Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short term toxicity to fish

A study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss) according to OECD 203 under GLP.

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). A semi-static limit test at 100 mg/L loading was performed. Exposure of rainbow trout to the test item gave LL50values of greater than 100 mg/L loading rate WAF. The No Observed Effect Loading Rate was 100 mg/L loading rate WAF.

One OECD 203 GLP study is available with one of the main components. The EC50 is greater than the maximum water solubility, thus it is not acutely toxic to fish. One OECD 236 study is available with the reaction mixture, the EL50 > 100 mg/L

 

Long term toxicity to fish

Long term toxicity testing is waived for fish.

 

Short term toxicity to aquatic invertebrates

Three OECD 202 GLP studies are available, with one as a supporting study with no analytics and the second one where no analysis was performed and the content of the test concentration is unknown. The third test conducted in 1997 is chosen as the key study, as it meets all the requirements of a valid study. Under the conditions of the test the EC50 (48h) could not be determined and may only be expressed as greater than the maximum water solubility in the test.

 

Long term toxicity to aquatic invertebrates

One OECD 211 GLP test is available with an overall NOEC of 2.7 mg/L (mean measured concentration) with the main component. A non-GLP supporting study with the test substance shows results in the same range, with a NOEC of 1.6 mg/L.

 

Toxicity to aquatic algae and cyanobacteria

The results of a valid OECD 201 test indicate based on measured data that the EC50 is in excess of the maximum achievable concentration of the active component in the test medium. The conclusion should therefore be no acute or chronic toxicity to algae at the limit of solubility for this test substance. The EL10 (72h, (growth rate) was calculated as 20.23 mg/l (Growth rate) and the EL50 > 838.4 mg/L (growth rate).

 

Toxicity to microorganisms

One OECD 209 GLP study is available with an 3 hr EC50 > 1000 mg/L (nominal).