Registration Dossier

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Fish Toxicity

LC50 = 14.5 mg/l

Short-term toxicity to aquatic invertebrates

EC50 > 67 mg/l

Toxicity to aquatic plants other than algae

ErC50 = 615 mg/l based on frond number

Additional information

Fish and Microorganisms Toxicity

The test substance was tested for short term toxicity to fish and for toxicity to microorganisms. The results, showed for fish an in vivo value LC50 = 14.5 mg/l.

The in vivo value registered for microorganism is BST > 300 mg/l. Moreover the test substance shows a logPow= - 0.4975 and no evidence of rapid biodegradation.

For acute fish toxicity the publication of Yung-Tse Hung (2013) (LD50 = 12 mg/l) is referred in the OECD Toolbox database.

Short-term toxicity to aquatic invertebrates

No studies on the "short-term toxicity to aquatic invertebrates" are available for the substance in itself.

Nevertheless a study has been conducted with an analogue molecule (Similar Substance 02). Further information are reported in the Read Across justification attached to section 13.

The short term toxicity to aquatic invertebrates was determined using the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test).

Although the test substance is soluble in pure (deionised) water ( about 80 g/l), most of the test substance in the stock solution settled down and build a sediment at the bottom of the flask. This effect was possibly caused by a reaction of the test substance with the water hardness compounds in the test water. For the preparation of the test concentrations only the supernatant of the stock solution was taken ( limit of the solubility ). The reported results are related to the actual mean values of the analysed conentrations of the test article measured at the beginning and at the end of the test. No immobilization and abnormal behaviour of the Daphnia was observed in the controls. The NOEC value after 48 hours was determined to be 34 mg/l, the EC50 and the EC 100 value could not be calculated, but are clearly higher than 67 mg/l.

Toxicity to aquatic plants other than algae

No studies on the "Toxicity to aquatic plants other than algae" are available for the substance in itself.

Nevertheless a study has been conducted with an analogue molecule (Similar Substance 03). Further information are reported in the Read Across justification attached to section 13.

The inhibitory effects of the test substance the duckweed Lemna minor were investigated over a period of 7 days, based on the frond number and biomass (dry weight), following the guideline OECD 221.

The test solutions were prepared by respective dilutions of a stock solution in Swedish standard-Medium (SIS Medium).

The test was performed at 611, 193, 61.1, 19.3 and 6.11 mg/l nominal concentration of the test item, corresponding to 500, 158.1, 50.0, 15.8 and 5.00 mg/l of the active ingredient.

Three parallel test vessels were used for each test concentration of the test item 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 loadings decreased over the whole 7-day test period after 7 days and did not remain within 80-120 % range of the initial value (67, 69, 103, 90 and 86 %, respectively, of the initial value). Therefore, the effective concentrations (ErC50and EyC50) were assessed based on the geometric mean (GM) of the measured concentrations of the active ingredient.

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. The EC50 values obtained were:

ErC50 = 615 mg/l based on frond number

EyC50 = 197 mg/l based on frond number

ErC50 = 889 mg/l based on dry weight

EyC50 = 178 mg/l based on dry weight

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.

Based on the above results, the Fish toxicity study provides the lowest toxicity endpoint, therefore the test substance has been classified as Category Chronic 3.

Categories Display