Pentasodium 2,2'-((2,4-diamino-5-(4-methoxy-2-sulfophenylazo)-1,3-phenylene)bis(azo))bis(5-(2-(sulfonatooxyethyl)sulfonyl)benzenesulfonate

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:

From August 16, 2006 to September 05, 2006

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: The analytical concentration of the test substance was determined at 0 and 96 h.
- Sample storage conditions before analysis: Routinely, the samples were analysed immediately. Otherwise, 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 KlöGer (Germany)
- Length at study initiation (length definition, mean, range and SD): 3.4 cm (SD = 0.14 cm)

ACCLIMATION
- Acclimation period: 1 month
- Temperature: 20-24°C
- Dissolved oxygen: >5 mg/L
- Type and amount of food: Commercial fish food
- Feeding frequency: Daily (but discontinued 24 h prior to the test)
- Health during acclimation (any mortality observed): Mortality <5%

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

268 mg CaCO3/L

Test temperature:

20-24°C

pH:

7.6-7.8

Dissolved oxygen:

8.0-9.1 mg/L

Nominal and measured concentrations:

- Nominal concentration: 100 mg/L (500.3 mg of the test item was added to 5 L of dilution water to give the final test concentration of 100 mg/L).
- Measured concentration: The measured concentration of the test substance was 100.26 mg/L at 0 h, and 99.95 mg/L at 96 h.

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria holding 5 L of test media
- Aeration: Gentle aeration via narrow glass tubes
- No. of organisms per vessel: 10
- No. of concentrations tested: 1
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.68 g bw (wet weight)/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water was prepared according to the recommendations of ISO 7346. The total hardness of the dilution water, measured at test start was 268 mg/L CaCO3.

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

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)

Details on results:

Mortality in control: 0/10
Mortality in test: 0/10

Sublethal observations / clinical signs:

Time [h]	LC 50 [mg/L] (Nominal concentration of the test substance)
2	>100
24	>100
48	>100
72	>100
96	>100

The measured concentrations of the test substance was 100.26 mg/L at 0 h, and 99.95 mg/L at 96 h.

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 concentrations) respectively.

Executive summary:

A study was conducted to determine the acute toxicity of the test substance to Zebra fish (Danio rerio) according to EU Method C.1 (which is in most parts equivalent to OECD Guideline 203), in compliance with GLP.

Groups of ten fish were exposed to a limit test concentration of 100 mg/L (nominal) test substance. Observations were made on the numbers of dead fish 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 100.26 mg/L at 0 h, and 99.95 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 concentrations) respectively.

Description of key information

The 96 h LC50 and NOEC of the test substance were found to be >100 mg/L and ≥100 mg/L (nominal concentrations) 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 rerio) according to EU Method C.1 (which is in most parts equivalent to OECD Guideline 203), in compliance with GLP. Groups of ten fish were exposed to a limit test concentration of 100 mg/L (nominal) test substance. Observations were made on the numbers of dead fish 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 100.26 mg/L at 0 h, and 99.95 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 concentrations), respectively (Weyers, 2006b).