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EC number: 206-033-9 | CAS number: 294-62-2
- 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:
- 2010-07-26 to 2010-07-30
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cyclododecane
- EC Number:
- 206-033-9
- EC Name:
- Cyclododecane
- Cas Number:
- 294-62-2
- Molecular formula:
- C12H24
- IUPAC Name:
- cyclododecane
- Details on test material:
- - Name of test material (as cited in study report): Cyclododecan
- Molecular formula: C12H24
- Molecular weight: 168.32 kg/kmol
- Physical state: Solidified melt, colourless
- Analytical purity: 99.3 - 99.8 %
- Purity test date: 2010-05-20
- Lot/batch No.: 3347/27173
- Expiration date of the lot/batch: 2011-05-20
- Storage condition of test material: Room temperature, protected from moisture and light
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Samples of the saturated test item solution and the control from the fresh media (0 and 24 h) and old media (24 and 48 h) were analytically verified by GC-MS.
- Sampling method: For the fresh media, samples of the freshly prepared test solutions were taken and analysed. Samples of the old media were taken directly from the test vessels.
The effect levels are given based on the geometric mean measured concentrations.
- Sample storage conditions before analysis:All samples were stored at room temperature until start of analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Following the recommendations of OECD guidance document no 23 (2000), a column elution system as generator system was applied. Two generator columns were prepared once for the test prior to application, one for the preparation of the saturated solution used at test start (0 h) and one for the preparation of the saturated solution used at the medium renewal after 24 h. For the preparation of a generator column 10 g glass beads (size 0.75 – 1.00 mm) were spiked with the test item. The test item (100 mg was weighed out) was dissolved in 5 mL acetone and mixed thoroughly with the glass beads in a glass beaker. After complete evaporation of the solvent, the dry glass beads were filled in the generator column.
For preparation of the saturated test solution the generator column was rinsed with 1 L of dilution water in a closed circuit within 24 h by a tubing pump with a flow rate of 2 mL/min.
- Eluate: Dilution water
- Differential loading: A limit test with the saturated solution (maximum solubility level of the test item in the test medium) was carried out.
- Controls: Four replicates of dilution water without test item tested under the same conditions as the test groups.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna (STRAUS)
- Strain: Clone 5
- Source: Institut für Wasser-, Boden- Lufthygiene (WaBoLu), further own breeding
- Age at study initiation (mean and range, SD): 2 to 24 h
- Method of breeding: In 2-3 L glass vessels with appr. 1.8 L culture medium, at 20 +/- 2 °C, in an incubator, 16 h illumination, illumination strength max. 20 µExm-2 x s-1
- Feeding during test: No feeding
ACCLIMATION
- Acclimation period: 2 h
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: No feeding
- Health during acclimation (any mortality observed): Healthy, no mortality observed
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- No
Test conditions
- Hardness:
- Dilution water: 231 anf 244 (mg CaCO3/L)
- Test temperature:
- 19.6 and 19.4 °C
- pH:
- Water Quality Parameters in the Old Media (24 h)
(measured in all replicates)
pH-Values
Replicates
1 2 3 4
Saturated test item solution 7.56 7.57 7.56 7.56
Control 7.60 7.71 7.65 7.59
: Water Quality Parameters in the Old Media (48 h)
(measured in all replicates)
pH-Values
Replicates
1 2 3 4
Saturated test item solution 7.60 7.58 7.57 7.57
Control 7.42 7.75 7.70 7.64 - Dissolved oxygen:
- Water Quality Parameters in the Old Media (24 h)
(measured in all replicates)
Dissolved O2 -Concentration [mg/L]
Replicates
1 2 3 4
Saturated test item solution 8.00 7.94 8.08 8.00
Control 8.65 8.69 8.70 8.73
Water Quality Parameters in the Old Media (48 h)
(measured in all replicates)
Dissolved O2 -Concentration [mg/L]
Replicates
1 2 3 4
Saturated test item solution 8.35 8.25 8.26 8.14
Control 8.77 8.85 8.82 8.81 - Salinity:
- Freshwater
- Nominal and measured concentrations:
- Please refer to "Any other information on materials and methods"
- Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers, 50 mL
- Type (delete if not applicable): closed with parafilm
- Material, size, headspace, fill volume: Glass beakers (4 cm ID x 7 cm H), 50 mL
- Aeration: No
- Renewal rate of test solution (frequency/flow rate): One application at test start, static test
- 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): None
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Acc. to Directive 92/69/EEC Method C.2, Annex 1
- Conductivity: Dilution water at test start: 640 µS/cm
- Culture medium different from test medium: Elendt M4 acc. to ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L
- Intervals of water quality measurement: At test start and test end
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16:8 light:dark cycle
- Light intensity: Diffuse light, illumination strength max. 20 µE x m-2 x s-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
TEST CONCENTRATIONS
- Spacing factor for test concentrations: None, limit test
- Range finding study
Immobilization Rates of the non GLP Preliminary Range Finding Test
(n = 20, divided into 2 replicates with 10 daphnids each)
Dilution Level
of the Saturated
Test Item Solution IMMOBILIZATION [%]
24 h 48 h
Replicates Replicates
1 2 MV 1 2 MV
Saturated solution 0 0 0 0 0 0
1:10 0 0 0 0 0 0
Control 0 0 0 0 0 0 - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 11.6 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 11.6 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: None
- Mortality of control: 0%
- Other adverse effects control: None
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- EC50/LC50: 1.82 (CI 1.70 - 1.95) mg/L - Reported statistics and error estimates:
- The EC50-value was calculated for the reference item by sigmoidal dose-response regression. The confidence interval of the EC50 was calculated from the best-fit values, the standard error and the t-distribution with the software GraphPad prism.
Any other information on results incl. tables
Immobilization Rates in the Definitive Test after 24 and 48 h of Exposure
(n = 20, divided into 4 replicates with 5 daphnids each)
Cyclododecane |
IMMOBILIZATION [%] |
|||||||||
Geometric Mean Measured Concentration [µg/L] |
24 h |
48 h |
||||||||
Replicates |
Replicates |
|||||||||
1. |
2. |
3. |
4. |
MV |
1. |
2. |
3. |
4. |
MV |
|
11.6 (Saturated test item solution) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- At the saturated solution of the test substance Cyclododecane, which corresponded to the geometric mean measured concentration of 11.6 µg/L, no effects were observed on Daphnia magna. The results indicate that at the saturated solution of the test substance no significant hazard to aquatic invertebrates is expected.
- Executive summary:
In the acute immobilization test to Daphnia magna (STRAUS) the effects of the saturated solution* of the test item Cyclododecane (batch number: 3347/27173) as a limit concentration were determined according to OECD 202 (2004). The limit test was conducted under semi-static conditionsfrom 2010-07-26 to 2010-07-30, with the definitive exposure phase of 48 h from 2010-07-28 to 2010-07-30 at Dr.U.Noack-Laboratorien-
Twenty test organisms were each exposed to the saturated solution* and the control.
The concentrations of Cyclododecane were analysed in both the saturated test item solution* and the control by GC-MS in samples of the fresh media (0 and 24 hours) and the old media (at 24 and 48 hours).
The recoveries of Cyclododecane in the saturated test item solution were determined to be 66 and 72 % of the initially measured values at 24 and 48 hours, respectively. The overall geometric mean measured concentration of Cyclododecane was calculated to be 11.6 µg/L. No immobilization was observed at the maximum concentration of the test item in this system (Table 1).The overall geometric mean measured concentration was used to assess the effect levels. The validity criteria of the test guideline were fulfilled.
EC50-Values, NOEC and LOEC
(based on the geometric mean measured concentration of Cyclododecane)
Test Duration
[h]
Geometric Mean
Measured Concentration of
Cyclododecane
[µg/L]
Confidence Interval
p = 95%[µg/L]
EC50
24
> 11.6
not applicable
48
> 11.6
not applicable
NOEC
48
11.6
---
LOEC
48
> 11.6
---
At the saturated solution* of the test item Cyclododecane, which corresponded to the geometric mean measured concentration of 11.6 µg/L,
no effects were observed on Daphnia magna.
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