efsa-opinion-chromium-food-drinking-water

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Chromium in food and bottled water a) Result of PROAST for all models Weibull Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL 0.3 Weibull BMD Lower Bound 0.25 Fraction Affected 0.2 0.15 0.1 0.05 0 17:41 01/20 2014 BMDL BMD 0 2 4 6 8 10 12 dose b) Result of BMDS when pooling the data of males and female for the Weibull model used to illustrate the data since the log-probit model failed to get fitted with BMDS software Figure J12: Fit of all models 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). EFSA Journal 2014;12(3):3595 242
Chromium in food and bottled water J2. BMD analysis of Chromium (VI): non-neoplastic lesions This part of the appendix informs on the details when applying the BMD approach to the incidences of the following five types of non-neoplastic lesions: • chronic inflammation of the liver in female rats; • diffuse epithelial hyperplasia in the duodenum in male and female mice; • hystiocytic cellular infiltration in mesenteric lymph nodes in male and female mice; • hystiocytic cellular infiltration in liver in female mice; • acinus,cytoplasmic alteration in pancreas. reported in Table 22. The dose-response data of the respevive endpoint are shown on top of the five tables displayed below. J.2.1. Chronic inflammation of the liver in female rats For the dose-resposne analysis of the incidence of chronic inflammation of the liver in female rats five of the non-restricted models (log-probit, log-logistic, multistage, Weibull, and Gamma) showed an acceptable fit (p > 0.05). However the BMD 10 values ranged from 0.2 to 0.001 mg/kg b.w. per day and the BMDL 10 values from 0.14 (multistage) to 0.00005 (Gamma) mg/kg b.w. per day, see Table J13. The two graphs in Figure J13 show the fit of the Multistage and the Weibull (BMDL 10 = 0.0005) models, respectively. No BMDL 10 was determined from the dose-response data for this endpoint and this data set since the BMD/BMDL ratios and the range of the BMDL values of the acceptable models are larger than one order of magnitude. Using a modelling policy different from EFSA (2009) and allowing restrictions to the models the ADTSR reported a BMDL 10 = 0.14 mg/kg b.w. per day, which would correspond to the highest BMDL 10 value observed among non-restricted models. Restricted models resulted, as expected, in higher BMDL 10 values, e.g. 0.37 mg/kg b.w. per day for the multistage and the Weibull model but were not used for dose-response assessment in this opinion. EFSA Journal 2014;12(3):3595 243
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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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efsa-opinion-chromium-food-drinking-water

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