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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short term toxicity to fishes:

Short term toxicity study of N4-Acetylsulfanilamide on the growth of fishes Petromyzon marinus, Salmo gairdnerii and Lepomis macrochirus for 24 hrs.Measured concentration of 5 mg/l Chemicals were weighed in calibrated weighing bottles to the nearest milligram on a Volland Speedigram balance. Test performed in the 10 liter of glass battery jar contain 5 liter of water having the headspace of 5 liter. After the exposure of 24 hrs with chemical no any mortality and other effect was observed. Based on the mortality of fishes Salmo gairdnerii and Lepomis macrochirus, due to the N4-Acetyl -sulfanilamide the NOEC was 5 ppm.

Short term toxicity to aquatic invertebrates:

Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the six closest read across substances, toxicity on Daphnia magna was predicted for N-(4-sulfamoylphenyl) acetamide (121-61-9). The EC50 value was estimated to be 243.72 mg/l when N-(4-sulfamoylphenyl) acetamide wasexposed todaphnia magna for 48 hrs.

Toxicity to aquatic algae and cyanobacteria:

Based on the prediction done using the three different models i.e, Battery, Leadscope and SciQSAR used within Danish QSAR database, the short term toxicity on green algae was predicted for test substance N-(4-sulfamoylphenyl)acetamide(121 -61 -9). The average EC50 value was given by the third model i.e, Battery model. On the basis of effects observed in a static freshwater system, the effect concentration EC50 value for the substance  N-(4-sulfamoylphenyl)acetamide is estimated to be 161.75mg/l for Pseudokirchneriella subcapitata during 72 hr exposure duration. Thus, on the basis of EC50 value,it can be concluded that the test chemical N-(4-sulfamoylphenyl)acetamide can be considered as non-toxic to green algae at environmentally relevant concentrations and can be considered to be not-classified as per the CLP classification criteria.

Additional information

Summarized result of toxicity of N-(4-sulfamoylphenyl) acetamide (121-61-9) on the growth and other activity of aquatic fishes, invertebrates and algae and cyanobacteria by considering the data for target as well as RA chemical which was selected on the basis of structure similarity are as follows:

Short term toxicity to fishes:

Based on the various experimental data for the target chemical study have been reviewed to determine the toxic nature of N-(4-sulfam -oylphenyl) acetamide (121-61-9), on the growth of fishes. The studies are as mentioned below:

 

In the first key study for the target chemical N-(4-sulfamoylphenyl) acetamide (121-61-9) from Spec.Sci.Rep.Fish.No.207, Fish Wildl.Serv., U.S.D.I., Washington, Short term toxicity study of N4-Acetylsulfanilamide on the growth of fishes Petromyzon marinus, Salmo gairdnerii and Lepomis macrochirus for 24 hrs. Measured concentration of 5 mg/l Chemicals were weighed in calibrated weighing bottles to the nearest milligram on a Volland Speedigram balance. Test performed in the 10 liter of glass battery jar contain 5 liter of water having the headspace of 5 liter. After the exposure of 24 hrs. with chemical no any mortality and other effect was observed. Based on the mortality of fishes Salmo gairdnerii and Lepomis macrochirus, due to the N4-Acetyl -sulfanilamide the NOEC was 5 ppm.

 

 

Based on the data obtain from various sources i.e from publication and lab report for target and RA chemicals, it can be concluded that the substance N-(4-sulfamoylphenyl) acetamide (121-61-9) is considered to be not toxic to fishes and cannot be classified toxic as per the criteria mentioned in CLP regulation.

Short term toxicity to aquatic invertebrates:

Based on the various experimental data and prediction data for the target chemical study have been reviewed to determine the toxic nature of N-(4-sulfamoylphenyl) acetamide (121-61-9),on the growth of acquatic invertebrates.The studies are as mentioned below:

In the first weight of evidence study from QSAR, 2017 for the target chemical, N-(4-sulfamoylphenyl) acetamide. Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the six closest read across substances, toxicity on Daphnia magna was predicted for N-(4-sulfamoylphenyl) acetamide (121-61-9). The EC50 value was estimated to be 243.72 mg/l when N-(4-sulfamoylphenyl) acetamide wasexposed todaphnia magna for 48 hrs.

In the second weight of evidence study from EPIsuite 2017 for determination of toxicity of N-(4-sulfamoylphenyl) acetamide was carried out. Based on the prediction done by EPI suite, ECOSAR version 1.1, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program, the LC 50 value for short term toxicity to aquatic invertebrates was predicted. On the basis of this program, the LC 50 value for short term toxicity to aquatic invertebrates was predicted to be 3662 mg/l for CAS name N-(4-sulfamoylphenyl)acetamide in 48 hrs. Based on this value it can be concluded that the substance is considered to be not toxic to aquatic environment and can not be classified as per the criteria mentioned in CLP regulation.

Similarly study was carried out on the RA chemical Paracetamol (103 -90 -2) from food and chemical toxicology journal, 1994 on the basis of structure similarity. The lethal concentration (LC50) value of Paracetamol in aquatic invertebrate (Daphnia magna) in a 24 hr study on the basis of immobility effects was 269.153 mg/L.Thus considering the CLP Criteria for aquatic classification of the substance , it is concluded that Paracetamol does not exhibit short term toxicity to aquatic invertebrate (Daphnia magna) i.e. it is non hazardous to the aquatic environment.

Similarly study for theParacetamol (103 -90 -2), Environmental toxicology and chemistry journal, 1995 was consider as it supports the classification of target chemical and structuraly similar. Study conducted on daphnia pulex for 24 hrs indicate the effective concentration (EC50) value of N-(4-hydroxyphenyl)acetamide (Paracetamol) was 136mg/L; based on intoxication effect .Thus considering the CLP Criteria for aquatic classification of the substance , it is concluded that Paracetamol does not exhibit short term toxicity to aquatic invertebrate (Daphnia pulex) i.e. it is non hazardous to the aquatic environment.

Based on the data obtain from various sources for target and RA chemicals, it can be concluded that the substance N-(4-sulfamoylphenyl) acetamide (121-61-9) is considered to be not toxic to aquatic environment and can not be classified toxic as per the criteria mentioned in CLP regulation.

Toxicity to aquatic algae and cyanobacteria:

Based on the various experimental data and prediction data for the target chemical study have been reviewed to determine the toxic nature of N-(4-sulfamoylphenyl) acetamide (121-61-9),and RA chemical 4-acetamidobenzenesulfonyl chloride (121-60-8), N-(4-hydroxyphenyl)acetamide (103-90-2) on the growth of green algae. The studies are as mentioned below:

 

 

The first weight of evidence study was from Danish QSAR, 2017 for the target chemical, N-(4-sulfamoylphenyl) acetamide. Based on the prediction done using the three different models i.e, Battery, Leadscope and SciQSAR used within Danish QSAR database, the short term toxicity on green algae was predicted for test substance N-(4-sulfamoylphenyl)acetamide(121 -61 -9). The average EC50 value was given by the third model i.e, Battery model. On the basis of effects observed in a static freshwater system, the effect concentration EC50 value for the substance  N-(4-sulfamoylphenyl)acetamide is estimated to be 161.75mg/l for Pseudokirchneriella subcapitata during 72 hr exposure duration. Thus, on the basis of EC50 value,it can be concluded that the test chemical N-(4-sulfamoylphenyl)acetamide can be considered as non-toxic to green algae at environmentally relevant concentrations and can be considered to be not-classified as per the CLP classification criteria.

 

In the second weight of evidence study from QSAR, 2017 for the target chemical, N-(4-sulfamoylphenyl) acetamide. Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, toxicity on Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) was predicted for N-(4-sulfamoylphenyl) acetamide (121-61-9). The EC50 value was estimated to be 156.28 mg/l when N-(4-sulfamoylphenyl) acetamide was exposed toon Desmodesmus subspicatus for 72 hrs.

 

Similarly another weight of evidence study for N-(4-sulfamoylphenyl) acetamide was taken from ECOSAR, 2017. Based on the prediction done using theEPI Suite ECOSAR version 1.10, the short term toxicity on green algae was predicted for test substance N-(4-sulfamoylphenyl) acetamide (121 -61 -9). On the basis of effects observed in a static freshwater system, the effect concentration EC50 value for the substance is estimated to be 1360mg/l for green algae for 96hrs duration. Based on this value, it can be concluded that the test chemical N-(4-sulfamoylphenyl)acetamide can be considered as non-toxic to green algae at environmentally relevant concentrations and can be considered not-classified as per the CLP classification criteria.

 

Similarly the effect of test substance N-acetylsulphanilyl chloride, CAS No. (121-60-8), Lab report Sustainable support service was studied on the growth of fresh water green alga Chlorella vulgaris. The study was conducted following OECD guideline 201- Alga growth inhibition test. The test concentration chosen for the study were 6.25, 12.5, 25, 50, 100 and 200 mg/L were prepared using stock solution of the test substance using de-ionized water. 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 test substance. EC50 calculated from equation and graphically through probit analysis was observed to be193.43 mg/L and 200 mg/L respectively. Thus chemical was consider as nontoxic to aquatic algae and not classified as per the CLP classification criteria.

 

The effect of test item paracetamol, CAS No. 103-90-2 which was the RA chemical from UERL lab was studied on the growth of fresh water green alga Chlorella 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. EC50 calculated graphically through probit analysis was observed to be 112.666mg/l. Based on this EC50 value and after comparing with CLP criteria for aquatic classification of the substance it is concluded that the substance Paracetamol does not exhibit toxicity to aquatic algae (Chlorella vulgaris).

 

Similarly in sixth weight of evidence study for N-(4-hydroxyphenyl) acetamide (103-90-2) J-check, 2017, Short term toxicity study of Acetaminophen on the growth of freshwater green algae was carried out for 72 hrs. The effective concentration (EC50) value of N-(4-Hydroxyphenyl) acetamide (Paracetamol) in aquatic green algae in a 72 hr study on the basis of growth rate effect and AUG was > 460 mg/l and 150 mg/l. But the NOEC on the basis of AUG and growth rate was 22 mg/l and 46 mg/l. Based on the growth rate and AUG of green algae by considering EC50 (>460 mg/l), N-(4-Hydroxyphenyl) acetamide was nontoxic and cannot be classified as toxic to aquatic algae as per the CLP classification criteria.

 

Based on the data obtain from various sources for evaluating the toxicity of target and RA chemicals on the fishes, invertebrates and algal growth, it can be concluded that the substance N-(4-sulfamoylphenyl) acetamide (121-61-9) is considered to be not toxic to algae and cannot be classified toxic as per the criteria mentioned in CLP regulation.