Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short-term toxicity to fish

A Pimephales promelas bioassay examined under static condition to study the effects of Bis(4-hydroxy-N-methylanilinium) sulphate at concentration range of 0.0, 0.025, 0.045, 0.08, 0.14, 0.25 mg/L.

Each bioassay series was conducted over the recommended 96 hour period. Moribund fish were removed from the test containers, and their numbers recorded on a daily basis. Daily monitoring for pH and dissolved oxygen was practiced. A minimum dissolved oxygen concentration of 4 mg/l was presumed acceptable for a valid experiment, and at no time during the program did the dissolved oxygen fall below this level.Similarly, no significant pH changes were observed. At least one control unit was included with every experiment. It contained the same number of fish as an individual test unit and served as a monitor of the diluent water. At highest concentration level, 53.3% mortality was observed in 96 hrs.

The lethal concentration LC50 to 50 % of Pimephales promelas is 0.25 mg/l. Hence from the value it can be concluded that the Bis(4-hydroxy-N-methylanilinium) sulphate is toxic to the aquatic fish and can be considered as “aquatic acute 1” as per classification for aquatic environment.

Short-term toxicity to aquatic invertebrates

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the closest read across substances, the toxicity on aquatic invertebrate predicted for bis(4-hydroxy-N-methylanilinium) sulfate (CAS: 55-55-0). Effect concentration i.e EC50 value estimated to be 0.724 mg/l for Daphnia magna for 48 hrs duration. It can be concluded that the bis(4-hydroxy-N-methylanilinium) sulfate (CAS: 55-55-0) is likely to be toxic to aquatic invertebrate, hence it can be considered to be “Aquatic Acute 1” as per the CLP classification criteria for aquatic environment.

Long-term toxicity to aquatic invertebrates

Daphnia magna Bioassay was carried out under static condition to study the effects of Bis(4-hydroxy-N-methylanilinium) sulphate on aquatic environment. At the start of each bioassay, appropriate dilutions of each test chemical were prepared and dispensed into 150 milliliter Griffin beakers. The pH of each test solution was adjusted to between pH 7.0-7.5. A final volume of 100-110 milliliters was used throughout the testing program. Controls, which contained only Daphnia in dilution water, were included in every bioassay. Adult mortalities were recorded on a daily basis. Births and newborn mortalities observed during the experiment were noted but not enumerated. The lethal concentration LC50 to 50% of daphnia magna is 0.019 mg/L at 96 hrs. It can be concluded from the value that the Bis(4-hydroxy-N-methylanilinium) sulphate is toxic to the aquatic environment and can be considered as “aquatic Chronic 1” as per classification for the aquatic environment.

Toxicity to aquatic algae and cyanobacteria

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the closest read across substances, the toxicity on aquatic algae predicted for bis(4-hydroxy-N-methylanilinium) sulfate (CAS: 55-55-0). Effect concentration i.e EC50 value estimated to be 0.506 mg/l for Pseudokirchneriella subcapitata for 72 hrs duration. It can be concluded that the bis(4-hydroxy-N-methylanilinium) sulfate (CAS: 55-55-0) is likely to be toxic to aquatic algae, hence it can be considered to be “Aquatic Acute 1" as per the CLP classification criteria for aquatic environment.

Toxicity to micro-organisms

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the closest read across substances, the toxicity on micro-organisms was predicted Bis(4-hydroxy-N-methylanilinium) sulphate (CAS:55-55-0). Growth inhibition concentration i.e IGC50 value was estimated to be 59.84 mg/l for Tetrahymena pyriformis for 48 hrs duration. It was concluded that the Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatesilicate (CAS: 63022) was likely to be toxic to micro-organisms

Additional information

Short-term toxicity to fish

Following studies includes the experimental study for the target chemical and structurally similar read across to conclude the toxicity extent of 4-aminophenol (CAS: 55-55-0) towards fishe is summarized as follows:

The exoerimental study of the target chemical from Environmental Effect of Photoprocessing Chemicals Vol I and II 1974, suggests that, A Pimephales promelas bioassay examined under static condition to study the effects of Bis(4-hydroxy-N-methylanilinium) sulphate at concentration range of 0.0, 0.025, 0.045, 0.08, 0.14, 0.25 mg/L.

Each bioassay series was conducted over the recommended 96 hour period. Moribund fish were removed from the test containers, and their numbers recorded on a daily basis. Daily monitoring for pH and dissolved oxygen was practiced. A minimum dissolved oxygen concentration of 4 mg/l was presumed acceptable for a valid experiment, and at no time during the program did the dissolved oxygen fall below this level.Similarly, no significant pH changes were observed. At least one control unit was included with every experiment. It contained the same number of fish as an individual test unit and served as a monitor of the diluent water. At highest concentration level, 53.3% mortality was observed in 96 hrs.

The lethal concentration LC50 to 50 % of Pimephales promelas is 0.25 mg/l. Hence from the value it can be concluded that the Bis(4-hydroxy-N-methylanilinium) sulphate is toxic to the aquatic fish and can be considered as “aquatic acute 1” as per classification for aquatic environment.

Above study is supported by the another experimental study of target chemical from Environmental Protection Agency 1992, which also suggegsts that the Short-term toxicity to fish was carried out under static to study the effects of Bis(4-hydroxy-N-methylanilinium) sulphate on aquatic environment.

The lethal concentration LC50 to 50 % of Fathead minnows is 0.3 mg/l at 96 hrs. Mortality was observed during the assay. It can be concluded from the value that the Bis(4-hydroxy-N-methylanilinium) sulphate is toxic to the aquatic fish. Hence from the value it can be concluded that the Bis(4-hydroxy-N-methylanilinium) sulphate is toxic to the aquatic fish and can be considered as “aquatic acute 1” as per classification for aquatic environment.

Further the assissted by thestructurally similar read across4-aminophenol (CAS: 123-30-8) from J-Check 2010, inidctaes that the Short-term toxicity to fish test was carried out according to the OECD Guideline 203 (Fish, Acute Toxicity Test) at concentrations of2.00, 1.33, 0.889, 0.593, 0.395 mg/L to study the effects of 4-aminophenol on fish.

Test was carried out underflow-throughcondition at 24±1 degree C in 1.8 L per vessel, using 10 organismsper concentration. Aeration was not provided, Photoperiod: room light, 16 hours light - 8 hours dark. Mortalitywas observed during the test.

The lethal concentration LC50 to 50% ofOryzias latipesin 96 hr is 0.925 mg/L. It can be concluded from the value that the 4-aminophenol is toxic to the fish and can be considered as “Aquatic Acute 1” as per the classification for aquatic environment.

Thus based on the effect concentrations which is in the range 0.25 mg/l to 0.925 mg/l give the conclusion that test substance 4-aminophenol (CAS: 55-55-0) was likely to be toxic to fish at environmentally relevant concentrations and applying weight of evidence approach it can be considered to beAquatic Acute 1as per the CLP classification criteria for aquatic environment.

Short-term toxicity to aquatic invertebrates

Following studies include the predicted data and experimental study for the target chemical and structurally similar read across to conclude the toxicity extent of 4-aminophenol (CAS: 55-55-0) towards aquatic invertebrate is summarized as follows:

 

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the closest read across substances, the toxicity on aquatic invertebrate predicted for bis(4-hydroxy-N-methylanilinium) sulfate (CAS: 55-55-0). Effect concentration i.e EC50 value estimated to be 0.724 mg/l for Daphnia magna for 48 hrs duration. It can be concluded that the bis(4-hydroxy-N-methylanilinium) sulfate (CAS: 55-55-0) is likely to be toxic to aquatic invertebrate, hence it can be considered to beAquatic Acute 1as per the CLP classification criteria for aquatic environment.

 

Further it is supported by the experimental study of structurally similar read across 4-aminophenol (CAS: 123-30-8) from the publication Water Research 1989 suggests that the Short-term toxicity to aquatic invertebrates test was carried out for 48 hr to study the effects of 4-aminophenol. The effective concentration to 50% of Daphnia magna at 48 hrs is 0.24 mg/L. The number of animals in the control and test solutions that could still swim were counted. It can be concluded form the value that the 4-aminophenol is toxic to the aquatic environment.

 

Another experimental study of structurally similar read across 4-aminophenol (CAS: 123-30-8) from the

J-check 2010, indicates that the Short-term toxicity to aquatic invertebrates test was carried according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test). Immobilizationwas observed during the test. The effective concentrationEC50 to 50% of Daphnia magnain 48 hr is 0.315 mg/L. It can be concluded from the value that the 4-aminophenol is toxic to the aquatic environment and can be considered asAquatic Acute 1as per the classification for aquatic environment.

 

Thus based on the effect concentrations which is in the range 0.019 mg/l to 0.724 mg/l give the conclusion that test substance 4-aminophenol (CAS: 55-55-0) was likely to be toxic to aquatic invertebrate at environmentally relevant concentrations and applying weight of evidence approach it can be considered to beAquatic Acute 1as per the CLP classification criteria.

Long-term toxicity to aquatic invertebrates

Daphnia magna Bioassay was carried out under static condition to study the effects of Bis(4-hydroxy-N-methylanilinium) sulphate on aquatic environment. At the start of each bioassay, appropriate dilutions of each test chemical were prepared and dispensed into 150 milliliter Griffin beakers. The pH of each test solution was adjusted to between pH 7.0-7.5. A final volume of 100-110 milliliters was used throughout the testing program. Controls, which contained only Daphnia in dilution water, were included in every bioassay. Adult mortalities were recorded on a daily basis. Births and newborn mortalities observed during the experiment were noted but not enumerated. The lethal concentration LC50 to 50% of daphnia magna is 0.019 mg/L at 96 hrs. It can be concluded from the value that the Bis(4-hydroxy-N-methylanilinium) sulphate is toxic to the aquatic environment and can be considered as “aquatic Chronic 1” as per classification for the aquatic environment.

Toxicity to aquatic algae and cyanobacteria

Following studies include the predicted data and experimental study for the target chemical and structurally similar read across to conclude the toxicity extent of 4-aminophenol (CAS: 55-55-0) towards aquatic algae is summarized as follows:

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the closest read across substances, the toxicity on aquatic algae predicted for bis(4-hydroxy-N-methylanilinium) sulfate (CAS: 55-55-0). Effect concentration i.e EC50 value estimated to be 0.506 mg/l for Pseudokirchneriella subcapitata for 72 hrs duration. It can be concluded that the bis(4-hydroxy-N-methylanilinium) sulfate (CAS: 55-55-0) is likely to be toxic to aquatic algae, hence it can be considered to be “Aquatic Acute 1" as per the CLP classification criteria for aquatic environment.

The above predicted data of the target chemical is assissted by the exeprimental study ofstructurally similar read acrossOxybenzone (CAS:131-57-7) from Chemosphere 2014, indicates thatthe Aquatic algae and cyanobacteria test was carried for 72 Hour(s) under static condition to study the effects of Oxybenzone on aquatic algae. The test was carried out at temp: 20 C, pH:~ 8, salinity: 34 0/00, DISSOLVED OXYGEN: >= 8 mg/L, Population growth rate was measured during the test.

Lowest observable effect concentration (LOEC) to Isochrysis galbana 0.3 mg/L at 72 hrs. It can be concluded that Oxybenzone is toxic to the aquatic algae and can be considered as “aquatic acute 1” a per classification for aquatic environment.

Further it is supported by another exeprimental study ofstructurally similar read across4-aminophenol (CAS:123-30 -8) from J-check database indicates that effective concentration EC50 to 50% ofPseudokirchnerella subcapitata in 72 hr is 0.67mg/L. Growth Inhibition was observed during the test. It can be concluded from the value that the 4-aminophenol is toxic to the aquatic algae and can be considered as “Aquatic Acute 1” as per the classification for aquatic environment.

Thus based on the effect concentrations which is in the range 0.30 mg/l to 0.67 mg/l give the conclusion that test substance 4-aminophenol (CAS: 55-55-0) was likely to be toxic to aquatic algae at environmentally relevant concentrations and applying weight of evidence approach it can be considered to beAquatic Acute 1as per the CLP classification criteria for aquatic environment.

Toxicity to micro-organisms

Following studies include the predicted data and experimental study for the target chemical and structurally similar read across to conclude the toxicity extent of 4-aminophenol (CAS: 55-55-0) towards aquatic algae is summarized as follows:

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the closest read across substances, the toxicity on micro-organisms was predicted Bis(4-hydroxy-N-methylanilinium) sulphate (CAS:55-55-0). Growth inhibition concentration i.e IGC50 value was estimated to be 59.84 mg/l for Tetrahymena pyriformis for 48 hrs duration. It was concluded that the Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatesilicate (CAS: 63022) was likely to be toxic to micro-organisms

Further it is supported by the experimental study of structurally similar read across 4-aminophenol (CAS: 123-30-8) from the publicationFresenius Environmental Bulletin 2011,The study was carried out according to the broth macrodilution method to investigate the antibacterial potentials of p-aminophenol. PH of the growth medium had a slight effect on the MIC values and the MIC value was higher in the growth medium with a lower pH. Time-kill analyses of p-aminophenol were performed against Staphylococcus aureus and concn. dependent killing curves were obtained.

The results demonstrated that p-aminophenol could inhibit the bacterial growth.

Minimum inhibitory concentration(MIC) to Staphylococcus aureus is 3.125 mg/L. It  can be concluded from the value that the  p-aminophenol is toxic to the micro-organisms.

Thus based on the effect concentrations which is in the range 3.125 mg/l to 59.84 mg/l give the conclusion that test substance 4-aminophenol (CAS: 55-55-0) was likely to be toxic to micro-organism at environmentally relevant concentrations and applying weight of evidence approach it can be considered to be toxic as per the CLP classification criteria for aquatic environment.