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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
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:
- 24 May 2011 - 25 Jul 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 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 440/2008 C.2, Acute Toxicity for Daphnia
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures
- Version / remarks:
- 2000
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
- Version / remarks:
- 1996
- Deviations:
- not specified
- 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, 10, 22, 46, 100 and 220 μg/L (10 μg/L sampled but not analyzed).
- Sampling method: Duplicate samples, at start and end of test. Additionally, one sample was taken from the highest concentrated application solution at the start of the test.
- For the 48-hour stability samples, the contents of the respective replicates were combined prior to sampling.
- Sample storage conditions before analysis: Immediately after sampling, acetonitrile in the ratio of 1:1 was added to each sample from the test media of all test concentrations and the solvent control to stabilize the latter during the storage period. Thereafter, all samples were stored deep-frozen (at about -20 °C) until analysis.
Test solutions
- Vehicle:
- yes
- Remarks:
- N,N-Dimethylformamide p.a. (DMF)
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The application solution for the highest test concentration (2200 mg/L) was freshly prepared by dissolving 88.0 mg of the test item in 40 mL of DMF. Adequate volumes of this application solution were diluted with DMF to obtain the application solutions for 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 adequate volumes of the respective application solution or DMF (for the solvent control) directly into the test water. A solvent concentration of 100 μL/L was finally reached in all treatments. Thereafter, the test vessels were stoppered with glass stoppers and left for about 1 hour. After the preconditioning period, the test media were discarded, the test flasks rinsed with test water (without test item), 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. For the control, test water without addition of test item or solvent was used.
- Controls: test water without addition of test item or solvent; solvent control.
- Chemical name of vehicle: N,N-Dimethylformamide p.a. (DMF)
- Concentration of vehicle in test medium: 100 μL/L
- Evidence of undissolved material: no.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Strain/clone: Straus, clone 5.
- Source: in-house laboratory culture, original supplier University of Sheffield / UK (1992).
- Age of organisms at start of test: 6-24 h, not first brood progeny.
- Feeding during test: no
BREEDING
- Medium: reconstituted water of the quality identical to the water quality used in the tests (in respect to pH, main ions, and total hardness) and under temperature and light conditions identical to those of the tests.
- Feeding: three times a week with an algal suspension of the green algae Desmodesmus subspicatus CHODAT, Strain No. 86.81 SAG, or a mixture of this algal suspension and a commercial fish diet (Tetra Min® Hauptfutter).
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- Test water: 2.5 mmol/L (250 mg/L as CaCO3)
- Test temperature:
- 21-22 °C
- pH:
- Start: 7.9
End: 7.7 - Dissolved oxygen:
- Start: 8.3-8.6 mg/L
End: 8.0-8.1 mg/L - Nominal and measured concentrations:
- Nominal: 10, 22, 46, 100, 220 μg/L
Measured (four highest test concentrations only): 19.8, 44.1, 99.1, 218 μg/L (fresh, i.e. 90-99% of nominal); 18.5, 39.9, 88.7, 200 μg/L (old, i.e. 84-91% of nominal). Effect parameters are expressed as nominal test item concentrations. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 300 mL Erlenmeyer flasks, completely filled, tightly closed with glass stoppers
- Preconditioning of vessels: one hour with respective test medium prior to star of the test, see 'Details on test solution'.
- Aeration: no
- 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): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted test water according to ISO 6341.
- Culture medium different from test medium: no
- Intervals of water quality measurement: At the start and end of the test, the pH values, dissolved oxygen concentrations and watertemperature were determined at each treatment. The appearance of the test media was visually recorded at the start of the test and after 24 and 48 hours.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 8:16 dark:light cycle with a 30 min transistion period.
- Light intensity: approx. 485-640 Lux.
EFFECT PARAMETERS MEASURED
- The immobility of the daphnids was determined by visual inspection after 24 and 48 hours ofexposure.
VEHICLE CONTROL PERFORMED: yes
RANGE-FINDING STUDY
- The selection of the test concentrations was based on the results of range-finding tests and of pre-experiments to the dosage and solubility of the test item (non-GLP); details on range-finding test not specified. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (performed April 2011)
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 92 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% C.I. 57-188 ug/L
- Details on results:
- - Behavioural abnormalities: none
- Mortality of control: none
- Effect concentrations exceeding solubility of substance in test medium: no
- No immobility or adverse effects were observed in any treatment at 24 h. After 48 h, 5% immobility was observed at 46 ug/L, which was considered a toxic effect, and 65% immobility was observed at 100 ug/L.
Other effect parameters determined:
– 24-hour EC50: >220 μg/L
– 24-hour EC0: ≥220 μg/L
– 24-hour EC100: >220 μg/L
– 48-hour EC50: 92 μg/L
(95% confidence limits: 57 and 188 μg/L)
– 48-hour EC0 and
48-hour NOEC: 22 μg/L
– 48-hour EC100: >220 μg/L - Results with reference substance (positive control):
- - Results with reference substance valid?
Yes, the sensitivity of the test organisms was within the internal historical range (48-hour EC50 from 2000 to 2011: 0.43-1.1 mg/L).
- 48-hour EC50: 0.62 mg/L - Reported statistics and error estimates:
- 48-hour EC50 and the 95% confidence limits were calculated by Weibull Analysis
Any other information on results incl. tables
Table 1: Effect of 2,6-di-tert-butyl-4-sec-butylphenol on the Mobility of Daphnia magna
Nominal test item concentration (μg/L) |
No. of daphnids tested |
Immobilized daphnids after 24 hours |
Immobilized daphnids after 48 hours |
||
No. |
% |
No. |
% |
||
Solvent control |
20 |
0 |
0 |
0 |
0 |
Control |
20 |
0 |
0 |
0 |
0 |
10 |
20 |
0 |
0 |
0 |
0 |
22 |
20 |
0 |
0 |
0 |
0 |
46 |
20 |
0 |
0 |
1 |
5 |
100 |
20 |
0 |
0 |
13 |
65 |
220 |
20 |
0 |
0 |
17 |
85 |
Table 5 Results for Test Samples and Application Solution Samples
Timepoint
[day] |
Nominal concentration of test item Cnom [μg/L] |
Measured concentration of test item x [μg/L] |
Sample preparation factor F |
Determined concentration of test item C [μg/L] |
% of nominal concentration
[%] |
|
0 (fresh) |
Control |
* |
2 |
<LOQ |
n.a. |
|
22 |
9.89 |
2 |
19.8 |
90 |
|
|
46 |
22.0 |
2 |
44.1 |
96 |
|
|
100 |
49.6 |
2 |
99.1 |
99 |
|
|
220 |
109 |
2 |
218 |
99 |
|
|
2200000 |
89.7 |
25000 |
2242491 |
102 |
|
|
2 (old) |
Control |
* |
2 |
<LOQ |
n.a. |
|
22 |
9.24 |
2 |
18.5 |
84 |
|
|
46 |
20.0 |
2 |
39.9 |
87 |
|
|
100 |
44.3 |
2 |
88.7 |
89 |
|
|
220 |
100 |
2 |
200 |
91 |
|
|
|
*the measured concentration was below the lowest calibration concentration
LOQ = 2.58 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 48-hour EC50 was calculated to be 92 μg/L with 95% confidence limits of 57 and 188 μg/L.
- Executive summary:
In a 48 h acute toxicity test conducted according to OECD Guideline 202 and GLP principles, Daphnia magna were exposed to the test item at nominal loading rates of 10, 22, 46, 100 and 220 μg/L, and a control and a solvent control, under static conditions. The measured concentrations were between 84 and 99% of the nominal values. Therefore, the effect parameters are based on nominal concentrations. At 24 h, no immoblity or adverse effects were observed. At 48 h, 85% of the test organisms were immobile in the highest test concentration. The 48h-EC50 for Daphnia magna was 92 μg/L with 95% confidence limits of 57 and 188 μg/L. The study met all validity criteria and is considered to be reliable without restrictions.
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