Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short-term toxicity to aquatic invertebrates

EC50 (48h) > 100 mg/l

Toxicity to aquatic plants other than algae

ECr50 (7d)> 100 mg/l based on frond number

ECr50 (7d)> 100 mg/l based on dry weight

Additional information

Short-term toxicity to aquatic invertebrates

The test substance was tested in acute immobilisation test on Daphnia magna. The test was performed according to OECD guideline 202.

The preliminary test was performed in a range of the test substance nominal concentrations 1 – 100 mg/l. The test was performed with a static protocol. Based on no toxicity of the test substance found in the preliminary test, the study was terminated. The experiment with the concentration of 100 mg/l included in the preliminary test has been performed using 20 daphnia, there through the conditions of the limit testgiven in guidelinehave been fulfilled. It was demonstrated that the EC50 is higher than this concentration.

The study was performed without analytical determination of the test substance concentrations. The test substance concentration control was performed by TOC method.

The concentrations of Total Organic Carbon (TOC) in the lowest and in the highest tested concentration were analysed in the preliminary test. Samples for determination of the TOC concentrations were taken at the beginning and at the end of the test. The nominal concentrations were used for all evaluation and results. The EC50 value, in a 48 hours observation period, was greater than 100 mg/l.

Toxicity to aquatic plants other than algae

The growth inhibitory effects of the test substance to the duckweed Lemna minor were investigated according to test guideline OECD 221, under static conditions over a period of 7 days.

The test solutions were prepared by dissolving the test item in Swedish Standard medium. The test was performed as a limit test at 100 mg/l nominal concentration.

Six parallel test vessels were used for the test concentration and six vessels for the blank controls.

The test concentrations during the 7-day test period were determined by photometry at the beginning of the test, as well as after 3, 5 and 7 days of exposure. These analyses confirmed the right dosage of the test item, and showed that the concentrations of the test item could be satisfactorily maintained over the 7-days test period. Therefore, the effective concentrations (ErC50and EyC50) were assessed based on the nominal concentration. The two endpoints frond number and biomass (dry weight) were investigated at days 3, 5 and 7, and each of them were assessed as growth rate and yield.


 

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008), Part 4: Environmental Hazards, the substances can be classified for hazardous to the aquatic environment (fish toxicity) when the following criteria are met:

A )Acute (short-term) aquatic hazard

Category Acute 1:

96 hr LC 50 (for fish) ≤ 1 mg/l and/or, 48 hr EC 50 (for crustacea) ≤ 1 mg/l and/or, 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l

B) Long-term aquatic hazard

(iii) Substances for which adequate chronic toxicity data are not available

Category Chronic 1:

96 hr LC 50 (for fish) ≤ 1 mg/l and/or 48 hr EC 50 (for crustacea) ≤ 1 mg/l and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log K ow ≥ 4).

Category Chronic 2:

96 hr LC 50 (for fish) > 1 to ≤10 mg/l and/or 48 hr EC 50 (for crustacea) > 1 to ≤10 mg/l and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) > 1 to ≤10 mg/l (Note 2)

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log K ow ≥ 4).

Category Chronic 3:

96 hr LC 50 (for fish) > 10 to ≤ 100 mg/l and/or 48 hr EC 50 (for crustacea) > 10 to ≤ 100 mg/l and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/l

and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log K ow ≥ 4).

Category Chronic 4

Cases when data do not allow classification under the above criteria but there are nevertheless some grounds for concern. This includes, for example, poorly soluble substances for which no acute toxicity is recorded at levels up to the water solubility (note 4), and which are not rapidly degradable in accordance with section 4.1.2.9.5 and have an experimentally determined BCF ≥ 500 (or, if absent, a log K ow ≥ 4), indicating a potential to bioaccumulate, which will be classified in this category unless other scientific evidence exists showing classification to be unnecessary. Such evidence includes chronic toxicity NOECs > water solubility or > 1 mg/l, or other evidence of rapid degradation in the environment than the ones provided by any of the methods listed in section 4.1.2.9.5.

The EC50 value calculated for both Daphnia and Lemna is greater that 100 mg/l therefore the substance is not classified for aquatic toxicity according to the CLP Regulation (EC n. 1272/2008).