trisodium 3-amino-4-[4-[4-(2-(2-ethenylsulfonylethoxy)ethylamino)-6-fluoro-1,3,5-triazine-2-ylamino]-2-sulfophenylazo]-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:

Study initiation date - 12 March 1999; Experiment start date - 16 March 1999; Experiment completion date - 19 April 1999; Study completion date - 27 May 1999.

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

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identity: FAT 40'574/B
Batch: WP 23/99
Purity: Approx. 75 %
Appearance: Solid, dark-red powder
Storage: At room temperature at about 20 °C
Expiration Date: 08 February 2006

Analytical monitoring:

yes

Details on sampling:

All test medium samples for the analytical determinations were taken from the approximate centre of the test vessels (after mixing the medium) and kept at -18 °C to -25 °C until analysis.

Vehicle:

no

Details on test solutions:

99.9 mg test substance was mixed with 1000 ml test medium in a beaker, homogenized by ultrasonic treatment for 2 minutes and stirred continuously over night.

Test organisms (species):

Daphnia magna

Details on test organisms:

The organism used in this test system was the species Daphnia magna Straus. The Daphnia were bred in the laboratories of the Ecotox Center under standardised conditions.
Breeding: Cultures of Daphnia magna are held in glass vessels containing approx. 3.0 litre of reconstituted water at 18 - 22 °C. The water is renewed partially three times per week. The Daphnia are fed with a suspension of green algae (Scenedesmus subspicatus) supplemented by a Tetramin-extract in such quantities that the food is consumed within 24 hours.
Pre-treatment: 24 hours before the start of the exposure reproductive Daphnia were separated from the young Daphnia by sieving all individuals through a 1000 µm sieve. For each test concentration 20 Daphnia divided into two groups of 10 animals were used.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

214 mg CaCO3/L

Test temperature:

21 °C

pH:

7.6 - 8.0

Dissolved oxygen:

96 %

Nominal and measured concentrations:

Nominal concentration: 4.3, 9.4, 21, 45 and 100 mg test substance/l.

Details on test conditions:

Light: 14 hours photoperiod daily, 10 hours darkness.
Test vessels: 250 ml beakers containing 60-100 ml test medium with 10 animals per beaker. All tests were run in duplicate.
For each test concentration 20 Daphnia divided into two groups of 10 animals were used.

Test medium
The test medium used had the following composition:
NaHCO3 - 65 mg/L
MgSO4. 7H20 - 123.3mg/L
KCl - 5.8 mg/L
CaCl2* 2H2O - 294 mg/L
Na2SiO3 - 4.3 mg/L
NaNO3 - 274 mg/L
KH2PO4 - 143 mg/L
K2HPO4 - 184 mg/L

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

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:

Based on the results of a pre-test the nominal concentrations of FAT 40574/B for the main test were selected as 4.3, 9.4, 21, 45 and 100 mg test substance/l. Additionally, a blank control without test substance was tested. The water temperature was maintained constant at 21°C throughout the exposure period in all test vessels. The oxygen content was in the range of 96 - 100 % during the test and the pH in all test vessels 8.0. The analysed concentrations of FAT 40574/B were 100.3 % of the nominal values at the start and 102.4 % at the end of the test.
Therefore, the EC-values were determined based on the nominal values of the test substance concentrations. No immobilisation of the Daphnia and no sublethal effects were observed in the control and in the test concentration of 100 mg/l after the test period of 48 hours.

Results with reference substance (positive control):

The quality of the Daphnia is checked at least every 3 months by determining the EC50 value (24 h) for potassium dichromate.
Reference control January 08, 1999: EC50 1.1 mg/l

Validity criteria fulfilled:

yes

Conclusions:

No immobilisation of the Daphnia and no sublethal effects were observed in the control and in the test concentration of 100 mg/l after
the test period of 48 hours.

Executive summary:

The acute toxicity of the test item FAT 40574/B to Daphnia magna was determined in a 48-hour static test according to the EU Commission Directive 92/69/EEC, Part C.2 (1992) and the OECD Guideline for Testing of Chemicals, No. 202 (2004). The nominal concentration tested was as follows: 0, 4.3, 9.4, 21, 45 and 100 mg test substance/l. The analysed concentrations of FAT 40574/B were 100.3 % of the nominal values at the start and 102.4 % at the end of the test. Thus, the test item was stable during the test period of 48 hours under the test conditions. The reported biological results were based on the nominal concentration of the test item. No immobilization or sub-lethal effects on test organisms were observed during the test period of 48 hours. Based on the findings of this study, the EC50 was determined to be greater than 100 mg/L.

Description of key information

The EC50 for daphnia was determined to be greater than 100 mg/L

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

The acute toxicity of the test item FAT 40574/B to Daphnia magna was determined in a 48-hour static test according to the EU Commission Directive 92/69/EEC, Part C.2 (1992) and the OECD Guideline for Testing of Chemicals, No. 202 (2004). The nominal concentration tested was as follows: 0, 4.3, 9.4, 21, 45 and 100 mg test substance/l. The analysed concentrations of FAT 40574/B were 100.3 % of the nominal values at the start and 102.4 % at the end of the test. Thus, the test item was stable during the test period of 48 hours under the test conditions. The reported biological results were based on the nominal concentration of the test item. No immobilization or sub-lethal effects on test organisms were observed during the test period of 48 hours. Based on the findings of this study, the EC50 was determined to be greater than 100 mg/L.