Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

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 closest read across substances, the toxicity on aquatic invertebrate was predicted 2-amino-5-acetamidobenzene-1-sulfonic acid (CAS: 96-78-6). Effect concentration i.e EC50 value was estimated to be 107.67 mg/l for Daphnia magna for 48 hrs duration. It was concluded that the 2-amino-5-acetamidobenzene-1-sulfonic acid (CAS: 96-78-6) was likely to be not toxic to aquatic invertebrate, hence it can be considered to be “not Classified” as per the CLP classification criteria for aquatic environment.

Toxicity to aquatic algae and cyanobacteria

Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the closest read across substances, the toxicity on aquatic algae was predicted 2-amino-5-acetamidobenzene-1-sulfonic acid (CAS: 96-78-6). Effect concentration i.e EC50 value was estimated to be 117.56 mg/l for Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) for 72 hrs duration. It was concluded that the 2-amino-5-acetamidobenzene-1-sulfonic acid (CAS: 96-78-6) was likely to be not toxic to aquatic algae, hence it can be considered to be “not Classified” as per the CLP classification criteria for aquatic environment.

Additional information

Short-term toxicity to aquatic invertebrates

Following studies includes predicted data and experimental data of target chemical and stucturally similar read across to conclude the

2-amino-5-acetamidobenzene-1-sulfonic acid (CAS: 96-78-6) toxicity towards aquatic invertebrate is summarized as below:

Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the closest read across substances, the toxicity on aquatic invertebrate was predicted 2-amino-5-acetamidobenzene-1-sulfonic acid (CAS: 96-78-6). Effect concentration i.e EC50 value was estimated to be 107.67 mg/l for Daphnia magna for 48 hrs duration. It was concluded that the 2-amino-5-acetamidobenzene-1-sulfonic acid (CAS: 96-78-6) was likely to be not toxic to aquatic invertebrate, hence it can be considered to be “not Classified” as per the CLP classification criteria for aquatic environment.

The above predicted data is supported by the experimental syudy of stucturally similar read across 4-aminobenzenesulfonic acid (CAS: 121 -57 -3) from chemosphere 1994, suggests that the Short term toxicity test was carried out for 48 h to study the effects of 4-aminobenzenesulfonic acid on aquatic invertebrate. The effective concentration EC50 to 50% of Daphnia magna for Sulfanilic acid in 24 hrs is 109.13 mg/l. It can be concluded that the Sulfanilic acid is not toxic to the aquatic environment and can be considered as per CLP regulation.

Similar study of anotherstucturally similar read across N,N'-ethylenebis[N-acetylacetamide](CAS: 10543-57-4) from the U.S. Environmental Protection Agency 1992 indicates that the Short-term toxicity to aquatic invertebrates test was carried out under static condition to study the effects of N,N'-ethylenebis[N-acetylacetamide on aquatic invertebrate.

The Effective concentration EC50 to 50% of5 Daphnia magna at 48 hr is1000 mg/l. It can be concluded that the N,N'-ethylenebis[N-acetylacetamide] is not toxic to the aquatic invertebrate.

Thus based on the effect concentrations which is in the range 107.67 mg/l to 1000 mg/Lgive the conclusion that test substance 2-amino-5-acetamidobenzene-1-sulfonic acid (CAS: 96-78-6) was likely to be not toxic to aquatic invertebrate at environmentally relevant concentrations and applying the weight of evidence approach it can be considered to benot classifiedas per the CLP classification criteria.

Toxicity to aquatic algae and cyanobacteria

Following studies includes predicted data and experimental data of target chemical and stucturally similar read across to conclude the

2-amino-5-acetamidobenzene-1-sulfonic acid (CAS: 96-78-6) toxicity towards aquatic algae is summarized as below:

Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the closest read across substances, the toxicity on aquatic algae was predicted 2-amino-5-acetamidobenzene-1-sulfonic acid (CAS: 96-78-6). Effect concentration i.e EC50 value was estimated to be 117.56 mg/l for Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) for 72 hrs duration. It was concluded that the 2-amino-5-acetamidobenzene-1-sulfonic acid (CAS: 96-78-6) was likely to be not toxic to aquatic algae, hence it can be considered to be “not Classified” as per the CLP classification criteria for aquatic environment.

The above predicted data is supported by the experimental syudy of stucturally similar read across 4-amino-3-methylbenzenesulfonic acid; 3 - methylsulphanilic acid ( CAS: 98 -33 -9) from ABITEC Lab. 2017, indicates that theFreshwater algal growth inhibition test was carried out on Desmodesmus subspicatus with the substance 4-amino-3- methylbenzenesul- fonic acid according to OECD Guideline 201.

The test substance was dissolved in OECD growth medium and tested at the concentrations 0, 0, 30, 45, 67, 100, 150 mg/L. Effects on the growth rate of the organism were studied. The median effective concentration (EC50) for the test substance 4-amino-3-methylbenzene- sulfonic acid, in Desmodesmus subspicatus was determined to be 110.6 mg/L

This value indicates that the substance is likely to be non-hazardous to aquatic algae.

Similar study of anotherstucturally similar read across 2,4-diaminobenzenesulfonic acid (CAS: 88-63-1) from ABITEC Lab. 2017, indicates that the Short term toxicity study to algae was performed according to the OECD guideline 201 in a static system.

The test substance was dissolved in OECD growth medium and tested at the concentrations 0, 0, 30, 45, 67, 100, 150 mg/L. Effects on the growth rate of the organism were studied. The median effective concentration (EC50) for the test substance 2,4-diaminobenzenesulfonic acid in Desmodesmus subspicatus is 110.0 mg/L on the basis of effects on growth rate in a 72 hour study. It can be concluded from the value  that the 2,4-diaminobenzenesulfonic acid is not toxic to the aquatic environment.

Thus based on the effect concentrations which is in the range 110.0 mg/l to 117.56 mg/Lgive the conclusion that test substance 2-amino-5-acetamidobenzene-1-sulfonic acid (CAS: 96-78-6) was likely to be not toxic to aquatic algae at environmentally relevant concentrations and applying the weight of evidence approach it can be considered to benot classifiedas per the CLP classification criteria.