Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short term toxicity to fish:

Fish Acute Toxicity test according to OECD Guideline 203 was conducted for test chemical on Zebra fish. The nominal concentrations selected for the experiment were 8.2 mg/L, 11.48 mg/L, 16.072 mg/L, 22.500 mg/L, 31.501 mg/L & 100 mg/L, and Zebra FishDanio reriowere exposed to these concentration for 96 hours. The test substance was soluble in water. Therefore, the test solution was prepared by dissolving 82 mg, 114.8 mg, 160.7 mg, 225 mg, 315.01 mg & 1 gm of the test substance in 10 liters of potable water (passed through reverse osmosis system) with continuous stirring for achieving test concentrations of 8.2 mg/L, 11.48 mg/L, 16.072 mg/L, 22.500 mg/L, 31.501 mg/L & 100 mg/L, respectively . Bowl aquaria containing 2 liters of potable water (passed through reverse osmosis system) were loaded with 8 fish. A static procedure was used for the study and it was conducted in compliance with the OECD guideline 203. The nominal concentrations selected for the experiment were 8.2 mg/L, 11.48 mg/L, 16.072 mg/L, 22.500 mg/L, 31.501 mg/L & 100 mg/L and Zebra fish were exposed to this concentration for 96 hours. The lethal concentrations LC50 was determined to be >11.48 mg/L..

After 96 hours of exposure to test chemical to various nominal test concentrations, LC50 was determine to be 11.48 mg/l . Based on the LC50, it can be consider that the chemical was toxic and can be cclassified as aquatic chronic 3 as per the CLP classification criteria.

Long term toxicity to fish:

The long term toxicity on fish was predicted for test substance by using EPI suite ECOSAR version 1.1. On the basis of effects observed in a static freshwater system, the NOEC value for the test substance was estimated to be 0.547 mg/l for fish for 28 days of exposure duration. By considering the NOEC value, it can be concluded that the test chemical can be considered as toxic to fish at environmentally relevant concentrations and can be classified aquatic chronic 2 as per the CLP classification criteria.

Short-term toxicity to aquatic invertebrates:

The Lethal concentration (LC50) value of test material in aquatic invertebrate (Daphnia Magna) in a 48 hr study based on mortality effect was estimated to be 3.079 mg/L. Thus considering the value from CLP Criteria for aquatic classification of the substance , it is concluded that test material exhibit short term toxicity aquatic invertebrate (Daphnia Magna) and can be classified aquatic chronic 2 .

Long term toxicity to aqatic invertebrate:

The long term toxicity on aquatic invertebrate was predicted for test substance by using ECOSAR version 1.1. On the basis of effects observed in a static freshwater system, the NOEC value for the substance was estimated to be 0.495 mg/l for aquatic invertebrate for 21 days of exposure duration. By considering NOEC value, it is concluded that the test chemical can be considered as toxic to aquatic invertebrate and can be classified as aquatic chronic 2 per the CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria:

The short-term toxicity of the test substance to green algae is predicted using EPI Suite ECOSAR version 1.10. On the basis of effects observed in a static freshwater system during a 96 hr exposure, the effect concentration (EC50) for the substance is estimated to be4.821 mg/L. Based on this value, it can be concluded that the test chemical can be considered as toxic to green algae at environmentally relevant concentrations and can be considered to be classified in aquatic chronic category 2 as per the CLP classification criteria.

 

Toxicity to microorganism:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxicity of microroganism of the test chemical.The studies are as mentioned below:

The effect of test material was evaluated for microorganism Escherichia coli (Strain 50 and 90) , for two strain 50 and 90 the MIC was observed to be 256 mg/l. varied effect was observed on both the stains of test organism.

For another functionally similar read across substance ,the effect of test material was evaluated for microorganism Escherichia coli (Strain 50 and 90) , for two strain 50 and 90 the MIC was observed to be >512 mg/l. varied effect was observed on both the stains of test organism.

Additional information

Short term toxicity to fish:

Fish Acute Toxicity test according to OECD Guideline 203 was conducted for test chemical on Zebra fish. The nominal concentrations selected for the experiment were 8.2 mg/L, 11.48 mg/L, 16.072 mg/L, 22.500 mg/L, 31.501 mg/L & 100 mg/L, and Zebra FishDanio reriowere exposed to these concentration for 96 hours. The test substance was soluble in water. Therefore, the test solution was prepared by dissolving 82 mg, 114.8 mg, 160.7 mg, 225 mg, 315.01 mg & 1 gm of the test substance in 10 liters of potable water (passed through reverse osmosis system) with continuous stirring for achieving test concentrations of 8.2 mg/L, 11.48 mg/L, 16.072 mg/L, 22.500 mg/L, 31.501 mg/L & 100 mg/L, respectively . Bowl aquaria containing 2 liters of potable water (passed through reverse osmosis system) were loaded with 8 fish. A static procedure was used for the study and it was conducted in compliance with the OECD guideline 203. The nominal concentrations selected for the experiment were 8.2 mg/L, 11.48 mg/L, 16.072 mg/L, 22.500 mg/L, 31.501 mg/L & 100 mg/L and Zebra fish were exposed to this concentration for 96 hours. The lethal concentrations LC50 was determined to be >11.48 mg/L..

After 96 hours of exposure to test chemical to various nominal test concentrations, LC50 was determine to be 11.48 mg/l . Based on the LC50, it can be consider that the chemical was toxic and can be cclassified as aquatic chronic 3 as per the CLP classification criteria.

Long term toxicity to fish:

The long term toxicity on fish was predicted for test substance by using EPI suite ECOSAR version 1.1. On the basis of effects observed in a static freshwater system, the NOEC value for the test substance was estimated to be 0.547 mg/l for fish for 28 days of exposure duration. By considering the NOEC value, it can be concluded that the test chemical can be considered as toxic to fish at environmentally relevant concentrations and can be classified aquatic chronic 2 as per the CLP classification criteria.

Short-term toxicity to aquatic invertebrates:

The toxicity of test material to aquatic invertebrate based on prediction along with data from peer reviewed journal and handbook for structurally and functionally similar read across substance.

In the predicted data , the Lethal concentration (LC50) value of test material in aquatic invertebrate (Daphnia Magna) in a 48 hr study based on mortality effect was estimated to be 3.079 mg/L. Thus considering the value from CLP Criteria for aquatic classification of the substance , it is concluded that test material exhibit short term toxicity aquatic invertebrate (Daphnia Magna) and can be classified aquatic chronic 2 .

The above prediction was further supported by data for structurally similar read across substance ,the effect of test material on aquatic invertebrate Daphnia magna was observed for 48 h in accordance with OECD 2002 guideline.Monoclonal cultures of Daphnia magna were maintained in the laboratory for several generations in synthetic hard water medium –ASTM supplemented with an organic additive (suspension extracted from Ascophyllum nodosum). The cultures were maintained under a temperature of 20 ±2 C and a photoperiod of 16L:8D and were regularly renewed using neonates from 3rd to 5th broods. The organisms were fed thrice weekly, with a ration of 3.0x105 cells /ml/day of the algae Pseudokirchneriella subcapitata.

The acute assays were conducted in glass tubes containing 10mL of test solution and 10mL of clean ASTM medium (negative control).

Twenty animals (524 h old) divided into four groups of five animals per treatment concentration were used. The nominal concentration was in the range of 0.50–3.14 mg/l.After 48-h tests the immobile/dead organisms were observed, counted and registered. The EC50 value of test material observed after 48 h was 1.81 mg/l and the 95% confidence interval was 1.1 - 4.5 mg/l. Based on the effect concentration it can be considered that test material has toxic effects in aquatic invertebrate and can be classified as aquatic chronic- 2 as per CLP criteria.

The above data was further supported by data from handbook for functionally similar read across substance, short term toxicity of test material was evaluated for 48 h the effect concentation EC50 was observed to be 2.4 mg/l . Hence based on the above effect concentration it can be considered that test material was toxic to aquatic invertebrate, and can be classified as aquatic chronic 2.

Long term toxicity to aqatic invertebrate:

The long term toxicity on aquatic invertebrate was predicted for test substance by using ECOSAR version 1.1. On the basis of effects observed in a static freshwater system, the NOEC value for the substance was estimated to be 0.495 mg/l for aquatic invertebrate for 21 days of exposure duration. By considering NOEC value, it is concluded that the test chemical can be considered as toxic to aquatic invertebrate and can be classified as aquatic chronic 2 per the CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria:

The toxicity of test material to aquatic algae based on prediction along with data from authoritative data base for structurally and functionally similar read across substance.

The short-term toxicity of the test substance to green algae is predicted using EPI Suite ECOSAR version 1.10. On the basis of effects observed in a static freshwater system during a 96 hr exposure, the effect concentration (EC50) for the substance is estimated to be4.821 mg/L. Based on this value, it can be concluded that the test chemical can be considered as toxic to green algae at environmentally relevant concentrations and can be considered to be classified in aquatic chronic category 2 as per the CLP classification criteria.

The above prediction was further supported by data for functionally similar read across substance,the 72 h toxicity test was evaluated for aquatic alage and cyanobacteria. The effects were evaluated based on area under growth curve and growth rate of the green algae. The effect concentartion EC50 after 72 h was observed to be 8.9 based on the inhibiation of growth rate. Based on the EC50 value it can be ocncluded that test material has toxic effects on aquatic algae and can be classified as aquatic chcronic 2.

 The above data was further supported by data from another functionally similar read across substance,effect of test material was evaluated on green algae Selenastrum capricornutum for 72 h. The effect conccentration based on the growth rate was observed to be 2.6 mg/l . Based on the effect concentration it can be considered test substance has toxic effect on aquatic algae and can be classified as aquatic chronic 2.

Toxicity to microorganism:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxicity of microroganism of the test chemical.The studies are as mentioned below:

The effect of test material was evaluated for microorganism Escherichia coli (Strain 50 and 90) , for two strain 50 and 90 the MIC was observed to be 256mg/l. varied effect was observed on both the stains of test organism.

For another functionally similar read across substance ,the effect of test material was evaluated for microorganism Escherichia coli (Strain 50 and 90) , for two strain 50 and 90 the MIC was observed to be >512 mg/l. varied effect was observed on both the stains of test organism.