Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short term toxicity to invertebrates:

By applying weight of evidence approach the EC50 value of test chemical was determined to be in range from 410 mg/L to >940 mg/l after exposure of test chemical for 48 hrs. The range EC50 value indicates that the substance is likely to be nonhazardous to aquatic invertebrates and cannot be classified as per the CLP classification criteria.

Toxicity to aquatic algae:

By applying weight of evidence approach the EC 50 value if test chemical is expected to be in range from 500 to 1000 mg/L after exposure of test chemical for 24-96 hrs. The EC50 value indicates that the substance is likely to be nonhazardous to aquatic algae and cannot be classified as per the CLP classification criteria

Additional information

Summarized result for the determination of nature of chemical on the mobility, growth and other biological and physical activity of aquatic invertebrates, algae and cyanobacteria when chemical comes in contact with test organisms, by considering the data for closely related read across chemicals from various sources which are as follows:  

Short term toxicity to invertebrates:

Based on the experimental data for the target as well as read-across analogues which is extracted by using mechanistic approach and functionally and structurally similar to the target chemical, toxicity of test chemical were determine by observing the effect of chemical on the immobility of daphnia magna. The studies are summarized as below: 

 

Aim of this study was to determine the toxicity of test chemical on the mobility of aquatic invertebrate Cypris subglobosa. A stock solution from each metal salt was prepared in double glass-distilled water. Serial dilutions were prepared from the respective stocks to the desired range. 0.2 ml of acetone were used as a vehicle. Living specimens were taken to the laboratory and placed in 5 liter glass beaker filled with filtered well water. Test animals were acclimatized to laboratory conditions in environmental growth chamber at 21±1 °C for 2 to 3 days. Growth chamber was equipped with two 60W cool white fluorescent lights. Tests were carried under light and dark cycle of 12:12 h. 20 ml glass Petri- plate dishes were used in which 10 test organism added in each concentrations. Immobility implies the organism usually swim helplessly at the bottom of the container and use their limbs to crawl with difficulty. The 24 h and 48 h EC50 [effective concentration at which 50% immobilized response was recorded] values and their 95% confidence limits were calculated by the moving average-angle method. Based on the immobility of Cypris subglobosa by the test chemical exposure for 48 hrs, (EC50) was observed at 634 mg/l. Based on the EC50 value, chemical was consider to be nontoxic and not classified as per the CLP classification criteria.

 

Above study further supported by the second study from authoritative database. Principle of this study was to determine the effect of test chemical on aquatic invertebrate. The test chemical exposed with invertebrate for 48 hours. Based on the effects observation on the Crustaceans by the chemical exposure 48 hours, the LC50 was observed to be 410 mg/l. Thus based on the LC50 value, chemical was consider as nontoxic and can be consider to be not classified as per the CLP classification criteria.

 

 Similar study was conducted to investigate the effect of test chemical on the growth of Daphnia magna. Study conducted according to the ISO 6341 15 "Water quality – Determination of the inhibition of the mobility of Daphnia magna Straus (Cladocera, Crustacea)". Test chemical exposed with the Daphnia magna for 48 hrs. After the exposure of test chemical with the Daphnia magna for 48 hrs, no effect (EC0) was observed on the mobility at the concentration 940 mg/l. Thus on the basis of above result, it can be concluded that the chemical was nontoxic and not classified as per the CLP classification criteria.

 

Thus based on the overall studies from various sources, it is concluded that the test chemical is nontoxic and not classified as per the CLP classification criteria.

 

Toxicity to aquatic algae:

Summarized studies of the test chemical and closest similar read across chemical on the growth and other biological activity of aquatic algae were studied. The studies are as mentioned below:

 

Aim of this study was to investigate the effect of test chemical on the growth of aquatic algae. Test conducted under the static system continued for 24 hrs. Based on the effects observations on assimilation efficiency of Chlorococcales (Green Algae Order) after the exposure of test chemical for 24 hrs, the EC50 was determine to be 1000 mg/l. Thus on the basis of EC50 value, chemical was consider to be nontoxic and can be consider to be not classified as per the CLP classification criteria.

 

Similar study was also performed to determine the toxicity of test chemical. Principle of this study was to investigate the effect of test chemical on the growth of aquatic algae and cyanobacteria. Test conducted under the static system for 96 hrs of exposure with chemical. Based on the reduction in Chlorophyll A concentration of Skeletonema costatum (Diatom) by the chemical exposure for 96 hrs, the EC50 was determine to be 500 mg/l. Thus based on the EC50 value, chemical was consider to be nontoxic and can be consider to be not classified as per the CLP classification criteria.

 

Thus based on the overall studies for the test chemical from various sources, it is concluded that the test chemical was nontoxic and not classified as per the CLP classification criteria.

 

Thus based on the toxicity results on both invertebrates and algae, chemical was concluded to be not classified and nontoxic as per the CLP classification criteria