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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
None
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
adapted 4 April 84
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
EEC Directive 84/449, L 251, Part C 2
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Code number: FAT-31'016/P
- EN-Nr.: 414154.32
- Purity: 95 %
- Appearance: solid
- Solubility: 40 g/L (in water)
- Storage: room temperature
- Expiration date: 07/98
Analytical monitoring:
yes
Details on sampling:
Sampling for analysis.
All test medium samples for the analytical determinations were taken after mixing of the test solutions from the approximate center of the test vessels and kept at -18°C to -25 °C until analyses.
The concentrations of the test substance at the beginning and at the end of the test was analysed by the Analytical Services K, Textile Dyes Division.
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- The test water medium was prepared with bidistilled water.
- Stock solution: 0.5 g test substance were mixed with 200 ml test medium and fill up to 500 ml with test medium. The stock solution was homogenized for 5 minutes in the ultrasonic bath.
- The test medium used had the following composition :
-NaHCO3 65 mg/l
MgSO4 * 7 H2O 123.3 mg/l
KCl 5.8 mg/l
CaCI2 * 2 H2O 294 mg/l
Na2SiO3*9H2O 10 mg/l
NaNO3 274 µg/l
KH2PO4 143 µg/l
K2HPO4 184 µg/l

- The pH was in a range of 7.8 - 8.2.
- The medium was oxygen saturated at the beginning of the test.
- Theoretical water hardness: 136 mg/l CaCO3
- Ca / Mg ratio: 4:1
- Na / K ratio: 10:1
- alkalinity: 0.8 mmol/l
Test organisms (species):
Daphnia magna
Details on test organisms:
The Daphnia were bred in the testing facility of the Product Ecology TF, Textile Dyes Division understandardised conditions.

Breeding :
Cultures of Daphnia magna are maintained in glass vessels containing aprox. 3.0 litre of reconstituted water (test medium) at 18 - 22°C. The water was renewed partially three times weekly. The Daphnia were feed with a suspension of green algae (Scenedesmus subspicatus) supplemented by a suspension of TETRAMIN-extract in such quantités that the food was consumed within 24h.\

Pretreatment :
24 hours before the start of the exposure reproductive Daphnia were separated from the young Daphnia by sieving all individuals through a 710 urn sieve.

The quality of the Daphnia is checked at least every 3 months by determining the EC50 values (24 h) for potassium dichromate (range: 0.8 -1.5 mg/l).
For each concentration, of test substance, 20 Daphnia divided in two groups of 10 animals are used.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
Theoretical water hardness: 136 mg/l CaCO3
Test temperature:
21 ± 1°C
pH:
7.7 - 8.2.
Dissolved oxygen:
92 - 99 %
Nominal and measured concentrations:
Based on a pretest, the test concentrations were chosen as 0.58 /1.0 /1.8 / 3.2 / 5.8 and 10.0 mg test article / I nominal.
Details on test conditions:
48 hours at 21 °C, 16 hours light / 8 hours dark
The Daphnia were exposed to the test article in 250 ml beakers containing 100 - 200 ml test medium with 10 animals per beaker. All tests were run in duplicate. During exposure the animals were kept at 21 ± 1°C with 16 hours illumination.

- Determination of results
Test evaluations were done according to the guidelines by visual assessment of mobility of the Daphnia after 24 and 48 hours.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
1.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
>= 1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
3.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
In control and test concentrations 0.5 and 1.0 mg/l , no immobilisation was observed. At 1.8 mg/l, 80% immobility was observed at the end of 48 hour observation period. At test concentrations 3.3, 5.8 and 10.0 mg/l, 100% immobility was observed.
Results with reference substance (positive control):
Potassium dichromate (EC50 : 1.01 mg/l)
Reported statistics and error estimates:
The EC50 - value are calculated with the " Spearman - Kaerber's " method.

The reported results are related to the analytical concentrations of the test article. During test duration the test article concentrations in the analysed test media were in the range of 80.0 - 120.0 % of the nominal values. Therefore, under test conditions the test article was sufficiently stable.

Validity criteria fulfilled:
yes
Conclusions:
The EC50 value was determined to be 1.5 mg/l.
Executive summary:

The acute toxicity of FAT - 31'016/P to Daphnia magna was determined in a 48-hours static test according to the OECD Guideline for Testing of Chemicals, Section 2, No. 202, adapted 4

April 84, and EEC Directive 84/449, L 251, Part C 2. The test was performed in compliance with the Good Laboratory Practice Regulations. The nominal concentrations tested were 0.58 /1.0 /1.8 / 3.2 / 5.8 and 10.0 mg test article / l, and a control without any additions. The reported results are related to the analytical concentrations of the test article. During test duration the test article concentrations in the analysed test media were in the range of 80.0 - 120.0 % of the nominal values. Therefore, under test conditions the test article was sufficiently stable. In all test concentrations non alteration of the test substance after 48 hours was observed. In the control non immobilization of the Daphnia magna was observed after 48 hours. At test concentrations 0.5 and 1.0 mg/l , no immobilisation was observed, while at 1.8 mg/l, 80% immobility was observed at the end of 48 hour observation period. At test concentrations 3.3, 5.8 and 10.0 mg/l, 100% immobility was observed. Hence, the EC0 value was at least 1.0 mg/l, but might even be higher than this concentration. The EC50 value was determined to be 1.5 mg/l, while the EC100 value was 3.3 mg/l after 48 hours.

Description of key information

The EC50 value to Daphnia magna was determined to be 1.5 mg/l, while the EC100 value was 3.3 mg/l after 48 hours.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
1.5 mg/L

Additional information

The acute toxicity of FAT - 31'016/P to Daphnia magna was determined in a 48-hours static test according to the OECD Guideline for Testing of Chemicals, Section 2, No. 202, adapted 4 April 84, and EEC Directive 84/449, L 251, Part C 2. The test was performed in compliance with the Good Laboratory Practice Regulations. The nominal concentrations tested were 0.58 /1.0 /1.8 / 3.2 / 5.8 and 10.0 mg test article / l, and a control without any additions. The reported results are related to the analytical concentrations of the test article. During test duration the test article concentrations in the analysed test media were in the range of 80.0 - 120.0 % of the nominal values. Therefore, under test conditions the test article was sufficiently stable. In all test concentrations non alteration of the test substance after 48 hours was observed. In the control non immobilization of the Daphnia magna was observed after 48 hours. At test concentrations 0.5 and 1.0 mg/l , no immobilisation was observed, while at 1.8 mg/l, 80% immobility was observed at the end of 48 hour observation period. At test concentrations 3.3, 5.8 and 10.0 mg/l, 100% immobility was observed. Hence, the EC0 value was at least 1.0 mg/l, but might even be higher than this concentration. The EC50 value was determined to be 1.5 mg/l, while the EC100 value was 3.3 mg/l after 48 hours.