Tetralithium 5,5'-[vinylenebis[(3-sulphonato-4,1-phenylene)azo]]bis[3-methylsalicylate]

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

adopted April 13, 2004

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Date of receipt: 2016-06-20
Expiry date: 2018-06-17
Water solubility: 240 g/L at 20 °C
Stability of test concen tration/s during exposure: Examined by chemical analysis (HPLC) at 0 and 48 hours.

Analytical monitoring:

yes

Remarks:

HPLC analysis and UV/VIS-detection

Details on sampling:

Storage: Routinely, the samples were analysed immediately. Only in exceptional cases, they were stored overnight deep frozen and protected from light.

Vehicle:

no

Details on test solutions:

Pre-treatment of test item and preparation of test item concentrations
To produce the only test item concentration 116.0 mg of the test item (= 100 mg/L active ingredient) were added to 1 litre of dilution water and stirred for 1 h on a magnetic stirrer. The pH was measured to be 7.9.
50 mL of the solution were taken and diluted with 0.5 mL of dilution water containing 5 daphnids resulting in a final concentration of 100 mg/L. 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 1/m2 x 1/s). 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:

14.7 °dH (= 262 mg/L CaCO3)

Test temperature:

18 - 22 °C +/- 1 °C

pH:

7.9 - 8.0

Dissolved oxygen:

9.0 mg/L (105 - 106%)

Nominal and measured concentrations:

100 mg/L (active ingredient)

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: 20.0 to 20.4 °C
Aeration: none
Test item concentration/s: 100 mg/L (active ingredient)
Method of administration: direct weighing
Duration of exposure: 48 hours
Criteria of effects: The criterion of adverse effects used in this study was the 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:

24 h

Dose descriptor:

EC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

No toxic effects against Daphnia 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 106.5 % of nominal values at 0 hours and to 104.8 % of nominal values at 48 hours.

Reported statistics and error estimates:

Daphnia were exposed to the test item added to dilution water at a limit test concentration of nominally 100 mg/L for a period of 48 hours. At this concentration no toxic effects against Daphnia were observed at the end of the 48 hour study period, thus no statistical analysis was required to determine the EC 50.

Analysis

Nominal concentration (active ingredient) [mg/L]	HPLC value [mg/L] at 0 hours	HPLC value [mg/L] at 48 hours
control	--	< 0.011
100	106.466	104.838

Validity criteria fulfilled:

yes

Remarks:

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

Conclusions:

No toxic effects against Daphnia were observed at a limit test concentration of 100 mg/L (active ingredient) of Bayscript Gelbkomponente under exposure conditions according to Council Regulation (EC) No 440/2008, Method C.2 and OECD guideline No. 202.

Executive summary:

A study was performed to assess the acute toxicity of Bayscript Gelbkomponente to Daphnia magna STRAUS under static conditions.

Daphnia were exposed to the test item added to dilution water at a limit test concentration of nominally 100 mg/L for a period of 48 hours. At this concentration no toxic effects against Daphnia were observed at the end of the 48 hour study period, thus no statistical analysis was required to determine the EC 50. Immobilisation rates were recorded at 24-hour intervals. Additionally any abnormal behaviour or appearance of the Daphnia was reported every 24 hours.

The 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).

The Daphnia were exposed to a limit test concentration of nominally 100 mg/L (active ingredient) of Bayscript Gelbkomponente dissolved in dilution water. Auxiliary used to prepare the test media was a magnetic stirrer.

Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. The following values were determined:

Time [h]	EC50 [mg/L]
24	> 100
48	> 100

No toxic effects against Daphnia 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 106.5 % of nominal values at 0 hours and to 104.8 % of nominal values at 48 hours.

The hardness of the dilution water used was 14.7 °dH (= 262 mg/L CaCO3).

At a concentration of 100 mg/L no toxic effects against Daphnia were observed at the end of the 48 hour study period, thus no statistical analysis was required to determine the EC 50.

Description of key information

A study was performed to assess the acute toxicity of Bayscript Gelbkomponente to Daphnia magna STRAUS under static conditions.

Daphnia were exposed to the test item added to dilution water at a limit test concentration of nominally 100 mg/L for a period of 48 hours. At this concentration no toxic effects against Daphnia were observed at the end of the 48 hour study period, thus no statistical analysis was required to determine the EC 50. Immobilisation rates were recorded at 24-hour intervals. Additionally any abnormal behaviour or appearance of the Daphnia was reported every 24 hours.

The 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).

The Daphnia were exposed to a limit test concentration of nominally 100 mg/L (active ingredient) of Bayscript Gelbkomponente dissolved in dilution water. Auxiliary used to prepare the test media was a magnetic stirrer.

Observations were made on the swimming ability and the immobilisation rate, respectively, after 24 and 48 hours of exposure. The following values were determined:

Time [h]	EC50 [mg/L]
24	> 100
48	> 100

No toxic effects against Daphnia 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 106.5 % of nominal values at 0 hours and to 104.8 % of nominal values at 48 hours.

The hardness of the dilution water used was 14.7 °dH (= 262 mg/L CaCO3).

At a concentration of 100 mg/L no toxic effects against Daphnia were observed at the end of the 48 hour study period, thus no statistical analysis was required to determine the EC 50.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

Should read "> 100 mg/L"