Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Aquatic toxicity studies were conducted at the three trophic levels; algae, invertebrates and fish.

The acute sensitivity of Oncorhynchus mykiss to the test material was determined in a GLP-compliant test performed to standard guidelines. The 96 hour-LC50 for Oncorhynchus mykiss exposed to the test material could only be estimated as > 0.55 mg/L, because no mortalities were observed at the highest concentration tested, which was the solubility limit of the test substance in the test medium.

The acute sensitivity of Danio Rerio to the test material was also determined. The 96 hour-LC50 for Danio Rerio exposed to the test material could be estimated as > 1.03mg/L, as no mortalities were observed at the highest concentration tested.

A fish embryo tests was conducted and The overall NOEC of the test substance on embryos and freshly hatched larvae of fathead minnow was determined to be at the mean measured concentration of 0.22 mg/L, based on development rate of larvae. The overall LOEC was 0.45 mg/L based on development rate of larvae.

The acute sensitivity of Daphnia magna the test material was determined in a GLP-compliant test performed to standard guidelines.

The 48 hour-EC50 for Daphnia magna exposed to the test material could only be estimated as > 1.7 mg/L, because none of the responses exceeded 50%, and thus, was above the practical limit of solubility of the test item in the test water. The 48-hour NOEC was determined to be 0.35 mg/L. The results are based on the mean measured test item concentration calculated as the geometric means of the concentrations measured at the start and end of the test.

A reproduction test of the test item was conducted with Daphnia magna over a 21-day exposure period in a GLP-compliant test performed to standard guideline.

The test was performed with a semi-static water renewal system.

The NOEC for the first brood time was found to be 0.062 mg/L.

The toxicity of the test material to the green algae Pseudokirchneriella subcapitata was tested in an GLP compliant, guideline study.

The 96-hour EC50 are 1.4, >1.5 and > 1.5 mg/L based on biomass, growth rate and yield, respectively. The 96-hour NOEC was 0.12 mg/L for biomass and 0.67 mg/L for growth rate and yield.

Additionally, the sensitivity of activated sludge microorganisms to the test material was determined in a GLP-compliant test performed to standard guidelines. In a limit test, the test item has no inhibitory effect on the respiration rate of activated sludge after the incubation period of three hours at the test item concentration of 1000 mg/L. The 3-hour NOEC value was determined to be 1000 mg/L. The results are based on nominal concentrations and the test concentration was clearly above the water solubility of the test material under the test conditions.

Additional information

One fish acute toxicity study on Zebra fish and a fish embryo acute toxicity study were conducted solely to comply with a non-EU national registration requirement, and has been provided in accordance with REACH, Article 22(1)e.