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Ecotoxicological information

Short-term toxicity to fish

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Description of key information

Exposure of rainbow trout to the test item gave LL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF (OECD 203 and EU Method C.1).

Key value for chemical safety assessment

Additional information

GUIDELINE

 

A study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). The method 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.

 

METHODS

 

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. If no mortalities are observed this indicates that fish are not the most sensitive species and that the LL50 is greater than the 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 loading 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 14 to 15 °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.

 

RESULTS

 

Analysis of the 100 mg/L loading rate WAF test preparation at 0 and 72 hours (fresh media) showed measured concentrations of 0.636 and 0.251 mg/L respectively. Analysis at 24 and 96 hours (old media) showed measured concentrations of 0.912 and 0.429 mg/L respectively.

 

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. It was considered unnecessary and unrealistic to test at loading rates in excess of 100 mg/L loading rate WAF.

 

CONCLUSION

 

Exposure of rainbow trout to the test item gave LL50 values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.