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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
Short-term toxicity to fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 December 2010 – 10 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 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)
- Version / remarks:
- (Second edition, 1996-06-15)
- 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, after 24 hours of exposure and at the end of the test from the test vessels containing 10% and 100% of the WSF.
- Sampling volume: 2 ml
- 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: at t=0 and t=96 all test concentrations and the control group; In addition at t=3 and t=72 h for those groups in which all fish had died.
- Sampling volume: 2 ml (singular samples for regular analysis and singular reserve samples for possible re-analysis)
- Sample storage conditions before analysis: Samples were stored in a freezer until analysis.
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 20-22 hours of stirring followed by a 2-2½ 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.
Test organisms
- Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- Species: Carp (Cyprinus carpio, Teleostei, Cyprinidae) Linnaeus, 1758
Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands.
Mean length (1): Range-finding test: 3.2 ± 0.2 cm
Final test: 4.0 ± 0.2 cm
Mean weight(1): Range-finding test: 0.90 ± 0.16 g
Final test: 1.64 ± 0.34 g
Characteristics: F1 from a single parent-pair bred in UV-treated water.
Reason for selection: This system has been selected as an internationally accepted species.
Total fish used: 54
(1) Ten fish of the batch used for the test, were weighed and measured prior to the start of the test.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Post exposure observation period:
- no
Test conditions
- Hardness:
- 180 mg CaCO3 per litre
- Test temperature:
- 21.5 - 22.4°C
- pH:
- 7.2 - 7.7
- Dissolved oxygen:
- 5.8 - 9.4
- 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): 7.2, 12.8, 23.4, 40.8 and 76.2 mg/l at test groups containing 10, 18, 32, 56 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: 35 litres, all-glass, containing 20 litres of test solution.
- Aeration: The test media were aerated between 24 and 48 hours of exposure.
- No. of organisms per vessel: 7 per concentration
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.57 g fish/litre, i.e. 7 fish per 20 litres of test medium
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium with a hardness of 180 mg CaCO3 per litre and a pH of 7.7 ± 0.3.
OTHER TEST CONDITIONS
- Photoperiod: 16 hours photoperiod daily
- Introduction of fish: Within 11 minutes after preparation of the test media from a holding tank with comparable water quality parameters and
pH and temperature differences between test and holding tank media of less than 0.5 unit and 0.5°C.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- mortality: At 3¼, 24, 48, 72 and 96 hours following the start of exposure. In addition, every afternoon from day 0 and every morning from day 1 to observe for any dead or severely distressed fish. Dead fish were removed when observed.
TEST CONCENTRATIONS
Range finding study
- Test concentrations: 0.1%, 1%, 10% and 100% of WSF at 100 mg/L loading rate (initially measured as 70 mg/L)
- Results used to determine the conditions for the definitive study: 10% and 100% of WSF (i.e. 7 and 70 mg/L)
Definitive study
- Test concentrations: 10%, 18%, 32%, 56% and 100% of WSF at 100 mg/L loading rate (initially measured as 7.2, 12.8, 23.4, 40.8 and 76.2 mg/L, respectively); During the exposure period the measured concentrations remained constant. - Reference substance (positive control):
- yes
- Remarks:
- pentachlorophenol (PCP)
Results and discussion
Effect concentrations
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 20 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: (95% confidence interval between 18 and 27 mg/l)
- Details on results:
- Range finding test:
All fish exposed to the WSF prepared at 100 mg/l died within the 1st day of exposure, whereas no mortality or clinical effects were observed in any of the dilutions prepared from the WSF during the test period.
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 70 and 7 mg/l, respectively and these concentrations remained stable during the 96-hour test period. Therefore, the expected LC50 was between 7 and 70 mg/l.
Final test:
see tables below
Note that aeration was introduced after 24 hours of exposure, as the oxygen concentration tended to drop below the optimum level for testing with carp, i.e. below 5 mg/l. - Results with reference substance (positive control):
- This reference test was carried out to check the sensitivity of the test system as used at the test facility.
- Concentrations: 0.10, 0.22 and 0.46 mg PCP/l in ISO-medium. (pentachlorophenol = PCP)
- Incidence of mortality observed in the reference study: 0% total mortality at 0.10 mg PCP/l (after 96 h), 100% total mortality at 0.22 and 0.46 mg PCP/l (already observed after 24 and 6.5 hours, respectively)
- 96h-LC50 for carp exposed to PCP: 0.15 mg/l (95 % confidence interval between 0.10 and 0.22 mg/l). This effect was already reached within 24 hours of exposure.
The range of the 96h-LC50 for carp is generally between 0.10 and 0.46 mg/l based on historical data of reference tests performed approximately every 3 months from April 1988 until the end of 2000, and annually since then. Hence, the sensitivity of carp originating from the present batch for PCP falls within the range of sensitivities generally observed during the past years. - Reported statistics and error estimates:
- The LC50 was determined using the maximum likelihood estimation method with the probits of the percentages of dead fish as function of the logarithms of the corresponding concentrations (Finney, D.J., 1971: Probit analysis, Cambridge University Press, Cambridge, U.K., 3rd edition).
Any other information on results incl. tables
- Sublethal observations / clinical signs:
The test was accepeted for the following reasons:
1. No mortality was observed in the control at the end of the test.
2. Test conditions were maintained constant throughout the test. (pH: 6.0-8.5, constant within 1 unit; temperature 20-24°C, constant within 2°C)
3. The dissolved oxygen concentration has been at least 60% of the air saturation value throughout the test (>5 mg/l at 22°C).
4. Since the measured concentrations deviated by more than 20% from nominal, but remained stable during the test period, results were based on the initial measured exposure concentration.
Mortality and other effects
Incidence of mortality and total mortality during the final test
Concentration
CAT-Acid
(mg/l)
Initial
number
of fish
Cumulative mortality
Total
Mortality
(%)
3¼h
24h
48h
72h
96h
Control
7
0
0
0
0
0
0
7.2
7
0
0
0
0
0
0
12.8
7
0
0
0
0
0
0
23.4
7
0
0
0
3
5
71
40.8
7
2
6
6
7
7
100
76.2
7
7
7
7
7
7
100
Clinical effects observed during the final test.
Concentration
CAT-Acid
(mg/l)
Time of
recording
(hours)
Specification of effects
Relative
number
12.8
96
Swimming at the surface
3/7
Swimming at the surface and loss of equilibrium
1/7
23.4
3¼
Swimming at the surface
6/7
24
Swimming at the surface and discoloured
7/7
48
Swimming at the surface and loss of righting reflex
7/7
72
Swimming at the surface and loss of righting reflex
4/4
96
Swimming at the surface and loss of equilibrium
2/2
40.8
3¼
Immobile and discoloured
3/5
Loss of righting reflex and discoloured
1/5
Discoloured
1/5
24
Swimming at the surface and discoloured
1/1
48
Swimming at the bottom
1/1
Effect parameters
Parameter
Concentration
CAT-Acid
(mg/l)
95%-
confidence
interval
24,48h-LC50
34
31-42
72h-LC50
23
20-31
96h-LC50
20
18-27
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Under the conditions of the described test CAT-Acid induced no lethal effects in carp at or below an initial exposure concentration of 12.8 mg/l.
The 96h-LC50 was 20 mg/l based on initial exposure concentrations (95% confidence interval between 18 and 27 mg/l).
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