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Description of key information

Short-term toxicity to fish:

Based on nominal concentrations, experimental median lethal Concentrations [LC-50 (96 h)] for test material. on Zebra Fish Danio rerio was determine to be > 50 mg/L<100 mg/l.  

Long- term toxicity to fish:

Based on the predicted data by ECOSAR v1.1 model of EPI suite the long term fish toxicity NOEC was predicted to be 6.496mg /l.

Short-term toxicity to aquatic invertebrates:

Study was conducted to determine effect of test chemical on aquatic invertebrates. Based on effect of test chemical on mobility of the test organism , the 48 h EC0 was determined to be 125 mg/l and EC50 value ranges from 230- 287.17 mg/l while EC100 determined to be 500 mg/l.

Long-term toxicity to aquatic invertebrates:

Based on the predicted data by ECOSAR v1.1 model of EPI suite the long term aquatic invertebrates toxicity NOEC value was predicted to be 3.923mg /l.

Toxicity to aquatic algae and cyanobacteria:

Study was conducted to determine effect of test chemical on Scenedesmus subspicatus. For the test chemical, based on effect on growth rate of the test organism green algae, the 72 hr EC10, EC50 and EC90 was determined to be 300,490 and 790 mgIL respectively and 96 h EC50 was 162 mg/l.

Toxicity to microorganism:

Study was carried out to determine the toxic effect of test chemical on Pseudomonas putida . Based on the effect of test chemical on growth of the test organism, the 17 h EC10, EC50 and EC90 value was determined to be 840, 1320 and  2300 mg/l respectively and 48 h IC50 determined to be 853.47 mg/L.

Additional information

Short-term toxicity to fish:

Following different studies includes experimental study for the target chemical and read-across analogues which is extracted by using mechanistic approach and functionally and structurally similar to the target chemical to observe the short- term toxicity of test chemical to fish.

First 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 soluble in water. Therefore, the test solution was prepared by dissolving 25 µl, 50 µl, 100 µl , 200 µl, 400 µl, 800µl and 1600 µl of the test substance in 4 liters of potable water (passed through reverse osmosis system) with continuous stirring for achievingof the test substance in 4 liters of potable water (passed through reverse osmosis system) with continuous stirring for achieving test concentrations of 6.25 mg/L, 12.5 mg/L, 25 mg/L, 50 mg/L, 100 mg/L & 400 mg/L, respectively. Zebra FishDanio reriowere 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 > 50 mg/L<100 mg/l . Based on the LC50, it can be consider that the chemical was and can be consider to be classified as aquatic chronic 3 as per the CLP classification criteria.

The above eperimental data was further supported by data summaried in authoritative database further explaining the toxicity of structurally similar read across substance

, Short term fish toxicity was conducted for 96 hrs for assessing the effect of test chemical. Study was performed using Menidia beryllina, saltwater fish of 40-100 mm in length. Test was conducted in static system for 96 h at 20°C and 7.6-7.9 pH. Test organisms were collected from Bayer AG Leverkusen. Test organisms became 14 d adapted to laboratory conditions.

Based on effect of test chemical on mortality of the test organism Menidia beryllina,the 96 hr LC50 was determined to be 15 mg/l.

On the basis of above determined LC50 value the test chemical was considered to be classified as category chronic-3 as per the CLP criteria and therefore toxic to fish.

In last study, short term fish toxicity was conducted for 96 hrs for assessing the effect of test chemical according to determination of the effect of water constituents Fish, DIN 38 412. Study was performed using Leuciscus idus , fresh-water fish in a static system. Test organisms were collected from BASF AG Ludwigshafen. Based on the effect , the 96 hr NOEC. LC0, LC50 and LC100  values was determined to be 22, 46, 46-100 and 100 mg/l respectively. On the basis of above determined LC50 value the test chemical was considered to be classified as category chronic -3 as per the CLP criteria and therefore considered to be toxic.

On the basis of above observations, test chemical was considered to be classified as category chronic -3 as per the CLP criteria and therefore considered to be toxic.

Long-term toxicity to fish:

Following different studies includes predicted study for the target chemical and experimental study for read-across analogues which is extracted by using mechanistic approach and functionally and structurally similar to the target chemical to observe the long term effect of test chemical on test organism..

Prediction of long term toxicity to test cemical to fish was done by ECOSAR v1.1model of EPI suite. NOEC value was estimated to be 6.496 mg/l.

Data from read across substance was used to further support the above data,l

ong term fish toxicity was conducted for 28days for assessing the effect of test chemical on growth of tes organism. Study was performed using Oryzias latipes. Test was conducted in flow-through system for 28 days at 25°C , 7.88 pH. Based on long term effect on mortality of the test organism Oryzias latipes, the 28 days LOEC value was determined to be 1.92 mg/l.

In last study, Long term fish toxicity was conducted for 21 days for assessing the effect of test chemical on test organism. Based on long term effect of test chemical on mortality of the test organism , the 14d LC50 value was determined to be 3.2 mg/l and 21d LC50 and NOEC determined to be 2.2 and 0.48 mg/l respectively.

Short-term toxicity to aquatic invertebrates:

Data available for the structurally and functionally similar read across substance has been reviewed to determine the short term toxicity of aquatic invertebrate .The studies are as mentioned below:

In first study, short term toxicity to aquatic Invertebrate was conducted for 48hrs for assessing the effect of test chemicalon test organism. Thus, effect of test chemical on mobility of the test organism Daphnia magna,the 48 hr EC50 value was determined to be 230 mg/l .Based on the above value, chemical can be considered as non-toxic to aquatic invertebrates and can be considered to be ‘’not classified’’ as per CLP classification criteria.

In last study, short term toxicity to aquatic Invertebrate was conducted for 48hrs for assessing the effect of test chemicalon test organism. Daphnia magna was used as a test organism for the study. Thus, effect of test chemical on mobility of the test organism, the  48 hr  EC0, EC50 and EC100 value was determined to be 125, 287.17 and 500 mg/l respectively..Based on the above value, chemical can be considered as non-toxic to aquatic invertebrates and can be considered to be ‘’not classified’’ as per CLP classification criteria.

On the basis of above value, chemical can be considered as non-toxic to aquatic invertebrates and can be considered to be ‘’not classified’’ as per CLP classification criteria.

Long-term toxicity to aquatic invertebrates:

Prediction of long term toxicity to test cemical to aquatic invertebrates was done by ECOSAR v1.1 model of EPI suite. NOEC value was estimated to be 3.923 mg/l.

Toxicity to aquatic algae and cyanobacteria:

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

In first study,toxicity to green algae was carried out according to Scenedesmus cell proliferation inhibition test, DIN 38412 part 9, Determination of the inhibitory effect of water constituents green algae

out for assessing the effect of the test chemical. The study was conducted for 72 hrs on test organism Scenedesmus subspicatus. Thus, based on effect on growth rate of the test organism green algae, the 72 hr EC10, EC50 and EC90 was determined to be 300,490 and 790 mgIL respectively and therefore chemical can be considered as non-toxic to aquatic algae and can be considered to be ‘’not classified’’ as per CLP classification criteria.

In last study, toxicity to green algae was carried out for assessing the effect of the test chemical. The study was conducted for 96hrs. On the basis of growth rate, the median effect concentration (EC50) was determined to be 162 mg/l. Thus, based on the growth rate effect with EC50 value , chemical can be considered as non-toxic to aquatic algae and can be considered to be ‘’not classified’’ as per CLP classification criteria.

Based on the EC50 values , it can be concluded that the chemical was not toxic and can be consider to be not classified 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 the test chemical to micro-organism .The studies are as mentioned below:

Toxicity to micro-organism study was carried out for 17 h to determine the effect of test chemical on micro-organism. Pseudomonas putida was used as test organism. Based on the effect of test chemical on growth of the test organism, the EC10, EC50 and EC90 value was determined to be 840, 1320 and 2300 mg/l respectively.

Toxicity to micro-organism study was carried out for 48 h to determine the effect of test chemical on micro-organism. Tetrahymena pyriformis was used as test organism. Based on the effect of test chemical on growth rate of the test organism, the IC50 value was determined to be 853.47 mg/L.

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