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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:
of 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
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
WoE report is based on three short term toxicity study of fish for the test chemical :1.ECOSAR estimates log Kow values using the US EPA's KOWWIN Program for aquatic toxicity.Toxicity of a chemical was measured on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program based upon the octanol /water partition coefficient (Kow). Data from ECOSAR class,neutral organics was used.2.The 48 h immobilization bioassay was performed to evaluate toxicity of test material on Daphnia magna3.Short term toxicity study to Daphnia similis was carried out for 48 hrs.
Specific details on test material used for the study:
- Name of test material (IUPAC name): tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate- Molecular formula: C29H20ClN9O12S4.4Na- Molecular weight:938.173 g/mol- Smiles notation: [Na+].[Na+].[Na+].[Na+].c1(c(cc(cc1)S(=O)(=O)[O-])\N=N\c1ccc(c2ccc(cc12)S(=O)(=O)[O-])\N=N\c1ccc(c2c(cccc12)S(=O)(=O)[O-])Nc1nc(nc(n1)N)Cl)S(=O)(=O)[O-]- InChl: 1S/C29H20ClN9O12S4.4Na/c30-27-33-28(31)35-29(34-27)32-22-10-9-20(17-2-1-3-25(26(17)22)55(49,50)51)37-36-19-7-8-21(18-12-14(52(40,41)42)4-6-16(18)19)38-39-23-13-15(53(43,44)45)5-11-24(23)54(46,47)48;;;;/h1-13H,(H,40,41,42)(H,43,44,45)(H,46,47,48)(H,49,50,51)(H3,31,32,33,34,35);;;;/q;4*+1/p-4/b37-36+,39-38+;;;;- Substance type: Organic- Physical State: Solid
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
other: 1 and 2 Daphnia magna 3. Daphnia similis
Details on test organisms:
2.- Common name: Daphnia magna- Age at study initiation: neonatal less than 24 h- Food type: lyophilized spirulina - Feeding during test: 2 h prior to the test3.TEST ORGANISM- Common name: Daphnia similis- Strain: No data available- Source: No data available- Age at study initiation (mean and range, SD): Neonates of less than 24 h old isolated from Daphnia culture were used for the study.- Weight at study initiation (mean and range, SD): No data available- Length at study initiation (length definition, mean, range and SD): No data available- Valve height at study initiation, for shell deposition study (mean and range, SD): No data available- Peripheral shell growth removed prior to test initiation: No data available- Method of breeding: No data available- Feeding during test: No data available- Food type: No data available- Amount: No data available- Frequency: No data availableACCLIMATION- Acclimation period: No data available- Acclimation conditions (same as test or not): No data available- Type and amount of food: No data available- Feeding frequency: No data available- Health during acclimation (any mortality observed): No data availableQUARANTINE (wild caught)- Duration: No data available- Health/mortality: No data available
Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h
Test temperature:
2) 20±1 °C, 3) 21 ± 0.3°C
Nominal and measured concentrations:
2) 100 mg/l ,
Details on test conditions:
2) - Test vessel: exposure chamber- No. of organisms per vessel: 25 organisms3)TEST SYSTEM- Test vessel: Screw cap tubes- Type (delete if not applicable): No data available- Material, size, headspace, fill volume: No data available- Aeration: No data available- Type of flow-through (e.g. peristaltic or proportional diluter): No data available- Renewal rate of test solution (frequency/flow rate): No data available- No. of organisms per vessel: 5 organism/vessel- No. of vessels per concentration (replicates): 4 repicates- No. of vessels per control (replicates): No data available- No. of vessels per vehicle control (replicates): No data available- Biomass loading rate: No data availableTEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: No data available- Total organic carbon: No data available- Particulate matter: No data available- Metals: No data available- Pesticides: No data available- Chlorine: No data available- Alkalinity: No data available- Ca/mg ratio: No data available- Conductivity: No data available- Culture medium different from test medium: No data available- Intervals of water quality measurement: No data availableOTHER TEST CONDITIONS- Adjustment of pH: No data available- Photoperiod: No data available- Light intensity: No data availableEFFECT PARAMETERS MEASURED (with observation intervals if applicable): After 48 hrs of exposure, the number of immobile organisms was recorded and EC50 was calculated.TEST CONCENTRATIONS- Spacing factor for test concentrations: No data available- Justification for using less concentrations than requested by guideline: No data available- Range finding study: No data available- Test concentrations: No data available- Results used to determine the conditions for the definitive study: No data available
Reference substance (positive control):
yes
Remarks:
K2Cr2o7
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
42.8 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
not specified
Remarks on result:
other: Neutral Organics
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
58.22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
87 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Confidence interval (p – 0.05) is 76-99 mg/l.
Conclusions:
The test chemical tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate is likely to be toxic to aquatic invertebrate in the concentration range of 42 - 87 mg/l
Executive summary:

Data available for the structurally similar read across chemicals and predicted study has been reviewed to determine the short term toxicity of aquatic invertebrate of the test chemical tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino] -5-sulphonato-1-naphthyl]azo] -7-sulphonato-1-naphthyl]azo] benzene-1,4-disulphonate (70161 -16 -9).The studies are as mentioned below:

1.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 42.8 mg/l for CAS nametetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonatein 48 hrs.

Based on this value it can be concluded that the substance is considered to be toxic to aquatic environment and can be classified in aquatic acute 3 category as per the criteria mentioned in CLP regulation.

2.Test material was used to evaluate short term toxicity on 24 h old neonates Daphnia magna as per OECD guideline 202. Untreated ISO formulation freshwater and potassium dichromate (0.32 – 3.2 mg/L) were used as negative and positive controls respectively. The effect concentration (LC50) with Daphnia magna at 48 h was observed to be 58.22 mg/l.

3.Short term toxicity study to Daphnia similis was carried out for 48 hrs. Neonates of less than 24 h old isolated from Daphnia culture were used for the study. Five test organisms were placed in each screw cap tubes, filled with 10 mL solution, and then incubated at 21±0.3°C in the dark. After 48 h of exposure, the number of immobile organisms was recorded. Jspear software was used to calculate the median 50% immobilization concentration (EC50). Based on immobilization of test organism by test chemical , the EC50 value was determine to be 87 mg/l along with confidence interval (p – 0.05) of 76-99 mg/l.

Thus, based on the above summarised studies, and it’s structurally similar read across substance, it can be concluded that effect concetration value is in the range of 42 - 87 mg/L. Thus, comparing this value with the criteria of CLP regulation, tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate can be classified as aquatic acute 3 for short term toxicity for aquatic invertebrate .

Description of key information

Short- term toxicity to aquatic invertebrate:

Data available for the structurally similar read across chemicals and predicted study has been reviewed to determine the short term toxicity of aquatic invertebrate of the test chemical tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino] -5-sulphonato-1-naphthyl]azo] -7-sulphonato-1-naphthyl]azo] benzene-1,4-disulphonate (70161 -16 -9).The studies are as mentioned below:

1.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 42.8 mg/l for CAS nametetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonatein 48 hrs.

Based on this value it can be concluded that the substance is considered to be toxic to aquatic environment and can be classified in aquatic acute 3 category as per the criteria mentioned in CLP regulation.

2.Test material was used to evaluate short term toxicity on 24 h old neonates Daphnia magna as per OECD guideline 202. Untreated ISO formulation freshwater and potassium dichromate (0.32 – 3.2 mg/L) were used as negative and positive controls respectively. The effect concentration (LC50) with Daphnia magna at 48 h was observed to be 58.22 mg/l.

3.Short term toxicity study t oDaphnia similis was carried out for 48 hrs. Neonates of less than 24 h old isolated from Daphnia culture were used for the study. Five test organisms were placed in each screw cap tubes, filled with 10 mL solution, and then incubated at 21±0.3°C in the dark. After 48 h of exposure, the number of immobile organisms was recorded. Jspear software was used to calculate the median 50% immobilization concentration (EC50). Based on immobilization of test organism by test chemical , the EC50 value was determine to be 87 mg/l along with confidence interval (p – 0.05) of 76-99 mg/l.

Thus, based on the above summarised studies, and it’s structurally similar read across substance, it can be concluded that effect concetration value is in the range of 42 - 87 mg/L. Thus, comparing this value with the criteria of CLP regulation, tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate can be classified as aquatic acute 3 for short term toxicity for aquatic invertebrate .

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
42.8 mg/L

Additional information

Short- term toxicity to aquatic invertebrate:

Data available for the structurally similar read across chemicals and predicted study has been reviewed to determine the short term toxicity of aquatic invertebrate of the test chemical tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino] -5-sulphonato-1-naphthyl]azo] -7-sulphonato-1-naphthyl]azo] benzene-1,4-disulphonate (70161 -16 -9).The studies are as mentioned below:

1.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 42.8 mg/l for CAS nametetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonatein 48 hrs.

Based on this value it can be concluded that the substance is considered to be toxic to aquatic environment and can be classified in aquatic acute 3 category as per the criteria mentioned in CLP regulation.

2.Test material was used to evaluate short term toxicity on 24 h old neonates Daphnia magna as per OECD guideline 202. Untreated ISO formulation freshwater and potassium dichromate (0.32 – 3.2 mg/L) were used as negative and positive controls respectively. The effect concentration (LC50) with Daphnia magna at 48 h was observed to be 58.22 mg/l.

3.Short term toxicity study toDaphnia similiswas carried out for 48 hrs. Neonates of less than 24 h old isolated from Daphnia culture were used for the study. Five test organisms were placed in each screw cap tubes, filled with 10 mL solution, and then incubated at 21±0.3°C in the dark. After 48 h of exposure, the number of immobile organisms was recorded. Jspear software was used to calculate the median 50% immobilization concentration (EC50). Based on immobilization of test organism by test chemical , the EC50 value was determine to be 87 mg/l along with confidence interval (p – 0.05) of 76-99 mg/l.

Thus, based on the above summarised studies, and it’s structurally similar read across substance, it can be concluded that effect concetration value is in the range of 42 - 87 mg/L. Thus, comparing this value with the criteria of CLP regulation, tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate can be classified as aquatic acute 3 for short term toxicity for aquatic invertebrate .