Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short term toxicity to aquatic invertebrates:

The EC 50 value of test chemical is expected to be range from 200 -224 mg/l. By considering this range EC 50 value test chemical is considered to be non toxic and not classified as per the CLP classification criteria. 

Toxicity to aquatic algae and cyanobacteria:

After exposure of test chemical to aquatic algaefor 72 hrs the  EC 50 value of test chemical is expected to be in range from  172.9 to 250 mg/l. By considering this range EC 50 value test chemical is considered to be non toxic and not classified as per the CLP classification criteria.  

Additional information

Short term toxicity to aquatic invertebrates:

Short term toxicity of test chemical on the growth of aquatic invertebrates was determined on the basis of data of structurally and functionally similar read across chemicals. The studies are as mentioned below:

 

The first study was reviewed from authoritative database in this the effect of test chemical on Daphnia magna was determined for the exposure period of 48 hrs. Test conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). Test solutions were prepared by mixing a stock solution of the test substance, which was prepared by mixing and stirring the test substance and water.Test performed at different concentrations 350, 230, 160, 104, 69 mg/L (geometric ratio 1.5), control. Test vessel filled with 400 mL/ concentration (100 mL/vessel) contain 20 daphnia per concentration (5 / vessel). Experiment repeated 4 times with the same condition. Analytical monitoring was done using the GC was the Frequency of analysis was at the start of exposure and the end of exposure

Based on the immobility of test organism daphnia magna due to the exposure of test chemical for 48 hrs, the median effect concentration was determined to be 200 mg/l. Thus on the basis of EC50, chemical was consider as nontoxic and not classified as toxic as per the CLP classification criteria

Another study was also reviewed from the authoritative database in this the experiment was conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). Test performed at different concentrations of test chemical, 41, 75, 134, 241, 435, 782 mg/L (geometric ratio 1.8) and control. In this study the test solution volume used was 100 mL and the number of organisms per vessel was 20 per concentration (5 per vessel) and number of vessels per concentration (replicates) was four.

Based on the immobility of test organism daphnia magna due to the exposure of test chemical for 48 hrs, the effect concentration (EC 50 ) value, EC100 value and NOEC value was determined to be 224 mg/L, 435 mg/L 134 mg/L respectively. Thus on the basis of EC50, chemical was consider as nontoxic and not classified as toxic as per the CLP classification criteria.

 

Thus based on the results of both the studies for test chemical, it can be concluded that  EC 50 value of test chemical is expected to be in range from 200 -224 mg/l. By considering this range EC 50 value test chemical is considered to be non toxic and not classified as per the CLP classification criteria. 

Toxicity to aquatic algae and cyanobacteria:

Short term toxicity of test chemical on the growth of aquatic algae was carried out on the basis of it structurally and functionally similar read across chemicals. The results of both the studies are as mentioned below:

 

Freshwater algal growth inhibition test was carried out according to OECD Guideline 201. The test organism used in this study was on Desmodesmus subspicatus .The stock solution (150 mg/L) of test chemical was prepared by dissolving test chemical in OECD growth medium. The solution was kept in ultrasonic bath for 20 min. Test solutions of required concentration were prepared by mixing the stock solution of the test sample with OECD growth medium and inoculum culture and tested at the concentrations 0, 30, 45, 67, 100 and 150 mg/L. Effects on the growth rate of the organism were studied. The median effective concentration (EC50) for the test chemical, in Desmodesmus subspicatus was determined to be 172.9 mg/L. This value indicates that the substance is likely to be non-hazardous to aquatic algae and can be considered as not classified as per the CLP criteria.

 

 In another study the Growth Inhibition of Alga (Pseudokirchneriella subcapitata) was determined by the exposing the test chemical for 72 hrs. Test conducted according to OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test). Test solutions were prepared by mixing a stock solution of the test substance, which was prepared by adding and stirring the substance under the water surface of the Erlenmeyer flask filled with medium. Test was conducted at the different concentrations 500, 160, 50, 16, 5.0 mg/L (geometric ratio; square root of 10), control. Analytical monitoring was also done using the GC were the Frequency of analysis was at the start of exposure, after 4 hours from start of exposure, and at the end of exposure. Based on the growth rate inhibition of test organism Pseudokirchneriella subcapitata due to exposure of test chemical for 72 hrs, the effect concentration EC50 and NOEC value was determined to be 250 mg/l and 16 mg/l respectively. Thus on the basis of EC50, test chemical was consider as nontoxic and not classified as toxic as per the CLP classification criteria.

 

Thus based on the results of both the studies for test chemical, it can be concluded that EC 50 value of test chemical is expected to be value range from 172.9 to 250 mg/l. By considering this range EC 50 value test chemical is considered to be nontoxic and not classified as per the CLP classification criteria.