Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short term toxicity to fish:

Data available for the structurally similar read across chemicals has been reviewed to determine the short term toxicity of fish of the test chemical Sodium 4-{[4-(diethylamino)phenyl][4-(diethyliminio)-2,5-cyclohexadien-1-ylidene]methyl}-6-hydroxy-1,3-benzenedisulfonate (20262 -76 -4).The studies

are as mentioned below:

1.Study was conducted to access the effect of test chemical on the growth 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 1 gm of the test substance in 1 liter of potable water (passed through reverse osmosis system) with continuous stirring for achieving test concentrations of 6.25 mg/L, 12.5mg/L,25mg/L, 50mg/L, 100mg/L, respectively.

Bowl aquaria containing 2 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 was subjected to various nominal test concentrations, 6.25 mg/L, 12.5mg/L,25mg/L, 50mg/L, 100mg/L . LC50 was determine to be >100 mg/l . Based on the LC50, it can be consider that the chemical was non toxic and can be consider to be not classified as per the CLP classification criteria.

2.Study was conducted to access the effect of test chemical on the growth 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 400 mg of the test substance in 4liters of potable water (passed through reverse osmosis system) with 2 hrs continuous stirring for achieving test concentrations of 100mg/L ,respectively

Bowl aquaria containing 2 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 was subjected to various nominal test concentration 100mg/L . LC50 was determine to be >100 mg/l .

Based on the LC50, it can be consider that the chemical was non toxic and can be consider to be not classified as per the CLP classification criteria.

Short term toxicity to aquatic invertebrate:

Data available for the structurally similar read across chemicals has been reviewed to determine the short term toxicity of aquatic invertebrate of the test chemical Sodium 4-{[4-(diethylamino)phenyl][4-(diethyliminio)-2,5-cyclohexadien-1-ylidene]methyl}-6-hydroxy-1,3-benzenedisulfonate (20262 -76 -4).The studies are as mentioned below:

1.Aim of this study was to assess the short term toxicity of test material to aquatic invertebrates daphnia magna. Study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system for the total exposure period of 48 hrs.

 

The solution 200 mg/l was prepared by dissolving dark green powder in reconstituted water.200 mg/l nominal concentrations were used in the study. Effects on immobilisation were observed for 48 hours. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously.

The inhibition percentage for the test substance in Daphnia magna was determined to be 0.4% on the basis of mobility inhibition effects in a 48 hour study. Based on the inhibition percentage , indicates that the substance is likely to be non-hazardous to aquatic invertebrates and cannot be classified as aquatic as per the CLP criteria.

2.The effect concentration (EC50) value of test material in aquatic invertebrate [Brine shrimp] in a 48 hr study on the basis of mortality effect was found to be 792.86 mg/L. Based on this EC50 value, the substance does not qualify for the aquatic classification as per the  CLP criteria.

The test chemical Sodium 4-{[4-(diethylamino)phenyl][4-(diethyliminio)-2,5-cyclohexadien-1-ylidene]methyl}-6-hydroxy-1,3-benzenedisulfonate is not likely to be toxic to aquatic invertebrate  atleast in the concentration range of 200-798 mg/l. Hence, on the basis of above test concentration it can be considered that test material is non toxic to aquatic environment and can not be classified as per CLP classification.

Toxicity to aquatic algae and cyanobacteria:

Data available for the structurally similar read across chemicals has been reviewed to determine the toxicity of aquatic algae and cyanobacteria of the test chemical Sodium 4-{[4-(diethylamino)phenyl][4-(diethyliminio)-2,5-cyclohexadien-1-ylidene]methyl}-6-hydroxy-1,3-benzenedisulfonate (20262 -76 -4).The studies are as mentioned below:

1.The effect of test item 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 6.25mg/l, 12.5mg/l, 25mg/l, 50mg/l, 100mg/l and 200mg/l. The test concentrations were prepared using stock solution of the test item using mineral media. 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 the test item. EC30 calculated graphically through probit analysis was observed to be 213.816mg/l. The EC50 was greater than 200 mg/L.Thus, based on this value, it can be concluded that the test chemicalcan be considered as non-toxic to aquatic organismsand thus cannot be classified as hazardous as per the CLP criteria.

2.The effect of test item 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 6.25mg/L, 12.5mg/L, 25mg/L, 50 mg/L, 100mg/L and 200mg/L. The test concentrations were prepared using stock solution of the test item using mineral media. 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 the test item. EC50 calculated graphically through probit analysis was observed to be 125.46 mg/L.

On the basis of above effect concentration the test material was considered to be not toxic and can not be classified as per CLP classification.

Toxicity to microorganism:

Data available for the structurally similar read across chemicals has been reviewed to determine the toxicity of microorganism of the test chemical Sodium 4-{[4-(diethylamino)phenyl][4-(diethyliminio)-2,5-cyclohexadien-1-ylidene]methyl}-6-hydroxy-1,3-benzenedisulfonate (20262 -76 -4).The studies are as mentioned below:

1.The Median Lethal Time for 50 percent mortality (LT50) value of test material in microorganism (Paramaecium caudatum) in a 17.283 min. study on the basis of mortality effect was estimated to be 1000 mg/L. It can be concluded from the value that the test materialis not toxic to the aquatic enviornment.

2.Toxicity to micro-organisms was carried out for 14.68 to study the effects on micro-organisms. The Median Lethal Time value for 50 percent mortality (LT50) value of test material in microorganism (Paramaecium caudatum) in a 14.68 min. study on the basis of mortality effect was found to be 10000 mg/L. It can be concluded from the value that the test material is not toxic to the aquatic enviornment.

On the basis of above LT50 concentrations test material Sodium 4-{[4-(diethylamino)phenyl] [4-(diethyliminio)-2,5-cyclohexadien-1-ylidene]methyl}- 6-hydroxy-1,3-benzenedisulfonate (20262 -76 -4) is considered to be non toxic to microorganisms.

Additional information

Short term toxicity to fish:

Data available for the structurally similar read across chemicals has been reviewed to determine the short term toxicity of fish of the test chemical Sodium 4-{[4-(diethylamino)phenyl][4-(diethyliminio)-2,5-cyclohexadien-1-ylidene]methyl}-6-hydroxy-1,3-benzenedisulfonate (20262 -76 -4).The studies

are as mentioned below:

1.Study was conducted to access the effect of test chemical on the growth 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 1 gm of the test substance in 1 liter of potable water (passed through reverse osmosis system) with continuous stirring for achieving test concentrations of 6.25 mg/L, 12.5mg/L,25mg/L, 50mg/L, 100mg/L, respectively.

Bowl aquaria containing 2 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 was subjected to various nominal test concentrations, 6.25 mg/L, 12.5mg/L,25mg/L, 50mg/L, 100mg/L . LC50 was determine to be >100 mg/l . Based on the LC50, it can be consider that the chemical was non toxic and can be consider to be not classified as per the CLP classification criteria.

2.Study was conducted to access the effect of test chemical on the growth 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 400 mg of the test substance in 4liters of potable water (passed through reverse osmosis system) with 2 hrs continuous stirring for achieving test concentrations of 100mg/L ,respectively

Bowl aquaria containing 2 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 was subjected to various nominal test concentration 100mg/L . LC50 was determine to be >100 mg/l .

Based on the LC50, it can be consider that the chemical was non toxic and can be consider to be not classified as per the CLP classification criteria.

Short term toxicity to aquatic invertebrate:

Data available for the structurally similar read across chemicals has been reviewed to determine the short term toxicity of aquatic invertebrate of the test chemical Sodium 4-{[4-(diethylamino)phenyl][4-(diethyliminio)-2,5-cyclohexadien-1-ylidene]methyl}-6-hydroxy-1,3-benzenedisulfonate (20262 -76 -4).The studies are as mentioned below:

1.Aim of this study was to assess the short term toxicity of test material to aquatic invertebrates daphnia magna. Study was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) in a static system for the total exposure period of 48 hrs.

 

The solution 200 mg/l was prepared by dissolving dark green powder in reconstituted water.200 mg/l nominal concentrations were used in the study. Effects on immobilisation were observed for 48 hours. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously.

The inhibition percentage for the test substance in Daphnia magna was determined to be 0.4% on the basis of mobility inhibition effects in a 48 hour study. Based on the inhibition percentage , indicates that the substance is likely to be non-hazardous to aquatic invertebrates and cannot be classified as aquatic as per the CLP criteria.

2.The effect concentration (EC50) value of test material in aquatic invertebrate [Brine shrimp] in a 48 hr study on the basis of mortality effect was found to be 792.86 mg/L. Based on this EC50 value, the substance does not qualify for the aquatic classification as per the  CLP criteria.

The test chemical Sodium 4-{[4-(diethylamino)phenyl][4-(diethyliminio)-2,5-cyclohexadien-1-ylidene]methyl}-6-hydroxy-1,3-benzenedisulfonate is not likely to be toxic to aquatic invertebrate  atleast in the concentration range of 200-798 mg/l. Hence, on the basis of above test concentration it can be considered that test material is non toxic to aquatic environment and can not be classified as per CLP classification.

Toxicity to aquatic algae and cyanobacteria:

Data available for the structurally similar read across chemicals has been reviewed to determine the toxicity of aquatic algae and cyanobacteria of the test chemical Sodium 4-{[4-(diethylamino)phenyl][4-(diethyliminio)-2,5-cyclohexadien-1-ylidene]methyl}-6-hydroxy-1,3-benzenedisulfonate (20262 -76 -4).The studies are as mentioned below:

1.The effect of test item 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 6.25mg/l, 12.5mg/l, 25mg/l, 50mg/l, 100mg/l and 200mg/l. The test concentrations were prepared using stock solution of the test item using mineral media. 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 the test item. EC30 calculated graphically through probit analysis was observed to be 213.816mg/l. The EC50 was greater than 200 mg/L.Thus, based on this value, it can be concluded that the test chemicalcan be considered as non-toxic to aquatic organismsand thus cannot be classified as hazardous as per the CLP criteria.

2.The effect of test item 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 6.25mg/L, 12.5mg/L, 25mg/L, 50 mg/L, 100mg/L and 200mg/L. The test concentrations were prepared using stock solution of the test item using mineral media. 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 the test item. EC50 calculated graphically through probit analysis was observed to be 125.46 mg/L.

On the basis of above effect concentration the test material was considered to be not toxic and can not be classified as per CLP classification.

Toxicity to microorganism:

Data available for the structurally similar read across chemicals has been reviewed to determine the toxicity of microorganism of the test chemical Sodium 4-{[4-(diethylamino)phenyl][4-(diethyliminio)-2,5-cyclohexadien-1-ylidene]methyl}-6-hydroxy-1,3-benzenedisulfonate (20262 -76 -4).The studies are as mentioned below:

1.The Median Lethal Time for 50 percent mortality (LT50) value of test material in microorganism (Paramaecium caudatum) in a 17.283 min. study on the basis of mortality effect was estimated to be 1000 mg/L. It can be concluded from the value that the test materialis not toxic to the aquatic enviornment.

2.Toxicity to micro-organisms was carried out for 14.68 to study the effects on micro-organisms. The Median Lethal Time value for 50 percent mortality (LT50) value of test material in microorganism (Paramaecium caudatum) in a 14.68 min. study on the basis of mortality effect was found to be 10000 mg/L. It can be concluded from the value that the test material is not toxic to the aquatic enviornment.

On the basis of above LT50 concentrations test material Sodium 4-{[4-(diethylamino)phenyl] [4-(diethyliminio)-2,5-cyclohexadien-1-ylidene]methyl}- 6-hydroxy-1,3-benzenedisulfonate (20262 -76 -4) is considered to be non toxic to microorganisms.