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Chromium in food and bottled water Table J13: Chronic inflammation of the liver 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. Data Dose 0 0.24 0.94 2.4 7.0 Response 12/50 21/50 28/50 35/50 39/50 Models Restriction N of parameters Minus Loglikelihood P- value Accepted BMD 10 (mg/kg b.w. per day) Full model na 5 152.7 – – – – Null (reduced) model na 1 172.5 - - - - BMDL 10 (mg/kg b.w. per day) Probit na 2 158.9 0.006 no 0.88 0.70 LogProbit none 3 1.52.9 0.91 yes 0.052 0.0031 Logistic na 2 1.58.7 0.008 no 0.84 0.65 LogLogistic none 3 1.52.8 0.92 yes 0.043 0.0021 Quantal-Linear (QL) na 2 157.0 0.04 no 0.51 0.37 Multistage Cancer na 1 157.0 0.04 no 0.52 0.37 Multistage none 3 153.4 0.51 yes 0.20 0.14 Weibull none 2 153.0 0.82 yes 0.021 0.0005 Gamma none 2 153.1 0.72 yes 0.0096 0.00005 b.w.: body weight; na: not applicable; if: invalid fit. Multistage Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL Weibull Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL 0.9 Multistage BMD Lower Bound 0.9 Weibull BMD Lower Bound 0.8 0.8 0.7 0.7 Fraction Affected 0.6 0.5 0.4 Fraction Affected 0.6 0.5 0.4 0.3 0.3 0.2 0.2 0.1 09:17 01/21 2014 BMDL BMD 0 1 2 3 4 5 6 7 dose 0.1 BMDLBMD 0 1 2 3 4 5 6 7 dose 09:15 01/21 2014 Figure J13: Fits of the Multistage model (left) and Weibull model (right) to the dose-response data on chronic liver inflammation in female rats. J 2.2. Diffuse epithelial hyperplasia in the duodenum in male mice For the dose-response analysis of the incidence of diffuse epithelial hyperplasia in the duodenum in male mice only one non-restricted model (multistage) showed an acceptable fit (p > 0.05) which resulted in a BMDL 10 = 0.11 mg/kg b.w. per day . Using a different modelling approach, not following EFSA (2009), ADTSR reported a BMDL 10 of 0.13 mg/kg b.w. per day. Two graphs in Figure J14 show the fit of the unrestricted Multistage model and Weibull model. EFSA Journal 2014;12(3):3595 244
Chromium in food and bottled water The restricted Weibull models resulted, as expected, in a higher BMDL 10 value of 0.25 mg/kg b.w. per day and was not used for dose-response assessment. Table J14: Diffuse epithelial hyperplasia in the duodenum in male 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. Data Dose 0 038 0.91 2.4 5.9 Response 0/50 11/50 18/50 42/50 32/50 Models Restriction BMD N of Minus 10 BMDL 10 P- (mg/kg (mg/kg parameter Loglikelihood Accepted value b.w. per b.w. per s day) day) Full model na 5 113.7 – – – – Null (reduced) model na 1 169.4 - - - - Probit na 2 146.1 < 10-13 no 0.90 0.76 LogProbit none 2 122.6 0.0004 no 0.11 0.04 Logistic na 2 1.58.7 0.05) which resulted in BMDL 10 values of 0.0065, 0.0052 and 0.0008 mg/kg b.w. per day, respectively. EFSA Journal 2014;12(3):3595 245
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EFSA Journal 2014;12(3):3595 SCIENT
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Chromium in food and drinking water
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4.2.2.1. Data collection on food (e
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Sampling year Number of samples Chr
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Number of analtycal results Samplin
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4.2.4. Occurrence data by food cate
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7.2.1.4. Genotoxicity Chromium in f
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7.5. Dose-response assessment Chrom
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Human observations Chromium in food
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