Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short term toxicity to aquatic invertebrate:

Various short term studies available for the test chemical were reviewed to determine the toxic nature of test chemical on the growth and mobility of aquatic invertebrates. The studies are as mentioned below:

An acute immobilisation test was used to test how a range of concentrations of test chemical exerts different degrees of toxic effects on the swimming capability of Daphnia magna under otherwise identical test conditions. The test was performed in close resemblance to OECD guideline 202. The testing aim was to determine a EC50 after 48 hours of exposure to D. magna. Daphnids were exposed to test chemical in 50 ml beakers in a volume of 25 ml of liquid solution containing both the chemical and media as specified in OECD 202. The beakers were placed in a temperature controlled room at 20±1 degrees Celsius. The D. magna (age ≤24) used for the test had been breed at lab. The animals were exposed to medium (i.e. a beaker containing only medium) and the tested chemical during 48 hours (±1 hour). None of the exposed animal’s immobilization were affected by exposure to only medium. The nominal concentrations used were: 100 mg/L (limit test). There were 5 Daphnia per test vessels and 5 replicates per concentration. The pH in test vessels were 7.7-7.8 mg/L. The positive control/reference substance used in the tested showed an expected result and gave an EC50 that corresponded to previous exposures with this chemical in D. magna. The IC50 was defined as a concentration that immobilizes 50% of the exposed D. magna. Eight percent immobilization in D. magna was observed after 48 hours of exposure to 100 mg/L of test chemical. The IC8 was therefore estimated to be 100 mg/L. Based on the IC8, it can be concluded that the chemical was nontoxic and can be consider to be "not classified" as per CLP classification criteria.

First study was supported by the second one. Determination of the inhibition of the mobility of daphnids was carried out with the chemical according to OECD Guideline 202. The limit test was performed at 100 mg/l. Effects on immobilisation were observed for 48 hours. The effective concentration (EC8) for the test chemical,, in Daphnia magna was determined to be 100 mg/L on the basis of mobility inhibition effects in a 48 hour study. This value indicates that the substance is likely to be non-hazardous to aquatic invertebrates and cannot be classified as toxic as per the CLP criteria.

Similarly determination of the inhibition of the mobility of daphnids was carried out with the test chemical according to OECD Guideline 202. A limit test at sample concentration of 100 mg/L was performed. Effects on immobilisation were observed for 48 hours. At 100 mg/l only 8% inhibition was observed, thus it can be concluded that the EC50 was >100 mg/l. The median effective concentration (EC50) for the test chemical, in Daphnia magna was determined to be >100 mg/L for immobilisation effects. Based on this EC50 value and after comparing with CLP criteria for aquatic classification of the substance it is concluded that the test chemical does not exhibit short term toxicity to aquatic invertebrate (Daphnia Magna).

Thus based on the above 3 studies, chemical consider to be non toxic to the aquatic invertebrates and not classified as per the CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria:

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

1)Freshwater algal growth inhibition test was carried out on Desmodesmus subspicatus with the substance according to OECD Guideline 201. The stock solution (200 mg/L) was prepared by dissolving brown powder in  OECD growth medium. 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, 12.5, 25, 50, 100, 200 mg/L. Effects on the growth rate of the organism were studied.

The median effective concentration (ErC50) for the test substance, in Desmodesmus subspicatus was determined to be 356.2 mg/L. This value indicates that the substance is likely to be non-hazardous to aquatic algae and can not be classified as toxic as per the CLP criteria.

2) Freshwater algal growth inhibition test was carried out on Desmodesmus subspicatus with the substance according to OECD Guideline 201. The test substance was dissolved in OECD growth medium and tested at the concentrations 0, 2.6, 5.6, 12.0, 27.0, 59.0 and 130 mg/L. Effects on the growth rate of the organism were studied. The median effective concentration (ErC50) for the test substance, Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo] naphthalene - sulphonate, in Desmodesmus subspicatus was determined to be 265.1 mg/L. Based on this ErC50 value and after comparing with CLP criteria for aquatic classification of the substance it is concluded that the test substance does not exhibit toxicity to aquatic algae (Desmodesmus subspicatus).

Thus, based on the above summarised studies, test substance and it’s structurally and functionally similar read across substance, it can be concluded that effect concetration value is greater than 365 mg/L. Thus, comparing this value with the criteria of CLP regulation,test material cannot be classified for toxicity of aquatic aquatic algae and cyanobacteria .Hence,based on the data available for the structurally and functionally similar read across, test chemical is not likely to be toxic atleast in the concentration range of 256 -365 mg/L .

Additional information

Short term toxicity to aquatic invertebrate:

Various short term studies available for the test chemical were reviewed to determine the toxic nature of test chemical on the growth and mobility of aquatic invertebrates. The studies are as mentioned below:

An acute immobilisation test was used to test how a range of concentrations of test chemical exerts different degrees of toxic effects on the swimming capability of Daphnia magna under otherwise identical test conditions. The test was performed in close resemblance to OECD guideline 202. The testing aim was to determine a EC50 after 48 hours of exposure to D. magna. Daphnids were exposed to test chemical in 50 ml beakers in a volume of 25 ml of liquid solution containing both the chemical and media as specified in OECD 202. The beakers were placed in a temperature controlled room at 20±1 degrees Celsius. The D. magna (age ≤24) used for the test had been breed at lab. The animals were exposed to medium (i.e. a beaker containing only medium) and the tested chemical during 48 hours (±1 hour). None of the exposed animal’s immobilization were affected by exposure to only medium. The nominal concentrations used were: 100 mg/L (limit test). There were 5 Daphnia per test vessels and 5 replicates per concentration. The pH in test vessels were 7.7-7.8 mg/L. The positive control/reference substance used in the tested showed an expected result and gave an EC50 that corresponded to previous exposures with this chemical in D. magna. The IC50 was defined as a concentration that immobilizes 50% of the exposed D. magna. Eight percent immobilization in D. magna was observed after 48 hours of exposure to 100 mg/L of test chemical. The IC8 was therefore estimated to be 100 mg/L. Based on the IC8, it can be concluded that the chemical was nontoxic and can be consider to be "not classified" as per CLP classification criteria.

First study was supported by the second one. Determination of the inhibition of the mobility of daphnids was carried out with the chemical according to OECD Guideline 202. The limit test was performed at 100 mg/l. Effects on immobilisation were observed for 48 hours. The effective concentration (EC8) for the test chemical,, in Daphnia magna was determined to be 100 mg/L on the basis of mobility inhibition effects in a 48 hour study. This value indicates that the substance is likely to be non-hazardous to aquatic invertebrates and cannot be classified as toxic as per the CLP criteria.

Similarly determination of the inhibition of the mobility of daphnids was carried out with the test chemical according to OECD Guideline 202. A limit test at sample concentration of 100 mg/L was performed. Effects on immobilisation were observed for 48 hours. At 100 mg/l only 8% inhibition was observed, thus it can be concluded that the EC50 was >100 mg/l. The median effective concentration (EC50) for the test chemical, in Daphnia magna was determined to be >100 mg/L for immobilisation effects. Based on this EC50 value and after comparing with CLP criteria for aquatic classification of the substance it is concluded that the test chemical does not exhibit short term toxicity to aquatic invertebrate (Daphnia Magna).

Thus based on the above 3 studies, chemical consider to be non toxic to the aquatic invertebrates and not classified as per the CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria:

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

1)Freshwater algal growth inhibition test was carried out on Desmodesmus subspicatus with the substance according to OECD Guideline 201. The stock solution (200 mg/L) was prepared by dissolving brown powder in  OECD growth medium. 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, 12.5, 25, 50, 100, 200 mg/L. Effects on the growth rate of the organism were studied.

The median effective concentration (ErC50) for the test substance, in Desmodesmus subspicatus was determined to be 356.2 mg/L. This value indicates that the substance is likely to be non-hazardous to aquatic algae and can not be classified as toxic as per the CLP criteria.

2) Freshwater algal growth inhibition test was carried out on Desmodesmus subspicatus with the substance according to OECD Guideline 201. The test substance was dissolved in OECD growth medium and tested at the concentrations 0, 2.6, 5.6, 12.0, 27.0, 59.0 and 130 mg/L. Effects on the growth rate of the organism were studied. The median effective concentration (ErC50) for the test substance, Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo] naphthalene - sulphonate, in Desmodesmus subspicatus was determined to be 265.1 mg/L. Based on this ErC50 value and after comparing with CLP criteria for aquatic classification of the substance it is concluded that the test substance does not exhibit toxicity to aquatic algae (Desmodesmus subspicatus).

Thus, based on the above summarised studies, test substance and it’s structurally and functionally similar read across substance, it can be concluded that effect concetration value is greater than 365 mg/L. Thus, comparing this value with the criteria of CLP regulation,test material cannot be classified for toxicity of aquatic aquatic algae and cyanobacteria .Hence,based on the data available for the structurally and functionally similar read across, test chemical is not likely to be toxic atleast in the concentration range of 256 -365 mg/L .