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EC number: 817-187-7 | CAS number: 1803088-15-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- 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
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- At the start of the exposure (0 hours), samples of the fresh media were taken after preparation of the limit concentration, filtered and analyzed.
The limit concentration and the control were analytically verified via LC-MS/MS in fresh media at the start of exposure (0 hours). All samples were filtered with a disposable syringe filter before analysis. Since the measured concentration was below the lowest calibration level at the start of the exposure (0 hours), analytical monitoring at the end of the exposure was waived and the test item concentrations was considered below the lowest calibration level in the old media, too. No method validation was performed either. - Vehicle:
- no
- Details on test solutions:
- A limit concentration of 100 mg/L of the test item was tested as a dispersion. Since the test item is sparingly soluble with a water solubility limit very likely below the analytical detection limit, a worst case approach was applied to ensure that the solubility limit under test conditions was maintained during the exposure period. Test item in excess of the water solubility limit was present in the test vessels throughout the exposure period. The limit concentration was selected based on the results of a non-GLP preliminary range finding test under static conditions, which demonstrated that the undissolved part of the test item had no adverse impact on the test organisms.
The limit concentration 100 mg/L was freshly prepared with dilution water directly in the test vessels. For this purpose, 2 mg of the test item were weighed into each test vessel and 20 mL of the dilution water were added. These dispersions were stirred with a magnetic stirrer at approximately 750 rpm for 72 hours at approximately 23 °C. The test solutions were not filtrated. Before insertion of the test organisms, the test solutions were allowed to stand for approximately 1 hour for separation of phases. Test item in excess of the water solubility limit was present in the test vessels throughout the exposure period. The test item floated on the water surface throughout the exposure period. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test system
Daphnia magna STRAUS (Clone 5).
Reason for the selection of the test system
Daphnia magna is the preferred species in accordance with the test guidelines and is bred at the test facility.
Origin
lnstitut für Wasser-, Boden- und Lufthygiene (WaBoLu), 14195 Berlin, Germany
Breeder
Noack Laboratorien GmbH, Kathe-Paulus-Str. 1, 31157 Sarstedt, Germany
Culture
In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 ± 2 °C, in an incubator, 16 hours illumination, light intensity of max. 1500 Ix
Culture medium
Elendt M4, according to OECD 202, Annex 3 (2004), modified to a total hardness of 160 to 180 mg CaCO3/L, is used.
Culture feeding
The culture daphnids were fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, with an algae cell density of> 106 cells/ml. The algae were cultured at the test facility.
Origin of the food algae
Sammlung von Algenkulturen (SAG), Pflanzenphysiologisches lnstitut der Universität Göttingen, Nikolausberger Weg 18, 37073 Göttingen, Germany - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 180 mg CaCO3/L (start of exposure)
- Test temperature:
- 20.9 deg. C (start of exposure)
- pH:
- Control: 7.75 (start of exposure); 7.53 - 7.99 (end of exposure)
100 mg/L: 8.11 (start of exposure); 7.54 - 7.61 (end of exposure) - Dissolved oxygen:
- Control: 8.37 mg/L (start of exposure); 8.32 - 8.48 mg/L (end of exposure)
100 mg/L: 8.26 mg/L (start of exposure); 7.99 - 8.56 mg/L (end of exposure) - Salinity:
- n/a
- Conductivity:
- 460 µS/cm (start of expsoure)
- Nominal and measured concentrations:
- nominal: 100 mg/L
measured: < calibration (calibration range 1 - 25 µg) - Details on test conditions:
- Test method
The study was performed under static conditions.
Test duration
48 hours
Test vessels
Glass beakers (4 (ID) x 7 (H) cm), 50 ml capacity, loosely covered with watch glasses
Test volume
20 ml
Dilution water
Same composition as the culture medium
Number of daphnids and replicates
20 daphnids, divided into 4 replicates, each with 5 daphnids were used for the limit concentration and the control.
Age of the daphnids at the start of the exposure
Less than 24 hours old daphnids from a healthy stock were used for the study. Juvenile daphnids were removed from the culture vessels at the latest 24 hours before the start of the exposure and discarded. The juveniles born within the following period of max. 24 hours preceding the exposure were used for the test. No first brood progeny was used for the test.
Acclimatization
Acclimatization was not necessary, because the composition of the dilution water was equivalent to the culture medium.
Application
The daphnids were inserted with a small amount of dilution water by pipette into the water body below the water surface.
Test temperature (target)
18 - 22 °C, constant within ± 1 °C
Illumination (target)
Diffuse light, light intensity of max. 1500 Ix
Photoperiod (target)
16/8 hours light/dark cycle
Feeding
The daphnids were not fed during the study.
Reference Test
A reference test was conducted as an acute immobilization test (acc. to AQS P 9/2 and OECD 202) in Elendt M4 medium under static conditions with a test duration of 24 hours once per month in order to prove the validity of the test system and test conditions at the test facility.
Reference item
Potassium dichromate p.a. (SIGMA)
Purity
99.0%
Batch number
MKBV0900V
Storage stability
2021-11-25
Test concentrations
1.00 - 2.00 - 4.00 mg/L
Ranges of validity
EC50 (24 hours): 0.6 - 2.4 mg/L, according to AQS P 9/2 (clone 5),
EC50 (24 hours): 0.6 - 2.1 mg/L, according to OECD 202 (clone A)
Test duration
2017-06-01 to 2017-06-02 - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate p.a. (SIGMA)
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EL10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EL100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item were determined at the test facility according to OECD 202 (2004), which is equivalent to the Commission Regulation (EC) No.440/2008 Method C.2 (2008), from 2017-06-16 to 2017-06-21, with the definitive exposure phase from 2017-06-19 to 2017-06-21. The study was conducted as a limit test under static conditions over a period of 48 hours with a nominal concentration of 100 mg/L of the test item (tested as a dispersion). Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to the test item concentration and the control. Since the test item is sparingly soluble with a water solubility limit very likely below the analytical detection limit, a worst-case approach was applied to ensure that the solubility limit under test conditions was maintained during the exposure period. 2 mg of the test item were weighed into each test vessel and 20 ml of the dilution water were added. These dispersions were stirred with a magnetic stirrer at 750 rpm for 72 hours at approximately 23 °C. The test solutions were not filtrated. Before insertion of the test organisms, the test solutions were allowed to stand for approximately 1 hour for separation of phases. Test item in excess of the water solubility limit was present in the test vessels throughout the exposure period. The test item floated on the water surface throughout the exposure period. The undissolved part of the test item had no adverse impact on the test organisms. The concentrations of the test item were analytically verified via LC-MS/MS in fresh media at the start of the exposure (0 hours) in the limit concentration and the control. Before analysis, all samples were filtered to remove undissolved test item. The measured concentration of the test item (dissolved part after filtration) was lower than the calibration range (1 - 25 μg/L). Therefore, the test item concentration in old media at the end of the exposure can be considered lower than the calibration range, too.
The validity criteria of the test guidelines were fulfilled.
The study was performed according to OECD Guideline 202 (2004), which is equivalent to the Commission Regulation (EC) No.440/2008 Method C.2 (2008). The validity criteria were fulfilled:
- In the control group, no daphnids were immobilized or showed any signs of disease or stress, e.g. discoloration or unusual behavior such as trapping on the surface of the water, during the 48-hour test period (required: not more than 10% of the daphnids in the control).
- The dissolved O2 concentration in the old media at the end of the exposure was ≥ 7.99 mg/L (required: > 3 mg/L at the test end of the exposure) in all test vessels of the limit concentration and the control. - Results with reference substance (positive control):
- The percentage of immobility for the reference item potassium dichromate (SIGMA-ALDRICH, batch number MKBV0900V, purity 99.0%, CAS RN 7778-50-9) was determined after 24 hours from 2017-06-01 to 2017-06-02.
EC50 = 2.05 mg/L
95% confidence limits: 1.80 – 2.33 mg/L
Valid range:
0.6 - 2.4 mg/L, acc. to AQS P 9/2 (02/2000); clone 5
0.6 - 2.1 mg/L, acc. to OECD 202 (2004); clone A - Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the nominal loading of the test item, the 48 hour-EL50 for Daphnia magna is > 100 mg/L.
Reference
Description of key information
There is a high probability that the product is not acutely harmful to aquatic invertebrates.
Key value for chemical safety assessment
Additional information
Short-term toxicity to aquatic invertebrates was tested in a study conducted according to OECD TG 202 under consideration of GLP. A limit test with a concentration of 100 mg/L (nominal) was conducted. The limit concentration was freshly prepared with dilution water directly in the test vessels. The test solutions were not filtrated. Before insertion of the test organisms, the test solutions were allowed to stand for approximately 1h for separation of phases. Test item in excess of the water solubility limit was present in the tes tvessels throught the exposure period. The test item floated on the wtaer surface throughout the exposure period and had no physical effect on the daphnids. After an exposure period of 48h the EL50 was determined as >100 mg/L. The validity criteria were fulfilled.
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