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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:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from SIDS report.
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
No data available
Deviations:
not specified
Principles of method if other than guideline:
Detection of the effect of test chemical on the growth of daphnia magna by following standard OECD guideline.
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-Naphthalenecarboxylic acid, 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-, calcium salt- Molecular formula (if other than submission substance): C18H14N2O6S.Ca- Molecular weight (if other than submission substance): 424.445 g/mole- Smiles notation (if other than submission substance): c12c(c(c(C(=O)[O-])cc1cccc2)O)\N=N\c1c(cc(C)cc1)S(=O)(=O)[O-].[Ca+2]- InChl (if other than submission substance): 1S/C18H14N2O6S.Ca/c1-10-6-7-14(15(8-10)27(24,25)26)19-20-16-12-5-3-2-4-11(12)9-13(17(16)21)18(22)23;/h2-9,21H,1H3, (H,22,23)(H,24,25,26);/q;+2/p-2/b20-19+;- Substance type: Organic - Physical state: Solid - Analytical purity: 87%- Impurities (identity and concentrations): 13%
Analytical monitoring:
no
Details on sampling:
No data available
Vehicle:
not specified
Details on test solutions:
No data available
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM- Common name: Water flea
Test type:
static
Water media type:
freshwater
Total exposure duration:
24 h
Remarks on exposure duration:
No data available
Post exposure observation period:
No data available
Hardness:
No data available
Test temperature:
No data available
pH:
No data available
Dissolved oxygen:
No data available
Salinity:
No data available
Conductivity:
No data available
Nominal and measured concentrations:
5 nominal concentrations (90-940 mg/l)
Details on test conditions:
- Type (delete if not applicable): Closed - No. of organisms per vessel: 5- No. of vessels per concentration (replicates): 4- No. of vessels per control (replicates): 4- No. of vessels per vehicle control (replicates): 4
Reference substance (positive control):
not specified
Key result
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
280 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: Nontoxic
Details on results:
No data available
Results with reference substance (positive control):
No data available
Reported statistics and error estimates:
No data available
Validity criteria fulfilled:
not specified
Conclusions:
Based on the immobilization of daphnia magna by the chemical 2-Naphthalenecar- boxylic acid, 3-hydroxy-4-[(4-methyl-2-sulfophenyl)azo]-, calcium salt (D & C Red no. 7) for 24hrs, the EC50 was 280 mg/l.
Executive summary:

Detection of the effect of calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate on the growth of daphnia magna by following standard OECD guideline. The test was performed in static system by following the OECD guideline. Daphnia magna exposed with the chemical for 24hrs. Based on the immobilization of daphnia magna by the chemical calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate (D & C Red no. 7) for 24hrs, the EC50 was 280 mg/l. Based on the EC50, chemical was consider as nontoxic and not classified as per the CLP classification criteria.

Description of key information

Detection of the effect of calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate on the growth of daphnia magna by following standard OECD guideline. The test was performed in static system by following the OECD guideline. Daphnia magna exposed with the chemical for 24hrs. Based on the immobilization of daphnia magna by the chemical calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate (D & C Red no. 7) for 24hrs, the EC50 was 280 mg/l. Based on the EC50, chemical was consider as nontoxic and not classified as per the CLP classification criteria.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
280 mg/L

Additional information

Based on the experimental data for the target compound calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate (CAS no. 5281-04-9) and experimental studies for supporting studies for its structural and functional similarity were reviewed for the short term toxicity on the aquatic invertebrates end point which are summarized as below: 

 

In the first key study for the target chemical calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate from secondary sources toxicity was measured. Detection of the effect of calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate on the growth of daphnia magna by following standard OECD guideline. The test was performed in static system by following the OECD guideline. Daphnia magna exposed with the chemical for 24hrs. Based on the immobilization of daphnia magna by the chemical calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate (D & C Red no. 7) for 24hrs, the EC50 was 280 mg/l. Based on the EC50, chemical was consider as nontoxic and not classified as per the CLP classification criteria.

 

First study was supported by the second experimental study for the structural and functional similarity read across chemical (from experimental study 2016). Determination of the inhibition of the mobility of daphnids was carried out with the test substance according to OECD Guideline 202. A limit test at sample concentration of 100 mg/L was performed. Effects on immobilisation were observed for 48 hours. The median effective concentration (EC50) for the test substance, in Daphnia magna was determined to be >100 mg/L for immobilisation effects. Based on this EC50 value and after comparing with CLP criteria for aquatic classification of the substance it is concluded that the substance, does not exhibit short term toxicity to aquatic invertebrate (Daphnia Magna) and not classified.

Similarly in the third study for the structurally similar read across chemical toxicity was measured (from experimental study 2016). Determination of the inhibition of the mobility of daphnids was carried out with the substance according to OECD Guideline 202. The limit test was performed at 100 mg/l. Effects on immobilisation were observed for 48 hours. The solution 100 mg/l was prepared by dissolving brown powder in reconstituted water. The effective concentration (EC8) for the test substance, in Daphnia magna was determined to be 100 mg/L on the basis of mobility inhibition effects in a 48 hour study. This value indicates that the substance is likely to be non-hazardous to aquatic invertebrates and cannot be classified as toxic as per the CLP criteria.

 

Based on the above experimental data from various sources, chemical calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate (CAS no. 5281-04-9) was consider as nontoxic and not classified as per the CLP classification criteria.