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EC number: 934-407-8 | CAS number: -
- 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
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- yes
- Remarks:
- No major (the temperature was not constant within ± 1°C for test concentrations 20.7, 45.5 and 100 mg/L. The test is still valid, as it was shown that validity criteria are met)
- GLP compliance:
- yes
Test material
- Test material form:
- solid: flakes
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:PREVOR, France - Batch number 070601
- Expiration date of the lot/batch:06 jun 2019
- Purity test date: 31 July 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:ambient (5 °C - 30 °C), dark, dry
- Stability under test conditions:stable
- Solubility and stability of the test substance in the solvent/vehicle: fully miscible
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:preparation of a gradient of solutions from a stock solution
- Final dilution of a dissolved solid:100, 45.5, 20.7, 9.39, 4.27 mg/L
- Final preparation of a solid:dilution into ISO water
FORM AS APPLIED IN THE TEST (if different from that of starting material): liquid
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control (0 mg/l), 100, 45.5, 20.7, 9.39, 4.27 mg/L
- Sampling method: 21 ml sampled ( (aliquots of 20 ml + 1 ml nitric acid for stabilization).
- Sample storage conditions before analysis: stored between 1-10°C until analysis
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:Dilution into test medium (ISO test water) from 100 mg/L solution to 4.27 mg/l solution using the preceding solution (more concentrated). Prior using a solution as the dilution solution of an other, the mixture is homogenised by shaking. Afterwards the solution is clear and transparent.
- Controls: Test medium (ISO test water)
- Evidence of undissolved material (e.g. precipitate, surface film, etc.):None
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia Magna Straus
- Clone: V
- Source: Federal Environment Agency in Berlin/Germany
- Feeding during test: none
- Exposure to light:16 hours photoperiod /8 hours darkness daily
ACCLIMATION
- Acclimation conditions (same as test or not):same as test (preconditioned in ISO test water)
- Health during acclimation (any mortality observed):only offsprings (< 24 hours) are used for the test
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
Daphnia magna was bred as single culture (1 daphnid per 100 mL) in Elendt M4 medium. The pH-value of the aerated water was within a range of 6.0 – 9.0. The dissolved oxygen was above 60 % saturation and the total hardness 140 - 250 mg/L (as CaCO3), corresponding to 7.8 - 14°dH. The animals were fed with single cell green algae (Desmodesmus subspicatus, formerly Scenedesmus subspicatus) at least three times a week.
The daphnids were reared at a temperature of 20 ± 2 °C in a climatic chamber with 16 hours of illumination and 8 hours of darkness. The medium was changed three times per week. A pipette was used to separate the young daphnids from the adults.
Freshly hatched daphnids less than 24 hours old were used for the test.
Study design
- Test type:
- static
- Water media type:
- other: ISO test water
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 13°dH (232 mg/L as CaCO3) (at test started, into the control, untreated test medium)
- Test temperature:
- 19.4 – 21.7 °C
- pH:
- 7.29 – 7.99
- Dissolved oxygen:
- ≥ 8.6 mg/L
- Salinity:
- no
- Nominal and measured concentrations:
- yes
- Details on test conditions:
- TEST SYSTEM
- Test vessel: four 100 mL glass beakers per treatment, each filled with ~ 50 mL, one additional replicate for physico - chemical measurements without test organisms
- Type (delete if not applicable): closed with a glass plate
- Material, size, headspace, fill volume: 50 ml of test solution
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter): none
- Renewal rate of test solution (frequency/flow rate):none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 5 (4+1 for physico-chemical test)
- loading: ~ 10 mL of test solution for each animal
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:prepared on site facility - ISO test water
Ultra pure water with a conductivity < 10 µS·cm-1 was used. For 1L:
With: CaCl2.2H2O: 11.76g + MgSO4.7H2O: 4.93g + NaHCO3 2.59g + KCl 0.23g
- Culture medium different from test medium:Yes. Culture medium = Elendt M4 medium
- Intervals of water quality measurement: mesasured at test tart
OTHER TEST CONDITIONS
- Photoperiod:16 hours photoperiod /8 hours darkness daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : count of immobilised daphnids after 24 and 48 hours. All daphnids not able to swim within 15 seconds after gentle agitation of the test vessel were considered to be immobilised. If present, behavioural changes of daphnids were recorded at 24 and 48 hours after starting the test.
RANGE-FINDING STUDY
- Test concentrations: 0.1, 1.0 and 10.0 mg/l
- Results used to determine the conditions for the definitive study: No daphnia immobilized after 24 hours for any concentrations. 10% of daphnids immobilised after 48 hours at 10.0 mg/l - Reference substance (positive control):
- yes
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- not determinable
- Remarks:
- Due to an inhibition below 50% the database was weak for probit analysis which hence was not performed
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 19.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 24 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 9.39 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 9.39 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 78 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- element
- Basis for effect:
- mobility
- Remarks on result:
- not determinable
- Remarks:
- Due to an inhibition below 50% the database was weak for probit analysis which hence was not performed
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 14.6 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- element
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 8.64 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- element
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 8.64 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- element
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: After 24 hours the mobile daphnids at 45.5 and 100 mg/L were slightly sticky. After 48 hours some of the mobile daphnids at 9.39 mg/L were weak.
- Mortality of control: none - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: potassium dichromate (1.00 mg/L, 2.00 mg/L) under similar conditions and around same time period.
For 1.00 mg/l : 20% of immobilised daphnids after 24hours of exposure.
70% of immobilised daphnids after 48hours of exposure.
For 2.00 mg/l: 100% f immobilised daphnids after 24 and 48 hours of exposure.
The results indicate an EC50 (24 h) of the reference item potassium dichromate between 1.00 and 2.00 mg/L. Since the results are in accordance with the requirements of the OECD guideline 202 and fall within the historical data generated with the reference item at the testing facility, the daphnids were suitable for the determination of the toxicological effects of the test item. - Reported statistics and error estimates:
- The value for EC50 (48 h) was determined by Probit analysis using linear max. likelihood regression. The evaluation of data was performed by ToxRat Professional 3.2.1.
The EC50 (24 h) was not determined statistically.
The NOEC was established based on the highest concentration at which the immobilisation is not higher than the allowed control immobilisation (≤ 10 % immobilisation).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- X300 was tested according to OECD 202 (2004) guideline for Toxicity to the Water Flea Daphnia magna Straus under Laboratory Conditions (Acute Immobilisation Test – Static) without any major deviation. According to the results of the test, the EC50 (48 h) was determined to be 19.3 mg/L (nominal) and 14.6 mg/L (measured). The corresponding NOEC (48 h) was 9.39 mg/L (nominal) and 8.64 mg/L (measured).
- Executive summary:
Guidelines: OECD 202 (2004).
Deviations to
Guidelines: No major (the temperature was not constant within ± 1°C for test concentrations 20.7, 45.5 and 100 mg/L. The test is still valid, as it was shown that validity criteria are met).
GLP: Yes (certified laboratory)
Study Objective: The objectives of this study were to determine the immobilisation effect of the test item X300 on the water flea Daphnia magna under worst-case exposure conditions, the no observed effect concentration (NOEC) and the effect median concentration (EC50), where possible.
Material and methods:
Test item: X300, batch number: 070601, purity analysed: 92.70 % w/w.
Test organisms: Daphnia magna Straus, Clone V, max. 24 hours old.
Test design: Static dose-response test with twenty test organisms per treatment (4 replicates of 5 test organisms each) were used. The duration of the test was 48 hours.
Endpoints: Endpoints reported are the EC50 and the NOEC after 24 and 48 hours.
Test rates: A static main test with nominal concentrations of 100, 45.5, 20.7, 9.39, 4.27 mg/L, and control was performed.
Test conditions: Temperature, pH-value and oxygen concentration of the test solutions measured after 0, 24 hours and 48 hours are reported. Hardness of the test medium (untreated control) was measured on the day of application.
Samples analysed: Analytical samples taken at 0 hours (initial value) and 48 hours from aged test solutions were analysed from control and all test item concentrations.
Statistics: The value for EC50 (48 h) was determined by Probit analysis using linear max. likelihood regression. The EC50 (24 h) was not determined statistically. The NOEC was established based on the highest concentration at which the immobilisation is not higher than the allowed control immobilisation (≤ 10 % immobilisation).
Dates of work: 14 Mar 2018 – 02 May 2018
Findings:
Validity criteria: Control immobilisation: The percentage of immobilisation should be ≤ 10 %. In this study the control immobilisation was 0 %.
Oxygen concentration: The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in all test units. In this test, the dissolved oxygen concentration at the end of the test was ≥ 8.6 mg/L.
Test conditions: The total hardness (as CaCO3) of the test medium (untreated control) was determined to be 13°dH (232 mg/L CaCO3); the mean pH-value of the untreated control was determined to be 7.59 ± 0.26 (Std. Dev.), the mean temperature of the control and all test item concentrations was measured to be 20.5 ± 0.9 °C (Std. Dev.) and the mean oxygen concentration was determined to be 8.9 ± 0.1 mg/L (Std. Dev.).
Analytical Results: The initial measured content of active ingredient was between 82 and 84 % of nominal and the aged measured content was between 60 and 103 % of nominal. Therefore toxicological endpoints were evaluated using the nominal and the actual concentrations (based on the geometric mean of each measured concentration) of the test item.
Statistical Results: EC50 and NOEC-values of daphnids exposed to the test item evaluated using nominal and actual concentrations
EC50 - X300 [mg/L] (nominal - 48h) 19.32 mg/l
EC50 - X300 [mg/L] (geometric mean from measured - 48h): 14.62 mg/l
NOEC - X300 [mg/L] (nominal - 48h) 9.39 mg/l
NOEC - X300 [mg/L] (geometric mean from measured - 48h): 8.64 mg/l
Conclusions: According to the results of the test, the EC50 (48 h) was determined to be 19.3 mg/L (nominal) and 14.6 mg/L (measured). The corresponding NOEC (48 h) was 9.39 mg/L (nominal) and 8.64 mg/L (measured
).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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