Tetra(sodium/potassium)-7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chlor-6-({2-[(4-fluor-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]propyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5-methoxyphenyl}diazenyl]-1,3,6-naphthalintrisulfonate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date - 31 July 2006; Experiment completion date - 15 August 2006; Study completion date - 24 December 2006.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identity: FAT 40827/A
Batch: T2 5572 BOP 01/06
Purity: determined in this study
Appearance: black sticky powder
Expiration date: 28.02.2011
Storage: at room temperature

Analytical monitoring:

yes

Details on sampling:

- Concentrations:
- Sampling method: All samples were taken from the approximate center of the aquaria without mixing the test medium.
- Sample storage conditions before analysis: All the samples were deep-frozen at about -20 °C immediately after sampling.

Vehicle:

no

Details on test solutions:

Standard Solutions used for Sample Quantification
The test item (44.5 mg) was dissolved in purified water and made up to the mark in a 100 mL volumetric flask to prepare a stock solution of 445 mg/L. Defined volumes of this stock solution were diluted with purified water to obtain standard solutions of the test item in the range of 3.34 to 111 mg/L. These solutions were used to calibrate the HPLC-system.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Strain: Brachydanio rerio
- Length at study initiation (length definition, mean, range and SD): 3.2 ± 0.2 cm
- Weight at study initiation: 0.33 ± 0.05 g
- Feeding during test: None

ACCLIMATION
- Acclimation period: one week
- Acclimation conditions (same as test or not): same
- Type and amount of food: commercial fish diet (Tetra Min®Hauptfutter, supplied by TETRA-Werke, D-49304 Melle, Germany)
- Health during acclimation: no fish died in the batch of test fish and all fish were healthy

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Remarks on exposure duration:

4 days for pre-test and 4 days for limit test

Hardness:

1.25 mmol/L (= 125 mg/L as CaCO3)

Test temperature:

22 °C

pH:

7.5

Dissolved oxygen:

8.4 - 8.5 mg/L

Nominal and measured concentrations:

Nominal: 100 mg/L
Measured: 105 mg/L at the start of the test; 107 mg/L at the end of the test

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquarium
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 5L
- Aeration: slightly aerated
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.46 g fish wet weight per liter test medium

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water
- Alkalinity: 0.4 mmol/ L
- Ca/mg ratio: 4 : 1 (based on molarity)

OTHER TEST CONDITIONS
- Photoperiod: A 16-hour light to 8-hour dark photoperiod, with a 30-minute transition period.
- Light intensity: 50 - 500 Lux

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The LOEC, the LC100 and the LC50 at the observation times could not be quantified due to the absence of a toxic effect of the test item at the tested concentration.

Validity criteria fulfilled:

yes

Conclusions:

The test substance did not show any mortality towards zebra fish up to 100 mg/l. Thus, the substance is considered to be of low toxicity to fish.

Executive summary:

A GLP-compliant study was performed to determine the toxic effects of test substance to zebra fish during 96 hours according to OECD TG 203. For this purpose, zebra fish (Brachydanio rerio) were exposed in a static non-renewal test to an aqueous test medium at the nominal concentration of 100 mg/L under defined conditions. The decision to perform a limit test was based on the results of a range-finding test. 100 mg/L of test substance and a control were applied in the limit test. The LC50, LOEC and LC100 could not be quantified due to the absence of a toxic effect of the test item at the tested concentration. But it indicated LC50, LC100 and NOEC of the test substance were all above 100mg/L. Thus, it can beconsidered the test substance is low toxicity to zebra fish and is not classified according to EU CLP (Regulation (EC) No 1272/2008).

Description of key information

The LC50, LC100 and NOEC of the test substance were all above 100 mg/L. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

A GLP-compliant study was performed to determine the toxic effects of test substance to zebra fish during 96 hours according to OECD TG 203. For this purpose, zebra fish {Brachydanio rerio) were exposed in a static non-renewal test to an aqueous test medium at the nominal concentration of 100 mg/L under defined conditions. The decision to perform a limit test was based on the results of a rangefinding test. 100 mg/L of test substance and a control were applied in the limit test. The LC50, LOEC and LC100 could not be quantified due to the absence of a toxic effect of the test item at the tested concentration. But it indicated LC50, LC100 and NOEC of the test substance were all above 100mg/L. Thus, it can be considered that the test substance is low toxicity to zebra fish and is not classified according to EU CLP (Regulation (EC) No 1272/2008).