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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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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:
1993.
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:
Temperature: Higher temperature variation.
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes
Specific details on test material used for the study:
Test substance
Code number: FAT-40'061/D
EN/Batch: 280736.26
Purity: 98.3
Appearance: Solid
Solubility: 100 g/l (in water)
Storage: room temperature
Expiration date: March 1998
Analytical monitoring:
yes
Details on sampling:
The concentration of the test substance at the beginning and at the end of the test was analysed by the Analytical Services K, Textile Dyes Division.
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 to -25 °C until analysis.
Vehicle:
yes
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
The test organism was the species Daphnia magna. The daphnids were bred in the laboratories of the Textile Dyes Division, Product Ecology TF under standardized conditions. For the test, animals with age of less than 24 hours were used.
For each concentration, 20 daphnids were used.

ACCLIMATION
48 hours at 21 °C, 16 hours light / 8 hours dark The daphnids were exposed to the test article in 250 ml beakers containing 100 - 200 ml test
medium with 10 animals per beaker. All tests are running in duplicate. During exposure the animals were kept at 21 ± 1°C with 16 hours illumination.

TEST ORGANISM
- Common name: Daphnia magna
- Source: Textile Dyes Division, Product Ecology TF
- Age at study initiation (mean and range, SD): less than 24 hours
- Number of daphnids: 20 daphnis were used

ACCLIMATION
- Acclimation period: 48 hours at 21 °C, 16 hours light / 8 hours dark. The daphnias were exposed to the test article in 250 ml beakers containing 100 - 200 ml test medium with 10 animals per beaker. During exposure the animals were kept at 21 ± 1 °C with 16 hours illumination.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
136 mg/l CaCO3
Test temperature:
21 ± 1 °C
pH:
The pH was in a range of 7.8-8.2
Nominal and measured concentrations:
Nominal: Based on a pretest, the test concentrations were chosen as 18 / 32 / 58 /100 and 180 mg/I
Actual: 19.3 / 33.9 / 60.8 /104.3 and 189.0 mg /I
Controls: Blank - test water
Vehicle -11.9 mg/l Tween 80 ( polyoxyethylensorbitanmonooleat )
Details on test conditions:
TEST SYSTEM
The daphnias were exposed to the test article in 250 ml beakers containing 100 - 200 ml test medium with 10 animals per beaker:

TEST MEDIUM / WATER PARAMETERS
The test medium used had the following composition:
stock solution
NaHCO-3: 65 mg/l
MgSO4 * 7H2O: 123.3 mg/l
KCl: 5.8 mg/l
CaCI2 * 2 H2O: 294 mg/l
Na2SiO3 * 9H2O: 10 mg/l
NaNO3: 274 mg/l
KH2PO4: 143 microgrgr/l
K2HPO4: 184 microgr/l
The test water medium was prepared with bidistilled water.

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

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light / 8 hours dark
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
189 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 189 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 189 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
Calculation of EC - values:
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 103.7 - 107.2 of the nominal values. Therefore, under test conditions the test article was sufficiently stable. In all test concentrations no alteration of the test substance after 48 hours was observed. In the controls and in all test concentrations no immobilisation of the daphnids was observed after 48 hours. The EC0 values are at least 189.0 mg/l, but might even be higher than this concentration. The EC50 and EC100 values are clearly higher than 189.0 mg/I. Therefore, the EC50 value could not be calculated.
Results with reference substance (positive control):
Potassium dichromate, EC50: 1.00 mg/l.
Validity criteria fulfilled:
yes
Conclusions:
FAT 40061/D is pratically non toxic to Daphnia magna with EC50 >189 mg/l.
Executive summary:

The acute toxicity of FAT 40061/D to Daphnia magna was determined in a 48-hour static test according to 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 18, 32, 58, 100 and 180 mg test article/l, and a control without any additions. During test duration the test article concentrations in the analysed test media were in the range of 103.7 - 107.2 of the nominal values. The actual concentrations were 19.3, 33.9, 60.8, 104.3 and 189.0 mg/L. Therefore, under test conditions the test article was sufficiently stable. In all test concentrations no alteration of the test substance after 48 hours was observed. The reported results are related to the analytical concentrations of the test article. In the control and in all test concentrations no immobilization of the daphnias’ was observed after 48 hours. Hence, the EC0 value is at least 189.0 mg/l, but might even be higher than this concentration. The EC50 and EC100 values are clearly higher than 189.0 mg /l. Therefore, the EC50 value could not be calculated.

Description of key information

The 48h EC50 for aquatic invertebrates is >189 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
189 mg/L

Additional information

The acute toxicity of FAT 40061/D to Daphnia magna was determined in a 48-hour static test according to 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 18, 32, 58, 100 and 180 mg test article/l, and a control without any additions. During test duration the test article concentrations in the analysed test media were in the range of 103.7 - 107.2 of the nominal values. The actual concentrations were19.3, 33.9, 60.8, 104.3 and 189.0 mg/L. Therefore, under test conditions the test article was sufficiently stable.In all test concentrations no alteration of the test substance after 48 hours was observed. The reported results are related to the analytical concentrations of the test article.In the control and in all test concentrations no immobilization of the daphnias’ was observed after 48 hours. Hence, the EC0 value is at least 189.0 mg/l, but might even be higher than this concentration. The EC50 and EC100 values are clearly higher than 189.0 mg/l.Therefore, the EC50 value could not be calculated.