m,m'-[carbonylbis[imino(3-methoxy-p-phenylene)azo]]bis(benzenesulphonic) acid, compound with 2,2'-iminodiethanol (1:2)

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:

Control at 96 h
test concentrations at 0 h and 96 h

Vehicle:

no

Details on test solutions:

Pre-treatment of test item and preparation of test item concentrations
A stock solution was prepared to give the desired limit test concentration of 100 mg/L active ingredient:
- 558 mg of Bayscript Yellow GGN ( = 500 mg/L active ingredient) were added to 5 litres of dilution water
- treated for 1 h in an ultrasonic bath and stirred for 1 h on a magnetic stirrer.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Name: Zebra fish (Danio rerio)
Source: Interaquaristik.de Shop (Germany)
Date of birth: --
Date supplied: 2016-08-24
Acclimatisation: Stock held since 2016-08-24 and acclimatised to the test conditions since then.
Temperature: 20 - 24 °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): 3.75 cm (S.D. = 0.24 cm)

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

14.2 °dH (=253.5 mg/L CaCO3)

Test temperature:

21.9 - 22.7 °C

pH:

7.5 - 7.9

Dissolved oxygen:

8.2 - 9.1

Nominal and measured concentrations:

nominal (mg/L): 100
measured (mg/L): 98.702 (0 h), 99.714 (96 h)

Details on test conditions:

Exposure 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: 1.62 g body weight (wet weight) per litre
Photoperiod: 16 h light: 8 h dark
Temperature: 21.9 to 22.7 °C
Aeration: gentle aeration via narrow glass tubes
Test item concentration: 100 mg/L active ingredient
Method of administration: direct weighing
Medium renewal: none
Duration of exposure: 96 hours
Criteria of effects: The 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):

not required

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:

All results are expressed in terms of nominal concentrations. Effective concentrations correspond to 98.7 % of nominal values at 0 hours and to 99.7 % of nominal values at 96 hours.
As no toxic effects against fish were observed, no statistical analysis was required to determine the LC50.

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:

After 96 h a LC50 > 100 mg/L (active ingredient) was determined for Bayscript Yellow GGN in a static test toward fish (Danio rerio). All results are expressed in terms of nominal concentrations.

Executive summary:

A study was performed to assess the acute toxicity of Bayscript Yellow GGN 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 group of seven fish was exposed to a limit test concentration of nominally 100 mg/L of the active ingredient of Bayscript Yellow GGN dissolved in dilution water. Auxiliaries used to prepare the test media were an ultrasonic bath and a magnetic stirrer.

During the test a temperature range of 20 - 24 °C was maintained in the test vessels, with a maximum temperature fluctuation of +/- 1 °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 numbers of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 h of exposure. After 96 h a LC50 > 100 mg/L (active ingredient) was determined.

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

All results are expressed in terms of nominal concentrations. Effective concentrations correspond to 98.7 % of nominal values at 0 hours and to 99.7 % of nominal values at 96 hours.

Description of key information

After 96 h a LC50 > 100 mg/L (active ingredient) was determined for Bayscript gelb GGN in a static test toward fish (Danio rerio). All results are expressed in terms of nominal concentrations.

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.