Disodium 5,5'-[(1-methylethylidene)bis(4,1-phenyleneoxysulphonyl-2,1-phenyleneazo)]bis[6-amino-4-hydroxynaphthalene-2-sulphonate]

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:

Study initiation date - 15 August 1995; Experiment start date - 22 August 1995; Experiment end date - 24 August 1995; Study completion date - 19 September 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar 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

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
- Identification: FAT 21021/D
- Purity test date: Ca. 70 %
- Lot/batch No.: 9
- Expiration date of the lot/batch: 12/1999
- Storage condition of test material: room temperature

Analytical monitoring:

yes

Details on sampling:

The concentrations of the test substance at the beginning and at the end of the test were analysed.

Vehicle:

no

Details on test solutions:

110 mg test substance were mixed with 200 ml test medium in a beaker, was homogenized for 15 minutes by ultrasonic treatment and then filled up to 500 ml with test medium.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna straus
- Method of 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 limes 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 will be consumed within 24 hours.

Pre-treatment:
- 24 hours before the start of the exposure reproductive Daphnia were separated from the young Daphnia by sieving all individuals through a 1000 µm sieve. For each test concentration 20 Daphnia divided in two groups of 10 animals were used.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

231 mg/L CaCO3

Test temperature:

18-22 °C ± 2 °C

pH:

7.6-8.0

Nominal and measured concentrations:

Nominal concentrations: 45, 100 and 220 mg/L.

Details on test conditions:

TEST SYSTEM:
- No. of organisms per vessel: 10 daphnids
- No. of vessels per concentration (replicates): Duplicate
- No. of vessels per control (replicates): Duplicate

TEST MEDIUM / WATER PARAMETERS
preparation of dilution water:
- NaHCO3: 65 mg/L
- Mgso4 7H2O: 123.3 mg/L
- KCl: 5.8 mg/L
- CaCl2 or CaCl2 H2O: 294 mg/L
- Na2SiO3: 4.3 mg/L
- K2HPO4: 184 mg/L
- KH2PO4: 184 mg/L
The test medium was prepared with bi-distilled water.

Ca : Mg ratio - 4:1
Na:K ratio- 10:1
Alkalinity: 0.8 mmol/l

Reference substance (positive control):

yes

Remarks:

Potassium dichromate (K2Cr2O7)

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 40.4 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: No
- Observations on body length and weight: No
- Other biological observations: No
- Mortality of control: 0% immobility in daphnia control.
- Other adverse effects control: No
- Abnormal responses: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No

Results with reference substance (positive control):

EC50 (24 hours) with Potassium dichromate is determined to be: 0.8-1.5 mg/L.
In general the EC50-24 h of the reference substance is around 1.02 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

The EC50 value after 24 and 48 hours could not be calculated, but was clearly higher than 220 mg/l (nominal; measured conc. 40.4 mg/L). The EC50 value of FAT 21021/D was above the limit of solubility of the test substance in the test medium.

Executive summary:

The acute toxicity of FAT 21021/D to Daphnia magna was determined in a 48 hours static test according to the OECD Guideline for Testing of Chemicals, Section 2, No. 202, adopted 4 April 1984 ( issued 1993 ) and EEC-Guideline 92/69, EEC Nr. L 383 A, C. 2, (29th Dec.1992). The study was performed under Good Laboratory Practice (GLP) conditions. Due to the results of a pretest the nominal concentrations for the main test were selected as 45, 100 and 220 mg test article/L, a vehicle control and a blank control without any additions. The test concentrations were prepared from a 0.22 g/L stock solution. The test substance is soluble in deionized water; most of the test substance in the test solution settled down and built sediment at the bottom of the flask. The reason may be the water hardness compounds in the test medium. For the preparation of the test concentrations only the supernatant of the stock solution was taken. This way the test substance was tested up to the maximum concentration soluble in the test medium. In all test concentrations, sediment at the bottom of the test vessel was observed after 24 hours. During the tes,t the actual test concentrations in the analyzed test media were in the range of 14.4-23.0 % of the nominal values. Therefore, the reported results are related to the actual mean values of the analyzed concentrations of the test article measured at the beginning and at the end of the test. No immobilization and abnormal behavior of the Daphnia was observed in the controls and in the test concentration up to 20.5 mg/L (nominal 100 mg/L). Therefore, the NOEC and EC0 value after 48 hours were determined to be 20.5 mg/L. The EC100 could not be determined. The EC50 value after 24 and 48 hours could not be calculated, but was clearly higher than 40.4 mg/L (Nominal: 220 mg/L). In conclusion, the EC50 value of FAT 21021/D was above the limit of solubility of the test substance in the test medium.

Description of key information

A 48-hour acute daphnia test was conducted in accordance with OECD TG 202 and in compliance with GLP. The EC50 value after 24 and 48 hours could not be calculated, but was clearly higher than the nominal concentration of 220 mg/L (measured 40.4 mg/L). In conclusion the EC50 value of FAT 21021/D was above the limit of solubility of the test substance in the test medium.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

40.4 mg/L

Additional information

The acute toxicity of FAT 21021/D to Daphnia magna was determined in a 48 hours static test according to the OECD Guideline for Testing of Chemicals, Section 2, No. 202, adopted 4 April 1984 ( issued 1993 ) and EEC-Guideline 92/69, EEC Nr. L 383 A, C. 2, (29th Dec.1992). The study was performed under Good Laboratory Practice (GLP) conditions. Due to the results of a pretest the nominal concentrations for the main test were selected as 45, 100 and 220 mg test article/L, a vehicle control and a blank control without any additions. The test concentrations were prepared from a 0.22 g/L stock solution. The test substance is soluble in deionized water; most of the test substance in the test solution settled down and built sediment at the bottom of the flask. The reason may be the water hardness compounds in the test medium. For the preparation of the test concentrations only the supernatant of the stock solution was taken. This way the test substance was tested up to the maximum concentration soluble in the test medium. In all test concentrations sediment at the bottom of the test vessel was observed after 24 hours. During the test the actual test concentrations in the analyzed test media were in the range of 14.4-23.0 % of the nominal values. Therefore, the reported results are related to the actual mean values of the analyzed concentrations of the test article measured at the beginning and at the end of the test. No immobilization and abnormal behavior of the Daphnia was observed in the controls and in the test concentration up to 20.5 mg/L (nominal 100 mg/L). Therefore, the NOEC and EC0 value after 48 hours were determined to be 20.5 mg/L. The EC 100 could not be determined. The EC50 value after 24 and 48 hours could not be calculated, but was clearly higher than 40.4 mg/L (Nominal: 220 mg/L). In conclusion, the EC50 value of FAT 21021/D was above the limit of solubility of the test substance in the test medium.