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Chromium in <strong>food</strong> and bottled <strong>water</strong><br />

Table J18: Incidence of liver histiocytic cellular infiltration in B6C3D1 female mice exposed to sodium<br />

dichromate dihydrate in <strong>drinking</strong> <strong>water</strong> for 2 years.<br />

Data:<br />

Dose 0 0.38 1.4 3.1 8.7<br />

Response 2/49 15/50 23/50 32/50 45/50<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 5 122.3 – – – –<br />

Null (reduced) model na 1 172.1 - - - -<br />

Probit na 2 132.3 0.0002 no 0.88 0.75<br />

LogProbit none 3 123.5 0.30 yes 0.16 0.058<br />

Logistic na 2 131.8 0.0003 no 0.85 0.70<br />

LogLogistic none 3 123.6 0.27 yes 0.15 0.050<br />

Quantal-Linear (QL) na 2 125.7 0.08 yes 0.35 0.28<br />

Multistage Cancer na same as QL<br />

Multistage none 3 124.3 0.14 yes 0.25 0.19<br />

Weibull none 3 122.7 0.70 yes 0.095 0.026<br />

Gamma none 0.81 yes 0.067 0.011<br />

b.w.: body weight; na: not applicable; QL: Quantal linear.<br />

a) b)<br />

Gamma Multi-Hit Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL<br />

Gamma Multi-Hit<br />

1<br />

BMD Lower Bound<br />

Gamma Multi-Hit Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL<br />

Gamma Multi-Hit<br />

1<br />

BMD Lower Bound<br />

0.8<br />

0.8<br />

Fraction Affected<br />

0.6<br />

0.4<br />

Fraction Affected<br />

0.6<br />

0.4<br />

0.2<br />

0.2<br />

0<br />

BMDL BMD<br />

0<br />

BMDL BMD<br />

12:02 01/21 2014<br />

0 1 2 3 4 5 6 7 8 9<br />

0 1 2 3 4 5 6 7 8 9<br />

dose<br />

dose<br />

12:10 01/21 2014<br />

c) d)<br />

Weibull Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL<br />

Weibull Model, with BMR of 10% Extra Risk for the BMD and 0.95 Lower Confidence Limit for the BMDL<br />

1<br />

Weibull<br />

BMD Lower Bound<br />

1<br />

Weibull<br />

BMD Lower Bound<br />

0.8<br />

0.8<br />

Fraction Affected<br />

0.6<br />

0.4<br />

Fraction Affected<br />

0.6<br />

0.4<br />

0.2<br />

0.2<br />

0<br />

BMDL BMD<br />

0 1 2 3 4 5 6 7 8 9<br />

dose<br />

12:12 01/21 2014<br />

0<br />

BMDL BMD<br />

0 1 2 3 4 5 6 7 8 9<br />

dose<br />

12:13 01/21 2014<br />

Figure J18: Fits of the unrestricted gamma model (a), restricted gamma model (b), unrestricted Weibull<br />

model (c) and restricted Weibull model (d) to the dose-response data on hystiocytic cellular infiltration<br />

in the liver in female mice.<br />

EFSA Journal 2014;12(3):3595 251

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