efsa-opinion-chromium-food-drinking-water

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