trisodium 3-[(E)-2-(4-{[4-chloro-6-({2-[(4-{[4-(ethenesulfonyl)phenyl]amino}-6-fluoro-1,3,5-triazin-2-yl)amino]propyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfonaphthalen-1-yl)diazen-1-yl]naphthalene-1,5-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:

01 August 2006 to 21 September 2006

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:

not specified

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identity: FAT 40826/A
Batch no.: TZ 5604 BOP 01/06
Expiration date: February 01, 2011
Purity: Content of organic part (Na-salt): approx. 78 %; Oligomers: 13 %; Main component: approx. 48 %
Solubility in water: Approx. >50 g/L at room temperature
Stability in water: Max. 7 days at room temperature
pH: 7.6 (1 g/L)
Aggregate state/physical form at room temperature: Solid (orange powder)
Storage conditions: At room temperature at about 20 °C, away from direct sunlight
Specific instructions: Store in desiccator

Analytical monitoring:

yes

Details on sampling:

For the determination of the actual test item concentrations, the following samples were taken: Just before the start of the test: - duplicate samples from the test medium (without daphnids) - duplicate samples from the control (without daphnids). After 48 hours: - duplicate samples from the test medium (stability samples) - duplicate samples from the control. For the 48-hour stability samples, the contents of the respective replicates were combined. All samples were deep-frozen (at about -20 °C) immediately after sampling. Based on pre-experiments for investigation of the storage stability (without GLP), the test item was found to be stable in the test water under these storage conditions.

Vehicle:

no

Details on test solutions:

The test medium was prepared by dissolving 29.6 mg of test item completely in 300 mL of test water- using intense stirring for 15 minutes at room temperature. The test medium was prepared just before introduction of the daphnids (i.e., start of the test).

Test organisms (species):

Daphnia magna

Details on test organisms:

The study was performed with young daphnids of a clone of the species Daphnia magna Straus. A clone of this species was originally supplied by the University of Sheffield/UK in 1992, defined by the supplier as clone 5. Since that time, the clone has been bred in the laboratories of RCC in reconstituted water of the quality identical to the water quality used in the tests (in respect to pH, main ions, and total hardness) and under temperature and light conditions identical to those of the tests. At the start of the test, the organisms used in the test were 6-24 hours old and were not first brood progeny.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

250 mg/L as CaC03

Test temperature:

20-21 °C

pH:

7.8-7.9

Dissolved oxygen:

8.6-8.8 mg/L

Nominal and measured concentrations:

100 mg/L. The analytically determined test item concentration in the test medium at the start and the end of the test was 100 and 103 % of the nominal value, respectively

Details on test conditions:

The test was performed in 100 mL glass beakers filled with 50 mL of test medium. The beakers were covered with glass plates to reduce the loss of water and to avoid the entry of dust into the solutions. The test vessels were labeled with the RCC study number and all necessary additional information to ensure unmistakable identification. At the test concentration and for the control, 20 daphnids were used divided into four replicates of five daphnids each. The daphnids were randomly distributed to the test vessels at initiation of the test. The loading rate was less than one daphnia per 5 mL of test solution. A static test without test medium renewal was chosen since in a pre-experiment (without GLP), the test item concentration in the test medium was constant during the test period of 48 hours. Light conditions were 16-h/8-h light/dark with a 30 min. transition period (light intensity approx. 470-640 Lux). Organsisms were not fed during the test.

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:

mortality

Details on results:

The 48-hour NOEC (highest concentration tested without toxic effects after the exposure period of 48 hours) and the 48-hour EC0 of FAT 40826/A to Daphnia magna were determined to be at least 100 mg/L. The 48-hour NOEC and the 48-hour EC0 might even be higher but concentrations above 100 mg/L were not tested, in accordance with the test guidelines. The 48-hour EC50 and the 48-hour EC100 were clearly higher than 100 mg/L. These values could not be quantified due to the absence of toxicity of FAT 40826/A at the test concentration of 100 mg/L. No remarkable observations were made concerning the appearance of the test medium. The test medium was a clear solution colored by the test item throughout the whole test duration.

Validity criteria fulfilled:

yes

Conclusions:

The 48-h EC50 and EC100 of FAT 40826/A in acute daphnia study were clearly higher than 100 mg/L.

Executive summary:

In a GLP-compliant study, the acute toxicity of the test substance to Daphnia magna was determined in a 48-hour static test according to the EU method C.2 and the OECD Guideline 202. A limit test was performed in accordance with the EU Commission Directive 92/69/EEC to demonstrate that the test item has no toxic effect on the test organisms up to and including a concentration of 100 mg/L. Thus, the only concentration tested was nominal 100 mg/L. Additionally, a control was tested in parallel. The test item concentration in the test medium at the start and the end of the test was 100 and 103 % of the nominal value, respectively. Thus, the test substance was stable over the test period of 48 hours. Therefore, all reported results are based on the nominal concentration of the test item. In the control and at the test item concentration of 100 mg/L, no significant number of immobilized test organisms were observed during the test period of 48 hours. The 48-hour NOEC (highest concentration tested without toxic effects after the exposure period of 48 hours) and the 48-hour EC0 to Daphnia magna were determined to be at least 100 mg/L. These values might even be higher but concentrations above 100 mg/L were not tested, according to the EU Commission Directive. The 48-hour EC50 and the 48-hour EC100 were clearly higher than 100 mg/L. These values could not be quantified due to the absence of toxicity at the test concentration of 100 mg/L.

Description of key information

The 48-h EC50 value of test substance is >100 mg/L in Daphnia magna.	

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

In a GLP-compliant study, the acute toxicity of the test substance to Daphnia magna was determined in a 48-hour static test according to the EU method C.2 and the OECD Guideline 202. A limit test was performed in accordance with the EU Commission Directive 92/69/EEC to demonstrate that the test item has no toxic effect on the test organisms up to and including a concentration of 100 mg/L. Thus, the only concentration tested was nominal 100 mg/L. Additionally, a control was tested in parallel. The test item concentration in the test medium at the start and the end of the test was 100 and 103 % of the nominal value, respectively. Thus, the test substance was stable over the test period of 48 hours. Therefore, all reported results are based on the nominal concentration of the test item. In the control and at the test item concentration of 100 mg/L, no significant number of immobilized test organisms were observed during the test period of 48 hours. The 48-hour NOEC (highest concentration tested without toxic effects after the exposure period of 48 hours) and the 48-hour EC0 to Daphnia magna were determined to be at least 100 mg/L. These values might even be higher but concentrations above 100 mg/L were not tested, according to the EU Commission Directive. The 48-hour EC50 and the 48-hour EC100 were clearly higher than 100 mg/L. These values could not be quantified due to the absence of toxicity at the test concentration of 100 mg/L.