes 4.96 3.65 Weibull none 3 45.51 0.38 yes 4.95 3.40 Gamma none 3 45.48 0.39 yes 4.82 3.38 b.w.: body weight; na: not applicable. 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 11:50 06/10 2013 BMDL BMD 0 1 2 3 4 5 6 7 8 9 dose Figure J2: Fit of the quantal-linear model to the dose-response data on the incidence of squamous cell carcinoma or papilloma in oral mucosa or tongue in female rats. EFSA Journal 2014;12(3):3595 228
Chromium in food and bottled water Table J3: Squamous cell carcinoma or papilloma of the oral mucosa or tongue in male and female rats combined using PROAST.The benchmark dose (BMD 10 ) and the 95 % benchmark dose lower confidence limits (BMDL 10 , BMDU 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 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 -93.28 – – – – full 10 -69.70 - - - - one-stage 2 -77.01 yes 4.85 3.36 7.55 two-stage 3 -77.01 yes 4.85 - - log-logist 3 -73.08 yes 5.25 4.22 6.14 Weibull 3 -73.08 yes 5.30 4.29 6.27 log-prob 3 -73.04 yes 5.02 4.01 6.22 gamma 3 -73.06 yes 5.18 4.20 6.24 logistic 2 -73.47 yes 5.35 4.71 6.18 probit 2 -73.66 yes 5.14 4.44 - EFSA Journal 2014;12(3):3595 229
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Chromium in <strong>food</strong> and bottled <strong>water</strong><br />
Table J2: Squamous cell carcinoma or papilloma in oral mucosa or tongue in female rats. The<br />
benchmark dose (BMD 10 ) and the 95 % benchmark dose lower confidence limit (BMDL 10 ) values are<br />
given for a BMR of 10 % extra risk with characteristics of the model fit. The model with lowest<br />
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 />
BMDL 10<br />
(mg/kg<br />
b.w. per<br />
day)<br />
Full model na 5 44.55 – – – –<br />
Null (reduced) model - 1 56.74 - - - -<br />
Probit na 2 45.72 0.50 yes 4.92 4.01<br />
LogProbit none 3 45.43 0.41 yes 4.58 3.20<br />
Logistic na 2 45.67 0.52 yes 5.17 4.31<br />
LogLogistic none 2 45.50 0.39 yes 4.87 3.34<br />
Quantal-Linear na 2 47.22 0.15 yes 4.11 2.61<br />
Multistage Cancer na 2 45.57 0.50 yes 4.73 3.52<br />
Multistage none 2 45.36 0.44 yes 4.96 3.65<br />
Weibull none 3 45.51 0.38 yes 4.95 3.40<br />
Gamma none 3 45.48 0.39 yes 4.82 3.38<br />
b.w.: body weight; na: not applicable.<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 />
11:50 06/10 2013<br />
BMDL<br />
BMD<br />
0 1 2 3 4 5 6 7 8 9<br />
dose<br />
Figure J2: Fit of the quantal-linear model to the dose-response data on the incidence of squamous cell<br />
carcinoma or papilloma in oral mucosa or tongue in female rats.<br />
EFSA Journal 2014;12(3):3595 228