Pentasodium 2-(bis{halo-[(halo- sulfonatoaryl)diazenyl]-2-(sulfonatoalkoxy)anilino}-triazin-ylamino)alkanesulfonate

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:

20-24 December 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed according to OECD guidelines and following GLP principles.

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: Alga growth inhibition test, Daphnia Sp. acute immobilisation test, and fish acute toxicity test"(Yakushokuhatsu No. 1121002, Heisei 15.11.13, Seikyoku No. 2, Kanpokihatsu No.031121002, November 21, 2003; the latest revision, November 20, 2006

GLP compliance:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): E-Y110
- Substance type: orange powder
- Physical state: solid
-Batch number: MB-1
- Stability under test conditions: stable
- Storage condition of test material: the test substance was stored in a desiccator (room temperature, shaded, air-tight)

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations:0 and 100 mg/L
- Sampling method: not indicated
- Sample storage conditions before analysis: not indicated

Test solutions

Vehicle:

no

Details on test solutions:

The test solutions were prepared by dissolving 500 mg substance in 5000 ml dechlorinated water. The solution was mixed by stirring with a magnetic stirrer for 5 min. New test solutions were prepared at 0 and 48 h

Test organisms

Test organisms (species):

Oryzias latipes

Details on test organisms:

TEST ORGANISM
- Common name: Medaka
- Strain: Oryzias latipes
- Source: Tsunashima Fishing Co.
- Age at study initiation (mean and range, SD): less than 1/2 year after hatching
- Length: 2.08 cm (1.91-2.41 cm), n=10 (measurements for the control fish at the end of exposure)
- Weight: 0.076 g (0.052-0.116 g), n=10 (measurements for the control fish at the end of exposure)
- Feeding during test: none


ACCLIMATION
- Acclimation period: 13-20 December, 2010
- Acclimation conditions (same as test or not): yes
- Type and amount of food: TetraMin, TetraWerke
- Feeding frequency: daily until 24 h before exposure
- Health during acclimation (any mortality observed): less than 5% mortality during 7 days before the test

Study design

Test type:

semi-static

Water media type:

freshwater

Total exposure duration:

96 h

Test conditions

Hardness:

48 mg CaCO3/L

Test temperature:

23.0 - 23.6

pH:

7.4 - 7.9

Dissolved oxygen:

7.2 - 8.2 mg/L

Nominal and measured concentrations:

Nominal: 0 and 100 mg/L
Measured (mean): 102 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 5 L glass
- Type: closed
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): batchwise renewal after 48 h exposure
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 10 fish per concentration

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:dechlorinated water processed by YOKOHAMA city tap water
- Total organic carbon: not detected
- Metals: only Al measured at 0.05 mg/L
- Pesticides: not detected
- Chlorine: not detected
- Alkalinity: at pH 4.8, 48 mg CaCO3/L
- Ca/mg ratio: 14/3 mg/L
- Culture medium different from test medium: no
- Intervals of water quality measurement: every six months

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/ 8 h dark
- Light intensity: 1000 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : median lethal concentration, every 24 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: only 0 and 100 mg/L; the results of the limit test were considered for the final test
- Range finding study: no
- Results used to determine the conditions for the definitive study:no death or abnormalityobserved up to 100 mg/L substance

Reference substance (positive control):

yes

Remarks:

CuSO4 (II)*5H2O

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

the measured concentration was within 20% of the nominal

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: no
- Observations on body length and weight: not reported
- Other biological observations: not reported
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no floating solids or precipitations observed
- Effect concentrations exceeding solubility of substance in test medium: no

Results with reference substance (positive control):

- Mortality: yes
- LC50: at 96 h was 0.57 mg/L (95% C.I of 0.39 - 0.80 mg/L)

the historical data from the laboratory (n = 59, since 1995). Average 0.81 +/- 0.27 mg/L (95% C.I. 0.33 - 1.5 mg/L)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the study, E-Y 110 did not cause mortality in fish up to 100 mg/L (LC50 > 100 mg/L).