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Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short-term toxicity to fish

This study was designed to assess the effect of test chemical on the mortality of Danio rerio. The study was conducted in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test) in a static sysytem. Preparation of the test solutions/dispersions :The test solution was prepared by dissolving 400 mg of the test substance in 4 liters deionized water with continuous stirring. Observations (mortality, visible symptoms, pH, Temperature, dissolved oxygen content) were recorded after 24 hours, 48 hours, 72 hours and 96 hours of the start of the experiment. Based on nominal concentration, the median lethal concentration LC-50 (96 h) for test chemical on Danio rerio was determine to be >100 mg/L according to probit analysis. The fishes were found to be freely swimming in the bowl aquaria without showing any abnormal symptoms. No mortalities were observed at the test concentration of 100 mg/l. It can be concluded from the value that the test chemical is no toxic to the aquatic environment can be considered to be “not classified” as per the CLP classification criteria.

Long-term toxicity to fish

Based on the prediction done using theEPI Suite ECOSAR version 1.11, the long term toxicity on fish was predicted for test chemical. On the basis of effects observed in a static freshwater system, the effect concentration NOEC value for the substance is estimated to be 6.867 mg/l for species for 28 days duration. Based on this value, and the test chemical is readily biodegradable it can be concluded that the test substance can be considered as non-toxic  to fish at environmentally relevant concentrations and can be considered as "not classified"  as per the CLP classification criteria.

Short-term toxicity to aquatic invertebrates

Daphnia sp., Acute Immobilization Test according to OECD Guideline 203 was conducted for test chemical . The test substance was soluble in water. Therefore, the stock solution was prepared by dissolving 100 mg of the test substance in 100 ml of ADaM’s media and from this stock, further test solution was prepared for achieving test concentrations of 100 mg/L, respectively. ADaM’s media is used, prepared in MiliQ water and test Daphnia magna were exposed to these concentration for 48 hours. Test conducted under the semi-static system in which 25 ml of glass beaker filled with 20 ml media having headspace of 5 ml were used. The median effect concentration (EC50) for test chemical on Daphnia magna in a 48 hours study on the basis of immobilization effect was determine to be > 100 mg/l. Test consider to be valid as fullfills all the criteria as per standards. Firstly In the control, including the control containing the solubilising agent, not more that 10 percent of the daphnids should have been immobilized. Secondly the dissolved oxygen concentration at the end of the test should be 3 mg/l in control and test vesselsBased on the EC50, it can be consider that the chemical was nontoxic and can be consider to be not classified as per the CLP classification criteria.

 

Long-term toxicity to aquatic invertebrates

Based on the prediction done using the EPI Suite ECOSAR version 1.11, the long term toxicity on daphnia was predicted for test chemical. On the basis of effects observed in a static freshwater system, the effect concentration NOEC value for the substance is estimated to be 4.126 mg/l for Species for 21 days duration. Based on this value, and the test chemical is readily biodegradable it can be concluded that the test substance can be considered as non-toxic  to daphnia magna at environmentally relevant concentrations and can be considered as "not classified"  as per the CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria

Experimental study performed for the target chemical suggests thatThis study was designed to assess the effect of the test substance on the growth of green algaChlorella vulgaris. The study was conducted in accordance with “OECD guideline for testing of chemicals No. 201 – Alga growth inhibition test”.

The effect of test substance was studied on the growth of fresh water green algaChlorella 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 and 200 mg/l were prepared using stock solution of the test substance using de-ionized water. 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 test substance. EC50 calculated from probit analysis was observed to be 48.29 mg/L and EC50 graphically was observed to be 63.10 mg/L. As the test chemical is readily biodegradable, it cannot be classfied as per CLP classification category

Toxicity to microorganisms

1. The minimum inhibition concentration (MIC) of test chemical on Staphylococcus aureus was observed to be 200mg/l.

2. Test chemical when evaluated for toxicity to microorganisms on  Activated sludge for 3 hrs the EC50 value was observed to be > 1000 mg/l.

Thus based on the above effects chemical toxicity value ranges from 200 to > 1000 mg/l.

Additional information

Short-term toxicity to fish

Following studies of target chemical includes experimental data to conclude the toxicity extent of test chemical towards fish is summarized as follows:

This study was designed to assess the effect of test chemcial on the mortality of Danio rerio. The study was conducted in accordance with OECD Guideline 203 (Fish, Acute Toxicity Test) in a static sysytem.

Preparation of the test solutions/dispersions :The test solution was prepared by dissolving 400 mg of the test substance in 4 liters deionized water with continuous stirring.

Observations (mortality, visible symptoms, pH, Temperature, dissolved oxygen content) were recorded after 24 hours, 48 hours, 72 hours and 96 hours of the start of the experiment.

Based on nominal concentration, the median lethal concentration LC-50 (96 h) for test chemical on Danio rerio was found to be >100 mg/L according to probit analysis. The fishes were found to be freely swimming in the bowl aquaria without showing any abnormal symptoms. No mortalities were observed at the test concentration of 100 mg/l.

The above study is supported by another experimental study from the handbook Acute Tox. of Organic Chemicals to Fathead Minnows (Pimephales promelas) 1985, suggests that the Acute Toxic studies of the test chemical was studied on the fresh water fish Pimephales promelas. The test was performed for the period of 96 hrs, based on the mortality of the fishes, the median lethal concentration was determined. Stocks were prepared in 18.9 L stainless steel carbonation vessels, by mixing test substance in the Lake Superior water. The median lethal concentration of test chemical (LC50) was determined to be 1370 mg/L. Most of the effected fishes at concnentration greater than 1370 have lost their schooling behaviour and were swimming at the surface.

Further it is supported by similar experimental study from the handbook Acute Tox. of Organic Chemicals to Fathead Minnows(Pimephales promelas) 1985. Test chemical was evaluated for the determination of median lethal concentration (LC50) using fish as a animal model, for the tenure of 96 h. Test chemical was exposed to the nominal concentrations, ranging from 0 to 3080 with the geometric mean of 1.53. The experiment was conducted in the flow through condition.

The basis for the determination of the LC50 concentration was mortality. Most of the fishes lost their schooling behaviour, equilibrium and were hyperactive prior to their death. The median lethal concentration of the fish was determined as 2160 mg/L.

Thus based on the effect concentrations which is in the range 100 mg/L to 2160 mg/lgive the conclusion that test substance is likely to be not toxic to aquatic environment at environmentally relevant concentrations and applying weight of evidence approach it can be considered to be “not classified” as per the CLP classification criteria.

Long-term toxicity to fish

Based on the prediction done using theEPI Suite ECOSAR version 1.11, the short term toxicity of test chemical on green algae was predicted. On the basis of effects observed in a static freshwater system, the effect concentration NOEC value for the substance is estimated to be 6.867 mg/l for fish species for 28 days duration. Based on this value, and the test chemical is readily biodegradable it can be concluded that the test substance can be considered as non-toxic  to fish at environmentally relevant concentrations and can be considered as "not classified"  as per the CLP classification criteria.

Short-term toxicity to aquatic invertebrates

Following experimental studies for the test chemical was summarized to conclude the toxicity extent of test chemical towards aquatic invertebrate is as follows:

In the first experimental key study daphnia sp., Acute Immobilization Test according to OECD Guideline 203 was conducted for test chemical. The test substance was soluble in water. Therefore, the stock solution was prepared by dissolving 100 mg of the test substance in 100 ml of ADaM’s media and from this stock, further test solution was prepared for achieving test concentrations of 100 mg/L, respectively. ADaM’s media is used, prepared in MiliQ water and test Daphnia magna were exposed to these concentration for 48 hours. Test conducted under the semi-static system in which 25 ml of glass beaker filled with 20 ml media having headspace of 5 ml were used. The median effect concentration (EC50) for test chemical on Daphnia magna in a 48 hours study on the basis of immobilization effect was determine to be > 100 mg/l.

First study was supported by the second from peer reviewed journal.Short term toxicty test was carried out according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) with Daphnia magna as a test organisms. The effective concentration (EC10) value of test chemical in Daphnia magna in a 24 hr study on mortality effect was found to be 304 mg/L.

Similar study from the other peer reviewed journal also suggests that To study the effects of test chemical on aquatic invertebrate short term toxicity test was carried out for 48 hr with Daphnia magnaas a test organisms. Lethal Threshold Concentration value of test substance in Daphnia magna in a 48 hr study on intoxication effect was found to be 1450 mg/L.

Thus based on the overall studies chemical concluded to be nontoxic and not classified as per the CLP classification criteria.

 

Long-term toxicity to aquatic invertebrates

Based on the prediction done using theEPI Suite ECOSAR version 1.11, the long term toxicity of test chemical on daphnia e was predicted. On the basis of effects observed in a static freshwater system, the effect concentration NOEC value for the substance is estimated to be 4.126 mg/l for daphnia magna for 21 days duration. Based on this value, and the test chemical is readily biodegradable it can be concluded that the test substance can be considered as non-toxic  to daphnia magna at environmentally relevant concentrations and can be considered as "not classified"  as per the CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria

Experimental study performed by the UERL Lab 2014 for the target chemical suggests that this study was designed to assess the effect of the test substance on the growth of green alga Chlorella vulgaris. The study was conducted in accordance with “OECD guideline for testing of chemicals No. 201 – Alga growth inhibition test”.

The effect of test substance 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 and 200 mg/l were prepared using stock solution of the test substance using de-ionized water. The green alga was expoed to the test concentration for a period of 72 hours to observe average specific growth rate and % growth inhibition under the effect of test substance. EC50 calculated from probit analysis was observed to be 48.29 mg/L and EC50 graphically was observed to be 63.10 mg/L.

Toxicity to microorganisms

In different studies, the given test chemical and structually and functionally similar read across chemicals has been investigated for toxicity to microorganisms to a greater or lesser extent. The studies are summarized as below –

 

In the first key studyevaluation of toxicity of test chemical on Staphylococcus aureus toxicity to micro-organisms test was carried for 24 h under static condition.An overnight culture of each organism S. aureus was prepared. The 0.1 ml of organism was taken into 9.9 ml of sterile distilled water (SDW) to give 10 ml of 1:100 (10 ) dilution. The stock was maintained on nutrient agar slant and sub-cultured in nutrient broth for incubation at 37 °C prior to each antimicrobial testing. Inoculation of the test organisms on nutrient agar-prepared plates was achieved by flaming a wire loop on a spirit lamp, cooling the wire loop (air cooling) and fetching the test organisms.The discs were prepared using a Grade No. 1 Whatman filter paper. One hundred discs were obtained by punching and putting in vial bottles and sterilizing in an oven at 150 °C for 15 min. Thereafter the cups (9 mm diameter) were aseptically bored into the solid nutrient agar using a sterile cork-borer. The test solution of Methyl salicylate was introduced .The plates were left at room temperature for 2 h, allowed to diffuse into the medium, turned upside-down and thereafter incubated at 37 °C for 24 h in an incubator. The minimum inhibition concentration (MIC) of test chemical on Staphylococcus aureus was observed to be 200mg/l.

First study was supported by the second study from peer reviewed journal. To evaluate antibacterial activity of  test chemical on Activated sludge toxicity to micro-organisms test was carried out according to the OECD Guideline 209 (Activated Sludge, Respiration Inhibition Test. The test was carried for 3 h under static condition. Test chemicalwas used as a test material to evaluate toxicity to microorganisms as per OECD guideline 209. Activated sludge was used as the test culture at pH 7.5 for 3 h The EC50 value on the basis of respiration inhibition test was observed to be >1000 mg/l.

Thus based on the above effects chemical toxicity value ranges from 200 to > 1000 mg/l.