Tetra(sodium/potassium)-7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chlor-6-({2-[(4-fluor-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]propyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5-methoxyphenyl}diazenyl]-1,3,6-naphthalintrisulfonate

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:

Experiment start date - 01 August 2006; Experiment completion date - 11 August 2006; Study completion date - 30 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:

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 40827/A
Batch: T2 5572 BOP 01/06
Purity: determined in this study
Appearance: black sticky powder
Expiration date: 28.02.2011
Storage: at room temperature

Analytical monitoring:

yes

Details on sampling:

- 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 (stability samples):
Duplicate samples from the test medium
Duplicate samples from the control

The 48-hour stability samples were taken from the actual test. For sampling, the contents of the respective replicates were combined prior to sampling. All samples were deep-frozen (at about -20 °C) immediately after sampling.

Vehicle:

no

Details on test solutions:

The test medium was prepared by dissolving 29.8 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:

TEST ORGANISM
- Common name:
- Strain: Daphnia magna
- Source: University of Sheffield/UK
- Age at study initiation: 6-24 hours old

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

2.5 mmol/L (= 250 mg/L as CaCO3)

Test temperature:

20-22 °C

pH:

7.8 - 7.9

Dissolved oxygen:

8.7 - 8.8

Nominal and measured concentrations:

Nominal: 100 mg/L
Measured: 107 mg/L (start), 104 mg/L (end)

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL glass beaker
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 50 mL
- Aeration: No
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 1
- Biomass loading rate: 10mL/daphnia

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted test water
- Alkalinity: 0.8 mmol/L
- Ca/mg ratio: 4 : 1 (based on molarity)

OTHER TEST CONDITIONS
- Photoperiod: 16-hour light to 8-hour dark photoperiod (with a 30 minute transition period)
- Light intensity: Approximately 470 and 640 Lux

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: No data
- Results used to determine the conditions for the definitive study: 100 mg/L

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EC0

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

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:

EC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

No remarkable observations were made concerning the appearance of the test medium.

Results with reference substance (positive control):

48-hour EC50: 0.67 mg/L

Validity criteria fulfilled:

yes

Conclusions:

The test substance did not show any mortality towards Daphnia magna up to 100 mg/L. Thus, the substance is considered to be of low toxicity to daphnids.

Executive summary:

The acute toxicity of the test item FAT 40827/A 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). A limit test was performed in accordance with the test guidelines to demonstrate that the test item has no toxic effect on the test organisms up to and including the concentration of 100 mg/L. Thus, the only nominal concentration tested was 100 mg/L and a control. The analytically determined concentration of the test item in the test medium at the start and the end of the test was 107 and 104 % of the nominal value, respectively. 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. In the control and at the test item concentration of 100 mg/L, no immobilized test organisms were observed during the test period of 48 hours. Therefore, the 48-hour NOEC (highest concentration tested without toxic effects after the exposure period of 48 hours) and the 48-hour ECO of FAT 40827/A 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, 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 40827/A at the test concentration of 100 mg/L.

Description of key information

The 48-hour EC50 and the 48-hour EC100 were higher 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 40827/A 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). A limit test was performed in accordance with the test guidelines to demonstrate that the test item has no toxic effect on the test organisms up to and including the concentration of 100 mg/L. Thus, the only nominal concentration tested was 100 mg/L and a control. The analytically determined concentration of the test item in the test medium at the start and the end of the test was 107 and 104 % of the nominal value, respectively. 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. In the control and at the test item concentration of 100 mg/L, no immobilized test organisms were observed during the test period of 48 hours. Therefore, the 48-hour NOEC (highest concentration tested without toxic effects after the exposure period of 48 hours) and the 48-hour ECO of FAT 40827/A 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, 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 40827/A at the test concentration of 100 mg/L.