Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Physico-chemical tests with the test substance demonstrated a very poor water solubility of the test substance with an overall solubility of less than1 µg/L

From a regulatory point of view tests on toxicity to the aquatic environment do not need to be performed.

Nevertheless, toxicity tests to fish have been performed in the past. A study performed in 1984 to determine the acute toxicity of FAT 46014 in fish following guideline similar to OECD test guideline 203 using rainbow trout reported an LC50 >1000 mg/L.

Further, several studies performed to determine the short term toxicity of FAT 46014 to fish, according to internal SOP Method A-11 reported TL50 (48 h) >1000 mg/l.

As an overall result and maybe due to the poor water solubility, toxicity to aquatic vertebrates caused by the test substance could not be demonstrated. Because of this result together with the poor water solubility obtained it was decided not to further test for toxicity to aquatic invertebrates and plant.

In general is has to be taken into account that all values are based on the theoretical test substance concentration in water. Real test substance concentrations have been far below since the water solubility of the test item is below 1 µg/l and analytical verification of test substance concentrations in the testing solutions have not been performed.

Independent to above findings toxicity data on Daphnia magna and microorganisms performed several years back are presented here.

A key study was performed to check the acute toxicity of FAT 46014 to aquatic invertebrates, Daphnia magna. The method followed was C.2 of Commission Regulation (EC) No. 440/2008 which is compatible with OECD Guidelines for Testing of Chemicals No 202. The test was performed in compliance with Good Laboratory Practice Regulations. Exposure of Daphnia magna to the test item FAT 46014 gave EC50 and EC100 value of greater than 17.1 mg/L at 48h. The No Observed Effect Concentration was 17.1 mg/L at 48 h of exposure.

A key study was conducted to determine the toxicity of FAT 46014/G to activated sludge in a 3-hour respiration inhibition test according to the OECD Guideline No. 209, and to the EEC Method No. L 133/118. The test was performed in compliance with the Good Laboratory Practice (GLP). The test substance was tested at concentrations of 320,100, 32 and 10 mg/l. The reference substance, 3,5-Dichlorophenol was tested at concentrations of 32, 10 and 3.2 mg/l. IC50 (3 h) of the test substance FAT 46014/G was found to be greater than 320.0 mg/l.

In several other support studies performed to determine the toxicity of FAT 46014, BST greater than 300 mg/L was found.

Considering the above results of key study and supporting study it can be concluded that FAT 46014 is non-toxic to fish, Daphnia magna and microorganisms.