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EC number: 235-878-6 | CAS number: 13019-22-2
- 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 January 2018 - 10 February 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
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- 28 July 2011
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- dd. 22 January 2018
Test material
- Reference substance name:
- Dec-9-en-1-ol
- EC Number:
- 235-878-6
- EC Name:
- Dec-9-en-1-ol
- Cas Number:
- 13019-22-2
- Molecular formula:
- C10H20O
- IUPAC Name:
- dec-9-en-1-ol
- Test material form:
- liquid
- Details on test material:
- - Physical appearance: clear colourless liquid
- Storage conditions: at room temperature, protected from light
Constituent 1
- Specific details on test material used for the study:
- The test item is insoluble in water.
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Samples for possible analysis were taken from all test concentrations and the control according to the schedule below.
Frequency: at t=0 h, t=24 h and t=72 h
Volume: 6.0 mL
Storage: Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility.
At the end of the exposure period, the replicates with algae were pooled at each concentration before sampling.
Compliance with the Quality criteria regarding maintenance of actual concentrations was checked by running a test vessel at an intermediate item concentration (i.e. 3.2% of SS) but without algae and samples for analysis were taken at the start, after 24 hours of exposure and at the end of the test period.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test solutions were prepared at a loading rate of 100 mg/L applying an overnight period of magnetic stirring to ensure maximum dissolution of the test item in medium. The obtained mixture was allowed to settle for 1 hour- 1 hour and 15 minutes. The aqueous Saturated Solution (SS) was collected by means of siphoning and used as the highest test concentration. Lower test concentrations were prepared by subsequent dilutions of the SS in test medium.
- Controls: Test medium without test item or other additives.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: Pseudokirchneriella subcapitata
- Strain: NIVA CHL 1
- Source: in-house laboratory culture
- Age of inoculum (at test initiation): 3 days
- Method of cultivation: Algae stock cultures were started by inoculating growth medium (M1; according to the NPR 6505 (“Nederlandse Praktijk Richtlijn no. 6505”) formulated using Milli-RO water (tap-water purified by reverse osmosis)) with algal cells from a pure culture on agar. The suspensions were continuously aerated and exposed to light in a climate room at a temperature of 21-24°C, until the pre-culture started.
PRE-CULTURE
- 3 days before the start of the test, cells from the algal stock culture were inoculated in culture medium at a cell density of 1 x 10^4 cells/mL. The pre-culture was maintained under the same conditions as used in the test. The cell density was measured immediately before use.
- Pre-culture medium as used in the Final test: Standard M2 medium, according to OECD 201 Guideline.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Hardness:
- 24 mg CaCO3/L
- Test temperature:
- 21.1-23.5 °C
- pH:
- At the start of the test: 8.2-8.3
At the end of the test: 7.9-8.2 - Nominal and measured concentrations:
- Nominal concentrations: 0.32, 1.0, 3.2, 10 and 32% of a saturated solution prepared at 100 mg/L
Measured concentrations (TWA): 0.034, 0.23, 0.82, 0.81, 2.7 and 7.9 mg/L, respectively to nominal concentrations stated above.
The Time Weighted Average was calculated as the concentrations decreased below the limit of detection at the end of the exposure perio at all test concentrations. For measured concentrations per time point, see table 1. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL all glass, capped, vessels; fill volume: 50 mL
- Aeration: no
- Initial cells density: 1 x 10^4 cells/mL
- Control end cells density: 206 x 10^4 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- In addition: 1 or 2 replicates of each concentration without algae; 1 replicates of each test concentration for sampling purposes after 24 hours of exposure.
- Other: during incubation the algal cells were kept in suspension by continuous shaking.
GROWTH MEDIUM
- Medium used: M2 medium
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M2; according to the OECD 201 Guideline, formulated using Milli-RO water.
- Intervals of water quality measurement: pH measured at beginning and end of test; temperature of medium continuously measured in a temperature control vessel.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: Continuously using TLD-lamps with a light intensity of 88 µE.m-2.s-1.
EFFECT PARAMETERS MEASURED
- Determination of cell concentrations: At the beginning of the test, cells were counted using a microscope and a counting chamber. Thereafter, cell densities were determined by spectrophotometric measurement of samples at 680 nm using a spectrophotometer with cuvettes (path length =10 mm). Algal medium was used as blank.
- At the end of the final test microscopic observations were performed on solutions containing 3.2 and 10% of the SS to
observe for any abnormal appearance of the algae compared to the control.
LIMIT/RANGE-FINDING STUDY:
- Test concentrations: 0.10, 1.0, 10 and 100% of the SS prepared at 100 mg/L
- Results used to determine the conditions for the definitive study: yes, at concentrations of 10% and 100% of the SS, growth inhibition was 66% and 100%, respectively, while inhibition of growth was only 0.039% and 0.63% in the 0.10 and 1.0% SS test solutions, respectively. The EC50 for growth rate inhibition was therefore expected to be between a concentration of 1.0% and 10% of the SS.
- Test item analysis of the 1.0 and 10% SS concentrations showed that initial test concentrations were 0.87 and 7.2 mg/L, respectively and that these concentrations decreased to 1.3% and 0.6% of initial at the end of the test. - Reference substance (positive control):
- yes
- Remarks:
- Potassium Dichromate (test performed January 2018).
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 3.6 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 3.4-3.8
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 1.8 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Remarks on result:
- other: 95% CI: 1.6-1.9 mg/L
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.82 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Remarks:
- Statistically significant
- Effect conc.:
- 0.034 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control: Yes
- Observation of abnormalities: Microscopic observations at the end of the test revealed a normal and healthy appearance of the algal cells exposed to a concentration of 0.28 and 2.7 mg/L (TWA) when compared to the control.
- All test concentrations were decreased below the limit of detection at the end of the test. The concentrations measured in samples with algae were comparable with the concentrations measured in the samples without algae. Based on these results, TWA concentrations were calculated.
- Growth rate inhibition was statistically significant at TWA concentrations of 0.23 mg/L and above but considered to be biologically not relevant (<10%) at TWA concentrations of 0.23 and 0.82 mg/L.
- The 72h-NOErC was 0.0.34 mg/L, based on statistical significance. Based on biological relevance (inhibition >10%), the 72h-NOErC was determined to be 0.82 mg/L. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Tested concentrations: 0.18, 0.32, 0.56, 1.0, 1.8 and 3.2 mg/L
- 72-h ErC50: 0.86 mg/L; 95% CI: 0.84-0.88 mg/L
- Other: the results were within the historical range of the test facility. - Reported statistics and error estimates:
- NOEC and EC50: Step-down Jonckheere-Terpstra test procedure, α=0.05, one-sided, smaller.
ECx values: probit analysis using linear maximum likelihood regression with the percentages of growth rate inhibition and the percentages of yield inhibition versus the logarithms of the corresponding TWA concentrations of the test item.
The calculations were performed with ToxRat Professional v. 3.2.1. (ToxRat Solutions® GmbH, Germany).
Any other information on results incl. tables
Table 1 Measured concentrations in the final test
Time of sampling |
Percentage of SSa |
Analyzed concentration |
Relative to |
0 |
0 |
< 0.01d |
|
|
0.32 |
0.223 |
|
|
1.0 |
0.71 |
|
|
3.2 |
2.40 |
|
|
3.2b |
2.46 |
|
|
10 |
7.89 |
|
|
32 |
23c |
|
24 |
0 |
< 0.01d |
n.a |
|
0.32 |
0.027 |
12 |
|
1.0 |
0.506 |
72 |
|
3.2 |
2.13 |
89 |
|
3.2b |
2.33 |
95 |
|
10 |
7.41 |
94 |
|
32 |
22c |
99 |
72 |
0 |
< 0.01d |
n.a. |
|
0.32 |
< 0.01d |
n.a. |
|
1.0 |
< 0.01d |
n.a. |
|
3.2 |
< 0.01d |
n.a. |
|
3.2b |
< 0.01d |
n.a. |
|
10 |
< 0.01d |
n.a. |
|
32 |
< 0.04d |
n.a. |
a Percentage of a saturated solution (SS) prepared at a loading rate of 100 mg/L; b Without algae.; c Estimated value, calculated by extrapolation of the calibration curve.; d Response below the limit of detection (LOD) of the analytical method which was determined to be at 0.010 mg/L and 0.040 mg/L taking a dilution factor of 0.333 or 1.33 into account, respectively.
n.a. Not applicable.
Table 2 Growth rate and percentage inhibition for the total test period
Test item |
Mean |
Std. Dev. |
n |
%Inhibition |
Control |
1.776 |
0.0143 |
6 |
|
0.034 |
1.759 |
0.0039 |
3 |
0.93 |
0.23 |
1.739 |
0.0059 |
3 |
2.1# |
0.82 |
1.663 |
0.0490 |
3 |
6.4# |
2.7 |
1.254 |
0.0395 |
3 |
29* |
7.9 |
0.129 |
0.1068 |
3 |
93* |
* - effect was statistically significant,#- effect was statistically significant but biologically not relevant (<10%)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the results of a toxicity study towards algae, performed according to OECD guideline 201 and GLP principles, the 72h-ErC and the 72h-ErC10 of Trepanol were determined to be 3.6 and 1.8 mg/L, respectively (based on TWA concentrations). The statistically significant 72h-NOErC was 0.034 mg/L (based on TWA concentrations). The biologically relevant 72h-NOErC was 0.82 mg/L (based on TWA concentrations).
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