Reaction mass of 3H-Indolium, 2-[[2-(4-methoxyphenyl)-2-methylhydrazinylidene]methyl]-1,3,3-trimethyl- and acetate

Endpoint summary

Description of key information

Short term toxicity to fish:

Data available for the functionally similar read across chemicals has been reviewed to determine the short term toxicity of fish of the test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate.The studies are as mentioned below:

1.Fish Acute Toxicity test according to OECD Guideline 203 was conducted for test chemical . The test solution was prepared by dissolving 100 mg of the test substance in 100 ml of potable water (passed through reverse osmosis system) with 1 hr.continuous stirring for achieving test concentrations of 1g/L. The nominal concentration selected for the experiment were 0.3125mg/L,0.625mg/L,1.25mg/L,2.5mg/L,5mg/Land test fish were exposed to these concentration for 96 hours. After 96hrs of exposure LC0, LC50 and LC100 was observed. The lethal concentrations LC50 was determine to be >0.3125 mg/L but <0.625 mg/L

LC0 (96 hours) (highest loading at which no mortality was observed) = 0.3125 mg/L LC50 (96 hours) Experimental = >0.3125 mg/L but <0.625 mg/L

LC100 (96 hours) (lowest loading at which 100% mortality was observed) = 0.625 mg/L.

2.Short term toxicity test for fish was performed to evaluate toxicity of test material on fish .The effect concentration of test material on fish was observed to be 0.60 mg/l after 96 h.

Thus, based on the above summarised studies, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate and it’s functionally similar read across substance, it can be concluded that effect concetration of test substance is in the range of 0.3125 to 0.60 mg/l Thus, comparing this value with the criteria of CLP regulation, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate can be classified as Aquatic acute/chronic 1 for short term toxicity for fish .

 

Short-term toxicity to aquatic invertebrates:

Data available for the functionally similar read across chemicals has been reviewed to determine the short term toxicity of fish of the test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate .The studies are as mentioned below:

1.Short term immobilization test of aquatic invertebrate was evaluated using the test chemical. The test chemical was subjected to Daphnia magna under static condition for 48 hr. The effect concentration (EC50) of test material on Daphnia magna was observed to be 0.27 after 48 h.

2.Determination of the inhibition of the mobility of daphnids was carried out with the substance test material according to OECD Guideline 202.

The test substance was tested at the concentrations 0, 0.006, 0.012, 0.025, 0.050, 0.100 mg/l. Effects on immobilisation were observed for 48 hours.

The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 0.037 mg/L for immobilisation effects.

This value indicates that the substance is likely to be hazardous to aquatic invertebrates and can be classified as aquatic acute 1 as per the CLP criteria.

Thus, based on the above summarised studies, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate and it’s functionally similar read across substance, it can be concluded that effect concetration value is greater than 0.27 - 0.037 mg/L. Thus, comparing this value with the criteria of CLP regulation, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate can be classified for short term toxicity for aquatic invertebrate as "Aquatic chronic 1" .

Toxicity to aquatic algae and cyanobacteria:

Data available for the functionally similar read across chemicals has been reviewed to determine the toxicity of aquatic algae and cyanobacteria of the test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate .The studies are as mentioned below:

1.The test material was subjected to green algae under static condition for 72 hr to evaluate its toxicity on growth rate of green algae.The effect concentration (EC50) was observed to be 0.15 mg/l , No effect on growth (NOEC) was observed in the concentration 0.027 mg/l . The effect concentration of area under growth curve was observed to be 0.037 mg/l.

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 0.5mg/l, 1.25mg/l, 3.125mg/l, 7.813mg/l, 19.531mg/l and 48.828mg/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 0.610 mg/L.Thus, based on the EC50 value, test substancecan be considered astoxic to aquatic organisms and thus can be classified as aquatic acute category 1 as per the CLP criteria.

Thus, based on the above summarised studies, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate and it’s functionally similar read across substance, it can be concluded that effect concetration value is greater than 0.15 - 0.61mg/L. Thus, comparing this value with the criteria of CLP regulation, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate can be classified for toxicity for aquatic algae ans cyanobacteria as "Aquatic chronic 1" .

Toxicity to microorganism:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the short term toxicity of fish of the test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate .The studies are as mentioned below:

A screening method based on the measurement of the respiration rate of activated sludge for assessing the possible inhibitory effect of dyestuffs on aerobic waste-water bacteria. The test principle involves measuring the respiration rate of an activated sludge and comparing it with the respiration rate of the same activated sludge under identical conditions, but in the presence of the chemical under test. The test was carried out in activated sludge respiration rate apparatus with constant 20 ± 2°C and pH about 7-8. The test concentration used was 100 mg/l. OECD recommended synthetic sewage was used as feed, while activated sludge was obtained from a sewage works treating predominantly domestic sewage or from a sewage works treating predominantly industrial waste water. The respiration rate of an activated sludge and the respiration rate of activated sludge with test chemical were noted down. In order to calculate the inhibitory effect of a particular chemical at 100 mg/l test concentration its respiration rate is expressed as a percentage of the mean of the two control respiration rates. Thus, IC50 value (concentration for 50% inhibition of respiration rate) for the test chemical on activated sludge (aerobic bacteria) is determined to be10 - 100 mg/1 after 3 hrs of exposure.

The test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate is  likely to be toxic to microorganism  in the concentration  range of 10-100 mg/l

Additional information

Short term toxicity to fish:

Data available for the functionally similar read across chemicals has been reviewed to determine the short term toxicity of fish of the test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate.The studies are as mentioned below:

1.Fish Acute Toxicity test according to OECD Guideline 203 was conducted for test chemical . The test solution was prepared by dissolving 100 mg of the test substance in 100 ml of potable water (passed through reverse osmosis system) with 1 hr.continuous stirring for achieving test concentrations of 1g/L. The nominal concentration selected for the experiment were 0.3125mg/L,0.625mg/L,1.25mg/L,2.5mg/L,5mg/Land test fish were exposed to these concentration for 96 hours. After 96hrs of exposure LC0, LC50 and LC100 was observed. The lethal concentrations LC50 was determine to be >0.3125 mg/L but <0.625 mg/L

LC0 (96 hours) (highest loading at which no mortality was observed) = 0.3125 mg/L LC50 (96 hours) Experimental = >0.3125 mg/L but <0.625 mg/L

LC100 (96 hours) (lowest loading at which 100% mortality was observed) = 0.625 mg/L.

2.Short term toxicity test for fish was performed to evaluate toxicity of test material on fish .The effect concentration of test material on fish was observed to be 0.60 mg/l after 96 h.

Thus, based on the above summarised studies, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate and it’s functionally similar read across substance, it can be concluded that effect concetration of test substance is in the range of 0.3125 to 0.60 mg/l Thus, comparing this value with the criteria of CLP regulation, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate can be classified as Aquatic acute/chronic 1 for short term toxicity for fish .

 

Short-term toxicity to aquatic invertebrates:

Data available for the functionally similar read across chemicals has been reviewed to determine the short term toxicity of fish of the test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate .The studies are as mentioned below:

1.Short term immobilization test of aquatic invertebrate was evaluated using the test chemical. The test chemical was subjected to Daphnia magna under static condition for 48 hr. The effect concentration (EC50) of test material on Daphnia magna was observed to be 0.27 after 48 h.

2.Determination of the inhibition of the mobility of daphnids was carried out with the substance test material according to OECD Guideline 202.

The test substance was tested at the concentrations 0, 0.006, 0.012, 0.025, 0.050, 0.100 mg/l. Effects on immobilisation were observed for 48 hours.

The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 0.037 mg/L for immobilisation effects.

This value indicates that the substance is likely to be hazardous to aquatic invertebrates and can be classified as aquatic acute 1 as per the CLP criteria.

Thus, based on the above summarised studies, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate and it’s functionally similar read across substance, it can be concluded that effect concetration value is greater than 0.27 - 0.037 mg/L. Thus, comparing this value with the criteria of CLP regulation, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate can be classified for short term toxicity for aquatic invertebrate as "Aquatic chronic 1" .

Toxicity to aquatic algae and cyanobacteria:

Data available for the functionally similar read across chemicals has been reviewed to determine the toxicity of aquatic algae and cyanobacteria of the test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate (58798-47 -3).The studies are as mentioned below:

1.The test material was subjected to green algae under static condition for 72 hr to evaluate its toxicity on growth rate of green algae.The effect concentration (EC50) was observed to be 0.15 mg/l , No effect on growth (NOEC) was observed in the concentration 0.027 mg/l . The effect concentration of area under growth curve was observed to be 0.037 mg/l.

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 0.5mg/l, 1.25mg/l, 3.125mg/l, 7.813mg/l, 19.531mg/l and 48.828mg/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 0.610 mg/L.Thus, based on the EC50 value, test substancecan be considered astoxic to aquatic organisms and thus can be classified as aquatic acute category 1 as per the CLP criteria.

Thus, based on the above summarised studies, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate and it’s functionally similar read across substance, it can be concluded that effect concetration value is greater than 0.15 - 0.61mg/L. Thus, comparing this value with the criteria of CLP regulation, Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate can be classified for toxicity for aquatic algae ans cyanobacteria as "Aquatic chronic 1" .

Toxicity to microorganism:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the short term toxicity of fish of the test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate .The studies are as mentioned below:

A screening method based on the measurement of the respiration rate of activated sludge for assessing the possible inhibitory effect of dyestuffs on aerobic waste-water bacteria. The test principle involves measuring the respiration rate of an activated sludge and comparing it with the respiration rate of the same activated sludge under identical conditions, but in the presence of the chemical under test. The test was carried out in activated sludge respiration rate apparatus with constant 20 ± 2°C and pH about 7-8. The test concentration used was 100 mg/l. OECD recommended synthetic sewage was used as feed, while activated sludge was obtained from a sewage works treating predominantly domestic sewage or from a sewage works treating predominantly industrial waste water. The respiration rate of an activated sludge and the respiration rate of activated sludge with test chemical were noted down. In order to calculate the inhibitory effect of a particular chemical at 100 mg/l test concentration its respiration rate is expressed as a percentage of the mean of the two control respiration rates. Thus, IC50 value (concentration for 50% inhibition of respiration rate) for the test chemical on activated sludge (aerobic bacteria) is determined to be10 - 100 mg/1 after 3 hrs of exposure.

The test chemical Reaction mass of 3H-​Indolium, 2-​[[2-​(4-​methoxyphenyl)​-​2-​methylhydrazinyliden​e]​methyl]​-​1,​3,​3-​trimethyl-​ & acetate is  likely to be toxic to microorganism  in the concentration  range of 10-100 mg/l