tetrasodium 3-amino-4-{[4-({4-fluoro-6-[phenyl(2-{[2-(sulfonatooxy)ethyl]sulfonyl}ethyl)amino]-1,3,5-triazin-2-yl}amino)-2-sulfonatophenyl]diazenyl}-5-hydroxynaphthalene-2,7-disulfonate

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:

From January 11, 2005 to January 13, 2005

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)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Sampling schedule for chemical analysis: Samples were taken at 0 and 48 h

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain: Straus
- Sex: Parthenogenetic females
- Source: Strain of Bundesgesundheitsamt Berlin
- Age at study initiation: Neonates
- Food type: Green algae (Desmodesmus subspicatus)
- Frequency: Ad libitum

ACCLIMATION
A population of parthenogenetic females of synchronized age structure which had been maintained for more than 15 years in the test facility under constant temperature conditions (20±1°C) at a 16:8 h light-dark photoperiod (illumination: <1000 lux) were used in the study. The culture water (so-called 'M4 medium') was partly renewed once a week.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

228.48 mg CaCO3/L

Test temperature:

18-22°C

pH:

Control: 8.2
Test: 8.2

Dissolved oxygen:

Control: 8.9 mg/L
Test: 9.0 mg/L

Nominal and measured concentrations:

To prepare the only test concentration, 105.3 mg of the test substance were dissolved in 1 L of dilution water.

- Nominal concentration: 100 mg/L
- Measured concentration:
0 h = 99.66 mg/L
48 h = 98.07 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 50 mL glass beakers holding 10 neonates in 20 mL of test medium
- Aeration: None
- Type of system: Static
- No. of organisms per vessel: 10 neonates per vessel
- Biomass loading rate: 2 mL per neonate
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Feeding: No feeding during exposure period

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water ('M4 medium', originally described in Water Research 1990; 24 (9): 1157-1167), prepared according to the recommendations of Bundesgesundheitsamt Berlin

OTHER TEST CONDITIONS
- Photoperiod: 16 h light : 8 h dark
- Test concentrations: 100 mg/L (nominal)

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Table 1: EC50 of the test substance

Time [h] EC 50 [mg/L] (nominal test substance concentration) 24 >100 48 >100

Validity criteria fulfilled:

yes

Conclusions:

Under the test conditions, the 48 h EC50 and NOEC of the test substance were >100 mg/L and 100 mg/L (nominal), respectively.

Executive summary:

A limit test was conducted to determine the acute toxicity of the test substance to Daphnia magna according to EU Method C.2 (equivalent or similar to OECD Guideline 202), in compliance with GLP.

In this test, 2 replicates of 10 Daphnia magna neonates were exposed to the substance at a nominal concentration of 100 mg/L under static conditions for 48 h. Immobility was recorded at 24 and 48 h.The analytical concentration of the test substance was measured by HPLC method and was found to be 99.7% of the nominal value at 0 h, and 98.1% of the nominal value at 48 h.

 

Under the test conditions, the 48 h EC50 and NOEC of the substance were >100 mg/L and 100 mg/L (nominal), respectively.

Description of key information

The 48-h EC50 and NOEC of the substance were >100 mg/L and ≥100 mg/L (nominal concentrations), respectively (Bruns, 2005).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

A limit test was conducted to determine the acute toxicity of the test substance to Daphnia magna according to EU Method C.2 (equivalent or similar to OECD Guideline 202), in compliance with GLP. Two replicates of 10 Daphnia magna neonates were exposed to the substance at a nominal concentration of 100 mg/L under static conditions for 48 h. Immobility was recorded at 24 and 48 h. The analytical concentration of the test substance was measured by HPLC method and was found to be 99.7% of the nominal value at 0 and 98.1% of the nominal value at 48 h. Under the test conditions, the 48 h EC50 and NOEC were >100 mg/L and 100 mg/L (nominal), respectively (Bruns, 2005c).