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EC number: 700-073-5 | CAS number: 1215036-04-6
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 29/01/09 to 30/03//09
- Reliability:
- 1 (reliable without restriction)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Isosorbide Diesters
- EC Number:
- 700-073-5
- Cas Number:
- 1215036-04-6
- Molecular formula:
- As it is an UVCB, we can not provide the exact molecular formula.
- IUPAC Name:
- Isosorbide Diesters
- Details on test material:
- - Name of test material (as cited in study report): LAB 3822
- Physical state: liquid
- Lot/batch No.: FAL07/25
- Expiration date of the lot/batch: March 2009
- Storage condition of test material: at room temperature but preferably between 10 and 15°C
- Other:During the first definitive test, measurements of organic carbon showed significant differences between the two preparations. In order to improve preparation and to achieve a better homogeneity of the test solutions, the preparation of the stock solutions of the test item (1000 mg/L) was slightly modified. The ultrasonic treatment was conducted in two stages instead of one as indicated in the study plan. This modification allowed to reduce the disparity between preparations (Test N°1: 176.9 and 316.9 mg/L DOC and Test N°2: 293.3 and 217.7 mg/L DOC).
Constituent 1
Test solutions
- Vehicle:
- no
- Details on test solutions:
- REFERENCE ITEM
Sensitivity of the test organism was checked using potassium dichromate.
The test carried out from 12 to 13 March 2009 gave the following results:
EC50 24h: 1.27 mg/L (1.18 – 1.36 mg/L).
The EC50 24 hours was calculated using a logistic regression analysis with a bootstrap estimation of the 95% confidence limits.
The EC50 24h is in the recommended range: 0.6 – 2.1 mg/L. This result confirms the appropriate sensitivity of the strain of Daphnia magna.
TEST ITEM PREPARATION
The hydrosolubility of diester d’isosorbide is equal or lower than 5 mg/L.
In order to test the dissolved part of the test item, a stock solution at 1000 mg/L was prepared, for each renewal, in dilution water as follows:
1/ Ultrasonication of the test item (1 g) during 10 minutes in about 500 mL of dilution water
2/ 450 mL are collected in a 1 liter flask
3/ Ultrasonication of the 50 mL residual solution during 2 minutes in about 100 mL of dilution water
4/ 150 mL are collected in the 1 liter flask and completed up to 1 liter with dilution water
5/ Magnetic stirring during 10 minutes
6/ Centrifugation for 30 minutes (3000 g)
The stock solution was then diluted in dilution water to get diluted solutions at 100 and 10 mg/L to achieve the range of concentrations necessary to perform the test.
The test solution was renewed after a period of 24 hours.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna Strus 1820 (Crustacea Cladocera) coming from a continuous and balanced breeding carried out in the test facility,
- Age at study initiation (mean and range, SD): aged less than 24 hours at the start of the test.
Culture conditions:
Medium: Elendt M4
Food: TetraMin + green algae
Light: 2500 lux ± 400 lux ; 16-hour light / 8-hour dark cycle
Temperature: 20 ± 2°C
Number of animals: 20 daphnias divided in four groups of five animals, at each test
solution and for the control.
Test concentrations:4.3; 9.4; 20.7; 45.5; 100; 220 and 484 mg/L (initial nominal concentrations)
Loading: 2 ml of test solution for each daphnid.
Feeding: none within the test period.
Aeration: none within the test period.
Environmental conditions: temperature, between 19 and 21°C ; complete darkness.
Renewal of test solutions: at 24 hours.
Time of observation: 24 h (before renewal) and 48 h.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 220mg/l expressed as CaCO3
- Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 49 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- · In the control vessels, the immobilisation of the daphnids did not exceed 10% at the end of the test. · The dissolved oxygen concentration at the end of the test was ³ 3 mg/L in control and test vessels.
- Conclusions:
- In semi–static conditions, an EC50 48h of 49.0 mg/L (nominal concentration) has been determined.
- Executive summary:
TEST PURPOSE
Determination, under defined conditions, of the inhibitory effects of WAFs of the test item on a test population of Daphnia magna within a 48-hour exposure period.
GUIDELINE Updated OECD guideline for testing of chemicals n°202 "Daphnia sp., Acute immobilisation test" (Adopted 13 April, 2004). TEST SYSTEM Daphnia magna
TEST ITEM LAB 3822
TEST SOLUTIONS Water-accommodated fractions; loading rates: 1 – 10 – 100 mg/L
DURATION 48 hours (semi-static conditions, renewal at 24 hours)
RESULTS Values observed in test: EC50 24h (95% confidence limits): 153.5 mg/L (127.2 – 177.2 mg/L)
EC50 48h (95% confidence limits): 49.0 mg/L (39.6 – 58.8 mg/L)
Observations at 24 hours
Testconcentration Number of daphnids immobilised per test vessel % ofimmobilisation A B C D Total/20 Control 0 0 0 0 0 0 4.3mg/L 0 0 0 0 0 0 9.4mg/L 0 1 0 0 1 5 20.7mg/L 0 0 0 0 0 0 45.5mg/L 0 0 0 0 0 0 100mg/L 1 3 2 2 8 40 220mg/L 2 2 4 3 11 55 484mg/L 5 5 5 5 20 100 The EC50 24 hours was calculated using a logistic regression analysis with a bootstrap estimation of the 95% confidence limits.
EC50 24h (95% confidence limits) = 153.5 mg/L (127.2 – 177.2)
Observations at 48 hours
concentration Number of daphnids immobilised per test vessel % ofimmobilisation A B C D Total/20 Control 0 0 0 0 0 0 4.3mg/L 0 0 0 1 1 5 9.4mg/L 0 1 1 0 2 10 20.7mg/L 0 1 2 1 4 20 45.5mg/L 2 3 2 2 9 45 100mg/L 5 5 4 3 17 85 220mg/L 5 5 5 4 19 95 484mg/L 5 5 5 5 20 100 The EC50 48 hours was calculated using a logistic regression analysis with a bootstrap estimation of the 95% confidence limits.
EC50 48h (95% confidence limits) = 49.0 mg/L (39.6 – 58.8)
Conclusion:
In semi–static conditions, an EC50 48h of 49.0 mg/L (nominal concentration) has been determined.
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