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EC number: 943-554-7 | 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:
- June-August 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- Principles of method if other than guideline:
- Preliminary solubility work indicated that it was not possible to obtain a testable 100 mg/L stock solution using traditional methods of preparation e.g. ultrasonication and high shear mixing, and so the test item was categorized as being a ‘difficult substance’ as defined by the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures (OECD 2000).
A media preparation trial determined that a prolonged stir method could produce a 100 mg/L solution. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Diethyldimethylcyclohex-2-en-1-one
- EC Number:
- 272-462-3
- EC Name:
- Diethyldimethylcyclohex-2-en-1-one
- Cas Number:
- 68845-36-3
- Molecular formula:
- C12H20O
- IUPAC Name:
- 2,3-diethyl-4,4-dimethylcyclohex-2-en-1-one
- Test material form:
- other: liquid
- Details on test material:
- Please note that although the substance is stated as the mono-constituent substance diethyldimethylcyclohex-2-en-1-one in the report, analytical data on the same batch shows that the test substance is in fact the multi-constituent substance Reaction mass of 3,5-diethyl-2,5-dimethyl-cyclohex-2-en-1-one and 3,5-diethyl-5,6-dimethylcyclohex-2-en-1-one .
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not applicable
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Not applicable
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A nominal amount of test item (1100 mg) was dissolved in 11 litres of test water with the aid of propeller stirring at approximately 1500 rpm for 24 hours. After 24 hours the stirring was stopped and, as a precautionary measure, any undissolved test item was removed by filtration through a 0.2 µm Sartorius Sartopore filter (first approximate 1 litre discarded in order to pre-condition the filter) to give the 100 mg/L test concentration.
- Eluate: Deionised reverse osmosis water
- Differential loading: No
- Controls: Test water only
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): not applicable
- Concentration of vehicle in test medium (stock solution and final test solution): not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): undissolved test item was filtered off
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain: no data
- Source: In-house laboratory cultures
- Age at study initiation (mean and range, SD): neonates <24 hours old (1st instar)
- Weight at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): no data
- Method of breeding: parthenogenesis
- Feeding during test: No
- Food type: no data
- Amount: no data
- Frequency: no data
ACCLIMATION
- Acclimation period: Not available
- Acclimation conditions: same as test
- Type and amount of food: mixture of Algal suspension (Desmodesmus subspicatus) and Tetramin flake food suspension
- Feeding frequency: daily
- Health during acclimation (any mortality observed): no data
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- Not applicable
Test conditions
- Hardness:
- 250 mg/L as calcium carbonate
- Test temperature:
- 20-21 deg C
- pH:
- 7.7 - 8.0
- Dissolved oxygen:
- 8.8 - 9.2 mg(O2)/L
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- 0.10, 1.0, 10 and 100 mg/L nominal test item concentrations (range finding test). Measured concentrations were in the range of 82 % to 90 % of the nominal concentrations.
10, 18, 32, 56 and 100 mg/L nominal test item concentrations (definitive test) . Measured concentrations were in the range of 81 to 88 % of the nominal concentrations. - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass jars
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 250 mL glass jars containing approximately 200 mL of test preparation
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter): Not available
- Renewal rate of test solution (frequency/flow rate): The test preparations were not renewed during the exposure period
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: not available
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (ISO medium): CaCl2.2H2O (294 mg/L); MgSO4.7H2O (123 mg/L); NaHCO3 (64.75 mg/L); KCl (5.75 mg/L)
- Culture medium different from test medium: Yes, Elendt M7 was used as culture medium
- Intervals of water quality measurement: daily
OTHER TEST CONDITIONS
- Adjustment of pH: If necessary with NaOH or HCl
- Photoperiod: 16 hours light, 8 hours darkness (20 minute dawn and dusk intervals)
- Light intensity: 502-521 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mobility at 24 and 48 hours
TEST CONCENTRATIONS
- Spacing factor for test concentrations: approximately 1.8
- Justification for using less concentrations than requested by guideline: Not applicable
- Range finding study: yes
- Test concentrations: 0.10, 1.0, 10, 100 mg/L in range finding study
- Results used to determine the conditions for the definitive study: Noimmobilisation was observed at the test concentrations of 0.10, 1.0 and 10 mg/L. However immobilisation was observed at 100 mg/L. Based on this information test concentrations of 10, 18, 32, 56 and 100 mg/L were used for the definitive test - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 35 mg/L
- Nominal / measured:
- nominal
- Basis for effect:
- mobility
- Remarks on result:
- other: 30-42 mg/L (95% CL)
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 18 mg/L
- Nominal / measured:
- nominal
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 32 mg/L
- Nominal / measured:
- nominal
- Basis for effect:
- mobility
- Details on results:
- No detailed results from the tested concentrations are presented in the report.
Other biological observations: No data - Results with reference substance (positive control):
- - Results with reference substance valid? Yes, within normal range (0.6-2.1 mg/L; EC50-24 hour)
- Mortality: None stated
- EC50: 0.87 mg/L (24 hour); 0.71 mg/L (48 hour)
Any other information on results incl. tables
Cumulative immobilisation data in the definitive test
Nominal concentration (mg/L) | Cumulative immobilised Daphnia (Initiall population: 5 per replicate) | |||||||||||
24 hours | 48 hours | |||||||||||
1 | 2 | 3 | 4 | Total | % | 1 | 2 | 3 | 4 | Total | % | |
Control | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
10 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
18 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
32 | 3 | 2 | 2 | 1 | 8 | 40 | 5 | 3 | 2 | 1 | 11 | 55 |
56 | 3 | 1 | 3 | 5 | 12 | 60 | 4 | 3 | 4 | 5 | 16 | 80 |
100 | 4 | 5 | 5 | 4 | 18 | 90 | 5 | 5 | 5 | 5 | 20 | 100 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Azarbre was observed to have a 48-hour Daphnid EC50 of 35 mg/L
- Executive summary:
In an OECD guideline study (TG 202), to GLP, Azarbre was observed to have a 48-hour Daphnid EC50 of 35 mg/L (95% CL = 30 - 42 mg/L).
The results were based on nominal concentrations, as measured test concentrations at 0 h and 48 h were in a range of 80% to 92% of the nominal concentrations
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