7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1985-10-14 to 1985-10-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 and 500 mg/L
- Sampling method: from center of vessel at study start and after 48 and 96 hours
- Sample storage conditions before analysis: directly analysed

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item was pre-diluted in test water and then thoroughly mixed with the test water in the tank
- Controls: blank control performed with the test solution without test substance.
- Evidence of undissolved material: no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Strain: no data
- Source: Hoechst AG, Brüningstr. 64 · 65929 Frankfurt, Germany
- Age at study initiation: 4 months
- Length at study initiation (length definition, mean, range and SD): range: 2.5-3.1 cm; mean: 2.8 cm; SD: 0.19 cm
- Feeding during test: no

ACCLIMATION
- Acclimation period: 12 days
- Feeding during test: yes
- Food type:Tetra Min, Tetra Werke, Mile
- Amount: ad libitum
- Frequency: 2 times per day

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

22 ± 1 °C

pH:

7.1 - 8.0

Dissolved oxygen:

7.8 - 9.4 mg/L

Nominal and measured concentrations:

Nominal concentration: 500 mg/L
Measured concentration: 505 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass
- Material, size, headspace, fill volume: calibrated for 10 L; 30x22x24 cm³
- Aeration:no
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1
- No. of vessels per vehicle control: 1

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 hours cycle dark/light
- Light intensity: 700 LUX

TEST CONCENTRATIONS
- Test concentrations: 0, 500 mg/L
- Range finding test: not performed.

EFFECT PARAMETERS MEASURED: The fish are monitored after 2 , 4, 24, 48, 72 and 96 hours. Mortality, mobility ,appearance and behavior were recorded.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 500 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: measured concentration: 505 mg/L

Details on results:

- Behavioural abnormalities: no abnormalities observed
- Mortality of control: no mortality observed

Validity criteria fulfilled:

yes

Conclusions:

LC50 after 48 and 96 hours is determined to be greater than 500 mg/L. No mortality has been observed.

Executive summary:

The effects of the test substance on the aquatic compartment have been tested for 96 hours in Zebrafish (Danio rerio) according to OECD 203. After administration of the highest concentration of 500 mg/L no mortality and no adverse effects were observed. The LC50 after 48 and 96 hours is more than 500 mg/L. The test substance was stable throughout the experimental period. The deviations from the nominal value (500 mg/L) were up to 1.2%.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 1981-01-09 to 1991-02-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 and 500 mg/L
- Sampling method: from center of vessel at study start and after 48 and 96 hours
- Sample storage conditions before analysis: directly analysed

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item was pre-diluted in test water and then thoroughly mixed with the test water in the tank
- Controls: blank control performed with the test solution without the test substance.
- Evidence of undissolved material: no evidence

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Source: West Aquarium, Bad Lauterberg, Germany
- Age at study initiation: no data
- Length at study initiation: 2.6 - 3.3 cm
- Weight at study initiation: no data
- Temperature: 22 +/- 1 °C
- Feeding during test: no

ACCLIMATION
- Acclimation period: 14 days
- Food type: Tetra Min, Tetra Work, Melle
- Frequency: twice a day, ad libitum

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

21.3 - 22.8 °C

pH:

7.8 - 8.0

Dissolved oxygen:

7.8 - 9.2 mg/L

Nominal and measured concentrations:

Nominal concentration: 0 (control) and 500 mg/L
Measured concentration: 0 and 502 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass
- Material, size, headspace, fill volume: calibrated for 10 L; 30x22x24 cm³
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 hours
- Light intensity: 700 LUX

TEST CONCENTRATIONS
- Test concentrations: 0, 500 mg/L

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 500 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 500 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Any observations: the substance colors the test tank of a dark red color that does not allow the clear evaluation of other parameters
- Effect concentrations exceeding solubility of substance in test medium: no
- Mortality of control: no
During the test no mortalities were observed.

Results with reference substance (positive control):

No test with reference substance was performed.

Validity criteria fulfilled:

yes

Conclusions:

During the test no mortalities were observed. Following results were determined: LC0 >= 500 mg/L, LC50 > 500 mg/L

Executive summary:

The effects of the test substance on the aquatic compartment have been tested for 96 hours in Zebrafish (Danio rerio) according to OECD 203. The test compound was the hydrolysis product in water of the structural analogue 01. After administration of the highest concentration of 500 mg/L no mortality and no adverse effects were observed. The LC50 after 48 and 96 hours is more than 500 mg/L.

The test item preparation appeared as a dark-colored solution. To determine the test item content, samples were taken at start of the experiment and after 48 , 96 hours from the middle of vessel. The analytical values​ ​were in the range ± 20% of the nominal concentration.

Description of key information

 The 96h LC50 for the read across substance (structural analogue 01 as lithium salt) or its hydrolysis product (structural analogue 01 -OH) was determined according to OECD 203 to be greater than 500 mg/L.

Additional information

The effects of the test substance (structural analogue 01 as lithium salt) on the aquatic compartment have been tested for 96 hours in Zebrafish (Danio rerio) according to OECD 203. After administration of the highest concentration of 500 mg/L no mortality and no adverse effects were observed. The LC50 after 48 and 96 hours is more than 500 mg/L. The test substance was stable throughout the experimental period. The deviations from the nominal value (500 mg/L) were up to 1.2 %.

In another test, the effects of the test substance on the aquatic compartment have been tested for 96 hours in Zebrafish (Danio rerio) according to OECD 203. The test compound was the hydrolysis product in water of the structural analogue 01 (SA01 -OH). After administration of the highest concentration of 500 mg/L no mortality and no adverse effects were observed. The LC50 after 48 and 96 hours is more than 500 mg/L.

The test item preparation appeared as a dark-colored solution. To determine the test item content, samples were taken at start of the experiment and after 48 , 96 hours from the middle of vessel. The measured deviations from the nominal value (500 mg/L) were 0.4%.