Sodium D-glycero-D-gulo-heptonate

Short-term toxicity to fish

Description of key information

The study was conducted according to GLP and according to OECD guideline 203. The test was actually conducted on the closely related structural surrogate sodium glucoheptonate. The test item was exposed to Oncorhynchus mykiss for 96 hours under semi-static test conditions. The EC50 value after 96 hours was 1000 mg ai/L and the NOEC was 1000 mg/ai/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

1 000 mg/L

Additional information

Read-across discussion:

In order to address ecotoxicological endpoints as part of the REACH registration of Sodium d-glycero-d-gulo-heptonate (target substance) it is proposed to read across data from Sodium glucoheptonate (source substance). The use of read across is within the spirit of REACH, in order to reduce animal testing where possible.

The source and target substances are structurally similar consisting of the alpha/ beta and alpha only form of the same isomer (respectively) and have the same molecular weight, the substances also have comparable physical chemical properties. Due to the similar properties shown between the two materials it is believed that the results obtained in the testing of sodium glucoheptonate (source substance) will be a reliable representation of the properties for sodium d-glycero-d-gulo-heptonate (target substance) to allow classification and labelling and for risk assessment purposes. Therefore read across is justified. The substance sodium d-glycero-d-gulo-heptonate is considered to have similar properties to sodium glucoheptonate and therefore is considered to be relatively harmless and would not be classified in accordance with Regulation (EC) No 1272/2008 (CLP).

Study Discussion:

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".

The study was actually conducted on a similar test material (Sodium Glucoheptonate) and hence this is only why a klimisch reliability of 2 has been assigned to this endpoint. Please see our justifications for using read across within section 13.

 

 

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 LC₅₀ based on nominal test concentrations was greater than 1000 mg ai/L. The No Observed Effect Concentration was 1000 mg ai/L.

 

Analysis of the 1000 mg ai/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.