Registration Dossier
Registration Dossier
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EC number: 278-140-9 | CAS number: 75214-72-1
Endpoint summary
Administrative data
Description of key information
Short-term toxicity to aquatic invertebrates:
EC50 (48 h, Daphnia magna) = 38.33 mg/L
Toxicity to aquatic plants other than algae:
ErC50 (7d, Lemna minor) = 121.7 and 164.5 mg/L, based on frond number and dry mass resplectively
Short-term toxicity to fish:
LC50 (48 h,Oncorhynchus mykiss) > 100 mg/L
Toxicity to microorganisms:
IC 50 >1000 mg/L
Additional information
The following data were obtained for the Similar Substance 01. It is expected that the Target Substance will present similar effects on aquatic invertebrates and plants. Justification for Read Across is given in Section 13 of IUCLID.
Short-term toxicity to aquatic invertebrates
The short-term toxicity to invertebrates was investigated to Daphnia magna, according to the OECD Guideline 202 (2004) and the EU method C.2 of the Regulation EC 440/2008. The study was performed using 5 concentrations ranging from 4.6 to 100 mg/L. For each test concentration, 20 Daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised Daphnia were counted. Potassium dichromate K2Cr2O7was used as positive control in a current reference study to assure that the test conditions are reliable. The measured concentrations were between 103 % and 105 % of the nominal concentration and the start concentration, and after 48 hours between 95 % and 111 % respectively. Therefore, the determination of the biological results was based on the nominal concentrations.
The EC50 (48 h) for the test item was determined to be 38.33 mg/L.
Toxicity to aquatic plants other than algae
Toxicity to aquatic algae was not investigated as the substance is coloured. Thus, the acute toxicity of the test item to aquatic plants was investigated in a 7–day static test to Lemna minor, according to the OECD Guideline 221 (2006). The study was performed using 5 concentrations ranging from 4.6 to 100 mg/L. The frond number and the dry mass of each replicate were determined during the experiment. Growth rate µ and the yield were determined from the frond number and the dry mass at the respective observation times. The measured concentrations lay between 85 % and 106 %, at the beginning, 103 and 120 %, at the end, of the nominal concentrations. Thus, the determination of the results was based on the nominal concentrations. All the validity criteria were met.
The ErC50 (7d) based on frond number and dry mass were found to be 121.7 mg/L and 164.5 mg/L respectively.
In addition, two summaries of old tests performed on the target substance are available in which the short-term toxicity to fish and the toxicity to microorganisms were evaluated respectively. Due to documentation insufficient for assessment, the reliability of the data cannot be judged.
The short-term toxicity to fish was investigated to the rainbow trout, according to an internal method. The LC50 after 48 hours was indicated to be >100 mg/L (nominal).
The toxicity to microorganisms (activated domestic water sludge) was investigated in a respiration rate test (ETAD Method Nr. 103). The IC50> 1000 mg/l was indicated.
Justification for classification or non-classification
According to the CLP Regulation (EC) no. 1272/2008, Part 4: Environmental Hazards, the substances can be classified for hazardous to the aquatic environment when the following criteria are met:
A )Acute (short-term) aquatic hazard Category Acute 1: 96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) 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 and the substance is not rapidly degradable and/or the experimentally determined BCF ≥ 500 (or, if absent, the log K ow ≥ 4).
Category Chronic 1: 96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC50 (for algae or other aquatic plants) ≤ 1 mg/L
Category Chronic 2: 96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC50 (for algae or other aquatic plants)> 1 to ≤10 mg/L
Category Chronic 3:96 hr LC 50 (for fish) and/or 48 hr EC 50 (for crustacea) and/or 72 or 96 hr ErC 50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/L.
The substance is not rapidly degradable and the available acute toxicity test to Daphnia magna fixed the effect level that meets the criteria related to the hazard Category Chronic 3 (> 10 to ≤ 100 mg/L). Therefore, the substance is classified as Aquatic Chronic 3 according to the CLP Regulation (EC) no. 1272/2008.
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