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EC number: 243-378-4 | CAS number: 19856-23-6
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
For details please refer to Read Across Justification Document, Section 13.2
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
For details please refer to Read Across Justification Document, Section 13.2
3. ANALOGUE APPROACH JUSTIFICATION
For details please refer to Read Across Justification Document, Section 13.2
4. DATA MATRIX
For details please refer to Read Across Justification Document, Section 13.2 - Reason / purpose for cross-reference:
- read-across source
- Vehicle:
- no
- Test organisms (species):
- Daphnia magna
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Mortality of control: 0 %
- No abnormal behavior was observed at the blank control and the tested concentration.
- At the start and at the end of the test, the content of the test item in the test solutions was determined using HPLC. The measured concentration was 93 % of the nominal concentrations at the beginning of the test and 104 % of the nominal concentrations at the end of the test. Therefore, the determination of the biological results was based on the nominal concentration
The mean QC recovery rate at the start and the end of the test lay in the demanded range and was not taken into account. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: 24h-EC50 value was determined as 2.22 mg/L - Validity criteria fulfilled:
- yes
- Remarks:
- - Immobilisation in the controls may not exceed 10 %. Immobilisation in the control was 0 %. - The concentration of dissolved oxygen at the end of the test must be at least 3 mg/l. The lowest concentration of dissolved oxygen at the end of the test was 8.
- Conclusions:
- EC50 (48h) > 100 mg/l (nominal)
- Executive summary:
This study is performed as a limit test in order to evaluate the toxicity of the test item in an acute immobilisation test under static conditions towards Daphnia magna. Daphnia magna Straus was chosen in the guideline as a typical species of zoo-plankton. Young daphnia, aged less than 24 hours at the start of the test, are exposed to the test item for a period of 48 hours. Immobilisation is recorded at 24 hours and 48 hours and compared with control values. Not more than 10 % of the control daphnia should show immobilisation or other signs of disease or stress, for example, discoloration or unusual behaviour such as trapping at surface of water. The results were analysed in order to determine the EC50at 48 h is determined.
A positive control was tested in a separate study to assure that the test conditions are reliable.
The limit test was chosen based on the results of the range finding test. Ten daphnids per concentration were exposed to 0 -1 -10 -100 mg/l and the immobilisation was observed at 24 and 48 hours. One daphnid was found immobilised at the highest tested concentration at 24 hours and at 48 hours. No daphnids were immobilised in the rest of the tested concentrations. Therefore, for the main study only one concentration at 100 mg/l was chosen. For the test concentration and the blank control, 20 daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised daphnia were counted.
At the start and at the end of the test, the content of the test item in the test solutions was determined using HPLC.
The measured concentration was 93 % of the nominal concentrations at the beginning of the test and 104 % of the nominal concentrations at the end of the test. Therefore, the determination of the biological results was based on the nominal concentration.None of the animals was immobilised in the blank control and the tested concentration.
The EC50 at 48 h (nominal) is therefore > 100 mg/l.
Reference
Non-GLP pre-test results
| Nominal Concentration in mg/L | Immobility 24 hours | Immobility 48 hours | ||||
| absolute | in % | absolute | in % | |||
| Blank control | 0 | 0 | 0 | 0 | 0 | 0 |
| 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| 10 | 0 | 0 | 0 | 0 | 0 | 0 |
| 100 | 1 | 0 | 5 | 1 | 0 | 5 |
Immobility
| Nominal Concentration in mg/L | Immobility 24 hours | Immobility 48 hours | ||||||||
| absolute in % | absolute in % | |||||||||
| Blank control | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 100 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
pH and oxygen values
| Nominal Concentration in mg/L | pH | O2-Concentration in mg/L | ||
| 0 h | 48 h | 0 h | 48 h | |
| Blank control | 7.6 | 8.0 | 8.6 | 8.8 |
| 100 | 6.0 | 6.2 | 8.7 | 8.8 |
Measured concentrations at 0h
| Nominal | Area | Measured Concentration | QC recovery | Dilution factor | Calculated Concentration | Mean Calculated Concentration * |
| Concentration | ||||||
| mg/L | mAU*min | mg/L | % | -- | mg/L | mg/L |
| QC sample (22 mg/L) | 0.5324 | 219.045 | 99.6 | -- | 22.00 | -- |
| 0.5314 | 218.609 | 99.4 | -- | 22.00 | ||
| Blank control | n. a. | -- | -- | -- | -- | -- |
| n. a. | -- | -- | -- | -- | ||
| 100 | 0.5386 | 221.583 | -- | 4.4 | 97.50 | 92.7 |
| 0.5427 | 223.259 | -- | 4.4 | 98.23 | ||
| QC sample (22 mg/L) | 0.5324 | 219034 | 99.6 | -- | 22.00 | -- |
| 0.5332 | 219360 | 99.7 | -- | 22.00 |
LOQ = 2 mg/L; Accuracy of 105.6 % was taken into account; n.a. = not analysable
Measured concentrations at 48 h
| Nominal | Area | Measured Concentration | QC recovery | Dilution factor | Calculated Concentration | Mean Calculated Concentration * |
| Concentration | ||||||
| mg/L | mAU*min | mg/L | % | -- | mg/L | mg/L |
| QC sample (22 mg/L) | 0.5446 | 224.013 | 101.8 | -- | 22.00 | -- |
| 0.5409 | 222.528 | 101.1 | -- | 22.00 | ||
| Blank control | n. a. | -- | -- | -- | -- | -- |
| n. a. | -- | -- | -- | -- | ||
| 100 | 0.6081 | 249.987 | -- | 4.4 | 109.99 | 104.0 |
| 0.6059 | 249.099 | -- | 4.4 | 109.60 | ||
| QC sample (22 mg/L) | 0.5403 | 222269 | 101.0 | -- | 22.00 | -- |
| 0.5401 | 222169 | 101.0 | -- | 22.00 |
Description of key information
EC50 (48h) > 100 mg/l (nominal)
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 100 mg/L
Additional information
Data from Similar Substance 01 were considered for the evaluation of the short-term toxicity potential of the substance to aquatic invertebrates. Justification for Read Across is given in Section 13.
The toxicity of test material to daphnids was evaluated according to the OECD Guideline 202. Twenty daphnids, divided in groups of five, were exposed to different concentrations of the substance ranging from 2200 and 10000 mg/l. After 24 h in darkness, the immobilization of the daphnids was measured. The daphnids that were unable to swim for 15 s after gentle stirring were considered immobile; EC50 (24h) = 6234 ± 466 mg/l (nominal)
A second study is performed according to the OECD 202 and EU Method C.2 and under GLP conditions. This study is performed as a limit test in order to evaluate the toxicity of the test item in an acute immobilisation test under static conditions towards Daphnia magna. Daphnia magna Straus was chosen in the guideline as a typical species of zoo-plankton. Young daphnia, aged less than 24 hours at the start of the test, are exposed to the test item for a period of 48 hours. Immobilisation is recorded at 24 hours and 48 hours and compared with control values. Not more than 10 % of the control daphnia should show immobilisation or other signs of disease or stress, for example, discoloration or unusual behaviour such as trapping at surface of water. The results are analysed in order to determine the EC50at 48 h is determined.
A positive control was tested in a separate study to assure that the test conditions are reliable.
The limit test was chosen based on the results of the range finding test. Ten daphnids per concentration were exposed to 0 -1 -10 -100 mg/l and the immobilisation was observed at 24 and 48 hours. One daphnid was found immobilised at the highest tested concentration at 24 hours and at 48 hours. No daphnids were immobilised in the rest of the tested concentrations.
Therefore, for the main study only one concentration at 100 mg/l was chosen. For the test concentration and the blank control, 20 daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised daphnia were counted.
At the start and at the end of the test, the content of the test item in the test solutions was determined using HPLC.
The measured concentration was 93 % of the nominal concentrations at the beginning of the test and 104 % of the nominal concentrations at the end of the test. Therefore, the determination of the biological results was based on the nominal concentration.
None of the animals was immobilised in the blank control and the tested concentration.
The EC50 at 48 h is therefore > 100 mg/l (nominal).
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