Pesticide residues in food â 2006: Toxicological ... - ipcs inchem

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101 Wiemann, C. & Hellwig, J. (1998a) BAS 510 F – maximization test in guinea pigs. Unpublished report No. 1998/10638 from BASF AG, Ludwigshafen/Rhein, Germany. Submitted to WHO by BASF. GLP compliant. Wiemann, C. & Hellwig, J. (1998b) BAS 510 F: acute dermal toxicity in rats. Unpublished report No. 1998/10642 from BASF AG, Ludwigshafen/Rhein, Germany. Submitted to WHO by BASF. GLP compliant. Wiemann C. & Hellwig J. (1998c) BAS 510 F: acute oral toxicity in rats. Unpublished report No. 1998/10643 from BASF AG, Ludwigshafen/Rhein, Germany. Submitted to WHO by BASF. GLP compliant. Wiemann, C. &, Hellwig, J. (1998d) Study on the acute dermal irritation/corrosion of BAS 510 F in the rabbit. Unpublished report No. 1998/10640 from BASF AG, Ludwigshafen/Rhein, Germany. Submitted to WHO by BASF. GLP compliant. Wiemann, C. & Hellwig, J. (1998e) Study on the acute eye irritation of BAS 510 F in the rabbit. Unpublished report No. 1998/10641 from BASF AG, Ludwigshafen/Rhein, Germany. Submitted to WHO by BASF. GLP compliant. Wiemann, C., Deckardt, K., Kaufmann, W., Kolling, A. & Hildeband, B. (2000) BAS 510 F – chronic oral toxicity study in beagle dogs – administration in the diet for 12 months. Unpublished report No. 2000/1016881 from BASF AG, Ludwigshafen/Rhein, Germany. Submitted to WHO by BASF. GLP compliant. BOSCALID X-X JMPR 2006
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Pesticide residues in food — 2006
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TABLE OF CONTENTS Page List of part
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Dr Helen Hakansson, Institute of En
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Abbreviations used ADI ALT APDM ARf
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Introduction The toxicological mono
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BIFENAZATE First draft prepared by
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5 In a series of experiments, group
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7 In a study of the time-course of
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9 the administered dose in males an
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11 limited absorption of parent com
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13 NAME/No. STRUCTURE D1989 OCH 3 D
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15 2.1 Acute toxicity Results of st
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17 (f) Sensitization In a study of
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19 Table 9. Clinical chemistry effe
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21 The degree of this finding was m
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23 On histopathological examination
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25 (equal to 0, 0.9, 10.4 or 25 mg/
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27 Haemoglobin (g/dl): Before treat
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29 weekly. Blood and urine samples
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31 (females) (equal to 0, 1.0, 3.9,
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33 Cytogenetic test Chinese hamster
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35 groups of 30 males and 30 female
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37 and placed in 10% ammonium sulfi
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39 was > 5000 mg/kg bw. The LC 50 i
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41 Multigeneration study of reprodu
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43 Medical data No significant adve
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45 Trutter, J.A. (1997a) 28-Day die
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48 Evaluation for acceptable daily
Page 63 and 64: 50 Table 2. Radioactivity in blood
Page 65 and 66: 52 10 10 0.42 0.0462 0.63 0.0080 8.
Page 67 and 68: 54 Figure 2. Transfer of radioactiv
Page 69 and 70: 56 Skin 33.07 61.59 0.5 17.94 17.29
Page 71 and 72: 58 Table 10. Summary of metabolites
Page 73 and 74: 60 Table 14. Summary of identified
Page 75 and 76: 62 Table 18. Summary of metabolites
Page 77 and 78: 64 Table 19. Structures of identifi
Page 79 and 80: 66 Metabolite Structure O M510F14 N
Page 81 and 82: 68 Metabolite Structure M510F39 N O
Page 83 and 84: 70 2. Toxicological studies 2.1 Acu
Page 85 and 86: 72 1% Tylose CB 30.000. The injecti
Page 87 and 88: 74 the end of dosing. Blood samples
Page 89 and 90: 76 examinations were carried out 8
Page 91 and 92: 78 concentrations were increased at
Page 93 and 94: 80 times were slightly, but signifi
Page 95 and 96: 82 in males and females rats at 250
Page 97 and 98: 84 End-point Test object Dose a (LE
Page 99 and 100: 86 parental rats was not markedly a
Page 101 and 102: 88 groups in conception frequencies
Page 103 and 104: 90 0.7 ± 3.5%, 1.8 ± 4.2%, 2.9 ±
Page 105 and 106: 92 In this study of developmental n
Page 107 and 108: 94 3. Observations in humans In the
Page 109 and 110: 96 was 100 ppm, equal to 10 mg/kg b
Page 111 and 112: 98 Acute toxicity Rat, LD 50 , oral
Page 113: 100 Mellert, W., Kaufmann, W. & Hil
Page 117 and 118: 104 5. Studies on metabolites .....
Page 119 and 120: 106 After oral administration of 0.
Page 121 and 122: 108 Cattle A lactating Holstein dai
Page 123 and 124: 110 Species Strain Sex Route Formul
Page 125 and 126: 112 cyfluthrin (0.1% v/v) at a dose
Page 127 and 128: 114 glandular epithelium of the sub
Page 129 and 130: 116 In a study performed according
Page 131 and 132: 118 termination, the rats were kill
Page 133 and 134: 120 when the increase was 232%), an
Page 135 and 136: 122 Table 3. Results of studies of
Page 137 and 138: 124 weight was accompanied by a dec
Page 139 and 140: 126 highest dose. Necropsy revealed
Page 141 and 142: 128 tilted plane was assessed at se
Page 143 and 144: 130 no catalepsy. In rats, doses of
Page 145 and 146: 132 Rat Wistar Male Female Male Fem
Page 147 and 148: 134 In a study of dermal sensitizat
Page 149 and 150: 136 inhalation for 6 h per day for
Page 151 and 152: 138 Groups of 12 male and 12 female
Page 153 and 154: 140 The metabolites of cyfluthrin s
Page 155 and 156: 142 The increased incidence of malf
Page 157 and 158: 144 Offspring toxicity 50 ppm, equa
Page 159 and 160: 146 Developmental target Lowest rel
Page 161 and 162: 148 Flucke, W. (1984b) FCR 1272, Pr
Page 163 and 164: 150 Herbold, B. (1981b) Dominant le
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152 Miksche, L. (1979) Symptoms of
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154 Sheets, L.P., Gilmore, R.G. & H
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CYPERMETHRIN (INCLUDING ALPHA- AND
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159 For alpha-cypermethrin, the spe
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161 depleted over the test interval
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163 in the heart (67.6 and 88.7 ng
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165 (DCVA) was rapid and confined t
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167 Thus, the results of the studie
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169 Rat M NS Oral Aqueous suspensio
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171 exposure at 1600 ppm, both male
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173 The NOAEL in rats was 1500 ppm,
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175 No dogs died during the study.
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177 The NOAEL was 400 ppm, equivale
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179 Table 4. Significant findings r
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181 Alkaline Comet assay D. melanog
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183 To evaluate the potential (note
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185 of cypermethrin (purity, 97%; c
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187 hepatic APDM activity in males
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189 of treatment. Microscopic findi
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191 (radiochemical purity, > 99%) a
Page 206 and 207:
193 4.2 Short-term studies of toxic
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195 increased. In both sexes at 540
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197 Table 9. Results of studies of
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199 and motor activity. In each stu
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201 10, 17, 34 and 68 mg/kg bw per
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203 Table 12. Statistically signifi
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205 were reduced by 13% relative to
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207 splayed hindlimbs, staggered ga
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209 related directly to symptoms in
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211 of the face which usually devel
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213 Cypermethrin, alpha-cypermethri
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215 (b) Alpha-Cypermethrin Species
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217 Summary for cypermethrins, incl
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219 Shell Toxicology Laboratory (Tu
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221 Freeman, C. (1990a) FMC 56701 t
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223 Hutson, D.H. (1977) Taurine con
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225 Prinsen, G.H. & Van Sittert, W.
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CYROMAZINE First draft prepared by
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229 24-48 h < 0.3 0.5 48-72 h < 0.2
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231 Seven days after an oral dose o
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233 kinetics, the elimination half-
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235 Cyromazine was rapidly absorbed
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237 gastrointestinal tract (1.1-1.3
Page 252 and 253:
239 Residue concentrations of cyrom
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241 Table 13. Quantification of fae
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243 Hens Two hens received capsules
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245 At the intermediate dose, the r
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247 In order to follow the fate of
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249 Table 21. Recovery of radioacti
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251 Cyromazine is of low acute toxi
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253 selected organs were weighed, a
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255 Cyromazine lowered erythrocyte
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257 Kidney, focal chronic epithelia
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259 Table 25. Incidence of hepatoce
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261 females at the intermediate dos
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265 or 600 mg/kg bw did not differ
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267 Table 29. Overall range and mea
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269 in the number of litters and fe
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271 30 and 60 mg/kg bw per day, res
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273 control groups. No significant
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275 Spina bifida 1 (1) 1 (1) 2 (2)
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277 3. Studies on metabolites There
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279 of most male rats in a dose-rel
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281 receiving 3% melamine in the di
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283 (e) Reproductive toxicity No to
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285 Dietary administration of cyrom
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287 Critical end-points for setting
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289 Clayson, D.B., Fishbein L. & Co
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291 National Toxicology Program (19
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DIAZINON (addendum) First draft pre
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295 appearance, behaviour, signs of
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297 deaths occurred. Body-weight lo
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299 cholinesterase activities were
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301 Significant and dose-related in
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303 p < 0.01 for both) at 2500 ppm
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305 the brain was significantly (p
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307 87.7%) at a concentration of 0,
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309 No clinical signs or changes in
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311 The lowest-observed-adverse-eff
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313 England on behalf of Makhteshim
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HALOXYFOP (INCLUDING HALOXYFOP-R AN
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317 Evaluation for acceptable daily
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319 excreted into urine with an eli
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321 found in the faeces over the 6
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323 (one major and two minor). The
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325 was well tolerated for the 5 da
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327 Rats In a 4-week probe study th
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329 In a GLP-compliant study, group
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331 before treatment and after 1, 2
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333 Organs were weighed and histopa
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335 treatment. At 6 and 12 months,
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337 adults. Some of the livers of t
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339 1.0, 7.5 or 20 mg/kg bw per day
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341 increase in peroxisome prolifer
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343 per day. The Meeting concluded
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345 Monkeys In a GLP-compliant 4-we
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347 seen and a NOAEL of 0.2 mg/kg b
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349 The Meeting established a group
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351 Summary for racemic haloxyfop,
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353 Linscombe, V.A., Jackson, K.M.
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PIRIMIPHOS-METHYL (ADDENDUM) First
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357 Dogs Groups of one male beagle
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359 In this study a NOAEL could not
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361 resorptions. A sample of brain
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363 Midbrain 90* 97 77* 83* 32* 41*
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365 In one 28-day and one 56-day st
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QUINOXYFEN First draft prepared by
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369 Figure 1. Chemical structure of
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371 ranged from 6 to 10 h. The tiss
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373 peaks Q3, Q6 and Q14, while pea
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375 2. Toxicological studies 2.1 Ac
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377 Rats In a GLP-compliant study,
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379 ALP (U/l) 125 128 129 112* 97 9
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381 in the highest dose males but t
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383 Liver, extramedullary h aematop
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385 of the treatment period. The me
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389 The NOAEL for maternal toxicity
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391 Microsomal P450 (nmol/mg) 0.9 1
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393 Lumbar root ganglion slight deg
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395 being observed at 250 mg/kg bw
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397 Levels relevant to risk assessm
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399 References Baker, P.C. & Yano,
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401 Szabo, J.R. & Rachunek, S.L (19
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404 programme recommended that teme
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406 In a study in mice, groups of f
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408 Table 2. Oral and dermal median
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410 2.2 Short-term studies of toxic
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412 no-observed-effect level (NOEL)
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414 study (31-47%) at 10 mg/kg bw p
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416 2.3 Long-term studies of toxici
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418 treatment-related effect. The N
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420 The Meeting concluded temephos
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422 bw per day in a 99-day dietary
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424 Humans Investigation of clinica
Page 439 and 440:
426 Laws, E.R. Jr., Morales, F.R.,
Page 442 and 443:
THIABENDAZOLE (addendum) First draf
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431 Table 1. Blood concentrations o
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433 In a dose range-finding study,
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435 higher for males (125% and 172%
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437 activity was most apparent for
Page 452 and 453:
439 consumption and body-weight gai
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441 Table 7. Incidence of external
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443 The paper by Ogata et al. (1984
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445 and body-weight gain (decrease
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447 included anorexia, nausea, vomi
Page 462 and 463:
449 References Campbell, W.C. & Cuc
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THIACLOPRID First draft prepared by
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453 In most of the tests, the elimi
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455 Table 3. Residual radioactivity
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457 0.5% tragacanth orally by gavag
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459 Thyroid 0.050 0.055 17.975 Skin
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461 (b) 14 C-thiazolidine-labelled
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463 2. Toxicological studies 2.1 Ac
Page 478 and 479:
465 In the main study, one test gro
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467 The NOAEL was 200 ppm, equal to
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469 Increased activities of asparta
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471 Bile acid (μmol/l) 45.9 31.7 5
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473 Week 12 40 39 42 48 37 49 45 51
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475 At the highest dose, clotting t
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477 reduced triglyceride concentrat
Page 492 and 493:
479 Haematological examination in s
Page 494 and 495:
481 Haematological investigations d
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483 107 weeks. In addition, groups
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485 Degeneration 1 0 5* 16** 0 0 0
Page 500 and 501:
487 Table 24. Relevant clinical and
Page 502 and 503:
489 The histopathological investiga
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491 Uterus; No. examined — —
Page 506 and 507:
493 S9). Duplicate cultures were us
Page 508 and 509:
495 “Ground glass” hepatocytes
Page 510 and 511:
497 Table 30. Relevant findings in
Page 512 and 513:
499 No. of litters 25 28 26 28 No.
Page 514 and 515:
501 % Postimplantation loss per dam
Page 516 and 517:
503 Thiacloprid was not teratogenic
Page 518 and 519:
505 A slight increase in the number
Page 520 and 521:
507 Observations during handling Di
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509 There were no deaths and no cli
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511 day 30. Female rats were examin
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513 Thiacloprid did not cause any s
Page 528 and 529:
515 (TA1535, TA100, TA1537, TA98 an
Page 530 and 531:
517 acid amide at 1000 ppm and thia
Page 532 and 533:
519 The NOAEL was 100 ppm, equal to
Page 534 and 535:
521 Vaginal smears were taken, exam
Page 536 and 537:
523 No. of animals delivered 27 25
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525 (four to six rats per dose) wer
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527 No. cannibalized 0 2 11 13 Mean
Page 542 and 543:
529 Corticosterone (ng/ml) After 9
Page 544 and 545:
531 was of low acute dermal toxicit
Page 546 and 547:
533 Mechanistic studies on uterine
Page 548 and 549:
535 The Meeting concluded that the
Page 550 and 551:
537 Reproductive toxicity Reproduct
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539 from Bayer AG, Wuppertal, Germa
Page 554 and 555:
541 Pauluhn, J. (1998) YRC 2894 sub
Page 556 and 557:
543 1.2 Postulated mode of action (
Page 558 and 559:
545 sensitive than female rats with
Page 560 and 561:
547 Table A2. NOAELs and LOAELs for
Page 562 and 563:
549 of estrogens that catalyses the
Page 564 and 565:
551 3.8 Other modes of action Genot
Page 566 and 567:
553 Metabolite Structure / trivial
Page 568 and 569:
555 Metabolite Structure / trivial
Page 570 and 571:
THIOPHANATE-METHYL (addendum) First
Page 572 and 573:
559 Table 2. Selected findings in d
Page 574 and 575:
561 smears were obtained from five
Page 576 and 577:
563 The NOAEL for parental toxicity
Page 578 and 579:
565 Table 7. Selected maternal and
Page 580 and 581:
567 Mean litter size 8.8 8.4 9.1 7.
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569 adverse changes in the FOB, inc
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571 Comments Toxicological data Thi
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573 Foss, J.A. (2005b) Oral (diet)
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576 14. Pesticide residues in food.
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578 49. Pesticide residues in food
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580 83. Pesticide residues in food
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