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Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short term toxicity to fish:

Study was conducted to access the effect of test chemical on the growth of fish Danio rerio. Test conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test).The test substance was soluble in water. Therefore, the test solution was prepared by dissolving 450 mg of the test substance in 4.5 liters of potable water (passed through reverse osmosis system) with 1hr stirring for achieving test concentrations of 100mg/L,respectively.This test solution was then added to the remaining three liters of water for achieving test concentrations of 100 mg/L and Zebra FishDanio reriowere exposed to these concentration for 96 hours. Bowl aquaria containing 2 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 >100 mg/l . Based on the LC50, it can be consider that the chemical was not toxic and can be consider to be not classified as per the CLP classification criteria.

Short term toxicity to aquatic invertebrates:

Aim of this study was to assess the short term toxicity of test material to aquatic invertebrates daphnia magna. Study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system for the total exposure period of 48 hrs. The stock solution 150 mg/l was prepared by dissolving white powder in reconstituted water. Test solutions of required concentrationas were prepared by mixing the stock solution of the test sample with reconstituted test water and 0, 30, 45, 67, 100 and 150 mg/l nominal concentrations were used in the study. Effects on immobilisation were observed for 48 hours. 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. The median effective concentration (EC50) for the test substance, test material, in Daphnia magna was determined to be 65.6 mg/L on the basis of mobility inhibition effects in a 48 hour study. Based on the EC50 value, indicates that the substance is likely to be hazardous to aquatic invertebrates and can be classified as aquatic chronic 3 category as per the CLP criteria.

Toxicity to aquatic algae and cyanobacteria:

The effect of test item was studied on the growth of fresh water green alga Chlorella vulgaris. The study was conducted following OECD guideline 201- Alga, growth inhibition test. The test concentration chosen for the study were 6.25 mg/L,12.5 mg/L, 25 mg/L, 50 mg/L,100 mg/L, 200 mg/L. The test concentrations were prepared using stock solution of the test item using mineral media. The green alga was exposed to the test concentration for a period of 72 hours to observe average specific growth rate and % growth inhibition under the effect of the test item. EC50 calculated graphically through probit analysis was observed to be >200 mg/L. Thus based on this value, it can be concluded that the substance can be considered as non-toxic to aquatic organisms and thus cannot be classified as hazardous as per the CLP classification criteria.

Toxicity to microorganisms:

1. Vibrio fischeri in a 15 min inhibition of bioluminescence test the 50% effect concentrations (EC50) of the test chemical was observed to be 284 mg/l with 95% confidence limit (241–336 mg/l).

2. Based on the cell proliferation inhibition of aquatic Pseudomonas putida (Bacteria) by the chemical exposure for 17 hrs, the EC50 was determine at 95 mg/l.

Thus based on the overall studies for the test material, it was concluded that chemical was nontoxic as value ranges from 95 -284 mg/l.

Additional information

Short term toxicity to fish:

Based on the data obtain from various sources for the target chemical and for structurally and functionally similar read across chemicals study have been reviewed to determine the toxic nature of target chemical on the mortality of fishes. The studies are as mentioned below:

Study was conducted to access the effect of test chemical on the growth of fish Danio rerio. Test conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test).The test substance was soluble in water. Therefore, the test solution was prepared by dissolving 450 mg of the test substance in 4.5 liters of potable water (passed through reverse osmosis system) with 1hr stirring for achieving test concentrations of 100mg/L,respectively.This test solution was then added to the remaining three liters of water for achieving test concentrations of 100 mg/L and Zebra FishDanio reriowere exposed to these concentration for 96 hours. Bowl aquaria containing 2 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 >100 mg/l . Based on the LC50, it can be consider that the chemical was not toxic and can be consider to be not classified as per the CLP classification criteria.

First study was supported by the second from experimental report. This study was designed to assess the toxic effects of the test compound on the Zebra fish(Danio rerio). 5 liters Bowl aquaria containing 2 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes each. A static procedure was used for the study and it was conducted in compliance with the OECD guideline 203. The experimental phase of the main study started at 06-11-2017 and lasted for a period of 96 hrs. The nominal concentration selected for the experiment were 6.25mg/L,12.5mg/L, 25mg/L, 50mg/L,100mg/L and Zebra FishDanio reriowere exposed to these concentration for 96 hours. The test substance was soluble in water. Therefore, the stock solution was prepared by dissolving 1g of the test substance in 1 liters of potable water (passed through reverse osmosis system) with continuous 1 hour stirring. After completion of stirring test solution prepare for achieving test concentrations. No effect were observed at 100 mg/l nominal concentration. After 96 hours of exposure of test itemTetraethylammonium Chloride on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for test chemical on Zebra Fish Danio rerio was determine to be > 100 mg/l. Based on the LC50, it can be consider that the chemical was nontoxic and can be consider to be not classified as per the CLP classification criteria.Thus based on the overall studies it was concluded that the chemical was nontoxic and not classified as per the CLP classification criteria.

Short term toxicity to aquatic invertebrates:

Aim of this study was to assess the short term toxicity of test material to aquatic invertebrates daphnia magna. Study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system for the total exposure period of 48 hrs. The stock solution 150 mg/l was prepared by dissolving white powder in reconstituted water. Test solutions of required concentrationas were prepared by mixing the stock solution of the test sample with reconstituted test water and 0, 30, 45, 67, 100 and 150 mg/l nominal concentrations were used in the study. Effects on immobilisation were observed for 48 hours. 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. The median effective concentration (EC50) for the test substance, test material, in Daphnia magna was determined to be 65.6 mg/L on the basis of mobility inhibition effects in a 48 hour study. Based on the EC50 value, indicates that the substance is likely to be hazardous to aquatic invertebrates and can be classified as aquatic chronic 3 category as per the CLP criteria.

Toxicity to aquatic algae and cyanobacteria:

Summarized result of the toxicity of test chemical on the growth and mobility of test chemical on the growth of aquatic algae and cyanobacteria. As mention below:

 

In an experimental key study the effect of test item was studied on the growth of fresh water green alga Chlorella vulgaris. The study was conducted following OECD guideline 201- Alga, growth inhibition test. The test concentration chosen for the study were 6.25 mg/L,12.5 mg/L, 25 mg/L, 50 mg/L,100 mg/L, 200 mg/L. The test concentrations were prepared using stock solution of the test item using mineral media. The green alga was exposed to the test concentration for a period of 72 hours to observe average specific growth rate and % growth inhibition under the effect of the test item. EC50 calculated graphically through probit analysis was observed to be >200 mg/L. Thus based on this value, it can be concluded that the substance can be considered as non-toxic to aquatic organisms and thus cannot be classified as hazardous as per the CLP classification criteria.

 

Similarly in the second study from experimental study 2017, Aim of this study was to evaluate the nature of chemical test chemical when comes in contact with the test organism Desmodesmus subspicatus (previous name: Scenedesmus subspicatus). Test was conducted according to the OECD guideline 201. The solution 100 mg/l was prepared by dissolving white powder in OECD growth medium. Limit test at 100 mg/l was performed. 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. Effect on the growth of algae was determine after an exposure period of 72 hrs. Based on the growth rate inhibition of algae Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) due to the exposure of chemical N, N, N-triethylethanaminium bromide, only 2.6% inhibition were observed at 100 mg/l. As the less effect were observed i.e only 2.6% inhibition were obtain at 100 mg/l, so on that basis chemical was consider as nontoxic and can be consider to be not classified as per the CLP classification criteria.

 

 

Similarly Short term toxicity to Pseudokirchneriella subcapitata (green algae) study was carried out for 48 hrs. The study was performed according to OECD Guideline 201 and ISO 8692 method. The study was based on the effects of the test compound on Pseudokirchneriella subcapitata (green algae) in a static fresh water system. The stock solutions were prepared with the growth media. All stock solutions were adjusted to the pH of the control media before use. The mini-scale algal growth inhibition tests were conducted with 4 ml of medium and 17 ml of CO2 -enriched headspace (1% CO2). The vials were closed with a Teflon covered membrane, and CO2 was added with a syringe. The diameter of the glass vial was 1.87 cm, which gave a glass surface area in contact with water of 11.3 cm2. The growth rates (exponential growth) of the cultures were used as the test parameter. Six control replicates were used together with 9 to 13 test concentrations with only one replicate to optimize the dose–response modelling and for cost-effectiveness. In combination with the CO2-enriched headspace, the resulting test pH was 7.0±0.2. The control growth rates were 1.7 to 1.9/d. The test vials were incubated and vigorously shaken on a microplate shaker (100 oscillations/min) in continuous white-fluorescent light (30W/33; Philips, Amsterdam, The Netherlands) with an intensity of 80µE/m2/s and a temperature of 20±1ᵒC. Cell density in the inoculation culture was counted on a particle counter (Coulter Counter Z2; Beckman Coulter, Hialeah, FL, USA). Algal biomasses were determined at the start, after 24 h, and at the end (48 h) from acetone pigment extractions. The growth rate in each vial was calculated directly from the log-transformed fluorescence measurements. EC50s and EC10s with 95% confidence limits using probit or Weibull models are calculated by nonlinear regression on the whole dataset using a dose–response regression program with variance weighting and proper inverse estimation. Based on effect on growth rate of the test organism Pseudokirchneriella subcapitata(green algae), the 48 hr EC50, EC10 value (by probit model) was determined to be 345 and 164 mg/l, respectively and on the basis effect on growth rate, the 48 hr EC50, EC10 value (by Weibull model), was determined to be 357 and 138 mg/l, respectively. Thus, based on the EC50 value, it can be concluded that the substance can be considered as non-toxic to aquatic organisms and thus cannot be classified as hazardous as per the CLP classification criteria.

Based on the overall studies chemical was consider as nontoxic and not classified as per the CLP classification criteria.

Toxicity to microorganisms:

Toxicity of test chemical on the growth and cell proliferation of aquatic microorganisms is predicted on the basis of it structurally and functionally similar read across chemicals. The studies are as mentioned below:

In the first study, toxicity to V. fischeri was measured as inhibition of bioluminescence using Microtoxs M500 Rapid Toxicity Testing System equipment and consumables.The assay was carried out in accordance with the 90% basic test for pure compounds protocol, as described in the Microtox user’s manual. The EC50 values of the tested chemical for V. fischeri range from 1.3 to 284 mg L1. The differences tested by ANOVA are highly significant (P o 0.001). In experiment the 50% effect concentrations (EC50) of the test chemical to Vibrio fischeri in a 15 min inhibition of bioluminescence test was observed to be 284 mg/l with 95% confidence limit (241–336).

Similarly in 2nd study was conducted to determine the effect of test chemical on the growth of Pseudomonas putida. Study conducted for 17 hrs. Based on the cell proliferation inhibition of aquatic Pseudomonas putida (Bacteria) by the chemical exposure for 17 hrs, the EC50 was determine at 95 mg/l. Thus based on the observed effect chemicla was not consider as toxic.Thus based on the overall studies for the test material, it was concluded that chemical was nontoxic as value ranges from 95 -284 mg/l.

Toxicity to microorganisms: