Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

In a study performed according to OECD TG 203 exposure of rainbow trout (Oncorhychus mykiss) to the test item gave a 96-h LL50 value of > 100 mg/L loading rate WAF. The NOELR was 100 mg/L loading rate WAF.

Key value for chemical safety assessment

Additional information

A study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorynchus mykiss). The method followed was designed to be compatible with OECD TG 203 referenced as Method C.1 of Commission Regulation (EC) No. 440/2008.

Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF).

In accordance with the recommendations of REACH, the test was conducted according to the threshold approach recommended by ECHA. Using this approach the lowest EL50 from either the acute algal or daphnia study is set as the threshold loading rate and a limit test conducted at this threshold loading rate. As the EL50 in both the algal and daphnia studies was > 100 mg/L loading rate WAF, the test was conducted at a single loding rate of 100 mg/L loading rate WAF to ensure that toxicity was not observed at this loading rate.

Seven fish were exposed to a WAF of the test item, at a single nominal loading rate of 100 mg/L for a period of 96 hours at a temperature of approximately 15 deg C under semi-static test 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.

Chemical analysis of the fresh test preparations at 0 and 72 hours showed measured test concentrations of 40 and 77 mg/L, and from the old test preparations at 24 and 96 hours showed measured test concentrations of 43 and 69 mg/L.

Given that the toxicity cannot be attributed to a single component or a mixture of components, but to the test item as a whole, the results were based on nominal loading rates only.

Exposure of rainbow trout to the test item gave a 96 -h LL50 value > 100 mg/L loading rate WAF. The NOELR was 100 mg/L loading rate WAF. It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L loading rate WAF.