Disodium 7-[[2-(acetylamino)-4-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]phenyl]azo]naphthalene-1,3-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:

From November 12th to December 19th, 1996

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, adopted April 04, 1984

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

December 29, 1992

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: freshly prepared test medium of the test concentration of nominal 100 mg test substance/l and the control.
- Number of sampling: duplicate samples.
- Sampling time: samples taken just before the start of the test and at the end of the test (after 48 hours).
- Sample storage conditions before analysis: all samples are kept stored at about -20 °C to enable additional analyses.

Details on test solutions:

The test medium with the test substance concentration of nominal 100 mg/l was prepared by dissolving the test substance homogeneously in test water by intense stirring. The test medium was freshly prepared just before the start of the test (= introduction of Daphnia).

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain/clone: Daphnra (defined Clone 2).
- Source: animals supplied by the Ruhrverband, Essen, F.R.G. in 1989.
- Breeding conditions: clone was bred in the laboratories of testing facility under similar temperature and light consitions as in the test, and in reconstitute water of a similar quality regarding to pH, components of the main ions and total hardness as the test water used in the test.
- Age of parental stock: animals were 6 - 24 hours old and were not first brood progeny.
- Feeding during test: the Daphnia wete not fed.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

20.7 - 20.8 °C during the test period.

pH:

The pH-values ranged from pH 7.7 to pH 8.0.

Dissolved oxygen:

The dissolved oxygen concentrations in the test media were at least 8.0 mg/l or higher.

Nominal and measured concentrations:

100 mg/l nominal

Details on test conditions:

TEST SYSTEM
- Test vessel: 100-ml-glassbeaker.
- Volume: 50 mI test medium.
- Aeration: the test media were not aerated during the test period.
- No. of organisms per vessel: 5 animals.
- No. of vessels per concentration: 4 replicates.
- No. of vessels per control: 4 replicates.

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: reconstituted water. In deionized water analytical grade salts were added to following nominal concentrations and the water was aerated to oxygen saturation: CaCl2 x2H2O 2.0 mmol/l (= 294.0 mg/l), MgSO4 x 7H2O 0.5 mmol/l (= 123.0 mg/l), NaHCO3 0.75 mmol/l (= 65.0 mg/l), KCI 0.075 mmo/l (= 5.8 mg/l).
- Water Hardness: 2.5 mmol/l (= 250.0 mg/l) as CaCO3
- Alkalinity: 0.8 mmol/l
- Ratio of Ca : Mg: 4 : 1
- Ratio of Na : K: 10 : 1

OTHER TEST CONDITIONS
- Photoperiod: a 16-hour light to 8-hour darkness photoperiod.
- Light intensity: 400 - 550 Lux

EFFECT PARAMETERS MEASURED
The immobility or mortality of the Daphnia was determined by visual controls after 24 and 48 hours. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker were considered to be immobile.

MESUREMENTS
At the start and at the end of the test, the pH-values and the dissolved oxygen concentrations were determined in the test media of the single test concentration and the control. The water temperature was determined in one control beaker at the start and the end of the test.

RANGE-FINDING STUDY
- Range finding: the test concentration was based on the results of a non-GLP range-finding test.

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:

In the control and in the test concentration of nominal 100 mg test substance/l no immobility or mortality of the test animals was 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 EC0 of test item to Daphnia magna were determined to be at least 100 mg test substance/l.
The 48-hour LOEC (lowest concentration with toxic effects) and the 48-hour EC50 were clearly higher than 100 mg test substance/I. These values could not be quantified due to the absence of
toxicity of test item up to this test concentration.

APPEARANCE OF THE TEST SOLUTION
The test medium was intensively coloured by the test substance.

MEASURED CONCENTRATIONS
The analytical determined test substance concentrations in the test medium of nominal 100 mg test substancell varied in the range of 91 % to 94 % of the nominal value during the test period. The mean measured concentration (calculated as the average over a1l measurements per concentration) was 92 % of nominal.
Therefore, all reported results are related to the nominal concentration of the test substance.

Conclusions:

EC50 (48h) > 100 mg/l (nominal)

Executive summary:

The acute toxicity of the test substance to Daphnia magna was determined in a 48-hour static test, according to the Commission Directive 92/69/EEC, Annex Part C.2, dated December 29, 1992, and the OECD Guideline for Testing of Chemicals, Section 2, No. 202, Part I, adopted April 04, 1984.

A limit test was performed to demonstrate that the test substance has no toxic effect on the test animals up to the concentration of nominal 100 mg test substance/l. Thus the only concentration tested was the nominal 100 mg test substance/l and a control.

The analytical determined test substance concentrations in the test medium varied in the range of 91 % to 94 % of the nominal value during the test period. The mean measured concentration (calculated as the average over all measurements per concentration) was 92 % of nominal. Therefore, all reported results are related to the nominal concentration of the test substance.

The 48-hour NOEC (highest concentration tested without toxic effects after the exposure period of 48 hours) and the 48-hour EC0 of test item to Daphnia megna were determined to be at least 100 mg test substance/l. The NOEC and the EC0 might even be higher than this concentration, but concentrations in excess of 100 mg test substance/l have not been tested. The 48-hour LOEC (lowest concentration with toxic effects) and the 48 -hour EC50 were clearly higher than 100 mg test substance/l. These values could not be quantified due to the absence of toxicity of test item up to this test concentration.

Conclusion

EC50 (48h) > 100 mg/l (nominal)

Description of key information

Not harmful/toxic to invertebrates (EC50 (48h) > 100 mg/l (nominal))

Additional information

There is no information about the short-term toxicity potential of Reactive Yellow 215 to aquatic invertebrates, thus the available information on the structural analogous Similar Substance 01 have 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 the OECD Guideline 202, Part I, adopted April 04, 1984. A limit test was performed to demonstrate that the test substance has no toxic effect on the test animals up to the concentration of nominal 100 mg test substance/l. The analytical determined test substance concentrations in the test medium varied in the range of 91 % to 94 % of the nominal value during the test period, therefore, all reported results are related to the nominal concentration of the test substance.

The 48-hour NOEC (highest concentration tested without toxic effects after the exposure period of 48 hours) and the 48-hour EC0 of test item to Daphnia megna were determined to be at least 100 mg test substance/l. The NOEC and the EC0 might even be higher than this concentration, but concentrations in excess of 100 mg test substance/l have not been tested.