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Short-term toxicity to fish

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Description of key information

A study was performed to assess the acute toxicity of the test material to Oncorhynchus mykiss. The method followed that described in the OECD Guidelines for Testing of Chemicals OECD Guideline 203 (Fish, Acute Toxicity Test).
Following a preliminary range finding study, twenty fish (2 replicates of 10 animals) were exposed to Water Accommodated Fractions of the test material at 0 and 100 mg/L for 96 hours at a temperature of 14 degrees C under semi-static test conditions. 
 
The 96 hour LL50 for the test material to fish based on nominal loading rates was >100 mg/L WAF. The 96 hour No Observed Effect loading rate was 100 mg/L loading rate WAF.

Key value for chemical safety assessment

Additional information

Value for CSA: >100 mg/L WAF.

- In the key study (Goodband, 2004; SPL project number: 1666/059) for the acute toxicity to Daphnia magna, the study was conducted according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test).

This study is presented as the key information as the reliability rating for this study is 2, according to the criteria of Klimisch, 1997 as analytical measurements on the test material were not conducted. This is the most recent and robust study available and has been used for classification purposes.

Other studies available are as follows:

- The Boeri RL et al, 1994(a) study was conducted to recognised OECD guidelines and GLP, however a dispersion method was used to disperse the test material in solution and it was noted in the study that undissolved insoluble test material was seen at all concentrations. It should also be noted that the TOC (Total Organic Carbon) level was ≥2 mg/l in all concentrations. The non dissolved material present in test media has the potential to exert physical effects on test organisms which are unrelated to toxicity and so a reliability rating of 3 was assigned according to the criteria of Klimisch, 1997.

Results: All non-control test vessels had insoluble material on the surface and were cloudy (cloudiness increased with concentration).

Affected fish were gasping at the surface, lethargic, and exhibiting a loss of equilibrium at 3 hours and affected fish were swimming erratically and exhibiting a loss of equilibrium at 48 hours.

Exposure of fathead minnows to the test material resulted in a 96 hour median lethal concentration (LC50) of 29 mg/L (95% confidence interval = 12.5 to 50 mg/L). The no observed effect concentration (NOEC) was estimated to be 12.5 mg/L.

- The Boeri RL et al et al, 1994(b) study was conducted to recognised OECD guidelines and GLP, however a WAF method was used to disperse the test material in solution. It was noted in the study that undissolved insoluble test material was seen at all concentrations and no attempt was made to removed the undissolved test material and surface slick, hence trapping or fouling of test organisms may occur which are physical affects rather than toxic effects. A reliability rating of 3 was assigned according to the criteria of Klimisch, 1997.

Results: The test vessels containing 500 mg/L WAF had a surface slick and were cloudy at 0, 3, and 24 hours of exposure. Test vessels containing 130 mg/L WAF had a surface slick at 24 hours of exposure. Test vessels containing 250 mg/L WAF were cloudy after 24 hours of exposure. No other insoluble material was noted.

After 3 and 24 hours of exposure affected fish were lethargic and gasping. After 48 hours affected fish were lethargic, gasping, and exhibited loss of equilibrium, continuing until the test was terminated or mortality had occurred.

The 96 hour median lethal concentration (reported as LL50) of the WAFs of the test material to fathead minnows was 95 mg/L (expressed as the nominal amount of test substance used to prepare the WAF) with a 95% confidence interval of 80 to 110 mg/L. The estimated no observed effect concentration (reported as NOELR) is 31 mg/L.