tetrasodium 3-amino-4-{[4-({4-fluoro-6-[phenyl(2-{[2-(sulfonatooxy)ethyl]sulfonyl}ethyl)amino]-1,3,5-triazin-2-yl}amino)-2-sulfonatophenyl]diazenyl}-5-hydroxynaphthalene-2,7-disulfonate

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:

Jan. 10, 2005 and Jan. 14, 2005

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:

yes

Remarks:

Some test fish had a bit larger size than the one recommended in the test guideline for the zebra fish. This deviatiation was not regarded to be relevant to the results.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: at 0, 24, 48, 72 and 96 h
- Storage: Routinely, the samples were analysed immediately. Only in exceptional cases, they were stored overnight deeply frozen and protected from light.

Vehicle:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Aqua K16Ger (Germany)
- Length at study initiation: 3.48 cm (S.D. = 0.14 cm, n = 20)
- Feeding during test: no feeding during the exposure period

ACCLIMATION
- Acclimation period: Dec. 06, 2004 to Jan. 09, 2005 (35 d)
- Acclimation conditions: Temperature 0 - 24°C, dissolved oxygen > 5 mg/L
- Type and amount of food: Commercial fish food. Discontinued 24 h prior to test.
- Feeding frequency: daily
- Health during acclimation (any mortality observed): <5 %

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

291 mg/L CaCO3

Test temperature:

21.1 - 22.0°C

pH:

7.6 - 8.1

Dissolved oxygen:

7.9 - 9.0 mg/L (89 - 101%)

Nominal and measured concentrations:

0, 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria holdiug 5 L of test media
- Aeration: gentle aeration via narrow glass tubes
- Renewal rate of test solution (frequency/flow rate): none
- No. of organisms per vessel:
- Biomass loading rate: 0.95 g bw (wet weight)/L

OTHER TEST CONDITIONS
- Photoperiod: 16 h light: 8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : observations on mortality at 2, 24, 48, 72 and 96 h and subjective assessments on type and incidence of sub-lethal effects compared with controI fish.

TEST CONCENTRATIONS
- Test concentrations: 0 and 100 mg/L

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Sublethal observations / clinical signs:

Recovery rates correspond to 99.7% of nominal values at 0 h, to 100.5% of nominal values at 24 h, to 100.3% of nominal values at 48 h, to 98.9% of nominal values at 72 h and 98.6% of nominal values at 96 h, respectively.

No deaths or abnormalities occurred in control or test groups during the exposure period.

Validity criteria fulfilled:

yes

Conclusions:

Under the test conditions, the 96 h LC50 and NOEC of the test substance were found to be >100 mg/L and 100 mg/L (nominal), respectively.

Executive summary:

A study was conducted to determine the acute toxicity of the test substance to zebra fish (Danio rario) according to EU method C.1 and in compliance with GLP.

The study consisted of two groups of ten fish exposed to at the concentrations of 0 mg/L (control) and 100 mg/L of test substance. Observations were made for the mortality and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 h of exposure. The analytical concentration of the test substance was measured by HPLC and was found to be 99.7 mg/L at 0 h, and 98.6 mg/L at 96 h. No mortality was observed in the control or test substance treated groups.

Under the test conditions, the 96 h LC50 and NOEC of the test substance were found to be >100 mg/L and 100 mg/L (nominal), respectively.

Description of key information

The 96-h LC50 and NOEC of the test substance were found to be >100 and 100 mg/L (nominal ), respectively.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

A study was conducted to determine the acute toxicity of the test substance to zebra fish (Danio rario) according to EU method C.1, in compliance with GLP. The study consisted of two groups of ten fish exposed to concentrations of 0 (control) and 100 mg/L of test substance. Observations were made for mortality and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 h. The analytical concentration of the test substance was measured by HPLC and was found to be 99.7 mg/L at 0 h and 98.6 mg/L at 96 h. No mortality was observed in the control or test substance treated groups. Under the test conditions, the 96 h LC50 and NOEC were found to be >100 and 100 mg/L (nominal concentrations), respectively (Bruns, 2005b).