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

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Table 12. Selected no-observed-effect levels (NOELs) and lowest-observed-effect levels (LOELs) of DDVP from reproductive toxicity studies. Plasma ChE a RBC ChE a Brain ChE a Other Effects Species Route Duration NOEL LOEL % C NOEL LOEL % C NOEL LOEL % C NOEL LOEL Effects Ref. b (mg/kg-day) (mg/kg-day) (mg/kg-day) (mg/kg-day) Rat water daily c (range finding) females and - 3 48-66% - 3 58-61% - 3 54-93% - 1 males F 0 females F 0 - - - - - - 11-17 22-44 maternal-reduced body weight gain, food consumption females F 0 - - - - - - 24 41 maternal- tremors (first on day 7) fetal F 1 - - - - - - 11 22 fetal-cholinergic signs Rat water daily c,d 2.7 9.5 parental 2* -decreased fertility, females F 0 1.1 4.6 45%
G. DEVELOPMENTAL TOXICITY Summary: DDVP, given by oral or inhalation routes, was not teratogenic in rats, mice, or rabbits. Cholinergic signs (tremors, ataxia, diarrhea, and other effects) were observed in the pregnant rats and rabbits. Selected studies are presented in Table 13. Gavage - Rat DDVP (97% purity; 0, 0.1, 3.0, or 21.0 mg/kg-day) was given to Sprague-Dawley pregnant rats (25/group) by gavage once daily from gestational days 6 to 15 (Tyl et al., 1991a). Systemic toxicity was observed only in the high dose group. There was a significant (p @ 0.05) reduction in the maternal body weight as the mean maternal weight gain was 66% of control value during the treatment period. Cholinergic signs observed were tremors and excitability. Tremors were observed in the 21.0 mg/kg-day group with the onset within 10-60 minutes after each daily dosing. Other signs of toxicity included prone positioning, hindlimb splay, circling, vocalization, hypoactivity, labored respiration, ear shaking, and coprophagia. Examination of the fetuses showed no significant increases in the incidence of gestational parameters and of individual or pooled external, visceral, skeletal, or total fetal malformations or variations. The incidence (18 fetuses/8 litters) of enlarged lateral ventricles of the cerebrum in the fetuses of the 21.0 mg/kg-day was slightly higher, though not statistically significant, than that (9 fetuses/5 litters) for the control group. The NOELs were 3.0 mg/kg-day for maternal toxicity and greater than 21.0 mg/kg-day for developmental toxicity. This study was considered acceptable to DPR according to FIFRA guidelines. Intraperitoneal - Rat Pregnant Sherman rats (6/group) were given a single dose of DDVP (purity not stated, 15 mg/kg) by intraperitoneal injection on day 11 after insemination (Kimbrough and Gaines, 1968). On day 20 of pregnancy, the fetuses were examined. Of the 41 fetuses examined, omphalocele was noted in 3 fetuses. There were no significant differences in the average weight gain of the dams, average number of fetuses per litter, average number of resorptions, average weight of fetuses, and average weight of placenta. The report noted that a dose of 20 mg/kg DDVP was lethal to pregnant rats. Except for lethality and dam body weights, the report did not include clinical observations. Inhalation - Rat Female rats (Carworth Farm E strain, 9-10/treated group) were exposed to DDVP (>97% purity; at nominal concentrations of 0, 0.25, 1.25, or 6.25 ug/L equivalent to 0, 0.23, 1.15, or 5.75 mg/kg-day) for 23 hours daily by inhalation (Thorpe et al., 1971a). They were treated from day 1 of insemination (pregnancy) to gestation day 20. At the end of the experiment, plasma, erythrocyte, and brain ChE activities of the 1.25 ug/L group were significantly (p
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DICHLORVOS (DDVP) RISK CHARACTERIZA
Page 3 and 4: transmitter of signals from the ner
Page 5 and 6: Contributors and Acknowledgments Pr
Page 7 and 8: List of Tables Pages 1. The acute t
Page 9 and 10: hematocrit) in rats. From studies w
Page 11 and 12: II. INTRODUCTION The human health r
Page 13 and 14: food service facilities); hand-held
Page 15 and 16: G. ENVIRONMENTAL FATE Summary: DDVP
Page 17 and 18: III. TOXICOLOGY PROFILE Pharmacokin
Page 19 and 20: Inhalation - Rat Carworth Farm stra
Page 21 and 22: DIMETHYL PHOSPHATE Oral - Rat Rats
Page 23 and 24: B. ACUTE TOXICITY Summary: The acut
Page 25 and 26: Oral - Human One hundred and eight
Page 27 and 28: Table 1. The acute toxicity of DDVP
Page 29 and 30: Table 1. The acute toxicity of DDVP
Page 31 and 32: Table 2. Selected no-observed-effec
Page 33 and 34: dose-related manner. At a dosage of
Page 35 and 36: pretreatment levels, respectively.
Page 37 and 38: Table 3. Selected no-observed-effec
Page 39 and 40: Gavage - Rat In a study conducted b
Page 41 and 42: ate (Appendix D) and the assumption
Page 43 and 44: Gavage - Mouse In a study conducted
Page 45 and 46: Capsules - Dog DDVP (97.3-99.5% pur
Page 47 and 48: Table 9. The no-observed-effect lev
Page 49 and 50: Mice exposed to DDVP by inhalation
Page 51 and 52: F. REPRODUCTIVE TOXICITY Summary: E
Page 53: Table 11. The dosages and the inhib
Page 57 and 58: levels not verified, too few pregna
Page 59 and 60: H. NEUROTOXICITY Summary: Possible
Page 61 and 62: IV. RISK ASSESSMENT A. HAZARD IDENT
Page 63 and 64: Acute Toxicity Inhalation The criti
Page 65 and 66: ates were not statistically signifi
Page 67 and 68: In mice, there were dose-related in
Page 69 and 70: B. EXPOSURE ASSESSMENT The exposure
Page 71 and 72: The U.S. Department of Agriculture
Page 73 and 74: Acute Exposure Estimates of potenti
Page 75 and 76: Table 19. Commodity contribution of
Page 77 and 78: C. RISK CHARACTERIZATION The potent
Page 79 and 80: Table 23. The margins of safety for
Page 81 and 82: Table 25. The margins of safety of
Page 83 and 84: label between treatment and the ava
Page 85 and 86: VI. TOLERANCE ASSESSMENT A. BACKGRO
Page 87 and 88: VII. CONCLUSIONS The toxicological
Page 89 and 90: Bomhard, E., and M. Rinke, 1994. Fr
Page 91 and 92: DPR, 1992. Sampling for pesticide r
Page 93 and 94: Horn, K.-H., B. Teichmann, and T. S
Page 95 and 96: NTP (National Toxicology Program),
Page 97 and 98: TAS, 1992a. Exposure 4 . Detailed
Page 99 and 100: Warf Institute Inc., 1977c. Acute e
Page 101 and 102: APPENDIX A U.S. ENVIRONMENTAL PROTE
Page 103 and 104: APPENDIX B Department of Pesticide
Page 105 and 106:
TABLE 2: Percent DDVP Dermal Absorp
Page 107 and 108:
RESIDENT EXPOSURES Environmental mo
Page 109 and 110:
post-treatment, respectively. Glove
Page 111 and 112:
Ross, J.H., H.R. Fong, , T. Thongsi
Page 113 and 114:
APPENDIX C NALED TOXICOLOGY OF NALE
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APPENDIX D CALCULATION EQUATIONS 1.
Page 117 and 118:
APPENDIX E ONCOGENICITY POTENCY CAL
Page 119:
APPENDIX E (continued) ONCOGENICITY
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