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

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)

Version / remarks:

2008

Deviations:

yes

Remarks:

Some test fish had a somewhat larger size than the one recommended in the test guideline for the zebra fish. This deviation is not regarded to be relevant to the results.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

yes

Remarks:

Some test fish had a somewhat larger size than the one recommended in the test guideline for the zebra fish. This deviation is not regarded to be relevant to the results.

Principles of method if other than guideline:

Groups of seven fish were exposed to a range of concentrations, nominally 50 and 100 mg/L of the 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 numbers of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 hours of exposure.

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 concentration/s during exposure: Examined by chemical analysis (HPLC at 0, 24 and 96) 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
1158.5 mg of the test item (= 100 mg/L active ingredient) were added to 10 litres of dilution water and stirred for 1 h on a magnetic stirrer. The pH was measured to be 7.7.
To produce the different test item concentrations appropriate amounts of the stock solution were diluted with dilution water to a volume of 5000 mL. Finally 7 fish were given to all test item concentrations and the control.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

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: 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 = 21): 3.49 cm (S.D. = 0.22 cm)

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Remarks on exposure duration:

The temperature, the pH and the oxygen values were measured at the beginning of the test and every 24 hours thereafter.

Hardness:

13.4 °dH (= 239 mg/L CaCO3).

Test temperature:

20 - 24 °C +/- 0.8 °C

pH:

7.5 - 7.8

Dissolved oxygen:

8.3 mg/L - 8.6 mg/L (Oxygen saturation 95 - 100 %)

Nominal and measured concentrations:

50 and 100 mg/L (active ingredient) at 0, 24 and 96 hours

Details on test conditions:

Exposure conditions
Test vessels: glass aquaria holding 5 L of test media covered by glass plates
Experimental design: 2 test concentrations plus 1 control; 7 fish per test concentration; no feeding during the exposure period; static
Method of initiation: fish were placed in prepared media
Loading: 0.62 g body weight (wet weight) per litre
Photoperiod: 16 h light: 8 h dark
Temperature: 22.2 to 23 0°C
Aeration: gentle aeration via narrow glass tubes
Test item concentration/s: 50 and 100 mg/L (active ingredient)
Method of administration: stock solution
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):

no

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

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.
All results are expressed in terms of nominal concentrations. Effective concentrations ranged from 94.9 % to 97.5 % of nominal values at 0 hours, from 98.7 % to 98.8 % of nominal values at 24 hours, and from 97.2 % to 98.6 % of nominal values at 96 hours.

Reported statistics and error estimates:

The recovery rate was 101.7 % (number of determinations: 7).

Sublethal observations / clinical signs:

Mortalities were recorded at 24 hour intervals.

Some test fish had a somewhat larger size than the one recommended in the test guideline for the zebra fish. This deviation is not regarded to be relevant to the results.

Validity criteria fulfilled:

yes

Remarks:

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

Conclusions:

No toxic effects against Danio rerio under static conditions were observed at a limit test concentration of 100 mg/L (active ingredient) of Bayscript Gelbkomponente under exposure conditions.

Executive summary:

A study was performed to assess the acute toxicity of Bayscript Gelbkomponente to Danio rerio under static conditions.

The study was conducted 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).

The purpose of this method was to determine the acute toxic effects at a maximum test concentration of 100 mg/L or at the limit of water solubility (limit test).

Groups of seven fish were exposed to a range of concentrations, nominally 50 and 100 mg/L of the 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 numbers 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:

Time [h]	LC50 [mg/L]
2	> 100 active ingredient
24	> 100 active ingredient
48	> 100 active ingredient
72	> 100 active ingredient
96	> 100 active ingredient

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.

All results are expressed in terms of nominal concentrations. Effective concentrations ranged from 94.9 % to 97.5 % of nominal values at 0 hours, from 98.7 % to 98.8 % of nominal values at 24 hours, and from 97.2 % to 98.6 % of nominal values at 96 hours.

The hardness of the dilution water used was 13.4 °dH (= 239 mg/L CaCO3).

The validity criteria of the test were met.

Description of key information

A study was performed to assess the acute toxicity of Bayscript Gelbkomponente to Danio rerio under static conditions.

The study was conducted 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).

The purpose of this method was to determine the acute toxic effects at a maximum test concentration of 100 mg/L or at the limit of water solubility (limit test).

Groups of seven fish were exposed to a range of concentrations, nominally 50 and 100 mg/L of the 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 numbers 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:

Time [h]	LC50 [mg/L]
2	> 100 active ingredient
24	> 100 active ingredient
48	> 100 active ingredient
72	> 100 active ingredient
96	> 100 active ingredient

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.

All results are expressed in terms of nominal concentrations. Effective concentrations ranged from 94.9 % to 97.5 % of nominal values at 0 hours, from 98.7 % to 98.8 % of nominal values at 24 hours, and from 97.2 % to 98.6 % of nominal values at 96 hours.

The hardness of the dilution water used was 13.4 °dH (= 239 mg/L CaCO3).

The validity criteria of the test were met.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

Should read "> 100 mg/L"