Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
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 secondary sources
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Principles of method if other than guideline:
Aim of this study was to investigate the effects of test chemical on the growth of fish.
GLP compliance:
not specified
Specific details on test material used for the study:
Details on test material- 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
Vehicle:
yes
Details on test solutions:
Details on test solutionsPREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Chemical name of vehicle (organic solvent, emulsifier or dispersant): DMSO- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 0.5 mg/l
Test organisms (species):
Oryzias latipes
Test type:
flow-through
Water media type:
freshwater
Total exposure duration:
96 h
Nominal and measured concentrations:
5 nominal concentrations ranges from 17.1-180 mg/l.
Details on test conditions:
Details on test conditions:- Type (delete if not applicable): openA group of 10 fishes were exposed to 5 nominal concentrations.
Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
33 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Other details not known
Validity criteria fulfilled:
not specified
Conclusions:
After the exposure of test chemical for 96 hrs, the LC50 was determine to be 33 mg/l for Oryzias latipes.
Executive summary:

Aim of this study was to investigate the effects of test chemical calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate (D & C Red no. 7) on the growth of fish. Study was conducted according to the OECD guideline 203. 0.5 mg/l DMSO were used as a solvent. Five different concentration were prepared which ranges from17.1-180 mg/l. Test performed in open system by following flow-through method. A group of 10 fishes were exposed to 5 nominal concentrations. After the exposure of test chemical for 96 hrs, the LC50 was determine to be 33 mg/l for Oryzias latipes. Based on the LC50, chemical calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate was consider as toxic and classified as aquatic chronic 3 as per the CLP classification criteria.

Description of key information

Aim of this study was to investigate the effects of test chemical calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate (D & C Red no. 7) on the growth of fish. Study was conducted according to the OECD guideline 203. 0.5 mg/l DMSO were used as a solvent. Five different concentration were prepared which ranges from17.1-180 mg/l. Test performed in open system by following flow-through method. A group of 10 fishes were exposed to 5 nominal concentrations. After the exposure of test chemical for 96 hrs, the LC50 was determine to be 33 mg/l for Oryzias latipes. Based on the LC50, chemical calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate was consider as toxic and classified as aquatic chronic 3 as per the CLP classification criteria.

Key value for chemical safety assessment

LC50 for freshwater fish:
33 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 fish 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 2017 toxicity was measured on fish. Aim of this study was to investigate the effects of test chemical calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate (D & C Red no. 7) on the growth of fish. Study was conducted according to the OECD guideline 203. 0.5 mg/l DMSO were used as a solvent. Five different concentration were prepared which ranges from17.1-180 mg/l. Test performed in open system by following flow-through method. A group of 10 fishes were exposed to 5 nominal concentrations. After the exposure of test chemical for 96 hrs, the LC50 was determine to be 33 mg/l for Oryzias latipes. Based on the LC50, chemical calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate was consider as toxic and classified as aquatic chronic 3 as per the CLP classification criteria.

 

Similarly in the second study from the secondary sources supports the classification for fish. Aim of this study was to investigate the effects of test chemical calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate (D & C Red no. 7) on the growth of fish. Study was conducted according to the Japanese Industrial Standard (JIS K 0 102- 1986-71). 0.5 mg/l DMSO were used as a solvent. Five different concentration were prepared which ranges from17.1-180 mg/l. Test performed in open system by following flow-through method. A group of 10 fishes were exposed to 5 nominal concentrations. Based on the mortality of fish Oryzias latipes by the chemical exposure calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2-naphthoate (D & C Red no. 7) for 48 hrs, the LC50 was determine to be 50 mg/l. Based on the LC50, chemical was consider as toxic and classified as aquatic chronic 3 as per the CLP classification criteria.

 

Above studies was supported by the third experimental study for the structural and functional similarity read across chemical (from experimental study report 2017). The study was designed to assess the toxic effects of the test compound on the Zebra Fish (Danio rerio). Study was conducted according to the OECD Guideline 203 (Fish, Acute Toxicity Test). The test substance was soluble in water. Therefore, the test solution was prepared by dissolving 1 g of the test substance in 1 liters of potable water (passed through reverse osmosis system) with 2 hours continuous stirring for achieving test concentrations of 6.25mg/L, 12.5mg/L, 25mg/L, 50mg/L,100mg/L ,respectively. The test vessels used were all plastic aquaria having the water capacity of 5liters. Bowl aquaria containing 2 liters of potable water (passed through reverse osmosis system) were loaded with 8 fishes each. A static procedure was used for the study. The experimental phase of the main study was for a period of 96 hrs. Observations (mortality, visible symptoms, pH, Temperature, dissolved oxygen content) were recorded after 24, 48, 72 and 96 hours of the start of the experiment. The fishes were moving slowly as compared to control. No mortalities were observed in the control aquaria. The lethal concentrations LC50 was determine to be 50 mg/L. As the experiment was conducted according to the OECD guideline and fulfill all the necessary criteria required for standard, thus it was consider as valid.

LC0 (96 hours) (highest loading at which no mortality was observed) = 25 mg/L

LC50 (96 hours) Experimental = 50 mg/L

LC100 (96 hours) (lowest loading at which 100% mortality was observed) = 100 mg/L

This value indicates that the substance is toxic to fish and can be classified as Aquatic chronic category 3.

 

Thus based on the above results for the chemical from various sources, it can be concluded that the test chemical calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl) diazenyl]-2- naphthoate (CAS no. 5281-04-9) was consider as toxic and classified as aquatic chronic 3 as per the CLP classification criteria.