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Description of key information

Short term toxicity to fish:

Study was conducted to assess the effect of test chemical on the mortality of fish Danio rerio. Test conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test). The test substance was moderately soluble in water. Initially, stock solution was prepared by dissolving 500 mg of the test substance in 1 liter of potable water (passed through reverse osmosis system) with 24 hrs of continuous stirring. After filtration water solubility obtained was 150 mg/L. From this stock solution, further test concentration was prepared for achieving test concentrations of 0.1 mg/L, 0.2 mg/L, 0.4 mg/L, 0.8 mg/L & 1.6 mg/L, respectively and Zebra Fish Danio rerio were exposed to these concentration for 96 hours. Bowl aquaria containing 4 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes. A static procedure was used for the study and it was conducted in compliance with the OECD guideline 203. After 96 hours of exposure to test item to various nominal test concentrations, LC50 was determine to be > 1.6 mg/l and LC0 was observed at 1.6 mg/l.

Long term toxicity to fish:

Based on the prediction done using ECOSAR version 1.1, the long term toxicity on fish was predicted for test substance. On the basis of effects observed in a flow through freshwater system, the NOEC value for the test substance is estimated to be 0.293 mg/l for fish after 28 days of exposure. As no effect were observed thus chemical cannot be classify in toxic category

Toxicity to aquatic invertebrates:

2nd study: The EC-values of Pigment violet 27 in Daphnia magna, which cause after 48 h no (EC0) or 50% (EC50) and 100% (EC100) inhibition of the swimming ability compared to an untreated control are:

EC0* = 1 mg/L (nominal)

EC50 = 10.8 mg/L (nominal)

EC100 =100 mg/L (nominal)

3rd study: The effect concentration EC50 was observed to be 22 mg/l for test chemical on daphnia magba after 24h of exposure.

Thus based on the above both studies, chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.

Long term toxicity to aquatic invertebrates:

Based on the prediction done using ECOSAR version 1.11, the long term toxicity on daphnia was predicted for test substance. On the basis of no effects observed in a flow through freshwater system, the NOEC value for the test substance is estimated to be 0.293 mg/l for daphnia magna for 21 days of exposure. As no effect were observed thus chemical cannot be classify in toxic category

 

Toxicity of aquatic algae and cyanobacteria:

The study was designed to assess the toxic effects of the test compound on the growth of green alga Chlorella vulgaris. Test was conducted in compliance with the OECD guideline 201 (Alga, Growth Inhibition Test). Test was carried out in 100mL conical flasks which were carefully autoclaved and sterilized. The test solution was prepared in aseptic condition. The test substance was prepared by adding 12.5 mg of test substance in 250 ml of BBM to get the final concentration of 50 mg/L. The remaining test solutions were prepared by dilution from the above stock solution. To have a better growth and visibility of cells, the initial cell density of the culture was kept 1 X 104cells/ml. Care was taken to have a homogeneous solution for the experiment. 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 which were maintained in duplicates. To obtain a quantitative concentration-response relationship by regression analysis, a linearizing transformation of the response data into probit was performed. Using the same, effective concentration (EC) were determined. Algal growth was calculated daily by counting the cells microscopically with the help of haemocytometer. For microscopic observations the cultures were observed daily with the help of a microscope to verify a normal and healthy appearance of the algal culture and also to observe any abnormal appearance of the algae (as may be caused by the exposure of the test item). Apart from this, the cell count of each test vessel was also noted with the help of a microscope and hemocytometer. By spectrophotometer the absorbance values of each test vessel and control vessel was noted at 680nm.The BBM was taken as blank for both control and test vessels. The absorbance value of each vessel was in line with the average specific growth rate. After the exposure of test chemical with green alga Chlorella vulgaris for 72 hrs, EC50 calculated from equation and graphically through probit analysis was found to be 14.05 mg/L and 12.59 mg/L respectively on the basis of growth rate inhibition. Based on the EC50 value, it can be concluded that the chemical was toxic and can be consider to be classified as aquatic chronic 3 as per the CLP classification criteria.

 

 

Toxicity to microorganisms:

2nd: Toxicity studies to determine the inhibitory concentration of test substance on the respiration of aerobic waste water bacteria were conducted according to EEC L 133, p. 118-122 (30. May 1988) guideline. The test was conducted on activated sludge from a sewage treatment plant for 3 hours at 20°C. The results were graphically determined based on nominal concentrations and  IC50 was determined to be 15 mg/L.

3rd: After the exposure period of 30 minutes, chemical have no toxic effects on V. fischeri NRRL B-1117 at the concentration upto 6 mg/L i.e. NOEC (No observed effect concentration) and EC50 was > 39.9 mg/l.

Additional information

Short term toxicity to fish:

Study was conducted to assess the effect of test chemical on the mortality of fish Danio rerio. Test conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test). The test substance was moderately soluble in water. Initially, stock solution was prepared by dissolving 500 mg of the test substance in 1 liter of potable water (passed through reverse osmosis system) with 24 hrs of continuous stirring. After filtration water solubility obtained was 150 mg/L. From this stock solution, further test concentration was prepared for achieving test concentrations of 0.1 mg/L, 0.2 mg/L, 0.4 mg/L, 0.8 mg/L & 1.6 mg/L, respectively and Zebra Fish Danio rerio were exposed to these concentration for 96 hours. Bowl aquaria containing 4 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes. A static procedure was used for the study and it was conducted in compliance with the OECD guideline 203. After 96 hours of exposure to test item to various nominal test concentrations, LC50 was determine to be > 1.6 mg/l and LC0 was observed at 1.6 mg/l.

Long term toxicity to fish:

Based on the prediction done using ECOSAR version 1.1, the long term toxicity on fish was predicted for test substance. On the basis of effects observed in a flow through freshwater system, the NOEC value for the test substance is estimated to be 0.293 mg/l for fish after 28 days of exposure. As no effect were observed thus chemical cannot be classify in toxic category

Toxicity to aquatic invertebrates:

Data available for the various test chemicals including for read across chemical selected on the basis of structurally and functionally similarity with the test chemical were reviewed to determine the toxicity of the test chemical on aquatic invertebrates. The studies are as mentioned below:

 

In this key study from experimental report toxicity were determine. Determination of acute toxicity of the test substance according to EEC Directive 93/32/EEC (December 1992) to freshwater invertebrate Daphnia magna was done using different test sample. The acute effect on the swimming ability of water flea under the influence of various concentrations 100 mg/l, 10 mg/I, 1 mg/l, 0.1 mg/l, 0.01 mg/l of test substance was studied for 48 hours. The EC-values indicating the concentrations of the test substance, which cause after 48 h were calculated (EC0) or 50% (EC50) and 100% (EC100) inhibition of the swimming ability compared to an untreated control are:

EC0* = 1 mg/l (nominal)

EC50 = 10.8 mg/l (nominal)

EC100 =100 mg/l (nominal)

*highest test concentration with an effect of ≤ 10%.

 

Similar study was to evaluate the toxicity of test chemical on the biological activity and mobility of daphnia magna. Test conducted under the static system for 24 hrs. The effect concentration EC50 was observed to be 22 mg/l for chemical after 24h of exposure. Based on the EC50 value, chemical was consider as toxic and can be consider to be classified as aquatic chronic category 3 as per the CLP classification criteria.

Thus based on the above both studies, chemical consider to be toxic and classified as aquatic chronic 3 as per the CLP classification criteria.

 

Long term toxicity to aquatic invertebrates:

Based on the prediction done using ECOSAR version 1.11, the long term toxicity on daphnia was predicted for test substance. On the basis of no effects observed in a flow through freshwater system, the NOEC value for the test substance is estimated to be 0.293 mg/l for daphnia magna for 21 days of exposure. As no effect were observed thus chemical cannot be classify in toxic category

 

Toxicity of aquatic algae and cyanobacteria:

The study was designed to assess the toxic effects of the test compound on the growth of green alga Chlorella vulgaris. Test was conducted in compliance with the OECD guideline 201 (Alga, Growth Inhibition Test). Test was carried out in 100mL conical flasks which were carefully autoclaved and sterilized. The test solution was prepared in aseptic condition. The test substance was prepared by adding 12.5 mg of test substance in 250 ml of BBM to get the final concentration of 50 mg/L. The remaining test solutions were prepared by dilution from the above stock solution. To have a better growth and visibility of cells, the initial cell density of the culture was kept 1 X 104cells/ml. Care was taken to have a homogeneous solution for the experiment. 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 which were maintained in duplicates. To obtain a quantitative concentration-response relationship by regression analysis, a linearizing transformation of the response data into probit was performed. Using the same, effective concentration (EC) were determined. Algal growth was calculated daily by counting the cells microscopically with the help of haemocytometer. For microscopic observations the cultures were observed daily with the help of a microscope to verify a normal and healthy appearance of the algal culture and also to observe any abnormal appearance of the algae (as may be caused by the exposure of the test item). Apart from this, the cell count of each test vessel was also noted with the help of a microscope and hemocytometer. By spectrophotometer the absorbance values of each test vessel and control vessel was noted at 680nm.The BBM was taken as blank for both control and test vessels. The absorbance value of each vessel was in line with the average specific growth rate. After the exposure of test chemical with green alga Chlorella vulgaris for 72 hrs, EC50 calculated from equation and graphically through probit analysis was found to be 14.05 mg/L and 12.59 mg/L respectively on the basis of growth rate inhibition. Based on the EC50 value, it can be concluded that the chemical was toxic and can be consider to be classified as aquatic chronic 3 as per the CLP classification criteria.

 

 

Toxicity to microorganisms:

Summarized result for the toxicity of test chemical were studied and reviewed as mention below:

In the first toxicity studies to determine the inhibitory concentration of test material on the respiration of aerobic waste water bacteria were conducted according to EEC L 133, p. 118-122 (30. May 1988) guideline. The test was conducted on activated sludge from a sewage treatment plant for 3 hours at 20°C. The results were graphically determined. Activated sludge collected from the sewage treatment plant of CH-4106 Therwil on 16/10/89. The preparation was carried out according to the method described in the guideline. The sludge was separated from the aqueous layer by settling instead of centrifugation. 3,5-Dichlorophenol was used as reference substance. The effect concentration (IC50) was determined to be 15 mg/l, Test substance can be concluded to have moderate toxicity on microorganisms.

 

Similarly according to ISO 11348-2 guidelines toxicity of test compound based on inhibition of luminescence emitted by bacteria was studied and EC50 was determined at 5, 15 and 30 min. After the exposure period of 30 minutes, chemical have no toxic effects on V. fischeri NRRL B-1117 at the concentration upto 6 mg/L i.e. NOEC (No observed effect concentration) and EC50 was > 39.9 mg/l.

 

 

As the chemical was toxic to aquatic lifes as per the above studies, chemical classified in aquatic chronic category 2 as per the CLP classification criteria.