Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short term toxicity to fish

The range of median lethal concentration of the test chemical was determined to be 1.77- 5.0  mg/L.

Long term toxicity to fish

The prediction tool was run to understand the effect of test chemical on the fish. the test was for the period of 28.0 days. The NOEC of the test chemical to fish is predicted to be 0.036 mg/L. Based on the outcomes the test chemical can be classified intoaquatic chronic category 2.

Short Term toxicity to aquatic invertebrates:

The range of median effective concentration of test chemical to daphnia magna was determined to be >0.010 - 0.346 mg/L

Long term toxicity to aquatic invertebrates:

The range of NOEC of test chemical to daphnia magna for 21 days was determined to be 0.0057 - 0.044 mg/L

Toxicity to aquatic algae and cyanobacteria:

The study was designed to assess the toxic effects of the test compound on the green alga Chlorella vulgaris. Test was conducted in compliance with the OECD guideline 201 (Alga, Growth Inhibition Test). For the assessment of algal growth, the test was conducted in replicates. The control flask was maintained in triplicates as recommended in the OECD guideline and the test concentration were selected in geometric series of 3, which were maintained in duplicates. After 72 hours of exposure to test item to various nominal test concentrations, EC30 was determine to be 18.05 mg/l graphically and through probit analysis. Based on the EC30, it can be concluded that the test chemical can be classified into aq aquatic chronic 3 as per the CLP classification criteria.

Toxicity to microorganisms:

he microbial growth was evaluated using the tetrahymena pyriformis population growth assay. The test was conducted in the static conditions for the period of 48 hours. Based on the outcomes the median inhibitory growth concentration was determied to be 116.16 mg/L.

Additional information

Short term toxicity to fish

Data available from various sources for test chemical and read across chemical has been reviewed to determine the toxicity of the test chemical on fish: the studies are as mentioned below.

The Primary study outlines the effect of test chemical on the early life stage of zebrafish. the test was conducted in accordance with OECD 236 guidelines, fish embryo toxicity test. Seven different concentrations was selected to evaluate the median lethal concentration i.e., 0.5, 1, 2, 5, 10, 20 and 50 μM. Test was conducted for the period of 120 h, in semi static conditions, and the median lethal concentration for 96 h was determined to be 1.77 mg/L (5.2µM).

The Secondary study outlines the effect of test chemical on the fish for the period of 96.0 h. the test was conducted in accordance with OECD 203 guidelines. After the exposure period the median lethal concentration was determiend to be >5 mg/L.

The toxicity range of the test chemical was determined to be 1.77 -5.0 mg/L. As per new CLP classification criteria the test chemical can be classified into aquatic chronic category 2.

Long term toxicity to fish

The prediction tool was run to understand the effect of test chemical on the fish. the test was for the period of 28.0 days. The NOEC of the test chemical to fish is predicted to be 0.036 mg/L.

Short Term toxicity to aquatic invertebrates:

Data available from various sources for test chemical and read across chemicals has been reviewed to determine the toxicity of the test chemical on Daphnia magna. The studies are as mentioned below

Firstly, Based on the prediction done by EPI suite, ECOSAR version 1.1, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program, the LC 50 value for short term toxicity to aquatic invertebrates was predicted.

On the basis of this program, the LC 50 value for short term toxicity to aquatic invertebrates was predicted to be 0.346 mg/l for in 48 hrs.

Secondly, both studies from authoritative database outlines the effect of test chemical on the daphnia magna for the period of 48 h. The range median effective concentration of test chemical to daphnia magna is 0.010 - 0.075 mg/L.

The toxicity range for the test chemical was determined to be 0.010 - 0.346 mg/L

Based on this value it can be concluded that the substance is considered to be toxic to aquatic environment and can be classified in aquatic acute 1 category as per the criteria mentioned in CLP regulation.

Long term toxicity to aquatic invertebrates:

Data available from various sources for test chemical has been reviewed to determine the toxicity of the test chemical on daphnia magna, the studies are mentioned below.

Study based on the prediction done by EPI suite, ECOSAR version 1.1, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program, the NOEC value for short term toxicity to aquatic invertebrates was predicted.

On the basis of this program, the NOEC value for short term toxicity to aquatic invertebrates was predicted to be 0.044 mg/l for in 21 days.

Another two studies from the authoritative database,The test outlines the effect of the test chemical on the daphnia magna for the period of 21.0 days on their reproduction capacity. Based on the out comes the NOEC of the test chemial to the test species was determined to be in range of 0.0057- 0.011 mg/L.

Based on this value it can be concluded that the substance is considered to be toxic to aquatic environment and can be classified in aquatic chronic 1 category as per the criteria mentioned in CLP regulation.

Toxicity to aquatic algae and cyanobacteria:

The study was designed to assess the toxic effects of the test compound on the green alga Chlorella vulgaris. Test was conducted in compliance with the OECD guideline 201 (Alga, Growth Inhibition Test). For the assessment of algal growth, the test was conducted in replicates. The control flask was maintained in triplicates as recommended in the OECD guideline and the test concentration were selected in geometric series of 3, which were maintained in duplicates. After 72 hours of exposure to test item to various nominal test concentrations, EC30 was determine to be 18.05 mg/l graphically and through probit analysis. Based on the EC30, it can be concluded that the test chemical can be classified into aq aquatic chronic 3 as per the CLP classification criteria.

Toxicity to microorganisms:

Data available from various sources for test chemical and functionally and structually similar read across chemicals has been reviewed to determine the toxicity of the test chemical on microorganisms. The studies are as mentioned below:

Data from the peer reviewed journal outlines that, The microbial growth was evaluated using the tetrahymena pyriformis population growth assay. The test was conducted in the static conditions for the period of 48 hours. Based on the outcomes the median inhibitory growth concentration was determied to be 116.16 mg/L.

Another study from the secondary source, summarizes the effect of test chemical on the microregma sp. a ciliated protozoan. Based on the feeding behaviour the effective concentration was determied to be 70 mg/L.

The effect of the test chemical to aquatic micro organisms was in a range of 70- 116.16 mg/L.

Based on the outcomes the test chemical can be classified into aquatic chronic category 1 as per CLP classification.