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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
for read across substance
Justification for type of information:
Data for the target chemical is summarized based on the structurally similar read across chemicals
Reason / purpose:
read-across source
Related information:
Composition 1
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on two short term toxicity study of aquatic invertebrate for the test chemical:
1.Short term toxicity of test materail to aquatic invertebrates was performed according to the OECD guideline in a static system.
2.To evaluate short term toxicity to Daphnia magna by the test chemical .
GLP compliance:
not specified
Test material information:
Composition 1
Specific details on test material used for the study:
- Name of test material (IUPAC name): 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid
- Molecular formula: C17H14N2O8S2
- Molecular weight: 438.4356 g/mol
- Smiles notation: c1cc(cc(c1)N)C(=O)Nc2ccc(c3c2c(cc(c3)S(=O)(=O)O)O)S(=O)(=O)O
-InChl:1S/C17H14N2O8S2/c18-10-3-1-2-9(6-10)17(21)19-13-4-5-15(29(25,26)27)12-7-11(28(22,23)24)8-14(20)16(12)13/h1-8,20H,18H2,(H,19,21)(H,22,23,24)(H,25,26,27)
- Substance type: Organic
- physical state: solid
Analytical monitoring:
yes
Details on sampling:
1.The stock solution 100 mg/l was prepared by dissolving orange powder in reconstituted water. Test solutions of required concentrationas were prepared by mixing the stock solution of the test sample with reconstituted test water.
Vehicle:
not specified
Test organisms (species):
Daphnia magna
Details on test organisms:
1.TEST ORGANISM
- Common name: Water flea
- Strain: Straus
- Source: Own breeding at University of Chemistry and Technology, Prague
- Age at study initiation (mean and range, SD): The animals used for the test shall be less than 24 h old and should not be first brood progeny
- Feeding during test: No feeding
Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h
Post exposure observation period:
2. test was performed for 24 h as well as 48 h
Test temperature:
1) 20±1°C
pH:
1) Test at 100 mg/l: 7.9 (changed to 7.7 during test)
Control 1: 7.7 (no change during test)
Control 2: 7.7 (changed to 7.6 during test)
Dissolved oxygen:
1.higher than 7.6 mg/L at the end of test
Nominal and measured concentrations:
1) 0, 6, 10, 18, 32, 58 and 100 mg/l
Details on test conditions:
1.TEST SYSTEM
- Test vessel: 50 ml glass vessel
- fill volume: 25 ml
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Natural water (surface or ground water), reconstituted water or dechlorinated tap water are acceptable as culturing and dilution water if D. magna survives in it for the duration of the culturing, acclimation and testing without showing signs of stress. Waters in the range pH 6 to pH 9, with hardness between 140 mg/l and 275 mg/l (as CaCO3) are recommended.
As an example, the preparation of dilution water meeting the requirements is described below.
Dissolve known quantities of reagents in water. The dilution water prepared shall have a pH of 7.8 ± 0.5, a hardness of (225 ± 50) mg/l (expressed as CaCO3), a molar Ca + Mg ratio close to 4 + 1 and a dissolved oxygen concentration above 7 mg/l.

Prepare the solutions specified below:
- Calcium chloride solution: Dissolve 117.6 g of calcium chloride dihydrate (CaCl2.2H2O) in water (4.2) and make up to 1 l with water (4.2).
- Magnesium sulfate solution: Dissolve 49.3 g of magnesium sulfate heptahydrate (MgSO4.7H2O) in water (4.2) and make up to 1 l with water (4.2).
- Sodium bicarbonate solution: Dissolve 25.9 g of sodium bicarbonate (NaHCO3) in water (4.2) and make up to 1 l with water (4.2).
- Potassium chloride solution: Dissolve 2.3 g of potassium chloride (KCI) in water (4.2) and make up to 1 l with water (4.2).

Mixing
Mix 2.5 ml of each of the four solutions and make up to 1 l with water.
The dilution water shall be aerated until the dissolved oxygen concentration has reached saturation and the pH has stabilized. If necessary, adjust the pH to 7.8 ± 0.5 by adding sodium hydroxide (NaOH) solution or hydrochloric acid (HCI). The dilution water prepared in this way shall not be further aerated before use.

- Sodium hydroxide solution, e.g. [NaOH] : 1 mol/l.
- Hydrochloric acid, e.g. [HCl] : 1 mol/l.

Reference substance:
Dissolve 600 mg of potassium dichromate (K2Cr2O7) in water and make up to 1 l with water (4.2).

OTHER TEST CONDITIONS
- Adjustment of pH: no adjustment done
- Photoperiod: No - Darkness
- Light intensity:

CALCULATION:
EC50 was calculated using non linear regression by the software Prism 4.0
Reference substance (positive control):
yes
Remarks:
K2Cr2O7
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
54.8 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CI was 41.8-71.8 mg/l
Remarks:
Read across 1
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
34 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Read across 2
Results with reference substance (positive control):
- Results with reference substance valid
- EC50: 0.79 mg/L (24 hours)
Validity criteria fulfilled:
not specified
Conclusions:
The test chemical 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid is likely to be toxic to Daphnia magna atleast in the concentration range 34-54 of mg/l
Executive summary:

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 .

Description of key information

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 .

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
54 mg/L

Additional information

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 .