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EC number: 619-508-4 | CAS number: 381209-09-2
- 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:
- 06 December 2010 – 07 January 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and EC guidelines and in compliance with GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- (2006)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Version / remarks:
- (2008, Amended by EC No. 761/2009, publication no. L220)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 8692 (Water Quality - Fresh Water Algal Growth Inhibition Test with Scenedesmus subspicatus and Selenastrum capricornutum)
- Version / remarks:
- (Second edition, 01 October 2004)
- 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, December 14, 2000.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-(2-ethylbutyl)cyclohexane-1-carboxylic acid
- EC Number:
- 619-508-4
- Cas Number:
- 381209-09-2
- Molecular formula:
- C13 H24 O2
- IUPAC Name:
- 1-(2-ethylbutyl)cyclohexane-1-carboxylic acid
- Details on test material:
- - Name of test material (as cited in study report): CAT-Acid
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in the dark
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- During the range finding test, samples for analytical confirmation of actual exposure concentrations were taken at the start of the test, after 24 hours and at the end of the test from the test vessels containing 10% and 100% of the WSF.
- Sampling volume: 2 ml from the approximate centre of the test vessels
- Sample storage conditions before analysis: Samples were stored in a freezer until analysis.
During the final test singular samples for possible analysis were taken from all test concentrations and the control according to the schedule below. The glass wool containing the undissolved residue was kept for possible analysis.
- Concentrations: all at t=0 h and t=72 h
- Sampling volume: 2 ml (singular samples for regular analysis and singular reserve samples for possible re-analysis, stored in the freezer)
- Sample storage conditions before analysis: Samples were stored in a freezer until analysis.
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 demonstrated by running a test vessel at the highest substance concentration but without algae and samples for analysis were taken at the start and at the end of the test period.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The batch of CAT-Acid tested was a clear orange liquid with big orange crystals and a purity of 99.7%.
The test substance was not completely soluble in test medium at the loading rate initially prepared. Note that CAT-Acid was heated up to 50ºC for 1-2 hours before weighing resulting in a yellow solution.
Preparation of test solutions started with a loading rate of 100 mg/l applying approximately 20-21 hours of stirring followed by a 2-hour settlement period. This resulted in a clear and colourless solution containing a floating layer and precipitate. The middle fraction was subsequently collected using a tube filled with glass wool to remove any remaining larger undissolved particles. The resulting clear and colourless Water Soluble Fraction (WSF) was used as highest test concentration.
Lower test concentrations were prepared by serial dilution of the WSF prepared at a loading rate of 100 mg/l.
After preparation, volumes of 50 ml were added to each replicate of the respective test concentration. Subsequently, 1 ml of an algal suspension was added to each replicate providing a cell density of 10^4 cells/ml.
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- Species: Pseudokirchneriella subcapitata, strain: NIVA CHL 1
Source In-house laboratory culture.
Reason for selection: This system is an unicellular algal species sensitive to toxic substances in the aquatic ecosystem and has been selected as an internationally accepted species.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Post exposure observation period:
- no
Test conditions
- Hardness:
- 24 mg CaCO3/L
- Test temperature:
- 21.5 - 22.6°C
- pH:
- 7.6 - 8.1
- Dissolved oxygen:
- not determined
- Nominal and measured concentrations:
- nominal concentrations: WSF at 100 mg/L loading rate and dilutions thereof
measured concentrations (at the start of the final test): 0.59, 1.9, 6.3, 20.1 and 69.1 mg/l at test groups containing 1.0, 3.2, 10, 32 and 100% of the WSF, respectively; During the exposure period the measured concentrations remained constant. Consequently, all results were based on the initial measured concentrations. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 ml, all-glass, containing 50 ml of test solution
- Aeration: No
- Initial cells density: 1 x 10^4 cells/mL
- Control end cells density (mean of 6 values): 134.9 x 10^4 cells/mL (range finding test), 119.2 x 10^4 cells/mL (final test)
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
- Other: 1 replicate of the highest concentration without algae.
GROWTH MEDIUM
- Standard medium used: yes, M2
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M2 medium, according to the OECD 201 Guideline, formulated using Milli-Q water (tap water purified by reverse osmosis (Milli-RO)
OTHER TEST CONDITIONS
- Sterile test conditions: not indicated
- Photoperiod and light intensity: no; Continuous illumination using TLD-lamps of the type "Cool-white" of 30 Watt, with a light intensity within the range of 86 to 98 µE.m-2.s-1.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: t=0: microscope + counting chamber; t > 0: spectrophotometer at 720 nm with a cuvette (pathlength = 10 mm)
- Other: Appearance of the cells: At the end of the final test microscopic observations were performed on the test concentration closest to the EC50 to observe for any abnormal appearance of the algae
TEST CONCENTRATIONS
- Controls: Test medium without test substance or other additives.
Combined limit/Range finding test:
- Test concentrations: 0.1%, 1%, 10% and 100% of the WSF at 100 mg/L loading rate (initially measured as 73 mg/L)
- Results used to determine the conditions for the definitive study: 10% and 100% of WSF (i.e. 7.3 and 73 mg/L)
Definitive study (final test):
- Test concentrations: 1.0%, 3.2%, 10%, 32% and 100% of WSF at 100 mg/L loading rate (initially measured as 0.59, 1.9, 6.3, 20.1 and 69.1 mg/L, respectively); During the exposure period the measured concentrations remained constant. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.9 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: same NOEC for yield inhibition
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 69 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: is the concentration measured in a WSF prepared at a loading rate of 100 mg/L
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 8.2 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Remarks on result:
- other: (95% confidence interval between 5.7 and 12 mg/l)
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 14 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield inhibition
- Remarks on result:
- other: (95% confidence interval between 8.1 and 22 mg/l)
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 2.9 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- other: yield inhibition
- Remarks on result:
- other: (95% confidence interval between 1.7 and 4.9 mg/l)
- Details on results:
- Combined limit/range finding test:
- The highest concentration tested , i.e. 100% of the WSF, reduced growth rate by 56.3% and inhibited yield by 94.4%. The second highest concentration tested , i.e. 10% of the WSF, reduced growth rate by 6.5% and inhibited yield by 27.3%.
- Samples taken from the WSF prepared at 100 mg/l and the ten-fold dilution of the WSF were analysed. The measured concentrations in the WSF and the ten-fold dilution were 73 and 7.3 mg/l, respectively and these concentrations remained stable during the 72-hour test period. Therefore, the expected EC50 for growth rate reduction approximated the concentration of 73 mg/l present in the highest test group, while the expected EC50 for yield inhibition was between 7.3 and 73 mg/l.
Final test:
see tables below
- Growth rates were in the range of the controls at the concentrations of 0.59 and 1.9 mg/l during the 72-hour test period, whereas the growth rate of algae exposed to 6.3 mg/l and higher were increasingly reduced. Statistically significant reduction of growth rate was found at concentrations of 6.3 mg/l and higher (Bonferroni t test, a = 0.05).
- No inhibition of yield was recorded up to 1.9 mg/l. Inhibition of yield increased with increasing concentration of CAT-Acid from 6.3 mg/l upwards resulting in 89% inhibition at 69.1 mg/l. Statistically significant inhibition of yield was found at test concentrations of 6.3 mg/l and higher (Bonferroni t test, a = 0.05).
- Microscopic observations at the end of the test revealed a normal and healthy appearance of the exposed cells when compared to the control. - Results with reference substance (positive control):
- The reference test was carried out to check the sensitivity of the test system as used at the test facility.
Algae (Pseudokirchneriella subcapitata, strain: NIVA CHL-1) were exposed for a period of 72 hours to K2Cr2O7 (Potassium dichromate) concentrations of 0.18, 0.32, 0.56, 1.0, 1.8 and 3.2 mg/l and to a control. The initial cell density was 1.0 x 10^4 cells/mL.
- Potassium dichromate reduced growth rate of this fresh water algae species at nominal concentrations of 0.32 mg/l and higher.
- The EC50 for growth rate reduction (ERC50: 0-72h) was 1.0 mg/l with a 95% confidence interval ranging from 0.66 to 1.4 mg/l. The historical ranges for growth rate reduction lie between 0.82 and 2.3 mg/l. Hence, the ERC50: 0-72h for the algal culture tested corresponds with this range.
- The EC50 for yield inhibition (EYC50: 0-72h) was 0.37 mg/l with a 95% confidence interval ranging from 0.28 to 0.51 mg/l. The historical ranges of the 72h-EC50 for yield inhibition lie between 0.43 and 1.1 mg/l. Hence, the EYC50: 0-72h for the algal culture tested corresponds with this range. - Reported statistics and error estimates:
- - For determination of the NOEC and the EC50 the approaches recommended in the OECD guideline 201 were used. An effect was considered to be significant if statistical analysis of the data obtained for the test concentrations compared with those obtained in the negative control revealed significant reduction of growth rate or inhibition of yield (ANOVA, Bonferroni t-test, TOXSTAT Release 3.5, 1996, D.D. Gulley, A.M. Boelter, H.L. Bergman).
- Additionally, the EC10 was determined to meet the recommendations as put down in "A Review of Statistical Data Analysis and Experimental Design in OECD Aquatic Toxicology Test Guidelines" by S. Pack, August 1993.
- Calculation of the EC50 and EC10 values was based on log-linear regression analysis of the percentages of growth rate reduction and the percentages of yield inhibition versus the logarithms of the corresponding initial meaqsured concentrations of the test substance.
- No EC50-values could be calculated for growth (EC50 > maximum soluble concentration).
Any other information on results incl. tables
The test was accepted for the following reasons:
1. In the controls, cell density increased by an average factor of > 16 within two days.
2. The mean coefficient of variation for section-by-section specific growth rates in the control cultures did not exceed 35%.
3. The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures did not exceed 7%.
Mean cell densities (x 104 cells/ml) during the final test
Concentration CAT-Acid (mg/l) |
Exposure time (hours) |
|||
0 |
24 |
48 |
72 |
|
control |
1.0 |
5.7 |
27.3 |
119.2 |
0.59 |
1.0 |
5.9 |
26.9 |
114.7 |
1.9 |
1.0 |
6.5 |
27.4 |
120.7 |
6.3 |
1.0 |
5.1 |
20.2 |
86.7 |
20.1 |
1.0 |
4.9 |
13.9 |
40.3 |
69.1 |
1.0 |
3.5 |
7.9 |
13.7 |
Percentage reduction of growth rate (total test period) and percentage inhibition of yield during the final test
Concentration CAT-Acid (mg/l) |
Mean growth rate |
Yield (0-72 h) |
||
µ (0-72 h) |
Reduction (%) |
x104cells/ml |
Inhibition (%) |
|
control |
0.06635 |
|
118.22 |
|
0.59 |
0.06582 |
0.8 |
113.65 |
3.9 |
1.9 |
0.06656 |
-0.3 |
119.68 |
-1.2 |
6.3 |
0.06195 |
6.6 |
85.73 |
27.5 |
20.1 |
0.05128 |
22.7 |
39.25 |
66.8 |
69.1 |
0.03627 |
45.3 |
12.66 |
89.3 |
Percentage reduction of growth rate at different time intervals during the final test
Concentration CAT-Acid (mg/l) |
Mean growth rate |
|||||
µ (0-24 h) |
Reduction (%) |
µ (24-48 h) |
Reduction (%) |
µ (48-72 h) |
Reduction (%) |
|
control |
0.07215 |
|
0.06554 |
|
0.06135 |
|
0.59 |
0.07392 |
-2.4 |
0.06320 |
3.6 |
0.06035 |
1.6 |
1.9 |
0.07768 |
-7.7 |
0.06028 |
8.0 |
0.06174 |
-0.6 |
6.3 |
0.06806 |
5.7 |
0.05709 |
12.9 |
0.06069 |
1.1 |
20.1 |
0.06571 |
8.9 |
0.04399 |
32.9 |
0.04413 |
28.1 |
69.1 |
0.05074 |
29.7 |
0.03521 |
46.3 |
0.02287 |
62.7 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of the described study with Pseudokirchneriella subcapitata, CAT-Acid reduced growth rate and inhibited the yield of this fresh water algae species significantly at an initially measured concentration of 6.3 mg/l and higher.
The EC50 for growth rate reduction (ERC50: 0-72h) exceeded an initial measured concentration of 69 mg/l, being the concentration measured in a WSF prepared at a loading rate of 100 mg/l.
The EC10 for growth rate reduction (ERC10: 0-72h) was 8.2 mg/l with a 95% confidence interval ranging from 5.7 to 12 mg/l (initial measured concentrations).
The EC50 for yield inhibition (EYC50: 0-72h) was 14 mg/l with a 95% confidence interval ranging from 8.1 to 22 mg/l (initial measured concentrations).
The EC10 for yield inhibition (EYC10: 0-72h) was 2.9 mg/l with a 95% confidence interval ranging from 1.7 to 4.9 mg/l (initial measured concentrations).
The NOEC for both growth rate reduction and yield inhibition was 1.9 mg/l based on initial measured concentrations.
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