Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate

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

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Name: FAT 20033/L
Batch number: AT-PD13-359A1
EAS Test item code: 2014-000179
Appearance / colour: solid / dark blue
Molecular weight 544.58 g/mol (base) 567.57 g/mol (salt)
Date of analysis: 07 Jan 2014
Expiry date: 07 Jan 2019
Storage conditions: ambient (+5 to +30 °C), dark, dry

Analytical monitoring:

yes

Details on sampling:

After sampling, the test medium samples (0.5 mL) were mixed with 0.5 mL methanol and stored deep-frozen (below -18 °C) until analysis.

Vehicle:

no

Details on test solutions:

The necessary amount of FAT 20033/L for preparing the test solution was weighed on weighing scoops and transferred to a volumetric flask. Test medium was added up to the bench mark and the solution was homogenised by shaking. 50 mL of the prepared solution was transferred to each test vessel.

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna STRAUS, Clone V, was used as the test organism. The animals are continuously bred in the laboratory and were originally purchased in a healthy condition from the Umweltbundesamt (Federal Environment Agency) in Berlin/Germany.
Daphnia magna was bred as single culture (one daphnid per 100 mL) in Elendt M4 medium. The pH-value of the aerated water was within a range of 6.0 – 9.0. The dissolved oxygen was above 60 % saturation and the total hardness 140 - 250 mg/L (as CaCO3), corresponding to 7.8 - 14°dH. The animals were fed with single cell green algae (Desmodesmus subspicatus, formerly Scenedesmus subspicatus) at least three times a week.
The daphnids were reared at a temperature of 20 ± 2 °C in a climatic chamber with 16 hours of illumination and 8 hours of darkness. The medium was changed three times per week. A pipette was used to separate the young daphnids from the adults.
Freshly hatched daphnids less than 24 hours old were used for the test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

13°dH (232 mg/L as CaCO3)

Test temperature:

20.3 - 20.9 °C

pH:

7.21 - 7.95

Dissolved oxygen:

>= 8.3 mg/L

Nominal and measured concentrations:

0 and 100 mg/L

Details on test conditions:

Exposure to light: 16 hours photoperiod / 8 hours darkness daily
Test vessels: four 100 mL glass beakers per concentration, each filled with 50 mL, one additional replicate for measurements without test organisms
Loading: 10 mL of test solution for each animal
Aeration: none
Number of animals: 20 per concentration in 4 replicates of 5

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

After 24 and 48 hours of exposure no immobilisation was observed in the control and at 100 mg/L.

Results with reference substance (positive control):

Reference substance: Potassium dichromate
EC50 (24 h) lies between 1.0 and 2.0 mg/L

Reported statistics and error estimates:

The 24 h and 48 h EC50 are the estimated concentrations where 50 % of the daphnids were immobilised after 24 and 48 hours, respectively.
No statistical evaluation was indicated since no immobilisation occurred at the limit test concentration of 100 mg/L.
The NOEC was established based on the highest concentration at which the immobilisation is not higher than the allowed control immobilisation (>= 10 % immobilisation).

Validity criteria fulfilled:

yes

Conclusions:

Tthe EC50 (48 h) for immobilisation was determined to be >100 mg/L (nominal). The corresponding NOEC (48 h) was 100 mg/L (nominal).

Executive summary:

The toxicity of FAT 20033/L on Daphnia magna was tested in a 48 hour acute immobilisation test. The test was performed according to OECD Guideline 202. Twenty organisms per test concentration (4 replicates of 5 animals each) were used. The duration of the test was 48 hours. A semi-static limittest with concentrations of 0 and 100 mg/L was performed. Test solutions were prepared by dilution of the test item in test medium and application of defined volumes of the test solutions to the test vessels. Endpoints reported are the EC50 and the NOEC after 24 and 48 hours. The initial mean measured contents at 100 mg/L were 93 % of nominal and the aged measured content was 81 % of nominal. Therefore the toxicological endpoints were evaluated using nominal concentrations. After 24 and 48 hours of exposure no immobilisation was observed in the control and at 100 mg/L. Hence, the EC50 (48 h) for immobilisation was determined to be >100 mg/L (nominal). The corresponding NOEC (48 h) was 100 mg/L (nominal).

Description of key information

The EC50 (48 h) for immobilisation was determined to be >100 mg/L (nominal). The corresponding NOEC (48 h) was 100 mg/L (nominal).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

The toxicity of FAT 20033/L on Daphnia magna was tested in a 48 hour acute immobilisation test. The test was performed according to OECD Guideline 202. A static limit test with concentrations of 0 and 100 mg/L was performed. According to the results of the test, the EC50 (48 h) for immobilisation was determined to be > 100 mg/L (nominal). The corresponding NOEC (48 h) was 100 mg/L (nominal).