Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

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:
December 11, 1990 to March 21 1991
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:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: SR 6947/14
- Expiration date of the lot/batch: July 1995

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: water: >48 hours; DMSO : >48 hours; DMF : >48 hours
- Solubility of the test substance in the solvent/vehicle: water: >100 g/L; DMSO : >10 g/L; DMF : >10 g/L
Analytical monitoring:
yes
Details on sampling:
Analytical measurements of the test substance were performed in test media samples of the nominal test concentrations 62.6, 250 and 1000 mg test substance/L and control at the start and the end of the test by sampling freshly prepared test media and media, which were incubated during test duration under the same conditions as in the test itself (but without Daphnia).
Vehicle:
no
Details on test solutions:
A stock solution was prepared by dissolving the test substance in test water (1 g/L). The stock solution was diluted in a series of sequential dilutions with test water to prepare the following final nominal concentrations: 62.6, 125, 250, 500 and 1000 mg test substance/L and a control without any additions.
Test organisms (species):
Daphnia magna
Details on test organisms:
The study was performed with young Daphnia magna Straus (6-24 h old), bred in the laboratories of RCC under standardized conditions. The parental Daphnia were maintained in the same reconstituted water as in the test for at least 24 hours prior to the start of the test.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
No
Hardness:
2.5 mmol/L as CaCO3
Test temperature:
18.1 - 18.9 °C
pH:
7.8 - 8.1
Dissolved oxygen:
8.6 - 9.4 mg/L
Nominal and measured concentrations:
- Nominal concentrations: 62.6, 125, 250, 500 and 1000 mg/L.
- Measured concentrations: 99.5 - 114.7 % of nominal values
Details on test conditions:
In each test concentration and controls 20 daphnids were tested, divided into four groups of five animals, each group in 50 mL test medium in a glass-beaker (100 mL). The test was performed in an air-conditioned room.
- Light: 16 hours/day, about 200 - 600 Lux
- Test water: Reconstituted water aerated to saturation was used in the test (according to the EEC Directive).
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
420.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 95% CL: 333.5-530.1 mg/L
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
1 000 mg/L
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
After 48 h exposure, 5 % immobility was observed at a concentration of 62.6 mg/L (1/20 daphnids), 10 % immobility was observed at 250 mg/L (2/20 daphnids) and 65 % immobility was observed at 500 mg/L (13/20 daphnids). 100 % immobility was observed at 1000 mg/L (20/20 daphnids) No immobility was seen at any of the other concentrations.
Reported statistics and error estimates:
The 24 and 48-h EC50 and their 95 %-confidence limits were calculated by the Moving Average Interpolation.
Validity criteria fulfilled:
yes
Conclusions:
The 48h EC50 of FAT 40406/A was calculated to be 420.5 mg test substance/L (95 % Conf. limits: 333.5 - 530.1 mg test substance/L).
Executive summary:

The acute toxicity of FAT 40406/A to Daphnia magna was determined in a 48-h static test according to the OECD Guideline for Testing of Chemicals, Section 2, No. 202, adopted April 04, 1984 and the EEC Directive 84/449, L 251, Part C 2. The test was performed in compliance with the GLP. The nominal concentrations tested were 62.6, 125, 250, 500 and 1000 mg test substance/L and a control without any additions. The 24-h EC50 of the test substance was calculated to be 840.9 mg test substance/l with 95 % confidence limits from 723.7 to 977.0 mg test substance/l. The 24-h EC0 (= NOEC, No Observed Effect Concentration after 24 h) was 250 mg test substance/L. The immobility of one Daphnia in the nominal concentration of 62.6 mg/L was obviously not caused by a toxic effect of the test substance, since in the next higher concentration no immobility was observed.


The 24-hour EC100 was higher than 1000 mg test substance/L. After 48 hours exposure, 5 % immobility was observed at a concentration of 62.6 mg/L (1/20 daphnids), 10 % immobility was observed at 250 mg/L (2/20 Daphnia) and 65 % immobility was observed at 500 mg/L (13/20 daphnids). 100 % immobility was observed at 1000 mg/L (20/20 daphnids)  No immobility was seen at any of the other concentrations. After 48 hours test duration the toxicity of the test substance has increased. The 48-h EC50 was calculated to be 420.5 mg test substance/l with 95 % confidence limits from 333.5 to 530.1 mg test substance/L. The 48 -h EC0 (NOEC after 48 h) was 125 mg test substance/L, the 48h EC100 amounted to 1000 mg test substance/L. In the control no immobility or mortality of the test animals was observed.


 


The test results:


- 24h EC50: 840.9 mg test substance/L (95 % Conf. limits: 723.7- 977.0 mg test substance/L)


- 24h EC0: 250.0 mg test substance/L


- 24h EC100: >1000 mg test substance/L


- 48h EC50: 420.5 mg test substance/L (95 % Conf. limits: 333.5 - 530.1 mg test substance/L)


- 48h EC0: 125.0 mg test substance/L


- 48h EC100: 1000 mg test substance/L


 


All reported results are related to nominal concentrations of the test substance. During test duration the test substance concentrations were in the range of 99.5 - 114.7 % of the nominal values, under test conditions the test substance was sufficiently stable.

Description of key information

The 48-h EC50 of Reactive Red 245 value is 420.5 mg/L in Daphnia magna. 

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
420.5 mg/L

Additional information

The acute toxicity of the test substance to Daphnia magna was determined in a 48-h static test according to the OECD Guideline for Testing of Chemicals, Section 2, No. 202, adopted April 04, 1984 and the EEC Directive 84/449, L 251, Part C 2. The test was performed in compliance with the GLP. The nominal concentrations tested were 62.6, 125, 250, 500 and 1000 mg test substance/L and a control without any additions. The 24-h EC50 of the test substance was calculated to be 840.9 mg test substance/l with 95 % confidence limits from 723.7 to 977.0 mg test substance/l. The 24-h EC0 (= NOEC, No Observed Effect Concentration after 24 h) was 250 mg test substance/L. The immobility of one Daphnia in the nominal concentration of 62.6 mg/L was obviously not caused by a toxic effect of the test substance, since in the next higher concentration no immobility was observed. The 24-hour EC100 was higher than 1000 mg test substance/L. After 48 hours exposure, 5 % immobility was observed at a concentration of 62.6 mg/L (1/20 Daphnia), 10 % immobility was observed at 250 mg/L (2/20 Daphnia) and 65 % immobility was observed at 500 mg/L (13/20 Daphnia). 100 % immobility was observed at 1000 mg/L (20/20 Daphnia)  No immobility was seen at any of the other concentrations. After 48 hours test duration the toxicity of the test substance has increased. The 48-h EC50 was calculated to be 420.5 mg test substance/l with 95 % confidence limits from 333.5 to 530.1 mg test substance/L. The 48 -h EC0 (NOEC after 48 h) was 125 mg test substance/L, the 48h EC100 amounted to 1000 mg test substance/L. In the control no immobility or mortality of the test animals was observed.


 


The test results:


- 24h EC0: 250.0 mg test substance/L


- 24h EC50: 840.9 mg test substance/L (95 % Conf. limits: 723.7- 977.0 mg test substance/L)


- 24h EC100: >1000 mg test substance/L


- 48h EC0: 125.0 mg test substance/L


- 48h EC50: 420.5 mg test substance/L (95 % Conf. limits: 333.5 - 530.1 mg test substance/L)


- 48h EC100: 1000 mg test substance/L


All reported results are related to nominal concentrations of the test substance. During test duration the test substance concentrations were in the range of 99.5 - 114.7 % of the nominal values, under test conditions the test substance was sufficiently stable.