Octasodium 2,2'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino(1-hydroxy-3,6-disulphonatonaphthalene-2,8-diyl)azo]]bisnaphthalene-1,5-disulphonate

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

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)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Remarks:

HPLC-UV/vis

Details on sampling:

Sampling schedule:
- Control: at 96 hours
- Test item concentrations: at 0 and 96 hours

Vehicle:

no

Remarks:

Auxiliary: ultrasonic bath

Details on test solutions:

Pre-treatment of test item and preparation of test item concentrations
- a direct weighing was prepared to give the limit test item concentration of 100 mg/L active ingredient, which equals to 129 mg/L test item
- 649.2 mg of the test item (= 100 mg/L active ingredient) were added to 5 litres of dilution water, for 1 h in an ultrasonic bath
- pH was measured to be 7.6

Standard Solutions used for Calibration of the test item
- 25.3 mg of the test item were dissolved and made up with Millipore water to the mark in a 100 mL volumetric flask to prepare a stock solution of 196.075 mg/L calculated as active ingredient
- Defined volumes of this stock solution were diluted with Millipore water to obtain standard solutions in the range of 58.823 to 137.253 mg/L

Standard Solutions used for Verification of the Calibration of the test item and Blank Test
- 32.2 mg of the test item were dissolved and made up with Millipore water to the mark in a 100 mL volumetric flask to prepare a stock solution of 249.550 mg/L calculated as active ingredient
- solution was diluted with Millipore water to obtain a concentration of 124.775 mg/L

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

- Name: Zebra fish (Danio rerio)
- Source: Interaquaristik.de Shop (Germany)
- Date supplied: 2017-09-28
- Acclimatisation: Stock held since 2017-09-28 and acclimatised to the test conditions since then.
- Temperature: 22.2 - 22.5 °C
- Dissolved oxygen: > 5 mg/L
- Feeding: Commercial fish food, daily. Feeding discontinued 24 h prior to test start.
- Mortalities during acclimatisation period: < 5 %
- Medication: none
- Mean standard length (n =14): 3.47 cm (S.D. = 0.19 cm)

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

13.4 °dH (= 239 mg/L CaCO3)

Test temperature:

22.2 - 22.5 °C

pH:

7.4 - 7.8

Dissolved oxygen:

8.2 - 8.8

Nominal and measured concentrations:

nominal: 100 mg/L active ingredient
measured: 101.3 mg/L active ingredient

Details on test conditions:

- Test vessels: glass aquaria holding 5 L of test media covered by glass plates
- Experimental design: 1 test concentration plus 1 control, 7 fish per test concentration
- no feeding during the exposure period
- static system
- Method of initiation: fish were placed in prepared media
- Loading: 0.58 g body weight (wet weight) per litre
- Photoperiod: 16 h light: 8 h dark
- Temperature: 22.2 to 22.5 °C
- Aeration: gentle aeration via narrow glass tubes
- Test item concentration/s : 100 mg/L active ingredient
- Method of administration: stock solution
- Medium renewal: none
- Duration of exposure: 96 hours
- Criteria of effects: criterion of death used in this study was the absence of response to physical stimulation; in addition to observations on mortality at 2, 24, 48, 72 and 96 hours, type and incidence of sub-lethal effects compared with control fish were observed

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

The results are expressed in terms of nominal concentrations (active ingredient). Effective concentrations correspond to 101.3 % of nominal values at 0 hours and to 101.3 % of nominal values at 96 hours.

Validity criteria fulfilled:

yes

Remarks:

mortality in the controls did not exceed 10 % by the end of the test; dissolved oxygen concentration remained above 60 % of the air-saturation value throughout the exposure period; pH did not vary by more than 1 unit

Conclusions:

No toxic effects against fish (Danio rerio) were observed at a limit test concentration of 100 mg/L (active ingredient) of Reactive Red 141 under exposure conditions after 96 h.

Executive summary:

A study was performed to assess the acute toxicity of Bayscript Magenta BB to Danio rerio under static conditions in accordance with Council Regulation (EC) No 440/2008, Method C.1 'Acute toxicity for Fish' (2008) which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992).

A range finding test preceded the main test. It provided information about the range of concentrations which were used in the main test. The following nominal concentrations of the test item were tested in the range-finding test: 1, 10 and 100 mg/L.

A group of seven fish of the recommended size was exposed for 96 h to a limit test concentration of nominally 100 mg/L (active ingredient) of Bayscript Magenta BB dissolved in dilution water. Auxiliary used to prepare the test media was an ultrasonic bath. During the test a temperature range of 20 - 24 °C was maintained in the test vessels, with a maximum temperature fluctuation of +/- 0.3 °C in the test. The temperature, the pH and the oxygen values were measured at the beginning of the test and every 24 hours thereafter.

Observations were made on the number of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 hours of exposure. The following values were determined: 96 h-LC50 > 100 mg/L.

No toxic effects against fish were observed at a limit test concentration of 100 mg/L (active ingredient) of the test item under exposure conditions.

The results are expressed in terms of nominal concentrations. Effective concentrations correspond to 101.3 % of nominal values at 0 hours and to 101.3 % of nominal values at 96 hours.

Description of key information

No toxic effects against fish (Danio rerio) were observed at a limit test concentration of 100 mg/L (active ingredient) of Reactive Red 141 under exposure conditions after 96 h.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

Should read LC50 > 100 mg/L