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Description of key information

Short term toxicity to fish

The short-term toxicity of the test chemical to fish is predicted using EPI Suite ECOSAR version 1.11 (2018). On the basis of effect of test chemical observed in a static freshwater system on the mortality of the test organism during the 96 hr exposure duration, the lethal effect concentration (LC50) for the test chemical is estimated to be 2.336 mg/l.Thus, based on the LC50 value, chemical can be considered as toxic to fish and thus can be considered to be classified in ‘aquatic chronic category 2’ as per CLP classification criteria.

Short term toxicity to aquatic invertebrates

An acute immobilisation test was conducted for 48 hrs for assessing the effect of test chemical on Daphnia magna(Experimental study report, 2018). The test was performed in accordance to OECD guideline No. 202 “Daphnia sp.,Acute Immobilization Test”. Own breeding stock at University of Chemistry and Technology, Prague of Daphnia magna was used as a test organism for the study. The stock solution 10 g/ml was prepared by dissolving white powder in acetone. Test solutions of required concentrationas were prepared by mixing the stock solution of the test sample with reconstituted test water. Nominal test chemical conc. used for the study were 0, 0, 1, 2, 4, 8 and 16 mg/L, respectively. Study was performed using total 5 organisms per vessel/replicates in a static fresh water system. Daphnids were exposed to test chemical in 50 ml glass vessel in a volume of 25 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 20±1°C. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. On the basis of the effect of test chemical on the mobility of the test organism Daphnia magna, the 48 hr EC50 value was determined to be 6.9 mg/l with a 95% confidence interval value ranging from 5.6 to 8.4 mg/l, respectively. Thus, based on the EC50 value, test chemical can be considered as toxic to aquatic invertebrates and thus can be considered to be classified in ‘aquatic chronic category 2’ as per CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria

An acute test was conducted for 48 hrs for assessing the effect of test chemical on Desmodesmus subspicatus (Experimental study report, 2018). The test was performed in accordance to OECD Guideline 201 (Alga, Growth Inhibition Test). Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) of strain 86.81 SAG obtained from Institute of botany of the ASCR with an initial biomass conc. 5x10(3) cells /ml was used as a test organism for the study. The solution 10 g/l was prepared by dissolving white powder in acetone. Test concentrations 10 mg/l was prepared by mixing the stock solution of the test sample with OECD growth medium. Nominal test chemical conc. used for the study were 0, 0, 5, 9, 16, 23 and 42 mg/l, respectively. Study was performed using Desmodesmus subspicatus as a test organism in a static fresh water system. Desmodesmus subspicatus were exposed to test chemical in 50 ml glass vessel in a volume of 15 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 23±2°C with a continuous light intensity of 6000-8000 lx, respectively. Alongwith the test chemical, one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. Cell counting was carried out using electronic particle counter. ErC50 was calculated using non-linear regression by the software Prism 4.0. On the basis of the effect of test chemical on the growth rate of the test organism Desmodesmus subspicatus, the 72 hr effect concentration (ErC50%) value was determined to be 92.6 mg/l (95 % CI was 58 - 148 mg/l). Thus, based on the ErC50 value, test chemical can be considered as toxic to aquatic algae and thus can be considered to be classified in ‘aquatic chronic category 3’ as per CLP classification criteria.

Toxicity to microorganisms

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach, the EC50 value was determined to be 190 mg/l, respectively.

Additional information

Short term toxicity to fish

Predicted data of the test chemical and various supporting weight of evidence studies for its structurally similar read across chemical were reviewed for the short term toxicity to fish end point which are summarized as below:

 

In a prediction done using EPI Suite ECOSAR version 1.11, the short-term toxicity of the test chemical to fish is predicted. On the basis of effect of test chemical observed in a static freshwater system on the mortality of the test organism during the 96 hr exposure duration, the lethal effect concentration (LC50) for the test chemical is estimated to be 2.336 mg/l.

 

In a supporting weight of evidence study from authoritative database (J-CHECK, 2018),an acute toxicity test was conducted for 96 hrs for assessing the effect of test chemical on Oryzias latipes (Japanese rice fish). The test was performed in accordance to OECD guideline No. 203 “Fish Acute Toxicity Test”. Oryzias latipes (Japanese rice fish) was used as a test organism for the study. Test chemical conc. used for the study were1.00, 1.80, 3.20, 5.60 and 10.0 mg/l (geometric ratio ca. 1.8), control, vehicle control. Analytical monitoring involve the use of HPLC. Study was performed using 10 per conc. Oryzias latipes in a semi-static fresh water system. Total 50 fishes were exposed to test chemical in a vessel covered water surface with teflon sheet. The test vessels were placed under a photoperiod of room light, 16:8 hr light: dark conditions, respectively. On the basis of mortality of the test organism Oryzias latipes (Japanese rice fish), the 96 hrs LC50 value was determined to be 1.88 mg/l (95% C. I. – 1.42 to 2.48 mg/l), respectively. 

 

For the test chemical,short term toxicity to fish study was conducted for 96 hrs for assessing the effect of test chemical on fish. The study was performed under static conditions. On the basis of mortality of the test organism, the 96 hrs LC50 value was determined to be 1.8 mg/l. 

 

On the basis of the above results, it can be concluded that the test chemical can be considered astoxic to fish and thus can be considered to be classified in ‘aquatic chronic category 2’ as per CLP classification criteria.

Short term toxicity to aquatic invertebrates

An acute immobilisation test was conducted for 48 hrs for assessing the effect of test chemical on Daphnia magna(Experimental study report, 2018). The test was performed in accordance to OECD guideline No. 202 “Daphnia sp.,Acute Immobilization Test”. Own breeding stock at University of Chemistry and Technology, Prague of Daphnia magna was used as a test organism for the study. The stock solution 10 g/ml was prepared by dissolving white powder in acetone. Test solutions of required concentrationas were prepared by mixing the stock solution of the test sample with reconstituted test water. Nominal test chemical conc. used for the study were 0, 0, 1, 2, 4, 8 and 16 mg/L, respectively. Study was performed using total 5 organisms per vessel/replicates in a static fresh water system. Daphnids were exposed to test chemical in 50 ml glass vessel in a volume of 25 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 20±1°C. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. On the basis of the effect of test chemical on the mobility of the test organism Daphnia magna, the 48 hr EC50 value was determined to be 6.9 mg/l with a 95% confidence interval value ranging from 5.6 to 8.4 mg/l, respectively. Thus, based on the EC50 value, test chemical can be considered as toxic to aquatic invertebrates and thus can be considered to be classified in ‘aquatic chronic category 2’ as per CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria

An acute test was conducted for 48 hrs for assessing the effect of test chemical on Desmodesmus subspicatus (Experimental study report, 2018). The test was performed in accordance to OECD Guideline 201 (Alga, Growth Inhibition Test). Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) of strain 86.81 SAG obtained from Institute of botany of the ASCR with an initial biomass conc. 5x10(3) cells /ml was used as a test organism for the study. The solution 10 g/l was prepared by dissolving white powder in acetone. Test concentrations 10 mg/l was prepared by mixing the stock solution of the test sample with OECD growth medium. Nominal test chemical conc. used for the study were 0, 0, 5, 9, 16, 23 and 42 mg/l, respectively. Study was performed using Desmodesmus subspicatus as a test organism in a static fresh water system. Desmodesmus subspicatus were exposed to test chemical in 50 ml glass vessel in a volume of 15 ml of liquid solution containing both the chemical and media. The beakers were placed in a room at a temperature of 23±2°C with a continuous light intensity of 6000-8000 lx, respectively. Alongwith the test chemical, one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. Cell counting was carried out using electronic particle counter. ErC50 was calculated using non-linear regression by the software Prism 4.0. On the basis of the effect of test chemical on the growth rate of the test organism Desmodesmus subspicatus, the 72 hr effect concentration (ErC50%) value was determined to be 92.6 mg/l (95 % CI was 58 - 148 mg/l). Thus, based on the ErC50 value, test chemical can be considered as toxic to aquatic algae and thus can be considered to be classified in ‘aquatic chronic category 3’ as per CLP classification criteria.

Toxicity to microorganisms

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxic effect of the test chemical on micro-organisms. The studies are as mentioned below:

 

Short term toxicity to Pseudomonas fluorescens study was carried out for 24 hr. The study was based on the effects of the test chemical on Pseudomonas fluorescens. Pseudomonas fluorescens was used as a test organism. On the basis of the effect of test chemical on growth rate, i.e, multiplication of the test organism Pseudomonas fluorescens, the 24 h EC0 value was determined to be 500 mg/l.

 

Another short term toxicity to Pseudomonas putida study was carried out for 17 hr. The study was based on the effects of the test chemical on Pseudomonas putida. Pseudomonas putida was used as a test organism. On the basis of the effect of test chemical on growth rate, i.e, cell multiplication of the test organism Pseudomonas putida, the 17 h EC10, EC50 and EC90 value was determined to be 140, 190 and 240 mg/l, respectively.

 

On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach, the EC50 value was determined to be 190 mg/l, respectively.

On the basis of the available information of aquatic toxicity studies, it can be concluded that the test chemical can be considered astoxic to aquatic organisms at environmental relevant concentrations and thus can be considered to be classified in ‘aquatic chronic category 2’ as per CLP classification criteria.