Tetrasodium 2-[[8-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]benzoyl]amino]-1-hydroxy-3,6-disulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

October from 18 to 28, 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

The read across approach is detailed into the document attached to the IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Part I, 1984

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Sample replicates: duplicate samples from the test medium (without daphnids) and duplicate samples from the control (without daphnids). From the control samples only one of the duplicate samples was analyzed from each of both sampling times.
- Frequency of sampling: samples were taken just before test start and after 48 hours.
- Sample storage: all samples were deep-frozen (at about -20 °C) immediately after sampling. Based on preexperiments for investigation of the storage stability the test item is sufficiently stable in the test medium under these storage conditions.

Vehicle:

no

Details on test solutions:

The test medium of the only test concentration of nominal 110 mg/l was prepared dissolving 33 mg test item completely in 300 ml test water by intense stirring for 5 minutes at room temperature. The test medium was prepared just before introduction of the daphnids (= start of the test).

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain/clone: the study was performed with young daphnids of a clone of the species Daphnia magna Straus.
- Source: the clone was originally supplied by the University of Sheffield/UK in 1992, defined from the supplier as clone 5. Since this date the clone is bred in the testing laboratories in reconstituted water of identical quality (regarding pH, main ions and total hardness) and under identical temperature and light conditions as in the tests.
- Age of animals: 6-24 hours old and were not first brood progeny.
- Feeding during test: the daphnids were not fed and the test medium.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

20 - 21 °C during the test period

pH:

The pH-values ranged from pH 7.8 to 7.9.

Dissolved oxygen:

The oxygen concentrations was 8.2 mg/l.

Nominal and measured concentrations:

Nominal 110 mg/l

Details on test conditions:

TEST SYSTEM
- Test vessel: 250-ml glass-beaker.
- Type: the beakers were covered with glass plates.
- Aeration: the test water was aerated until oxygen saturation was reached. The test medium and the control were not aerated during the test period.
- No. of organisms per concentration: 20 daphnids.
- No. of organisms per vessel: 10 daphnids.
- No. of vessels per concentration: 2 replicates
- No. of vessels per control: 2 replicates

TEST MEDIUM / WATER PARAMETERS
- Test water: reconstituted test water; analytical grade salts were dissolved in purified water to obtain the following nominal concentrations:
CaCl2 x 2H2O 2.0 mmol/l (= 294.0 mg/l)
MgSO4 x7H2O 0.5 mmol/l (= 123.0 mg/l)
NaHCO3 0.75 mmol/l (= 65.0 mg/l)
KCl 0.075 mmol/l (= 5.8 mg/l)
Water Hardness 2.5 mmol/l (= 250.0 mg/l) as CaCO3
Alkalinity 0.8 mmol/l
Ration Ca : Mg = 4 : 1 (based on molarity)
Ration Na : K = 10 : 1 (based on molarity)

OTHER TEST CONDITIONS
- Photoperiod: a 16-hour light to 8-hour darkness photoperiod.
- Light intensity: light intensity at light period between 200 and 1200 Lux.

EFFECT PARAMETERS MEASURED
The daphnids were observed for immobility or mortality after 24 and 48 hours of exposure (those organisms not able to swim within 15 seconds after gentle agitation of the test beaker are considered to be immobile).

RANGE-FINDING STUDY
The test concentration was based on the results of a range-finding test and on results of a pre-experiment to the solubility of the test item.
The range-finding test and the pre-experiment were not performed in compliance with GLP Regulations.

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 110 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

ln the control and in the test concentration of 110 mg/l no immobilized or dead 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), respectively the 48-hour EC0 of test item to Daphnia magna were determined to be at least 110 mg/l; the 48-hour NOEC and the 48-hour EC0 might even be higher, but concentrations in excess of 110 mg/l have not been tested, according to the guidelines. The 48-hour EC50 and the 48-hour EC100 were clearly higher than 110 mg/l. These values could not be quantified due to the absence of toxicity at the test concentration of 110 mg/l.

APPEARANCE OF TEST MEDIUM
No remarkable observations were made concerning the appearance of the test medium. The test medium was a clear, intensively colored solution throughout the whole test duration.

MEASURED CONCENTRATIONS
The analytically determined mean test item concentration at the start and the end of the test was 106 and 104 % of the nominal value, respectively. Under the test conditions the test item was stable during the test period of 48 hours. Therefore all reported results are related to the nominal concentration of the test item.

Conclusions:

EC50 (48h) > 110 mg/l (nominal)

Executive summary:

The acute toxicity of the test item to Daphnia magna was determined in a 48-hour static test according to the Commission Directive 92/69/EEC, Part C.2 (1992), and the OECD Guideline for Testing of Chemicals, No. 202, Part I (1984).

A limit test was performed in accordance with the Commission Directive 92/69/EEC to demonstrate that the test item has no toxic effect on the test organisms up to and including the concentration of nominal 110 mg/l. Thus the only concentration tested was nominal 110 mg/l and a control.

During the test period the mean test item concentration in the duplicate samples was measured to be 106 and 104 % of the nominal value. Under the test conditions the test item was sutficiently stable during the test period of 48 hours. Therefore all reported results are related to the nominal concentration of the test item.

In the control and at the test item concentration of 110 mg/l no immobilized or dead test organisms or other signs of intoxication were determined during the test period of 48 hours.

The 48-hour NOEC (highest concentration tested without toxic effects after the exposure period of 48 hours), respectively the 48-hour EC0 of test item to Daphnia magna were determined to be at least 110 mg/l. These values might even be higher, but

concentrations in excess of 110 mg/l have not been tested, according to the guidelines. The 48-hour EC50 and the 48-hour EC100 were clearly higher than 110 mg/l. These values could not be quantified due to the absence of toxicity of test item at that test concentration.

Conclusion

EC50 (48h) > 110 mg/l (nominal)

Description of key information

Not harmful/toxic to aquatic invertebrates, after short-term exposure (EC50 (48h) > 110 mg/l (nominal)).

Additional information

There is no information about the short-term potential toxicity of Reactive Red 147 to acquatic invertebrates, thus the available information on the structural analogous Similar Substance 01 has been taken into consideration; the read across approach can be considered as appropriate and suitable to assess the property under investigation (details about the approach are reported into the IUCLID section 13).

The acute toxicity of the Similar Substance 01 to Daphnia magna was determined in a 48-hour static test, according to EU method C.2 and the OECD Guideline 202, Part I. A limit test was performed; the only concentration tested was nominal 110 mg/l and a control. During the test period the mean test item concentration in the duplicate samples was measured to be 106 and 104 % of the nominal value, thus under the test conditions, the test item was sutficiently stable during the test period of 48 hours. In the control and at the test item concentration of 110 mg/l no immobilized or dead test organisms or other signs of intoxication were determined during the test period of 48 hours.