Sodium glucoheptonate

Project ID

2731

Category

OPPT

Added on

Sept. 11, 2018, 5:14 a.m.

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Technical Report

Abstract  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).

Technical Report

Abstract  Introduction: A study was performed to assess the effect of the test item on the growth of the green alga Pseudokirchneriella subcapitata. The method followed that described in the OECD Guidelines for Testing of Chemicals (2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" referenced as Method C.3 of Commission Regulation (EC) No 761/2009 and the US EPA Draft Ecological Effects Test Guideline OPPTS 850.5400. Methods: Following a preliminary range-finding test, Pseudokirchneriella subcapitata was exposed to an aqueous solution of the test item at concentrations of 10, 32, 100, 320 and 1000 mg active ingredient (ai)/L (three replicate flasks per concentration) for 96 hours, under constant illumination and shaking at a temperature of 24 ± 1 °C. Samples of the algal populations were removed daily and cell concentrations determined for each control and treatment group, using a Coulter Multisizer Particle Counter. Results: Exposure of Pseudokirchneriella subcapitata to the test item gave the following results: *See results chart in PDF download* Analysis of the test preparations at 0 and 96 hours showed measured test concentrations to range from 93% to 105% of nominal and so the results are based on nominal test concentrations only. A re-growth test was performed which showed the test item to be algistatic in effect.

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