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EC number: 241-533-0 | CAS number: 17540-75-9
- 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:
- 26 Aug 2011 - 20 Sep 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)
- Version / remarks:
- 2006
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.3 (Algal Inhibition test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Swiss Federal Office of Public Health, Consumer protection directorate, Bern, 11 January 2011
Test material
- Reference substance name:
- 4-sec-butyl-2,6-di-tert-butylphenol
- EC Number:
- 241-533-0
- EC Name:
- 4-sec-butyl-2,6-di-tert-butylphenol
- Cas Number:
- 17540-75-9
- Molecular formula:
- C18H30O
- IUPAC Name:
- 4-(butan-2-yl)-2,6-di-tert-butylphenol
- Test material form:
- liquid: volatile
- Details on test material:
- Storage conditions: At room temperature at about 20 °C, under nitrogen in the dark.
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Solvent control, all test concentrations
- Sampling method: duplicate samples at start of the test (without algae) and at the end of the test (containing algae). For the 72-hour stability samples, the contents of the respective replicates were combined prior to sampling
- Sample storage conditions before analysis: Immediately after sampling, acetonitrile (1 mL acetonitrile per mL sample volume) was added to each sample in order to stabilize the latter during the storage period. Thereafter, all samples were stored deep-frozen (at about -20 °C).
Test solutions
- Vehicle:
- yes
- Remarks:
- N,N-dimethylformamide (DMF)
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The application solution for the dosage of the highest test concentration was prepared by dissolving 92.1 mg of the test item in 20 mL of DMF. This application solution was diluted with DMF to prepare the application solutions for the dosage of the lower test concentrations. Initially, the test vessels were preconditioned. Therefore, the test vessels were filled with test water and treatment replicates were applied individually by adding and mixing 28.5 μL of the respective application solution or DMF (for the solvent control) directly into 285 mL of the test water. A solvent concentration of 100 μL/L was finally reached in all treatments. Thereafter, the test vessels were stirred for 5 minutes and stoppered with glass stoppers and left for 55 minutes. After the preconditioning period, the test media were discarded, the test flasks rinsed with purified water, and remaining test water was drained off. Subsequently, the test vessels were used for the test and the application solutions respectively DMF (for the solvent control) were applied again to the test water as described above.
- Controls: test water without addition of test item or solvent; solvent control
- Chemical name of vehicle: N,N-dimethylformamide (DMF)
- Concentration of vehicle in test medium: 100 μL/L
- Evidence of undissolved material: no
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Strain: Strain No. 61.81 SAG
- Source: Collection of Algal Cultures (SAG, Institute for Plant Physiology, University of Göttingen, 37073 Göttingen / Germany).
- Age of inoculum: 4 days
- Method of cultivation: An inoculum culture was set up four days before the start of the exposure. The algae were cultivated under the test conditions. The inoculum culture was diluted threefold one day before the start of the test to ensure that the algae were in the exponential growth phase when used to inoculate the test solutions.
- Cultivation and test medium: Reconstituted test water (OECD medium), buffered with 6 mmol/L HEPES-buffer (corresponding to 1430 mg/L)
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 d
Test conditions
- Hardness:
- 0.24 mmol/L (= 24 mg/L as CaCO3)
- Test temperature:
- 22 °C
- pH:
- Start: 7.8-8.0
End: 10.7-11.1 - Nominal and measured concentrations:
- Nominal: 22, 46, 100, 220, 460 μg/L
Measured: 14, 22, 64, 145, 320 μg/L (geometric means of measured concentration at start and end of the test). The effect levels were expressed as mean measured test item concentrations. See table 5 in 'Any other information on results incl. tables' for the measured concentrations. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 285 mL glass Erlenmeyer flasks, completely filled, tightly closed with glass stoppers
- Aeration: no
- Initial cells density: 10000 cells/mL, 0.99 x 10^3 relative fluorescence units.
- Control end cells density: 306 x 10^3 relative fluorescence units (solvent control).
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- No. of vessels per vehicle control (replicates): 6
- The test flasks were incubated in a temperature-controlled water bath, positioned randomly and repositioned daily.
GROWTH MEDIUM
- Standard medium used: yes, reconstituted water according to OECD Guideline.
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted test water (OECD medium), made with sterile purified water.
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH: in each treatment at start and end of the test; temperature: daily in an Erlenmeyer flask filled with water and incubated under the same conditions as the test flasks.
OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: continuously
- Light intensity and quality: fluorescent tubes (Philips TLD 36W-1/840), approximately 6630 Lux (range: 6200 to 6930 Lux).
EFFECT PARAMETERS MEASURED
- Determination of cell concentrations: pre-culture: electronic particle counter (Coulter Counter, Model ZM); test samples: fluorescence measurement (BIO-TEK Multi-Detection Microplate Reader, Model FLx800)
TEST CONCENTRATIONS
- Range finding study performed, not further specified.
- Results used to determine the conditions for the definitive study: yes. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (performed April 2011)
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 320 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- > 320 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 22 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 64 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): none observed
- The algal growth (biomass) in the solvent control was not statistically significantly different from the control after 72 hours.
- The test item had a statistically significant inhibitory effect on the growth of the algae of the algae after the test period of 72 hours at the mean measured concentration of 64 μg/L and at all higher test concentrations. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- 72-hour EC50 for the growth rate: 1.3 mg/L; within the historical range (2000-2011) of 0.71-1.7 mg/L. - Reported statistics and error estimates:
- Student-t test, α = 0.05, two-sided (to compare control and solvent-control). Williams t-test, onesided smaller, α = 0.05 (to determine NOEC). Probit Analysis.
Any other information on results incl. tables
Table 1 Biomass of Algae
Nominal test item concentration [µg/L] |
Mean measured concentration [µg/L] |
Rep. no. |
Biomass of algae* 24 hours 48 hours 72 hours |
||
Solvent Control |
-- |
1 2 3 4 5 |
9.7 9.2 8.9 9.8 9.5 |
77.6 79.0 79.6 70.8 84.3 |
299.8 303.0 304.1 273.8 333.8 |
|
|
6 |
9.6 |
82.2 |
321.8 |
Mean |
9.4 |
78.9 |
306.0 |
||
|
|
SD |
0.3 |
4.6 |
20.5 |
Control |
-- |
1 2 3 |
9.7 9.4 9.3 |
74.0 85.6 83.4 |
262.1 305.9 287.8 |
Mean |
9.5 |
81.0 |
285.3 |
||
|
|
SD |
0.2 |
6.1 |
22.0 |
22 |
14 |
1 2 3 |
9.2 8.6 9.4 |
76.4 82.4 87.0 |
265.8 327.1 290.6 |
Mean |
9.1 |
81.9 |
294.5 |
||
|
|
SD |
0.4 |
5.4 |
30.8 |
46 |
22 |
1 2 3 |
9.4 9.3 9.4 |
82.0 83.1 93.0 |
248.4 311.6 267.8 |
Mean |
9.4 |
86.0 |
275.9 |
||
|
|
SD |
0.0 |
6.1 |
32.4 |
100 |
64 |
1 2 3 |
9.6 9.2 9.9 |
84.2 83.4 90.6 |
225.3 248.1 288.7 |
Mean |
9.6 |
86.1 |
254.0 |
||
|
|
SD |
0.3 |
3.9 |
32.1 |
220 |
145 |
1 2 3 |
9.0 9.1 8.8 |
72.5 78.0 74.3 |
249.5 253.0 256.3 |
Mean |
9.0 |
74.9 |
252.9 |
||
|
|
SD |
0.1 |
2.8 |
3.4 |
460 |
320 |
1 2 3 |
8.5 7.9 8.2 |
65.6 66.3 66.4 |
250.3 226.2 260.1 |
Mean |
8.2 |
66.1 |
245.5 |
||
|
|
SD |
0.3 |
0.4 |
17.5 |
SD: Standard deviation
*: The biomass was determined by fluorescence measurement (at least duplicate measurements per replicate) and is given as relative fluorescence units (E+03). At the start of the test, the initial cell density was 10000 algal cells/mL, corresponding to 0.99E+03 relative fluorescence units.
Table 2: Average Growth Rates ( μ)
Nominal test item concentration (µg/L) |
Mean measured concentration (µg/L) |
Average growth rate µ (day-1) and inhibition of µ (Ir) |
|||||
0-24 h |
0-48 h |
0-72 h |
|||||
µ |
Ir (%) |
µ |
Ir (%) |
µ |
Ir (%) |
||
Solvent Control |
--- |
2.26 |
0.0 |
2.19 |
0.0 |
1.91 |
0.0 |
Control |
--- |
2.26 |
-0.3 |
2.20 |
-0.6 |
1.89 |
1.2 |
22 |
14 |
2.21 |
1.8 |
2.21 |
-0.9 |
1.90 |
0.7 |
46 |
22 |
2.25 |
0.4 |
2.23 |
-2.0 |
1.88 |
1.9 |
100 |
64 |
2.27 |
-0.7 |
2.23 |
-2.0 |
1.85* |
3.3 |
220 |
145 |
2.20* |
2.3 |
2.16 |
1.2 |
1.85* |
3.3 |
460 |
320 |
2.12* |
6.2 |
2.10* |
4.0 |
1.84* |
3.8 |
*: mean value statistically significantly lower than in the solvent control (according to Williams t-test, one-sided smaller, α = 0.05)
Table 5 Results for Test Samples
Timepoint |
Nominal Concentration of Test Item cnom |
Measured Concentration of Test Item |
Sample Preparation Factor F |
Determined Concentration of Test Item c |
% of Nominal Concentration |
[day] |
[µg/L] |
[µg/L] |
|
[µg/L] |
[%] |
0 |
Control |
* |
2 |
<LOQ |
n.a. |
(fresh) |
22 |
9.10 |
2 |
18.2 |
83 |
|
46 |
18.0 |
2 |
36.0 |
78 |
|
100 |
41.3 |
2 |
82.7 |
83 |
|
220 |
88.7 |
2 |
177 |
81 |
|
460 |
193 |
2 |
386 |
84 |
3 |
Control |
* |
2 |
<LOQ |
n.a. |
(old) |
22 |
5.15 |
2 |
10.3 |
47 |
|
46 |
7.00 |
2 |
14.0 |
30 |
|
100 |
25.1 |
2 |
50.2 |
50 |
|
220 |
59.1 |
2 |
118 |
54 |
|
460 |
132 |
2 |
265 |
58 |
*the measured concentration was below the lowest calibration concentration
LOQ = 10.1 µg test item/L
n.a. = not applicable
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- See 'Overall remarks' for details on validity criteria
- Conclusions:
- The biological results of the study were as follows (based on mean measured test item concentrations):
EC50 (μg/L): >320
EC20 (μg/L): >320
EC10 (μg/L): >320
NOEC (μg/L): 22
LOEC (μg/L): 64 - Executive summary:
In a 72 h toxicity study conducted according to OECD guideline 201 and GLP principles, freshwater algae (Pseudokirchneriella subcapitata) were exposed to the test substance at nominal concentrations of 22, 46, 100, 220, 460 μg/L. Geometric mean measured concentrations were 14, 22, 64, 145 and 320 μg/L, and thus the effect parameters were based on mean measured concentrations. Growth rate was statistically significantly reduced at and above 64 μg/L. The EC50 for growth rate inhibition (72h-ERC50) was >320 μg/L. The 72h-NOEC for growth rate inhibition was 22 μg/L, the 72 -h LOEC was 64 μg/L. The study met all validity criteria and is considered to be reliable without restrictions.
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