Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid (70239 -77 -9).The studies are as mentioned below:

1.Test material was used to evaluate the short term toxicity onBruchydunio rerio. The effect concentration (EC50 was considered to be less the 100 mg/l.

2.Test material was used as a test material to evaluate its acute toxicity effect on Fathead Minnow (Pimephales promelas)

 

10 Fathead Minnow (Pimephales promelas) were acclimatized in 5-gallon wide mouth glass jar for 10 days before the test in the test temperature 17°C. The test organisms were pre-treated with tetracycline .

  Test material was subjected in the test vessel upto the concentration of 12 mg/l . Toxic effect were observed after 96 hrs. Hence the effect concentration was considered to be >12 mg/l

Before death, fish tended to become very slow moving at higher concentration. Dead fish were dyed on heads and fins . Surviving fish were dyed dark green in concentration above 1mg/l.

Thus, based on the above summarised studies, 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid and it’s structurally and functionally similar read across substance, it can be concluded that effect concetration value is in the range of 12 -100 mg/ L. Thus, comparing this value with the criteria of CLP regulation, 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid can be classified for short term toxicity of fish as " acute Aquatic 3" .Hence,based on the data available for the structurally and functionally similar read across, test chemical 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid is likely to be toxic atleast in the concentration range 12 -100mg/L .

Short-term toxicity to aquatic invertebrates:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the short term toxicity of Daphnia magna of the test chemical 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid (70239 -77 -9).The studies are as mentioned below:

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

The test substance was tested at the concentrations 0, 6, 10, 18, 32, 58 and 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 54.8 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 chronic 3 category as per the CLP criteria.

2.Test material was used to evaluate its toxicity on Daphnia magna . The effect concentration (EC50) was observed to be 34 mg/l after 48 h and 34mg/l after 24 h.

Thus, based on the above summarised studies, 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid and it’s structurally and functionally similar read across substance, it can be concluded that effect concetration value is in the range of 34 -54 mg/ L. Thus, comparing this value with the criteria of CLP regulation, 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid can be classified for short term toxicity of aquatic invertebrate as " acute Aquatic 3" .Hence,based on the data available for the structurally and functionally similar read across, test chemical 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid is likely to be toxic atleast in the concentration range 34 -54 mg/L .

Toxicity to aquatic algae and cynobacteria:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxicity of aquatic algae and cyanobacteria of the test chemical 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid (70239 -77 -9).The studies are as mentioned below:

1.

Short term toxicity study of test chemical to aquatic algae Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) was conducted for 72 hrs. Test was performed according to the 201 OECD guideline in a static system.

The stock solution 100 mg/l was prepared by dissolving black powder in OECD growth medium. Test solutions of required concentration were prepared by mixing the stock solution of the test sample with OECD growth medium and inoculum culture and tested at the 0, 12, 20, 35, 60, 100 mg/l nominal concentrations. Effects on the growth rate of the organism were studied. Potassium dichromate (K2Cr2O7) were used as a reference positive control. Effects on growth rate were observed for 72 hours by using non linear regression by the software Prism 4.0.

Based on the growth rate inhibition of test organism Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) due to the test material the effect concentration ErC50 was 76.8 mg/l.

2.Test material was used to evaluate its toxicity on aquatic green algae .The effect concentration of test chemical on green algae after 96 h was observed to be 54.3 mg/l.

Thus, based on the above summarised studies, 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid and it’s structurally and functionally similar read across substance, it can be concluded that effect concetration value is in the range of 54 -78 mg/ L. Thus, comparing this value with the criteria of CLP regulation, 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid can be classified for toxicity for aquatic algae and cynobacteria as "Aquatic tox 3" .Hence,based on the data available for the structurally and functionally similar read across, test chemical 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid is likely to be toxic atleast in the dose range of 54 -78 mg/L .

Toxicity to microorganisms:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxicity of microorganism of the test chemical 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid (70239 -77 -9).The studies are as mentioned below:

1.The Microtox acute toxicity assay was performed by using a modified strain ofVibrio fischeri. Frozen samples were brought to room temperature, and centrifuged. The pH of the samples was adjusted where necessary to 6 by adding 0.5 ml 0.58 M KH2 PO4 and 70μl 1 M NaOH. Colour correction was done at 490 nm. The Microtox acute toxicity assay was performed in a Microtox 500 Analyzer on samples before and after decoloration according to the test protocols defined by the manufacturer From eight serial dilutions, the percent concentration to decrease 20% of the luminescence of amodified strain ofVibrio fischeri(EC20)after 5 min incubation was calculated with the Microtox data analysis program [Microtox Omni Software(1999) Azur Environmental, Newark, Del.]. A solution of 1 g/l ZnSO4·7H2O was used as the positive control and 1 g/l glucose as the negative control. Each EC20 reported is the average of triplicate analysis.

The concentration to decrease 50% of the bacterial luminescence in the Microtox acute assay (EC50) is normally reported. However, in most of these studies, the EC50 before or after decoloration was greater than 100% indicating that there was no toxicity or toxicity change. To better evaluate whether the decoloration process affected toxicity, the dilution required to decrease 20% of the bacterial luminescence relative to the control (EC20)was reported instead. The following rating was adapted from Coleman & Qureshi (1985) –

EC20:>100%=nontoxic;

>75–100%=slightly non-toxic;

 >50–75%=toxic;

>25–50%=moderately toxic;

<25% very toxic.

The toxicity of 100mg/l of test material determined in terms of EC20 (% dilution) was 44.6 ± 11.6. According to the ranking scheme for Microtox assay using EC20 values, test material can be categorized under moderately toxic category.

2.Toxicity value of test materila to Vibrio fisheri was found to be EC50: 22.19+/-2.47 on the basis of inhibition of the light output after a 5 min exposure period.

Thus, based on the above summarised studies, Ammonium iodide and it’s structurally and functionally similar read across substance, it can be concluded that

4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid is moderately toxic to microorganism.

Additional information

Short-term toxicity to fish:

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 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid (70239 -77 -9).The studies are as mentioned below:

1.Test material was used to evaluate the short term toxicity onBruchydunio rerio. The effect concentration (EC50 was considered to be less the 100 mg/l.

2.Test material was used as a test material to evaluate its acute toxicity effect on Fathead Minnow (Pimephales promelas)

 

10 Fathead Minnow (Pimephales promelas) were acclimatized in 5-gallon wide mouth glass jar for 10 days before the test in the test temperature 17°C. The test organisms were pre-treated with tetracycline .

  Test material was subjected in the test vessel upto the concentration of 12 mg/l . Toxic effect were observed after 96 hrs. Hence the effect concentration was considered to be >12 mg/l

Before death, fish tended to become very slow moving at higher concentration. Dead fish were dyed on heads and fins . Surviving fish were dyed dark green in concentration above 1mg/l.

Thus, based on the above summarised studies, 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid and it’s structurally and functionally similar read across substance, it can be concluded that effect concetration value is in the range of 12 -100 mg/ L. Thus, comparing this value with the criteria of CLP regulation, 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid can be classified for short term toxicity of fish as " acute Aquatic 3" .Hence,based on the data available for the structurally and functionally similar read across, test chemical 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid is likely to be toxic atleast in the concentration range 12 -100mg/L .

Short-term toxicity to aquatic invertebrates:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the short term toxicity of Daphnia magna of the test chemical 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid (70239 -77 -9).The studies are as mentioned below:

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

The test substance was tested at the concentrations 0, 6, 10, 18, 32, 58 and 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 54.8 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 chronic 3 category as per the CLP criteria.

2.Test material was used to evaluate its toxicity on Daphnia magna . The effect concentration (EC50) was observed to be 34 mg/l after 48 h and 34mg/l after 24 h.

Thus, based on the above summarised studies, 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid and it’s structurally and functionally similar read across substance, it can be concluded that effect concetration value is in the range of 34 -54 mg/ L. Thus, comparing this value with the criteria of CLP regulation, 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid can be classified for short term toxicity of aquatic invertebrate as " acute Aquatic 3" .Hence,based on the data available for the structurally and functionally similar read across, test chemical 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid is likely to be toxic atleast in the concentration range 34 -54 mg/L .

Toxicity to aquatic algae and cynobacteria:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxicity of aquatic algae and cyanobacteria of the test chemical 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid (70239 -77 -9).The studies are as mentioned below:

1.

Short term toxicity study of test chemical to aquatic algae Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) was conducted for 72 hrs. Test was performed according to the 201 OECD guideline in a static system.

The stock solution 100 mg/l was prepared by dissolving black powder in OECD growth medium. Test solutions of required concentration were prepared by mixing the stock solution of the test sample with OECD growth medium and inoculum culture and tested at the 0, 12, 20, 35, 60, 100 mg/l nominal concentrations. Effects on the growth rate of the organism were studied. Potassium dichromate (K2Cr2O7) were used as a reference positive control. Effects on growth rate were observed for 72 hours by using non linear regression by the software Prism 4.0.

Based on the growth rate inhibition of test organism Desmodesmus subspicatus (previous name: Scenedesmus subspicatus) due to the test material the effect concentration ErC50 was 76.8 mg/l.

2.Test material was used to evaluate its toxicity on aquatic green algae .The effect concentration of test chemical on green algae after 96 h was observed to be 54.3 mg/l.

Thus, based on the above summarised studies, 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid and it’s structurally and functionally similar read across substance, it can be concluded that effect concetration value is in the range of 54 -78 mg/ L. Thus, comparing this value with the criteria of CLP regulation, 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid can be classified for toxicity for aquatic algae and cynobacteria as "Aquatic tox 3" .Hence,based on the data available for the structurally and functionally similar read across, test chemical 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid is likely to be toxic atleast in the dose range of 54 -78 mg/L .

Toxicity to microorganisms:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxicity of microorganism of the test chemical 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid (70239 -77 -9).The studies are as mentioned below:

1.The Microtox acute toxicity assay was performed by using a modified strain ofVibrio fischeri. Frozen samples were brought to room temperature, and centrifuged. The pH of the samples was adjusted where necessary to 6 by adding 0.5 ml 0.58 M KH2 PO4 and 70μl 1 M NaOH. Colour correction was done at 490 nm. The Microtox acute toxicity assay was performed in a Microtox 500 Analyzer on samples before and after decoloration according to the test protocols defined by the manufacturer From eight serial dilutions, the percent concentration to decrease 20% of the luminescence of amodified strain ofVibrio fischeri(EC20)after 5 min incubation was calculated with the Microtox data analysis program [Microtox Omni Software(1999) Azur Environmental, Newark, Del.]. A solution of 1 g/l ZnSO4·7H2O was used as the positive control and 1 g/l glucose as the negative control. Each EC20 reported is the average of triplicate analysis.

The concentration to decrease 50% of the bacterial luminescence in the Microtox acute assay (EC50) is normally reported. However, in most of these studies, the EC50 before or after decoloration was greater than 100% indicating that there was no toxicity or toxicity change. To better evaluate whether the decoloration process affected toxicity, the dilution required to decrease 20% of the bacterial luminescence relative to the control (EC20)was reported instead. The following rating was adapted from Coleman & Qureshi (1985) –

EC20:>100%=nontoxic;

>75–100%=slightly non-toxic;

 >50–75%=toxic;

>25–50%=moderately toxic;

<25% very toxic.

The toxicity of 100mg/l of test material determined in terms of EC20 (% dilution) was 44.6 ± 11.6. According to the ranking scheme for Microtox assay using EC20 values, test material can be categorized under moderately toxic category.

2.Toxicity value of test materila to Vibrio fisheri was found to be EC50: 22.19+/-2.47 on the basis of inhibition of the light output after a 5 min exposure period.

Thus, based on the above summarised studies, Ammonium iodide and it’s structurally and functionally similar read across substance, it can be concluded that

4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid is moderately toxic to microorganism.