Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study according to OECD Guideline No. 203 and GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Appr. 100 mL samples were taken from the middle of the test vessel at 0, 48 and 96 hours respectively.

Vehicle:

yes

Details on test solutions:

PREPARATION OF TEST SOLUTION
the test item was mixed with 0.095 mL Tween 80/L in dilution water. After homogenizitation by ultrasound and intensive stirring the mixture was incorporated into the test vessel and stirred for another 2 hours.
Concentration of the test item in the treatment vessel was determined after 0, 48 and 96 h respectively.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Strain: Brachydanio rerio (Hamilton-Buchanan)
- Source: West Aquarium, D-37431 Bad Lauterberg, Germany
- Age at study initiation: 5 months
- Length at study initiation (mean, range and SD): 2.9 cm, 2,6 - 3.3 cm, SD 0.22
- Feeding during test: No feeding during the test

ACCLIMATION
- Acclimation period: at least 14 days
- Type and amount of food: Tetra Min, ad libitum
- Feeding frequency: 2 times per day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Photoperiod (hrs dark / hrs light): 12/12
- The dissolved oxygen concentration was more than 80 % of the air saturation value

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

Observations were carried out during exposure at the beginning of the experiment and after 2 - 4, 24, 48, 72 and 96 hours.

Test temperature:

21.9°C - 22.2°C (treatment), 20.8°C - 22.2°C (control; due to a technical defect of the thermostat the temperature shortly fell to 20.8°C)

pH:

7.4 - 7.9 (treatment), 7.3 - 8.3 (control)

Dissolved oxygen:

6.7 - 8,8 mg/L (treatment); 6.0 - 9.2 mg/L (control)

Nominal and measured concentrations:

Nominal concentration: 500 mg/L
Measured concentrations: 536.9 mg/L - 500.2 mg/L - 432.4 mg/L (mean 465 mg/L)

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass-aquaria 30 cm x 22 cm x 24 cm, 10 L per vessel
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 2 (1 with solutizer)
- Biomass loading rate: fish density in the tanks was less than 1 g per litre test solution.


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water, quality according ISO 7346/1. The water was saturated with oxygen. pH-value: 8.2.
pH , temperature and oxygen saturation were observed at the beginning, after 2-4, 24, 48, 72 and 96 h in all vessels


OTHER TEST CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
- Light intensity: 700 Lux


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and behavior of the test fish and control fish were observed at 2-4, 24, 48, 72, 96 h.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Details on results:

- There was no mortality in control as well as in treated fish at any observation time point.
- Behavioural abnormalities: Neither in treated nor in control fish could any abnormalities be observed at any observation time points. Due to yellow staining in the treatment group observation of symptoms was restricted.

Validity criteria fulfilled:

yes

Conclusions:

In this study the test item did not cause any effects to zebrafish after 96 h when tested with a 500 mg/L (nominal) solution using Tween 80 as solubilzer.

Executive summary:

The acute toxicity of the test item to fish (zebrafish) was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1984) at Hoechst AG, Frankfurt, Germany. A static limit test with a 500 mg/L solution, using a solutizer was conducted. The preparation method has been chosen with regard to the test item properties and in accordance with the relevant OECD guidance document. Duration of the test was 96 h. 10 test organisms were exposed to the test solution and the controls. Water quality parameters pH-value, temperature and oxygen-saturation measured after 0, 2 -4, 24, 48, 72 and 96 h were determined to be within the acceptable limits. Test item analysis was carried out at 0, 48 and 96 h. Concentrations were above 80 % of the initial concentration.

The 500 mg/L solution of the test item didn´t show any signs of toxicity nor lethality at all observation time points up to 96 hours.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

GLP compliance:

yes

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Details on results:

- There was no mortality in control as well as in treated fish at any observation time point.
- Behavioural abnormalities: Neither in treated nor in control fish could any abnormalities be observed at any observation time points. Due to yellow staining in the treatment group observation of symptoms was restricted.

Validity criteria fulfilled:

yes

Conclusions:

In this study the test item did not cause any effects to zebrafish after 96 h when tested with a 500 mg/L (nominal) solution using Tween 80 as solubilzer.

Executive summary:

The acute toxicity of the test item to fish (zebrafish) was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1984) at Hoechst AG, Frankfurt, Germany. A static limit test with a 500 mg/L solution, using a solutizer was conducted. The preparation method has been chosen with regard to the test item properties and in accordance with the relevant OECD guidance document. Duration of the test was 96 h. 10 test organisms were exposed to the test solution and the controls. Water quality parameters pH-value, temperature and oxygen-saturation measured after 0, 2 -4, 24, 48, 72 and 96 h were determined to be within the acceptable limits. Test item analysis was carried out at 0, 48 and 96 h. Concentrations were above 80 % of the initial concentration.

The 500 mg/L solution of the test item didn´t show any signs of toxicity nor lethality at all observation time points up to 96 hours.

Description of key information

The acute toxicity of the test item to fish (zebra fish) was determined according to OECD-Guideline for Testing of Chemicals No. 203. A static limit test with a 500 mg/L solution was conducted. The 500 mg/L solution of the test item didn´t show any signs of toxicity nor lethality at all observation time points up to 96 hours.