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Chemical test rule data. Sodium glucoheptonate, acute oral toxicity in the rate - up-and-down procedure.
Harlan Laboratories :: Harlan Laboratories
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Harcros Chemicals Inc
Project Number: 41104687
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Introduction: The study was performed to assess the acute oral toxicity of the test item following a single oral administration in the Wistar strain rat. The method was designed to be compatible with the following:
• OECD Guidelines for the Testing of Chemicals No. 425 "Acute Oral Toxicity - Up-and-Down-Procedure (UDP)" (adopted 03 October 2008)
Method: A total of five female animals were dosed individually in sequence with sufficient time (at least 48 hours) between each animal, at dose levels of 354, 1112 or 4040 mg/kg bodyweight (equivalent to 175, 550 and 2000 mg active ingredient/kg bodyweight, respectively). The test item was administered orally undiluted at dose levels of 1112 and 4040 mg/kg bodyweight (equivalent to 550 and 2000 mg active ingredient/kg bodyweight, respectively) and as a solution in distilled water at a dose level of 354 mg/kg bodyweight (equivalent to 175 mg active ingredient/kg bodyweight). Clinical signs and bodyweight development were monitored during the study. AH animals were subjected to gross necropsy.
Mortality. There were no deaths.
Clinical Observations: Hunched posture was noted in the animal treated at a dose level of 1112 mg/kg (equivalent to 550 mg active ingredient/kg bodyweight). No other signs of systemic toxicity were noted.
Bodyweight: Animals showed expected gains in bodyweight over the study period, except for one animal treated at a dose level of 4040 mg/kg (equivalent to 2000 mg active ingredient/kg bodyweight) which showed expected gain in bodyweight during the first week but no gain in bodyweight during the second week.
Necropsy: No abnormalities were noted at necropsy.
Conclusion: The acute oral median lethal dose (LD5o) of the test item in the female Wistar strain rat was found to be greater than 4040 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight).
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