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517 acid amide at 1000 ppm and thiacloprid-sulfonic acid Na-salt at 1000 ppm, did not induce liver aromatase activity in female rats (Kroetlinger et al., 2003). (c) Mechanistic studies on thyroid effects In a special short-term study of toxicity conducted to investigate the mechanism of thyroidal changes, groups of 10 male and 10 female Wistar (Hsd Cpb:WU) rats were given diets containing thiacloprid (purity, 96.8%) at a concentration of 0, 25, 100, 400 or 1600 ppm for 3 weeks. The mean test substance intakes were equal to 0, 2.6, 9.0, 36.9 and 145.1 mg/kg bw per day in males and 0, 3.1, 12.3, 44.6 and 190.8 mg/kg bw per day in females. The study complied with test guideline OECD 407. The experimental animals were inspected at least once a day. Any clinical signs and abnormalities were recorded. Feed intake and body weight of each animal was deternined weekly. T3, T4 (total), TBC and TSH levels and protein content were determined from heparinized plasma. The blood for these tests was withdrawn from animals under deep diethylether anesthesia from the retroorbital plexus (days –2 to 14) or by cardiac puncture (days 21 and 22) at predetermined times. UDP-GT was determined from liver samples taken at the time of necropsy. Animals were necropsied after exsanguination under deep ether anesthesia. Liver, thyroid, uterus and pinnae were preserved for microscopic examiation. Liver, uterus and the left thyroidal lobe were weighed at necropsy. At 1600 ppm, there was a decrement in body-weight development in males (transient) and in females. At 1600 ppm, body-weight gains were significantly reduced by 14.9% in males and by 43.5% in females. Determination of the thyroidal hormones T3 and T4 after exposure at 1600 ppm resulted in a significant reduction in T3 concentrations on day 2 in male and female rats, and a statistically significant reduction in total T4 concentrations on days 2, 7 and 21/22 in male rats and on day 2 in female rats. Also at 1600 pm, there was a biologically relevant increase in the concentration of TSH in males on day 14 and in females on days 7 and 22 (Table 42). There was considerable variation within the observations made in the control groups at different times. This was not unexpected as hormone determinations usually result in wide intra-individual variation. In order to interpret the hormone data more intelligently with regard to their biological relevance, an analysis of covariance has been made of the T3, T4 and TSH data. This comparison was based on the measurements before treatment (day –2). The comparison of the relative changes in thyroid parameters (%) indicated that there were significant changes only at 1600 ppm. There were reductions in T3 and T4 on day 2 of exposure. In male rats, T4 values were depressed persistently throughout the study and in female rats on days 7 and 22. The concentrations of TSH were increased in rats starting from day 7. In females, this increase in TSH was only seen at 1600 ppm. Because of wide intra-individual variation, this effect was statistically significant in female rats only on days 7 and 22. In male rats, the most pronounced increase in TSH concentrations was invariably seen at 1600 ppm. There were also some increases at 100 ppm (days 14 and 21) and at 400 ppm (days 7–21), which were above the range of the increases seen at less than 100 ppm. However, the effects observed at 100 and 400 ppm on days 7 and 14 were not dose-related, and, thus, the effects seen at 100 ppm were considered to be spurious results caused by wide intra-individual variation, while the effects seen at 400 ppm, which were consistently seen on days 7–21 were considered to represent an incipient response of the pituitary, which was more markedly expressed at 1600 ppm. The activity of UDP-GT, the enzyme catalysing the glucuronidation of T4, was significantly induced in both sexes at greater than 400 ppm at the time of necropsy. There was no evidence of enzyme induction at less than 100 ppm. At the end of the exposure period, there was a slight increase in protein concentrations in male and female rats at 1600 ppm. There was an increase in absolute THIACLOPRID X-X JMPR 2006
518 and relative liver weight in animals at the highest dose. The apparently statistically significant reductions of thyroid weights in females (absolute at > 400 ppm, relative at 400 ppm) were not regarded as treatment-related, as there was no dose–response relationship for the relative thyroid weight. Histopathology of the thyroid gland revealed treatment-related hypertrophy of the follicular epithelium in males at 400 ppm and higher and in females at 1600 ppm, with statistical significance in both sexes at 1600 ppm. Table 42. Selected findings in a special short-term study in rats fed diets containing thiacloprid for 3 weeks Finding Dietary concentration (ppm) Males Females 0 25 100 400 1600 0 25 100 400 1600 T3 (nmol/l): Day –2 2.24 2.24 2.34 2.37 2.23 2.36 2.26 2.37 2.45 2.33 Day 2 2.08 2.07 2.23 2.26 1.75* 2.19 2.04 2.29 2.25 1.60** Day 7 1.86 1.88 1.84 1.84 1.79 1.94 1.96 2.13* 2.16* 1.92 Day 14 1.87 1.98 1.92 1.98 1.81 1.95 1.87 1.95 2.17 2.17* Day 21/22 1.93 1.90 2.03 1.99 2.02 1.81 1.83 1.98** 2.12** 2.15** T4 (nmol/l): Day –2 117 126 121 127 124 113 110 100 118 102– Day 2 110 110 112 124 84* 98 94 92 115 67* Day 7 114 120 118 119 93* 102 97 96 107 80 Day 14 126 143 130 139 109 109 121 113 125 105 Day 21/22 95 95 93 94 75** 72 79 87 86* 59 TSH (μg/l): Day –2 2.42 3.46* 2.03 2.44 1.91 1.83 1.34 1.65 1.59 1.80 Day 2 3.56 3.90 2.81 2.41 1.29** 2.38 1.67 1.94 2.20 1.99 Day 7 2.81 3.94 3.33 5.40 4.33 1.67 1.39 1.64 2.09 3.87** Day 14 3.54 4.67 6.61* 6.06* 10.68* 2.97 1.91 2.13 2.00 3.47 Day 21/22 3.26 5.96 5.62 5.36 6.77 2.10 1.76 1.61 1.83 5.54** UDP-GT (nmol/g per min) 760 658 813 1507** 2676** 554 483 636 909** 2332** Plasma protein (g/l) 65.7 64.5 64.3 64.1 68.8** 66.0 66.8 67.1 65.9 70.0** Body weight (g): Day 7 209 209 211 214 187** 154 151 151 150 134** Terminal 269 271 278 289 254 184 175 185 182 162** Liver weight (g) 11.22 10.58 11.15 12.82* 14.83** 7.53 6.89 7.56 7.79 9.25** Relative liver weight (%) 4.158 3.900 4.002 4.43 5.85** 4.09 3.92 4.09 4.29 5.70** Thyroid weight (mg) 10 8 9 11 10 7 5 5 4* 4* Relative thyroid weight 4 3 3 4 4 4 3 3 2* 3 (mg/100g) Follicular cell hypertrophy 1 1 3 5 8** 0 0 1 2 5* Grade 1 0 1 3 3 3 0 0 1 2 3 Grade 2 1 0 0 2 5 0 0 0 0 2 From Andrews (2000) T3, triiodothyronine; T4, thyroxin; TSH, thyrid-stimulating hormone; UDP-GT, uridine diphosphate glucuronosyl t ransferase * p < 0.05, ** p < 0.01 THIACLOPRID 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
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50 Table 2. Radioactivity in blood
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52 10 10 0.42 0.0462 0.63 0.0080 8.
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54 Figure 2. Transfer of radioactiv
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56 Skin 33.07 61.59 0.5 17.94 17.29
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58 Table 10. Summary of metabolites
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60 Table 14. Summary of identified
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62 Table 18. Summary of metabolites
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64 Table 19. Structures of identifi
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66 Metabolite Structure O M510F14 N
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68 Metabolite Structure M510F39 N O
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70 2. Toxicological studies 2.1 Acu
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72 1% Tylose CB 30.000. The injecti
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74 the end of dosing. Blood samples
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76 examinations were carried out 8
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78 concentrations were increased at
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80 times were slightly, but signifi
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82 in males and females rats at 250
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84 End-point Test object Dose a (LE
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86 parental rats was not markedly a
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88 groups in conception frequencies
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90 0.7 ± 3.5%, 1.8 ± 4.2%, 2.9 ±
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92 In this study of developmental n
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94 3. Observations in humans In the
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96 was 100 ppm, equal to 10 mg/kg b
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98 Acute toxicity Rat, LD 50 , oral
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100 Mellert, W., Kaufmann, W. & Hil
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CYFLUTHRIN AND BETA-CYFLUTHRIN Firs
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105 Table 1. Diastereoisomer pairs
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107 (i) In vivo Rats Four groups of
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109 2. Toxicological studies 2.1 Ac
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111 Species Strain Sex Route Formul
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113 Rat Groups of 20 male and 20 fe
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115 group and in the groups at the
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117 cyfluthrin (purity, 95.5-95.9%)
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119 In a short-term study of exposu
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121 and dissection. At termination,
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123 2.5 Reproductive toxicity (a) M
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125 gestation. The vehicle was 1% C
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127 females was exposed during days
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129 were not seen in rats in the co
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131 men was exposed for 1 h to actu
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133 40 g/l, in a flowable concentra
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135 were removed from five males an
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137 weights and food consumption we
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139 In females at the highest dose,
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141 The dermal toxicity of cyfluthr
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143 The Meeting concluded that the
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145 Estimate of acute reference dos
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147 Cage, S. (2004) [ 14 C]-beta-cy
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149 Heimann, K.G. (1984c) FCR 4545
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151 Jones, R.D. & Hastings, T.F. (1
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153 Pauluhn, J. & Mohr, U. (1984).
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155 Von Keutz, E. (1987) FCR 4545 -
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158 Zeta-cypermethrin .............
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160 Evaluation for acceptable daily
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162 polar metabolites, which are fu
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164 for up to 70 days. Signs typica
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166 rapidly metabolized by cleavage
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170 Table 2. Effect of cis : trans
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172 Table 3. Significant haematolog
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174 Rabbits Occluded dermal applica
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176 1100 ppm in weeks 1-6, with inc
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178 Wistar-derived (Alderley Park)
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180 At 1500 ppm, liver APDM activit
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182 for premature deaths, 10 male a
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184 by gavage for days 7 to 19 of g
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186 observed at the intermediate an
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188 The females recovered from this
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190 tibial nerve (SPTN), trigeminal
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194 for 5 weeks. Observations inclu
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196 caused obvious irritation and r
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198 days 6-15 of gestation. After m
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200 was observed in two males at 72
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202 control and other treated group
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204 Table 14. Results of studies of
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206 (b) Developmental toxicity Rats
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208 mild and temporary paraesthesia
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210 range appeared to exist for the
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212 for which the LD 50 was > 2000
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214 substances. Since conventional
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216 Critical end-points relevant fo
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218 Butterworth, S.T.G. & Clark, D.
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220 East Millstone, New Jersey, USA
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222 Jersey, USA. Submitted to WHO b
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224 Toxicology Laboratory (Tunstall
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226 Ullrich, B. (2003) Report on a
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228 Cyromazine was first evaluated
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230 were taken for the measurement
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232 highest dose, rather than indic
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234 Tissue residues: Tissues a < 0.
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236 Because of the low total recove
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238 Name Description Compound found
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240 After each dose of [U- 14 C tri
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242 In male and female monkeys give
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244 stress and discomfort during th
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246 Table 18. Dermal absorption of
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248 rate under steady-state conditi
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252 the test substance. The method
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254 taken for haematological and bi
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256 not differ appreciably from pre
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258 Analysis of the diets showed th
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260 considered to be biologically s
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262 observed incidence probably rel
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264 c Cyromazine was assayed twice
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266 2.5 Reproductive toxicity (a) M
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268 either sporadic or as a consequ
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270 fetuses were removed, weighed a
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272 The NOAEL for maternal toxicity
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274 In New Zealand White rabbits, c
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276 and litters with malformations.
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278 of melamine powder into the rab
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280 reduction in the survival of ma
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282 There is significantly less ris
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284 Toxicological data Cyromazine h
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286 Toxicological evaluation The Me
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288 Other toxicological studies Tox
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290 IARC (1999a) Some chemicals tha
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292 Simoneaux, B. & Marco, G. (1984
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294 Declaration of Helsinki (Cristi
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296 lowered arousal level at doses
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298 Cerebellum 3 1 51** 76** 80** 7
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300 Table 4. Maximum inhibition of
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302 auditory/physical examination w
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304 • • • • • Home-cage o
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306 Dogs Groups of four male and fo
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308 capsules. Some volunteers recei
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310 Blood was taken for measurement
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312 Human a Dietary administration
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314 Piccirillo, V.J. (1978) Acute o
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316 Haloxyfop (racemic), its sodium
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318 Recovery of radioactivity in ur
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320 skin of nine male and nine fema
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322 1.2 Biotransformation Mice In a
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326 96%) at a concentration designe
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328 was centrilobular hepatocellula
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330 The treatment had no effect on
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332 All dogs were killed for autops
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334 with that of controls (but no s
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336 Table 4. Results of studies of
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338 doses of up to 1.0 mg/kg bw per
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340 delayed ossification in the hyo
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342 Mice In a GLP-compliant study,
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344 and in females at the highest d
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346 Between January 1999 and Januar
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348 The Meeting concluded that halo
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350 Critical end-points for setting
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352 Elcombe, B.M. (2002a) Effects o
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354 Scortichini, B.H., Bohl, R.W. &
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356 Economic Co-operation and Devel
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358 There were no treatment-related
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360 comparable to control levels. A
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362 Groups of 17 male and 17 female
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364 No compound-related effects wer
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366 Berry, D. & Gore, C.W. (1975) P
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368 Quinoxyfen has not been evaluat
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370 In the main study, which compli
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372 Concentrations of total radioac
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374 several hydroxy-quinoxyfen meta
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376 There were no mortalities or ad
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378 at doses of ≥ 100 mg/kg bw pe
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380 In a GLP-compliant study to det
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382 control group. This was observe
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384 The homogeneity and stability o
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386 Testes weight (g) at 24 months
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388 slight (3 out of 30) hepatocell
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390 marked inanition, decreased fae
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392 Females Relative liver weightt
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394 were patch-tested specifically
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396 In studies of developmental tox
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398 Rat, LC 50 , inhalation Rabbit,
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400 Gollapudi, B.B. & Lick, S.J. (1
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TEMEPHOS First draft prepared by De
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405 by thin-layer chromatography (T
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407 In a special study to investiga
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409 concluded that temephos was of
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411 Table 3. Effects on mean erythr
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413 Females 0 1.091 1.224 1.324 1.3
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415 of up to 18 ppm. In the group a
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417 Chromosomal aberration DNA repa
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419 of the birds treated with temep
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421 concentration of 1 ppm. Only on
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423 being appreciably less than thi
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425 Lowest relevant developmental N
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427 WHO (1991) Safe use of pesticid
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430 All new studies with thiabendaz
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432 use of this dose form was consi
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434 At 1000 mg/kg bw, qualitative e
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436 At 100 mg/kg bw, slightly decre
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438 There were no treatment-related
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440 Table 6. Incidence of malformat
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442 Dose (mg/kg bw) (grouped by exp
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444 1157 12/21 (57.1)*** 27.2 ± 33
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446 versus placebo): increased appe
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448 activity, tiptoe gait, landing
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450 Noakes, J.P. (2005a) Thianendaz
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452 tests normally performed and th
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454 Radiolabel was excreted primari
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456 the excretory organs, was the r
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458 Table 6. Excretion of radioacti
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460 of unchanged parent compound we
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462 M10 (KNO 1891) + M11 (KNO 1893)
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464 on body weights. Exposure at 15
Page 479 and 480: 466 The no-observed-adverse-effect
Page 481 and 482: 468 Hepatocytes, hypertrophy 0 2 6
Page 483 and 484: 470 they may also be related to var
Page 485 and 486: 472 weights of males were approxima
Page 487 and 488: 474 Thyroid weight (mg): Week 12 6
Page 489 and 490: 476 Table 17. Relevant findings in
Page 491 and 492: 478 Dogs In a dose range-finding st
Page 493 and 494: 480 Prostate / uterine weight (g) 2
Page 495 and 496: 482 the treatment groups receiving
Page 497 and 498: 484 No gross findings were observed
Page 499 and 500: 486 received a macroscopic examinat
Page 501 and 502: 488 Although decreased concentratio
Page 503 and 504: 490 Sciatic nerve; No. examined 50
Page 505 and 506: 492 are caused by the higher incide
Page 507 and 508: 494 2.5 Reproductive toxicity (a) M
Page 509 and 510: 496 In a two-generation study of re
Page 511 and 512: 498 In dams that died or were sacri
Page 513 and 514: 500 No clinical signs or increased
Page 515 and 516: 502 Table 33. Selected variations a
Page 517 and 518: 504 Days 16-21 73.3 78.7 62.5 44.3*
Page 519 and 520: 506 Thiacloprid was not teratogenic
Page 521 and 522: 508 Table 37. Motor and locomotor a
Page 523 and 524: 510 Day 91 19.78 20.00 19.58 18.22*
Page 525 and 526: 512 Table 40. Selected findings in
Page 527 and 528: 514 plate incorporation procedure,
Page 529: 516 (iv) Comparative study on liver
Page 533 and 534: 520 at 2500 ppm. The administration
Page 535 and 536: 522 No macroscopic changes were det
Page 537 and 538: 524 The following procedures were p
Page 539 and 540: 526 litter for the group at 1000 pp
Page 541 and 542: 528 Hepatic enzyme activities in th
Page 543 and 544: 530 subtypes 1A1, 2B1, 2D1 and othe
Page 545 and 546: 532 Long-term studies of toxicity a
Page 547 and 548: 534 The Meeting concluded that ther
Page 549 and 550: 536 Estimate of acceptable daily in
Page 551 and 552: 538 dated 27 July, from Bayer AG, W
Page 553 and 554: 540 Kroetlinger, F. (1995a) YRC 289
Page 555 and 556: 542 Wetzig, H. & Geiss, V. (1998b)
Page 557 and 558: 544 Table A1. NOAELs and LOAELs for
Page 559 and 560: 546 2.2 Postulated mode of action (
Page 561 and 562: 548 • • • Chromosomal aberrat
Page 563 and 564: 550 Table A3. NOAELs and LOAELs for
Page 565 and 566: 552 Appendix 2 Table B1. List of an
Page 567 and 568: 554 Metabolite Structure / trivial
Page 569 and 570: 556 Metabolite Structure / trivial
Page 571 and 572: 558 Evaluation for acute reference
Page 573 and 574: 560 increased thyroid weights in th
Page 575 and 576: 562 Table 4. Results of bone-marrow
Page 577 and 578: 564 malformations between the contr
Page 579 and 580: 566 In a study of prenatal developm
Page 581 and 582:
568 combination of heparin and an a
Page 583 and 584:
570 Table 10. Selected findings fro
Page 585 and 586:
572 In a short-term study of neurot
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ANNEX 1 Reports and other documents
Page 590 and 591:
577 31. Pesticide residues in food:
Page 592 and 593:
579 66. Pesticide residues in food
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581 100. Pesticide residues in food
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