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Description of key information

Short-term toxicity to fish. Key study: Test method according to OECD 203, GLP study. The 96h-LC50 of the test substance to zebrafish, Danio rerio, was found to be greater than 50.0 mg/L.

Long-term toxicity to fish. Data waiving: In accordance with column 2 of REACH Annex IX, the study does not need to be conducted since the chemical safety assessment indicates the no need to investigate further the effects on aquatic organisms.

Short-term toxicity to invertebrates. Key study: Test method according to OECD 202, GLP study. The 48h-EC50 of the test substance to Daphnia magna was found to be greater than 50.0 mg/L.

Long-term toxicity to aquatic invertebrates. Data waiving: In accordance with column 2 of REACH Annex IX, the study does not need to be conducted since the chemical safety assessment indicates the no need to investigate further the effects on aquatic organisms.

Toxicity to aquatic algae and cyanobacteria. Key study. Test method according to OECD 201, GLP study. In the Pseudokirchneriella subpicata green algae toxicity test the 72h-ErC50 of the test substance was determined to be 30.31 mg/L.

Toxicity to microorganisms. Key study. Test method according to OECD 209. GLP study: The EC50 was determined to be greater than 50 mg/L as no inhibition was observed for the dissolved part. The EC5 was calculated to be 1.13 mg/L.

Additional information

Short-term toxicity to fish. Key study: An acute aquatic toxicity study with zebrafish, Danio rerio, was conducted on test ítem according to OECD guideline 203, following GLP. A preliminary range finding study was conducted with test concentrations of 0.0 (control), 0.0 (vehicle Control), 0.1, 1.0, 10.0 and 50.0 mg/L for a period of 96 h with ten fish in each group. Based on no mortalities found in this preliminary study, the main test was restricted to limit study conducted with single test concentration of 50.0 mg/L. Reverse osmosis (RO) water was used as test medium. In the previous solubility study the test item was found to be insoluble in RO water and acetone was selected as the vehicle. Thus, the main test was conducted with test concentrations of 0.0 (control), 0.0 (vehicle Control) and 50.0 mg/L for a period of 96 h in semi-static conditions with ten fish in each group. The test solutions were changed every 24 h with freshly prepared solutions. The test solutions were not aerated during the exposure. A validated analytical method based on gas chromatography was used to monitor the concentration and stability of the main active ingredients in the test solution at 0 and 24 h of first renewal during main study. The active ingredient concentration in the test solution was within acceptable limit (> 80% of nominal concentration). All validity criteria were fulfilled. No mortality and no treatment related behavioural response were observed over a period of 96 h at the test concentration of 50.0 mg/L as well as in the control and vehicle control groups. Thus, LC50 (96 h), NOEC and LOEC to fish of the test substance were found to be greater than 50.0 mg/L.

Short-term toxicity to invertebrates. Key study: An acute aquatic toxicity study with Daphnia magna was conducted on test item according to OECD guideline 202, following GLP. A preliminary range finding study was conducted with test concentrations of 0.0 (control), 0.0 (vehicle Control), 0.01, 0.1, 1.0, 10.0 and 50.0 mg/L for a period of 48 h with 70 daphnids, divided into seven groups of 10 daphnids per group. Based on no mortalities found in this preliminary study, the main test was restricted to limit study conducted with single test concentration of 50.0 mg/L. Reconstituted water (ISO test water) was used as test medium. In the previous solubility study the test item was found to be insoluble in reconstituted water and acetone was selected as the vehicle. Thus, the main test was conducted with test concentrations of 0.0 (control), 0.0 (vehicle Control) and 50.0 mg/L for a period of 48 h in static conditions in 4 replicates of 5 daphnids per replicate. The test solutions were not aerated during the exposure. A validated analytical method based on gas chromatography was used to monitor the concentration and stability of the main active ingredients in the test solution at 0 and 48 h of the main study. The active ingredient concentration in the test solution was within acceptable limit (> 80% of nominal concentration). All validity criteria were fulfilled. No immobilisation and no abnormal behavioural symptoms were observed over the period of 48 h at the test concentration of 50.0 mg/L as well as in the control and vehicle control groups. Thus, EC50 (48 h), NOEC and LOEC to Daphnia magna of the test substance were found to be greater tan 50.0 mg/L.

Toxicity to aquatic algae and cyanobacteria. Key study. An Algae Growth Inhibition Test was performed withPseudokirchneriella subpicatagreen algae on the test substance over a period of 72 h in static conditions according to OECD Guideline 201, following GLP. OECD medium was used for algal culturing. In the previous solubility study the test ítem was found to be insoluble in OECD medium and acetone was selected as the vehicle. A preliminary range finding study, with 2 replicates for test item and 3 replicates for controls, was conducted with the test concentrations of 0.0 (control), 0.0 (vehicle control), 0.01, 0.1, 1.0, 10.0 and 50.0 mg/L, resulting in percent inhibitions of growth rate of 0.00, 0.15, 0.31, 0.15 and 109.91, respectively. Based on these results, the test concentrations selected for the main study were 0.0 (control), 0.0 (vehicle control), 10.0, 14.5, 21.0, 30.5 and 44.2 mg/L (geometric factor 1.45). Three replicates were taken for each concentration of the test item and six replicates for control group and vehicle control group. 1 mL of algal culture was inoculated into the test vessel for each replicate to obtain an initial mean cell concentration of 6986 cells/mL. A validated analytical method based on gas chromatography was used to monitor the concentration and stability of the main active ingredients in the test solution at 0 and 72 h. The active ingredient concentration in the test media was within acceptable limit (> 80% of nominal concentration). All validity criteria were fulfilled. The growth rate inhibition effect concentrations with their respective 95% lower and upper confidence limits for the inhibition of growth rate were ErC10 = 16.75 (14.94 – 18.77) mg/L, ErC20 = 20.53 (18.83 – 22.39) mg/L and ErC50 = 30.31 (28.29 – 32.48) mg/L. The yield inhibition effect concentrations with their respective 95% lower and upper confidence limits for the yield were EyC10 = 14.12 (13.20 – 15.12) mg/L, EyC20 = 16.19 (15.29 – 17.14) mg/L and EyC50 = 21.02 (19.95 – 22.15) mg/L. The LOEC (72h) and NOEC (72h) for growth rate and yield were 14.5 and 10 mg/L respectively.

Toxicity to microorganisms. Key study. The study of activated sludge respiration inhibition was carried out according with OECD Guideline 209. The inhibition of three different oxygen uptakes was determined, total, heterotrophic only and due to nitrification. 1.5 g/L suspended solid of inoculum were exposed up to 1000 mg/L test ítem for 3 hours. The results of blank and reference controls (3,5 -dichlorophenol) were found to lie in the ranges allowed by the validity criteria. Based on the respiration inhibition rate of test item, the EC50 was expected to be greater than 50 mg/L as no inhibition was observed for the dissolved part of test substance. Also, the undissolved test substance content, visible for test item content greater than 50 mg/L, had no significant effect on the inhibition values. The EC5 was calculated to be 1.13 mg/L.

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