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Short-term toxicity to fish

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Description of key information

No acute fish test results are available for the Reaction mass of (Gluconate)3Fe-Na3 and NaCl . For this reason the available study from the structurally similar substance Sodium glucoheptonate (CAS no 31138 -65 -5) has been read across to the Reaction mass of (Gluconate)3Fe-Na3 and NaCl.

Two studies are available for sodium glucoheptanoate CAS no 31138 -65 -5.

Both fish studies were conducted according to GLP and according to OECD guideline 203 and resulted in a 96h LC50 > 1000 mg/L. For the study from Harlan (2013) this is based on 100% active ingredient with quantification only at NOEC of 1000 mg/L. For the study from Balk&Meuwsen (1989) the study is performed as a limit test at 1000 mg/L test substance with renewal of the test solution after 48 and 72 hours. The LC50 is based on a test substance with 27% active ingredient. The exposure concentration was checked using NPOC analysis. During the study of Balk-&Meuwsen the Oxygen concentration in the test dropped probably due to bacterial growth.

In the study from Harlan (2013) Oncorhynchus mykiss was exposed to the test item under semi-static test conditions. The EC50 value after 96 hours was 1000 mg a.i. /L and the NOEC was 1000 mg a.i. /L. The study from Harlan is used as Key study.

Key value for chemical safety assessment

LC50 for freshwater fish:
1 000 mg/L

Additional information

Introduction

A study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Regulation (EC) No. 440/2008 and US EPA Draft Ecological Effects Test Guidelines OPPTS 850.1075 "Fish Acute Toxicity Test, Freshwater and Marine".

 

 

Methods

Following preliminary range-finding tests, fish were exposed, in groups of ten, to an aqueous solution of the test item over a range of concentrations of 100,180,320,560, and 1000 mg active ingredient (ai)/L for a period of 96 hours at a temperature of 13 °C to 14 °C under semi-static conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.

 

 

Results

The 96-Hour LC50based on nominal test concentrations was greater than 1000 mg a.i. /L. The No Observed Effect Concentration was 1000 mg a.i. /L.

 

Analysis of the 1000 mg a.i./L test preparation at 0, 24, 48, 72 and 96 hours showed measured test concentrations to range from 91% to 114% of nominal and so the results are based on nominal test concentrations only. The fresh test preparation at 48 hours was measured to be 184% of nominal, however, as the corresponding old preparation at 72 hours was near nominal it is considered that this result was anomalous and has no impact on the outcome of the test.