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EC number: 224-929-8 | CAS number: 4559-86-8
- 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:
- 19.11.2012 to 22.11.2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- (2011)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Fraunhofer Institute for Molecular Biology and Applied Ecology (IME), Schmallenberg (Germany)
Test material
- Reference substance name:
- Tetrabutylurea
- EC Number:
- 224-929-8
- EC Name:
- Tetrabutylurea
- Cas Number:
- 4559-86-8
- Molecular formula:
- C17H36N2O
- IUPAC Name:
- 1,1,3,3-tetrabutylurea
- Details on test material:
- - Name of test material (as cited in study report): Tetrabutyl urea; 1,1,3,3-tetrabutylurea
- Substance type: amide
- Physical state: liquid
- Analytical purity:99.6%
- Impurities (identity and concentrations): dibutylamine, water, chloride, sulfur
- Composition of test material, percentage of components: dibutylamine: 0.04%, water: 0.04%, chloride: 0.8 ppm, sulfur:<1 ppm
- Purity test date: 04.08.2012
- Lot/batch No.: 2011-11-4
- Expiration date of the lot/batch: 03.11.2013
- Storage condition of test material: test substance stored dry at room temperature (15-25°C) in the dark
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The concentration of tetrabutyl urea was analysed in all test solutions sampled at the beginning of the exposure period prior to the addition of the algae and in samples of the algae cultures taken from replicates pooled per test concentration at the end of the exposure period. Duplicate samples of approximately 20 mL were taken. The chemical analysis was performed using liquid chromatography/tandem mass spectrometry (LC-MS/MS). The samples were analysed immediately on the sampling day. Spare samples were frozen immediately and stored at -20°C.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The stock solution and the highest test concentration were prepared by dissolving 4.3 mg of the test item in 1000 mL growth medium and stirring vigorously for about 15 min at room temperature. The other four test concentrations of nominal 2.15, 1.075, 0.538 and 0.269 mg/L were obtained by dilution of the stock solution.
- Controls: Flask filled with growth medium served as control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): no vehicle used
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no
Test organisms
- Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Common name: green alga
- Strain: 61.81 SAG
- Source (laboratory, culture collection): SAG, Culture Collection of Algae at Pflanzenphysiologisches Institut of the University at Göttingen, Göttingen (Germany)
- Age of inoculum (at test initiation): exponentially-growing algae (not further specified)
- Method of cultivation:The stock cultures are maintained fulfilling the criteria of the OECD Guideline 201. Prior to testing, a pre-culture is established in standard OECD growth medium to obtain exponentially-growing algae for the test.
ACCLIMATION
- Acclimation period: not necessary
- Culturing media and conditions same as test: yes
- Any deformed or abnormal cells observed: no
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
Test conditions
- Test temperature:
- 21.0-21.5°C
- pH:
- controls
test start: 8.14
test end: 8.05-8.44
test vessels
test start: 7.86-8.34
test end: 8.01-8.48 - Nominal and measured concentrations:
- nominal: 0 (control), 0.269, 0.538, 1.075, 2.15, and 4.3 mg/L
geometric mean measured: 0 (control), 0.05, 0.14, 0.58, 1.56, and 2.95 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass flasks
- Type (delete if not applicable): the test vessels were covered with air-permeable silicone-sponge caps
- Material, size, headspace, fill volume: glass/250 mL/150 mL/100 mL
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): test conducted under static conditions
- Renewal rate of test solution (frequency/flow rate): test conducted under static conditions
- Initial cells density: 10000 cells/mL
- Control end cells density: 1082000 cells/mL
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 8
GROWTH MEDIUM
- Standard medium used: yes
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Culture medium different from test medium: no
- Intervals of water quality measurement: temperature was measured daily, pH on day 0 and after 3 d
OTHER TEST CONDITIONS
- Sterile test conditions: yes
- Adjustment of pH: no
- Photoperiod: continuous illumination
- Light intensity and quality: 7518-7578 lux (OSRAM "cool white")
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): growth rate, yield
- Determination of cell concentrations: electronic particle counter
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: performed
- Test concentrations: 0.1, 1.0, and 10 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- 3,5-dichlorophenol
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.58 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 1.56 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 2.95 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.14 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Remarks:
- (yield)
- Duration:
- 72 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.58 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Remarks:
- (yield)
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.11 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Remarks:
- (yield)
- Remarks on result:
- other: 95% c.i.: 0.85-1.42 mg/L
- Results with reference substance (positive control):
- Results with 3,5-dichlorophenol:
ErC50=2.42 mg/L nominal (95% confidence limits: 1.95-3.03 mg/L)
These results are in good agreement with the results of an international ring test with ErC50=3.38 +/- 1.30 mg/L - Reported statistics and error estimates:
- Probit-analysis was used for the determination of EC50, EC20 and EC10 values together with 95% confidence intervals in respect to yield. The NOEC and LOEC values for growth rate and yield were determined using the Williams t-test. The computer program ToxRat Professional was used for all statistical evaluations.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The toxicity of tetrabutyl urea to the unicellular, green alga Pseudokirchneriella subcapitata was investigated in a study conducted according to OECD Guideline 201. After 72 h of exposure, NOEC values of 0.14 mg/L and 0.58 mg/L were determined for yield and growth rate inhibition, respectively. The 72 h EC50 for yield was determined to be 1.11 mg/L. Since the growth rate inhibition was below 50 % compared to controls at the highest test concentration the 72 h EC50 value was determined to be higher as the highest test concentration (72 h EC50 > 2.95 mg/L; all effect concentrations based on geometric mean measured concentrations).
- Executive summary:
The toxicity of tetrabutyl urea to the unicellular, green alga Pseudokirchneriella subcapitata was investigated in a study conducted according to OECD Guideline 201 (Alga, Growth Inhibition Test; 2011). In this static test, exponentially growing cultures of the alga were exposed to nominal tetrabutyl urea concentrations of 0 (control), 0.269, 0.538, 1.075, 2.15, and 4.3 mg/L for 72 h. The cell density in each test culture was measured at least every 24 hours. The inhibition of growth in relation to the control cultures was determined for every exposure period. The concentration of tetrabutyl urea was assessed by chemical analysis (LC-MS/MS) at the beginning and at the end of the test. As the measured tetrabutyl urea concentrations were outside of the ± 20 % range of the measured initial concentrations for some treatment levels at the end of the study, the geometric mean measured concentrations for each test concentration was calculated resulting in actual concentrations of 0.05, 0.14, 0.58, 1.56, 2.95 mg/L. After 72 h exposure, NOEC values of 0.14 mg/L and 0.58 mg/L were determined for yield and growth rate inhibition, respectively. The 72 h EC50 for yield was determined to be 1.11 mg/L. Since the growth rate inhibition was below 50 % compared to controls at the highest test concentration the 72 h EC50 value was determined to be higher as the highest test concentration (72 h EC50 > 2.95 mg/L; all effect concentrations based on geometric mean measured concentrations).
The study is regarded as reliable without restriction and fulfills the requirements of the guideline.
Results Synopsis
Test organism: Pseudokirchneriella subcapitata
Test type: static
growth rate
72 h NOEC=0.58 mg/L
72 h LOEC=1.56 mg/L
72 h EC50>2.95 mg/L
yield
72 h NOEC=0.14 mg/L
72 h LOEC=0.58 mg/L
72 h EC50=1.11 mg/L
based on geometric mean measured concentrationsEndpoint(s) effected: growth rate, yield
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