Reaction mass of sodium potassium 7-amino-4-hydroxy-3,8-bis(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate, sodium potassium 7-amino-3-{2-[4-(ethenesulfonyl)-2-sulfonatophenyl]diazen-1-yl}-4-hydroxy-8-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate, sodium potassium 7-amino-8-{2-[4-(ethenesulfonyl)-2-sulfonatophenyl]diazen-1-yl}-4-hydroxy-3-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)naphthalene-2-sulfonate and sodium potassium 7-amino-3,8-bis({2-[4-(ethenesulfonyl)-2-sulfonatophenyl]diazen-1-yl})-4-hydroxynaphthalene-2-sulfonate

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:

1998

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:

yes

Remarks:

repetition of the test and different test concentrations

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Remarks:

Swiss GLP

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: TVR50
- Expiration date of the lot/batch: Sep 2004

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Solubility of the test substance in the solvent/vehicle: > 80 g/1 (in water)

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. The concentrations of the test substance at the beginning and at the end of the test were analysed by Analytical Services for Research TD 2.1, Ciba Specialty Chemicals, CH 4002 Basel. Test concentrations below the EC0 were not analysed.

Vehicle:

no

Details on test solutions:

The test medium used had the following composition :
NaHCO3 65 mg/l
MgSO4 • 7 H2O 123.3 mg/l
KCl 5.8 mg/l
CaCl2 • 2 H2O 294 mg/l
Na2SiO3 4.3 mg/l
NaNO3 274 µg/l
KH2PO4 143 µg/1
K2HPO4 184 µg/1
The test medium was prepared with bidistilled water. The pH was in a range of 7.6 - 8.0. The test medium was oxygen saturated at the beginning of the test.
Total hardness 196 mg/1 CaCO3
Ca / Mg ratio 4 : 1
Na / K ratio 10 : 1
Alkalinity 0.8 mmol/1

Test organisms (species):

Daphnia magna

Details on test organisms:

Specicies : Daphnia magna Straus.
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 h.
Pre-treatment: 24 h before the start of the exposure reproductive Daphnia were separated from the young Daphnia by sieving all individuals through a 1000 urn 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:

196 mg CaCO3/L

Test temperature:

19 - 21 °C

pH:

7.6 - 8

Dissolved oxygen:

95% of maximum

Nominal and measured concentrations:

Nominal concentrations : 4.3, 9.4, 21, 45 and 100 mg test substance/l
During the test the actual test concentration in the analysed test media was in the range of 97.9 - 98.2% of the nominal value.

Details on test conditions:

14 h light, 10 h dark

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

> 100 mg/L

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Basis for effect:

mobility

Results with reference substance (positive control):

Reference control October 28, 1998: 24h EC50 1.0 mg/1.

Reported statistics and error estimates:

In lack of effects no statistical evaluation was applied.

During the test the actual test concentration in the analysed test media was in the range of 97.9 - 98.2% of the nominal value. Therefore, the results are related to the nominal value of the test substance concentration.

 

No immobilisation and abnormal behaviour of the Daphnia was observed in the nominal test concentration of 100 mg/l after the test period of 48 h. Therefore, the EC₀value after 48 h was determined to be 100 mg/l. The EC₅₀value after 48 h was determined to be >100 mg/l.

Validity criteria fulfilled:

yes

Conclusions:

The determined EC50 (daphnia magna, immobilisation, 48h) is > 100 mg/l as no immobilisation was oibserved at all concentrations tested.

Executive summary:

Acute toxicity of FAT40571/A to Daphnia magna was carried out according to OECD 202 and EU C.2 guideline to determine the EC₅₀ (concentration at which 50% of the Daphnia population is immobilised).

Total 20 Daphnia at each test concentration (4.3, 9.4, 21, 45 and 100 mg/l nominal) for 48 h duration using Spectrophotometry analytical method.

During the test the actual test concentrations in the analysed test media were in the range of 97.9 - 98.2% of the nominal values. The results are related to the nominal values of the test substance concentrations.

The 24 h and 48 h EC₅₀ is greater than 100mg/l

Description of key information

The test substance did not show toxicity in daphnids, the 24 h and 48 h EC50  is greater than 100 mg/l 

Additional information

The acute toxicity to Daphnia magna was carried out according toOECD 202 and EU C.2 guideline to determine the EC₅₀ (concentration at which 50% of the Daphnia population is immobilised).

A total of 20 Daphnia were used at each test concentration and exposed for 48 h to concentrations of 4.3, 9.4, 21, 45 and 100 mg/l test substance. The test item concentrations in test medium were confirmedusing a spectrophotometry analytical method.

During the test the actual test concentrations in the analysed test media were in the range of 97.9 - 98.2% of the nominal values. The results are related to the nominal values of the test substance concentrations.

In this study, the 24 h and 48 h EC₅₀is greater than 100 mg/l, the NOEC was found to be >= 100 mg/l.