Dichlorvos (DDVP) Risk Characterization Document - California ...

Dichlorvos (DDVP) Risk Characterization Document - California ... Dichlorvos (DDVP) Risk Characterization Document - California ...

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APPENDIX D (continued) CALCULATION EQUATIONS 3. Margin of Safety: Margin of Safety NOEL exposure level 4. Human equivalency in potency from animal data to human: The equivalency in potency from animal to human is calculated based on the body weight to the 3/4 power (Davidson et al., 1986; Travis and White, 1988). Dose A Dose H × BW H BW 3 / 4 A BW A BW 3 / 4 H Dose H Dose A x ( BW A BW H ) 1 / 4 Therefore, q 1 H q 1 A ×(BW H BW A ) 1 / 4 BW=body weight, A=animal, and H=human. Body weights used were: 70 kg for human, 0.50 kg for rat, and 0.037 kg for mouse.

APPENDIX E ONCOGENICITY POTENCY CALCULATIONS GLOBAL 86 (MAY 1986) BY RICHARD B. HOWE AND CYNTHIA VAN LANDINGHAM CLEMENT ASSOCIATES, 1201 GAINES STREET, RUSTON, LA 71270 (318) 255-4800 Pancreatic adenoma in male rats dosed DDVP by gavage for 2 years POLYNOMIAL DEGREE SELECTED BY PROGRAM, (POLY-DEGREE=0) MONTE CARLO TEST USED IN SELECTION #RESPONSES #RESPONSES GROUP DOSE OBSERVED/#ANIMALS PREDICTED 1 0.00000 16/ 50 16.31 2 2.90000 25/ 49 24.06 3 5.70000 30/ 50 30.59 CHI-SQUARE GOODNESS OF FIT STATISTIC IS .11014 P-VALUE FOR THE MONTE CARLO TEST IS .4650000000 FORM OF PROBABILITY FUNCTION: P(DOSE) = 1 - exp( -Q0 - Q1 * D - Q2 * D^2 ) MAXIMUM LIKELIHOOD ESTIMATES OF DOSE COEFFICIENTS Q( 0) = .394703118704 Q( 1) = 9.680185659774E-02 Q( 2) = .000000000000 MAXIMUM VALUE OF THE LOG-LIKELIHOOD IS -99.0030875953 CALCULATIONS ARE BASED UPON EXTRA RISK GLOBAL 86 LOWER CONFIDENCE LIMITS ON DOSE FOR FIXED RISK ********************************************************* LOWER BOUND CONFIDENCE COEFFICIENTS FOR RISK MLE DOSE ON DOSE LIMIT SIZE CONFIDENCE LIMIT ---- -------- ----------- ---------- ---------------- 1.00000E-06 1.03304E-05 6.49111E-06 95.0% Q( 0) = .31574 Q( 1) = .15406 Q( 2) = .00000

APPENDIX D (continued)<br />

CALCULATION EQUATIONS<br />

3. Margin of Safety:<br />

Margin of Safety <br />

NOEL<br />

exposure level<br />

4. Human equivalency in potency from animal data to human:<br />

The equivalency in potency from animal to human is calculated based on the body weight to the 3/4<br />

power (Davidson et al., 1986; Travis and White, 1988).<br />

Dose A<br />

Dose H<br />

× BW H<br />

BW 3 / 4<br />

A<br />

BW A<br />

BW 3 / 4<br />

H<br />

Dose H<br />

Dose A<br />

x ( BW A<br />

BW H<br />

) 1 / 4<br />

Therefore,<br />

q 1 H q 1 A ×(BW H<br />

BW A<br />

) 1 / 4<br />

BW=body weight, A=animal, and H=human. Body weights used were: 70 kg for human, 0.50 kg for<br />

rat, and 0.037 kg for mouse.

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