Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short-term toxicity to invertebrates: EC50 (48h) = 4.40 mg/l

Toxicity to aquatic plants: ErC50(7d): 21.12 mg/l

Additional information

The studies on Daphnia magna and Lemna Gibba are performed on the Similar Substance 02 and considered for the chemical safety assessment due to the similarity between the similar substance 2 and the target substance. The complete evaluation and justification of the read across aprroach is attached at section 13..

Acute toxicity testing on invertebrates:

Acute Immobilization Toxicity Study in Daphnia magna was conducted on Similar Substance 02 in accordance with OECD guideline 202. Based on the results of the range finding experiment, main experiment was conducted with the following concentrations: 0.30, 0.60, 1.20, 2.40, 4.80, 9.60 and 19.20 mg/l.

NOEC (48h) = 0.60 mg/l LOEC (48h) = 1.20 mg/l

EC50 (48h) = 4.40 mg/l

Toxicity to aquatic plants other than algae:

Lemna gibba (Duckweed) were exposed to Similar Substance 02 at test concentration of 100 mg/l. Three replicates for each test concentration and six replicates for control were maintained.

After exposure, Lemna gibba was observed for frond count on days ‘3’, ‘5’ and ‘7’. Dry weight of the fronds were recorded at start (pre-culture representative samples) and at the end of the test. Fronds were observed for their appearance on days ‘3’, ‘5’ and ‘7’. All fronds were found normal and healthy in all replicates of control and test concentration except 51.54 mg/L where necrosis observed on day ‘5’ and in addition to necrosis, root filaments were turned blue in 10.65, 23.43 and 51.54 mng/l concentrations on day ‘7’.

The doubling time (Td) of frond number in the control group was calculated as 1.608 day-1.

ErC50(frond numbers) 21.12 mg/l

ErC50(frond dry weight) 21.67 mg/l

EyC50(frond numbers) 9.55 mg/l

EyC50(frond dry weight) 8.69 mg/l

NOEC = 2.2 mg/l

LOEC= 4.84 mg/l

Justification for classification or non-classification

The toxicity value for Daphnia magna (the most sensitive specie) are:

NOEC 48h = 0.60 mg/l

EC50 48h = 4.4 mg/l

EC100 48h = 19.20 mg/l.

The toxicity value for Lemna Gibba (Duckweed) are:

ErC50(frond numbers) 21.12 mg/l

ErC50(frond dry weight) 21.67 mg/l

EyC50(frond numbers) 9.55 mg/l

EyC50(frond dry weight) 8.69 mg/l

NOEC = 2.2 mg/l

LOEC= 4.84 mg/l

The values are below the limit for avoiding the classification (1 mg/l < Category Chronic 2 10 mg/l.

Based on values reported above the classification as Aquatic Category Chronic 2 (H411: Toxic to aquatic life with long lasting effects) is proposed according to the CLP Regulation (EC n. 1272/2008).