Dodeca (lithium, sodium)-2-({4-[4-(4-{bis[alkyl-(sulfonatoalkoxy)-4-({-sulfonato-[(substituted-phenyl)diazenyl]phenyl} diazenyl)anilino]-triazin-yl}-6-[alkyl-(sulfonatoalkoxy)-4-(sulfonato--[(substituted-phenyl)diazenyl]phenyl)diazenyl)anilino]piperazin-yl)-triazin-ylamino]-alkyl-5-(sulfonatoalkoxy)phenyl}diazenyl)-5-[(sulfonatophenyl)diazenyl]benzensulfonate

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16-20 May 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The test has been performed under GLP principles and following OECD and Chinese guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: State Environmental Protection Administration of China. The guidelines for the testing of chemicals, 203 fish acute toxicity test. China Environmental Science Press, 2004

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: State Environmental Protection Administration of China. The guidelines for the test of chemicals (HJ/T 153-2004), Beijing, 2004

Deviations:

no

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): E-BW 102
- Substance type: reddish brown powder
- Physical state: solid
- Stability under test conditions: stable
- Storage condition of test material: room temperature, avoiding light

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control and 108 mg/L
- Sampling method: not reported
- Sample storage conditions before analysis: not reported

Test solutions

Vehicle:

no

Details on test solutions:

0.323 g test substance was dissolved in test water, ultrasonicated for 5 min and then the volume adjusted to 3 L such as that the final concentration was 108 mg/L

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Strain: Brachydanio rerio
- Source: Kang Da breding farm
- Age at study initiation (mean and range, SD): not reported
- Length at study initiation (length definition, mean, range and SD): 22.99 mm - 26.71 mm
- Weight at study initiation (mean and range, SD): 0.144 g - 0.321 g
- Method of breeding: not reported
- Feeding during test no feeding


ACCLIMATION
- Acclimation period: 53 days before the start of the experiment, flow-through
- Acclimation conditions (same as test or not): yes
- Type and amount of food: not reported
- Feeding frequency: daily
- Health during acclimation (any mortality observed): mortality 0% during 7 days before the start

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

mortality and abnormality recorded at 24, 48, 72 and 96 h

Test conditions

Hardness:

131.97 mg/L (CaCO3)

Test temperature:

21.7 - 24.9 C

pH:

7.14 - 7.96

Dissolved oxygen:

61 - 102 mg/L

Nominal and measured concentrations:

Nominal: 108 mg/L
Measured: 106 mg/L (averaged)

Details on test conditions:

TEST SYSTEM
- Test vessel: not reported
- Material, size, headspace, fill volume: 3L
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1.0 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water



OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 14 h light/10 h darkness
- Light intensity: not reported

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality at 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: only a control and 108 mg/L used
- Justification for using less concentrations than requested by guideline: no mortality observed in the limit test
- Range finding study: no, only a limit test
- Test concentrations: 0 and 108 mg/L
- Results used to determine the conditions for the definitive study: no mortality or abnormal behavior observed

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 108 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

measured concentration was within 20% of nominal

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: none
- Observations on body length and weight: not reported
- Other biological observations: not reported
- Mortality of control: none
- Other adverse effects control: not reported
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: not reported
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

- Results with reference substance valid?
- Mortality: yes
- LC50: at 24 h was 301 mg/L (95 C.I of 262 - 346 mg/L)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the present test there was no mortality observed in zebra fish at concentrations of 108 mg/L E-BW 102 (LC50 > 108 mg/L).