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

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

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.2 (Acute Toxicity for Daphnia)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Remarks:

HPLC

Details on sampling:

Stability of test concentration/s during exposure: Examined by chemical analysis (HPLC) at 0 and 48 hours.

Vehicle:

no

Details on test solutions:

Pre-treatment of test item and preparation of test item concentrations
- 112.1 mg of the test item (= 100 mg/L active ingredient) were added to 1 litre of dilution water, treated for 1 h in an ultrasonic bath and stirred for 1 h on a magnetic stirrer
- pH was measured to be 7.8
- 50 mL of the solution were taken and diluted with 0.5 mL of dilution water
- for each test item concentration and the control 4 replicates were prepared

Test organisms (species):

Daphnia magna

Details on test organisms:

- Name: Daphnia magna STRAUS, parthenogenetic females
- Source: Strain of Bundesgesundheitsamt Berlin
- Maintenance and Acclimatisation: A population of parthenogenetic females of synchronized age structure has been maintained for more than 20 years in the test facility under constant temperature conditions (20 +/- 2 °C) at a 16 : 8 hour light-dark photoperiod (light intensity: < 20 μE x m-2 x s-1). The culture water (so-called 'M4 medium') was partly renewed once a week. The Daphnia were exclusively fed unicellular green algae (Desmodesmus subspicatus) 'ad libitum'. Mortalities of parent Daphnia during the culture period were recorded daily. The neonates were separated from their parent Daphnia by filtration prior to the acute test.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

14.3 °dH (= 255 mg/L CaCO3)

Test temperature:

19.6 - 20.3 °C

pH:

7.8 -8.1

Dissolved oxygen:

8.9 - 9.0 mg/L

Nominal and measured concentrations:

Nominal concentration of active ingredient: 100 mg/L
Effective concentrations correspond to 96.6 % of nominal values at 0 hours and to 95.7 % of nominal values at 48 hours.

Details on test conditions:

Exposure conditions
- Test vessels: 100 mL glass beakers covered with watch glasses holding 5 neonates in 50 mL of test medium
- Experimental design: 1 test concentration plus 1 control, 5 neonates per vessel, 4 replicates per concentration/control
- no feeding during the exposure period
- static system
- Method of initiation: neonates were placed in prepared media
- Photoperiod: 16 h light : 8 h dark
- Temperature of incubation unit: 19.8 to 20.0 °C
- Aeration: none
- Test item concentration: 100 mg/L (active ingredient)
- Method of administration: direct weighing
- Medium renewal: none
- Duration of exposure: 48 hours
- Criteria of effects: item-induced alteration of the normal mobility behaviour and the loss of locomotory actions of the neonates, observed at 24 and 48 hours

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

The results are expressed in terms of nominal concentrations. Effective concentrations correspond to 96.6 % of nominal values at 0 hours and to 95.7 % of nominal values at 48 hours.

Validity criteria fulfilled:

yes

Remarks:

immobilisation and other abnormalities in the controls did not exceed 10 % by the end of the test, dissolved oxygen concentration remained above 3 mg/L throughout the exposure period

Conclusions:

After 48 hours of exposure no toxic effects against Daphnia were observed for Bayscript Yellow GGN at a limit test concentration of 100 mg/L (active ingredient).

Executive summary:

A study was conducted in accordance with the Council Regulation (EC) No 440/2008, Method C.2 ‘Acute toxicity for Daphnia’ (2008) which is equivalent to OECD Guideline for Testing of Chemicals No. 202 'Daphnia sp., Acute Immobilisation Test' (adopted April 13, 2004) to assess the acute toxicity of Bayscript Yellow GGN to Daphnia magna STRAUS.

The Daphnia were exposed to a limit test concentration of nominally 100 mg/L of the active ingredient of Bayscript Yellow GGN dissolved in dilution water for a period of 48 h. Auxiliaries used to prepare the test media were an ultrasonic bath and a magnetic stirrer. The main test was conducted as a static test with the test medium unchanged throughout the duration of the test. During the test a temperature range of 18 - 22 °C was maintained in the test vessels, with a maximum temperature fluctuation of +/- 1 °C in each individual test. The temperature, the pH and the oxygen values were measured at the beginning and end of the test.

Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. After 48 h no toxic effects against Daphnia were observed at a limit test concentration of 100 mg/L of the active ingredient of Baycript yellow GGN under exposure conditions, thus no statistical analysis was required to determine the EC 50. The results are expressed in terms of nominal concentrations. Effective concentrations correspond to 96.6 % of nominal values at 0 hours and to 95.7 % of nominal values at 48 hours.

Description of key information

After 48 hours of exposure no toxic effects against Daphnia were observed for Bayscript Yellow GGN at a limit test concentration of 100 mg/L (active ingredient).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

Should read EC50 > 100 mg/L