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45537501.de1.pdf
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45537501
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Imidacloprid
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138261-41-3
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129099
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Sheets, L. (2001) A Developmental Neurotoxicity Screening Study with Technical Grade Imidacloprid in Wistar Rats: Lab Project Number: 99-D72-DV: 110245. Unpublished study prepared by Bayer Corporation. 1165 p. {OPPTS 870.6300}
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2001.0
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Imidacloprid: In a developmental neurotoxicity study (MRID 45537501), Imidacloprid (98.2-98.4% a.i., batch #803-0273) was administered to 30 parent female Wistar rats/group in the diet at concentrations of 0, 100, 250 or 750 ppm from gestation day 0 through postnatal day (PND) 21. The average daily intake of Imidacloprid was 0, 8.0-8.3, 19.4-19.7, and 54.7-58.4 mg/kg/day during gestation and 0, 12.8-19.5, 30.0-45.4, and 80.4-155.0 mg/kg/day during lactation, for the 0, 100, 250, and 750 ppm, respectively.
A Function Observational Battery (FOB) was performed on all dams on gestation days 6, 13, and 20 and on 10 dams/dose on lactation days 4,11, and 21. On postnatal day 4, litters were culled to yield four males and four females (as closely as possible). Offspring, representing at least 20 litters/dose, were allocated for detailed clinical observations (abbreviated FOB), assessment of motor activity, assessment of auditory startle response habituation, assessment of learning and memory, and ophthalmology. Neural tissues were also collected from selected offspring (10/sex/dose representing 10 litters) on PND 11 and at study termination (75 days of age). Pup physical development was assessed by body weight, day of surface righting, auditory startle, eye opening, pupillary constriction, vaginal patency in females and balanopreputial separation in males.
Treatment-related effects for maternal animals were limited to a 9% decrease (NS) in food consumption for dams in the high dose group compared to controls during the third week of gestation and 14% decrease (p<0.05) for high-dose animals during week 1 of lactation.
The maternal NOAEL is 55 mg/kg/day. A LOAEL was not observed.
Treatment-related effects for offspring were limited to the high dose group. Body weights of high-dose males and females were significantly (P<0.05) decreased 9-13% prior to weaning, and from 3-11% after weaning, with recovery: in females to control levels by PND 50; and in males to a 4% difference that persisted to study termination. Overall motor activity was decreased (not significantly) on PND 17 in high-dose males (38%) and females (31%) and in PND 21 females (37%).
The offspring LOAEL is 55 mg/kg/day, based on decreased absolute body weights, and decreased motor activity. The offspring NOAEL is 20 mg/kg/day.
This study is classified Acceptable/Guideline and satisfies the guideline requirement for a developmental neurotoxicity study in rats (OPPTS 870.6300, §83-6); OECD 426 (draft).
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Developmental-Neurotoxicity
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NA [83-6, Developmental Neurotoxicity]
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Oral
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No Duration Period; Day 0 through postnatal day (PND) 21
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57579.0
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2017-05-30
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2020-03-10
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Supplemental #1
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Added by
Madison Feshuk
on Apr 25, 2022
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