12H-phthaloperin-12-one

Endpoint summary

Description of key information

Short term toxicity to fish:

1: Based on the mortality rate of fish Oncorhynchus mykiss by the chemical exposure for 96 hrs, the LC50 was observed at 2.8 mg/L.

2: Based on the mortality rate of fish Oncorhynchus mykiss by the chemical exposure for 96 hrs, the LC50 was observed at 2.09 mg/L.

Based on the above results, chemical can be consider to be toxic, however the obtained median letal concentration is very much higher than the solubility of the test chemical. Thus considering water solubility and toxicity values test chemical can be categorised into not classified category

Long term toxicity to fish:

Based on the prediction done using ECOSAR version 1.1, the long term toxicity on fish was predicted for test substance. On the basis of effects observed in a flow-through freshwater system, the NOEC value for the substance is estimated to be 2.024 mg/l for fish for 28 days of exposure duration., it can be concluded that the test chemical can be considered as non-toxic to fish at environmentally relevant concentrations and can be considered not-classified as per the CLP classification criteria. 

 

Short term toxicity of aquatic invertebrate:

Aim of this study was to assess the short term toxicity of test material to aquatic invertebrate 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 stock solution 1.0 g/l was prepared by dissolving orange powder in acetone. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted water. 0, 0.25 , 0.50 , 1.00 , 2.00 , 4.00 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. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 3.19 mg/L on the basis of mobility inhibition effects in a 48 hour study. The water solubility of test substance was 0.11 mg/l. It was not possible to test higher sample concentrations due to low sample solubility. There was orange precipitate on the surface of the test medium at the concentrations higher than 0.25 mg/l. Result of 48h EC50 when all measured values are used: 48h EC50 = 3.91 mg/l, 95% CI = 2.25 - 6.79 mg/l. Based on the above results, chemical can be consider to be toxic, however the obtained median letal concentration is very much higher than the solubility of the test chemical. Thus considering water solubility and toxicity values test chemical can be categorised into not classified category

 

Long term toxicity of aquatic invertebrate:

Based on the prediction done using ECOSAR version, the long term toxicity on aquatic invertebrate was predicted for test substance. On the basis of effects observed in a flow-through freshwater system, the NOEC value for the substance is estimated to be 1.534 mg/l for aquatic invertebrate for 21 days of exposure duration. Since, it can be concluded that the test chemical can be considered as non-toxic to aquatic invertebrate at environmentally relevant concentrations and can be considered not-classified as per the CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria:

Aim of this study was to evaluate the nature of test chemical when comes in contact with the test organism Desmodesmus subspicatus (previous name: Scenedesmus subspicatus). Test was conducted according to the OECD guideline 201. The stock solution 1.0 g/l was prepared by dissolving orange powder in acetone. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample with OECD growth medium and inoculum culture the nominal concentrations were 0.25 , 0.50 , 1.00 , 2.00, 4.00 mg/l. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. Effect on the growth of algae was determine after an exposure period of 72 hrs. The median effective concentration (EC50) for the test substance, in algae was determined to be >2.0 mg/L. It was not possible to test higher sample concentrations due to low sample solubility. There was orange precipitate in the test medium at the concentration of 4.0 mg/l . On the basis of growth rate inhibition effects in a 72 hour study.

Based on the above results, chemical can be consider to be toxic, however the obtained median letal concentration is very much higher than the solubility of the test chemical. Thus considering water solubility and toxicity values test chemical can be categorised into not classified category

 

Toxicity to microorganisms:

1. The IC50 value (concentration for 50% inhibition of respiration rate) for the test chemical on activated sludge (aerobic bacteria) is determined to be 10-100 mg/1 after 3 hrs of exposure.

The IC50 value (concentration for 50% inhibition of respiration rate) for the test chemical on activated sludge (aerobic bacteria) is determined to be 10-100 mg/1 after 3 hrs of exposure.

Thus based on the above data, it was consider that the chemical was safe and nontoxic.

Additional information

Summarized result for the toxicity of test chemical on the growth and other behavior of test organisms fish, invertebrates, algae, cyanobacteria and microorganisms. The studies are as mentioned below:

 

Short term toxicity to fish:

Data available for the test chemical including structually and functionally similar read across chemical has been reviewed to determine the short term toxicity of the test chemical on the mortality of fish.The studies are as mentioned below:

In the first study test material was subjected to evaluate its acute toxicity effect onOncorhynchus mykiss. Aim of this study was determine the effect of test chemical on the mortality of fish Oncorhynchus mykiss. Test conducted under the static system for 96 hrs. Based on the mortality rate of fish Oncorhynchus mykiss by the chemical exposure for 96 hrs, the LC50 was observed at 2.8 mg/L. Hence chemical consider to be toxic and classified as aquatic chronic 2 category as per the CLP classification criteria.

Above results were supported by the second experimental study from authoritative database.Aim of this study was determine the effect of test chemical on the mortality of fish Ictalurus punctatus (Channel Catfish). Test conducted under the static system for 96 hrs. 1.3 g channel catfish were used in the study. Based on the mortality rate of fish Ictalurus punctatus(Channel Catfish) by the chemical exposure for 96 hrs, the LC50 was observed at 2.09 mg/L. Hence chemical consider to be toxic and classified as aquatic chronic 2 category as per the CLP classification criteria.

Based on the above results, chemical can be consider to be toxic, however the obtained median letal concentration is very much higher than the solubility of the test chemical. Thus considering water solubility and toxicity values test chemical can be categorised into not classified category

 

Long term toxicity to fish:

Based on the prediction done using ECOSAR version 1.1, the long term toxicity on fish was predicted for test substance. On the basis of effects observed in a flow-through freshwater system, the NOEC value for the substance is estimated to be 2.024 mg/l for fish for 28 days of exposure duration., it can be concluded that the test chemical can be considered as non-toxic to fish at environmentally relevant concentrations and can be considered not-classified as per the CLP classification criteria. 

 

Short term toxicity of aquatic invertebrate:

Aim of this study was to assess the short term toxicity of test material to aquatic invertebrate 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 stock solution 1.0 g/l was prepared by dissolving orange powder in acetone. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample in reconstituted water. 0, 0.25 , 0.50 , 1.00 , 2.00 , 4.00 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. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be 3.19 mg/L on the basis of mobility inhibition effects in a 48 hour study. The water solubility of test substance was 0.11 mg/l. It was not possible to test higher sample concentrations due to low sample solubility. There was orange precipitate on the surface of the test medium at the concentrations higher than 0.25 mg/l. Result of 48h EC50 when all measured values are used: 48h EC50 = 3.91 mg/l, 95% CI = 2.25 - 6.79 mg/l. Based on the above results, chemical can be consider to be toxic, however the obtained median effective concentration is very much higher than the solubility of the test chemical. Thus considering water solubility and toxicity values test chemical can be categorised into not classified category

 

Long term toxicity of aquatic invertebrate:

Data available for test chemicals including structurally and functionally similar read across chemical, study has been reviewed to determine the long term toxicity of the test chemical on the growth and reproduction of daphnia magna. The studies are as mentioned below:

 

Based on the prediction done using ECOSAR version, the long term toxicity on aquatic invertebrate was predicted for test substance. On the basis of effects observed in a flow-through freshwater system, the NOEC value for the substance is estimated to be 1.534 mg/l for aquatic invertebrate for 21 days of exposure duration. Since, it can be concluded that the test chemical can be considered as non-toxic to aquatic invertebrate at environmentally relevant concentrations and can be considered not-classified as per the CLP classification criteria.

 

Long term toxicity of test chemical were studied on the reproduction of test organism daphnia magna. Test conducted in accordance with OECD Test Guideline 202. 5 nominal concentrations (0.78-78 mg/l) were used for the study and performed under the closed static system. 9:1 DMSO:HCO-40 used as a vehicle. 4 replicates; 10 organisms per replicate) were exposed at the nominal concentrations. Effects were observed in the interval of 24 hrs, 48 hrs, 72 hrs, 96 hrs, 7 days and 14 days. Based on the effects observed on the mortality and reproduction of freshwater daphnia magna by the test chemical effects were observed. On the basis of mortality, the LC50 after 21 days were determine to be 2.6 mg/l and on the basis of effects on reproduction, the EC50 was 1.6 mg/l. The NOEC was observed at 0.78 mg/l and LOEC at 2.5 mg/l. Based on the LC50 and EC50, chemical consider to be nontoxic and not classified as per the CLP classification criteria.

 

Thus based on the EC50 and LC50, chemical consider to be nontoxic and not classified as per the CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria:

Aim of this study was to evaluate the nature of test chemical when comes in contact with the test organism Desmodesmus subspicatus (previous name: Scenedesmus subspicatus). Test was conducted according to the OECD guideline 201. The stock solution 1.0 g/l was prepared by dissolving orange powder in acetone. Test solutions of required concentrations were prepared by mixing the stock solution of the test sample with OECD growth medium and inoculum culture the nominal concentrations were 0.25 , 0.50 , 1.00 , 2.00, 4.00 mg/l. With the test substance one positive control Potassium dichromate (K2Cr2O7) was also run simultaneously. After the exposure of chemical, effect concentration EC50 was calculated using nonlinear regression by the software Prism 4.0. Effect on the growth of algae was determine after an exposure period of 72 hrs. The median effective concentration (EC50) for the test substance, in algae was determined to be >2.0 mg/L. It was not possible to test higher sample concentrations due to low sample solubility. There was orange precipitate in the test medium at the concentration of 4.0 mg/l . On the basis of growth rate inhibition effects in a 72 hour study.

Based on the above results, chemical can be consider to be toxic, however the obtained median effective concentration is very much higher than the solubility of the test chemical. Thus considering water solubility and toxicity values test chemical can be categorised into not classified category

 

Toxicity to microorganisms:

Data available for test chemicals including structurally and functionally similar read across chemical, study has been reviewed to determine the toxicity of microorganism of the test chemical .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.

 

First study was supported by the second. 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.

 

Based on the above results, chemical can be consider to be toxic, however the obtained median letal/effective concentration is very much higher than the solubility of the test chemical. Thus considering water solubility and toxicity values test chemical can be categorised into not classified category