Trisodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonatonaphthyl]azo]-2,5-dimethylphenyl]azo]benzene-1,4-disulphonate

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 40075/D
Batch number: BS-1113243
EAS Test item code: 2014-000184
Appearance / colour: solid / orange.
CAS number: 70210-13-8.
Content of a.i. nominal: 65 %.
Content of a.i. analysed: not available
Molecular weight: 745.14 g/mol (base), 814.11 g/mol (salt)
Date of analysis: 03 Dec 2013
Expiry date: 14 Mar 2017.
Storage conditions: cool (+1 to +10 °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:

yes

Remarks:

Methanol

Details on test solutions:

The necessary amount of FAT 40075/D 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 group culture (5 to 20 daphnids per litre) 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:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

13°dH (232 mg/L as CaCO3)

Test temperature:

20.5 - 21.0 °C

pH:

7.23 - 7.95

Dissolved oxygen:

≥ 8.8 mg/L

Nominal and measured concentrations:

see Table below

Details on test conditions:

pH-value: 7.23 – 7.95
Exposure to light: 16 hours photoperiod / 8 hours darkness daily
Feeding: none
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):

EC50(24 h) between 1 and 2 mg/L
Reference substance: potassium dichromate

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:

The 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:

Toxicity of FAT 40075/D was evaluated for toxicity to the Daphnia magna Straus under Laboratory Conditions (Acute Immobilisation Test – Static). This test was conducted in accordance with OECD Guideline 202 and GLP. Daphnia magna (max. 24 hours old) were used for the study. Twenty organisms per test concentration (4 replicates of 5 animals each) were used. The duration of the test was 48 hours. A static limit test with concentrations of 0 and 100 mg/L was performed. Endpoints reported were EC50 and the NOEC after 24 and 48 hours. Analytical samples taken at 0 hours (initial value) from fresh test solutions and after 48 hours from aged test solutions were analysed from control and 100 mg/L. The initial measured content at 100 mg/L was 97 % of nominal and the aged measured content was 100 % of nominal. Therefore the toxicological endpoints were evaluated using nominal concentrations. Based on the findings of the study, 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

A study was conducted to evaluate the acute toxicity of FAT 40075/D to Daphnia magna. The test was performed according to the OECD Guideline 202 and in accordance with GLP. 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). Based on this test result the substance FAT 40075 can be noted as non-toxic to aquatic invertebrates.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L