Registration Dossier

Registration Dossier

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short-term toxicity to fish

LC50 (96h) = 792 mg/l

Short term toxicity to aquatic inverterbrates

EC50 (48h) = 173 mg/l

Toxicity to aquatic plants other than algae

ECr50 > 100 mg/l

NOEC = 100 mg/l

Toxicity to microorganisms

IC50 (3h) > 320.0 mg/l

Additional information

The test substance has been tested for acute fish toxicity and for acute toxicity to microorganisms. The tests on both endpoints gave no concern for the aquatic compartment.

(Short-term toxicity to fish: LC50 (96h) = 792 mg/l; Toxicity to microorganisms: IC50 (3h) > 320.0 mg/l)

There are no experimental data available of the target substance on "Short term toxicity to aquatic inverterbrates" and "toxicity to aquatic plants other than algae", thus the information on a similar substance have been taken into account.

The structural differences occurring between the target substance and Similar Substance 01 are not expected to significantly impact the toxicity to invertebrates and aquatic plants, thus the read across approach can be considered as representavive and appropriate (details in the document attached to the IUCLID section 13).

Short-term toxicity to fish

The test substance has been tested for acute fish toxicity. The selected key study shows a LC50 = 792 mg/l, this result is confirmed by the other available tests. The Huntsman test (1973) indicates a lower value (302 ppm after 96 h) but no complete information about the sample composition is available.

Short term toxicity to aquatic inverterbrates

The acute toxicity of the Similar Substance 01 to Daphnia magna was determined in a 48 hours static test according to the OECD Guideline 202 and EU Method C.2. The study was performed under Good Laboratory Practice (GLP) conditions in Switzerland. Due to the results of a pretest the nominal concentrations for the main test were selected as 45, 100 and 220 mg test article/l, a vehicle and a blank control without any additions. The test concentrations were prepared from a 1.0 g/l stock solution.

In all test concentrations no alteration of the test substance was observed after 48 hours. During the test, the actual test concentrations in the analysed test media were in the range of 115-118 % of the nominal values. Therefore, the test substance was sufficiently stable in the test medium and the reported results are related to the nominal test concentrations. No immobilization and abnormal behaviour of the Daphnia was observed in the controls and in the test concentrations up to 100 mg/l.

The NOEC and EC0 value after 48 hours were determined to be 100 mg/l. The EC100 could not be determined, but was clearly higher than 220 mg/l.

The EC50 value after 48 hours was calculated as 173 mg/l.

Toxicity to aquatic plants other than algae

The study was performed to assess the effect of the Similar substance 01 on the growth of the freshwater plant Lemna minor. The method followed that described in the OECD Guideline No. 221 “Lemnasp.Growth Inhibition Test (March 2006)”. Following a preliminary range-finding test,Lemna minorwas exposed to an aqueous solution of the test item at a nominal concentration of 100 mg/L (six replicate flasks for a period of 7 days, under constant illumination at a temperature of 24 ± 1°C.  The number of fronds in each control and treatment group was recorded on days 0, 2, 5 and 7 along with observations on plant development. Chemical analysis of the test preparations on Day 0 (fresh media) and Day 7 (old media) showed measured test concentrations to range from 98 % to 100 % of nominal and so the results are based on nominal test concentrations only.

The resulting ECr50 was more than 100 mg/l and the NOECr was 100 mg/l.t

Toxicity to microorganisms

Three studies are available for the toxicity to microorganisms but just the Huntsman study (1994) contains sufficient details to be considered reliable to be choose as key study. The other two are just short abstracts which results are in agreement with the key study result. Therefore the key value for the risk assessment has been set as IC50 > 320 mg/l.

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) and/or48 hr EC 50 (for crustacea) and/or72 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 ErC 50 (for algae or other aquatic plants) ≤ 1 mg/l

Category Chronic 2: 96 hr LC 50 (for fish) and/or48 hr EC 50 (for crustacea) and/or72 or 96 hr ErC 50 (for algae or other aquatic plants) > 1 to ≤10 mg/l

Category Chronic 3: 96 hr LC 50 (for fish) and/or48 hr EC 50 (for crustacea) and/or72 or 96 hr ErC 50 (for algae or other aquatic plants) > 10 to ≤ 100 mg/l

The EC50 value calculated for the test substance on the "short-term aquatic toxicity to invertebrates" (Daphnia) was established to be 173 mg/l, therefore the substance, for this test, is not classified according to the CLP Regulation (EC n. 1272/2008).

The ErC50 value calculated for the test substance on the "toxicity to aquatic plants other than algae" was established to be > 100 mg/l. No classification is required according to teh CLP Regulation (EC n. 1272/2008)

These results are in line with those obtained on the fish toxicity studies carried out with the target substance, which confirm no concern on aquatic environment.

EU Privacy Disclaimer

This website uses cookies to ensure you get the best experience on our websites.