Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]

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:

11 October 1994 to 16 June 1995

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:

Limit test: 3 concentrations tested

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 number of test material: 1
- Expiration date of the lot/batch: Oct 1998

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Solubility of the test substance in the solvent/dispersant/vehicle/test medium: miscible

Analytical monitoring:

yes

Details on sampling:

All test medium samples for the analytical determinations were taken from the approximate center of the test vessels (without 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 the PE Analytical Services K, Textile Dyes Division.

Vehicle:

yes

Details on test solutions:

Stock solution
0.09 g test substance were mixed with 200 ml test medium in a beaker, was homogenized for 25 minutes by ultrasonic treatment and filled up to 500 ml with test medium.
Since the test substance was insoluble in the test medium, most of the test substance settled down and built a sediment at the bottom of the flask.

Test concentrations
The nominal test concentrations were chosen as 58 /100 and 180 mg test article/I. For the preparation of the test concentrations only the supernatant of the stock solution was taken.
All test concentrations contained the vehicle Tween 80 (Polyoxyethylensorbitanmonooleat) in a concentration of 5 ppm.

Test organisms (species):

Daphnia magna

Details on test organisms:

The organism used in this test system is the species Daphnia magna. The Daphnia were bred in the laboratories of the Product Ecology TF, Textile Dyes Division 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 was renewed partially three times per week. The daphnids were fed with a suspension of green algae (Scenedesmus subspicatus) supplemented by a TETRAMIN-extract in such quantities that the food was consumed within 24 h.

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

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

None

Post exposure observation period:

None

Hardness:

232 mg/l CaCO3

Test temperature:

48 h at 21 ± 1 °C, 12 h light/12 hours dark.

pH:

None

Conductivity:

None

Nominal and measured concentrations:

The nominal test concentrations were chosen as 58 /100 and 180 mg test article/I. For the preparation of the test concentrations only the supernatant of the stock solution was taken.
All test concentrations contained the vehicle Tween 80 (Polyoxyethylensorbitanmonooleat) in a concentration of 5 ppm.

Details on test conditions:

None

Reference substance (positive control):

yes

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 51.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

25.4 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

The test concentrations were prepared from a 0.18 g/l stock solution. Although, the test substance is miscible in pure (deionised) water, most of the test substance in the stock solution settled down and build a sediment at the bottom of the flask. This effect was possibly caused by a reaction of the test substance with the water hardness compounds in the test water. For the preparation of the test concentrations only the supernatant of the stock solution was taken ( limit of the solubility). The nominal concentrations tested were 58 / 100 and 180 mg test article/I, a blank and a vehicle control without any additions. In the two highest test concentrations again a small sediment at the bottom of the test vessel was observed after 48 hours. Because of the low solubility of the test article in the test media the actual test conentrations in the analysed test media were in the range of 18.5 - 36.3 % of the nominal values. Therefore, the reported results are related to the actual mean values of the analysed test concentrations of the test article measured after beginning and at the end of the test. No immobilization and abnormal behaviour of the Daphnia was observed in the controls. The NOEC and EC0 value after 48 h were determined to be 25.4 mg/l, the EC50 and the EC100 value could not be calculated, but are clearly higher than 51.1 mg/l.

Validity criteria fulfilled:

yes

Conclusions:

The NOEC and EC0 of FAT 21015/B after 48 h were determined to be 25.4 mg/l.

Executive summary:

The acute toxicity of FAT 21015/B to Daphnia magna was determined in a 48-h static test according to the OECD Guideline for Testing of Chemicals, No. 202, adopted 4 April 1984 and EEC-Directive , L 251, C. 2. The study was performed under Good Laboratory Practice (GLP) conditions. The test concentrations were prepared from a 0.18 g/l stock solution. Although the test substance is miscible in pure (deionised) water, most of the test substance in the stock solution settled down and build a sediment at the bottom of the flask. This effect was possibly caused by a reaction of the test substance with the water hardness compounds in the test water. For the preparation of the test concentrations only the supernatant of the stock solution was taken ( limit of the solubility). The nominal concentrations tested were 58/100 and 180 mg test article/l, a vehicle and a blank control without any addtions. In the two highest test concentrations again a small sediment at the bottom of the test vessel was observed after 48 h. Because of the low solubility of the test article in the test media, the actual test concentrations in the analysed test media were in the range of 18.5 - 36.3 % of the nominal values. Therefore, the reported results are related to the actual mean values of the analysed conentrations of the test article measured at the beginning and at the end of the test.

No immobilization and abnormal behaviour of the Daphnia was observed in the controls. The NOEC and EC₀ value after 48 h were determined to be 25.4 mg/l, the EC₅₀ and the EC₁₀₀ value could not be calculated, but are clearly higher than 51.1 mg/l.

Description of key information

The acute toxicity of FAT 21015/B to Daphnia magna was determined in a 48-h static test according to the OECD Guideline 202 1984 and EU method C. 2. The study was performed under Good Laboratory Practice (GLP) conditions. The test concentrations were prepared from a 0.18 g/l stock solution. Although the test substance is miscible in pure (deionised) water, most of the test substance in the stock solution settled down and build a sediment at the bottom of the flask. This effect was possibly caused by a reaction of the test substance with the water hardness compounds in the test water. For the preparation of the test concentrations only the supernatant of the stock solution was taken (limit of the solubility). The nominal concentrations tested were 58/100 and 180 mg test article/l, a vehicle and a blank control without any addtions. In the two highest test concentrations again a small sediment at the bottom of the test vessel was observed after 48 h. Because of the low solubility of the test article in the test media, the actual test concentrations in the analysed test media were in the range of 18.5 - 36.3 % of the nominal values. Therefore, the reported results are related to the actual mean values of the analysed conentrations of the test article measured at the beginning and at the end of the test. No immobilization and abnormal behaviour of the Daphnia was observed in the controls. The NOEC and EC₀ value after 48 h were determined to be 25.4 mg/l, the EC₅₀ and the EC₁₀₀ value could not be calculated, but are clearly higher than 51.1 mg/l.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

51.1 mg/L