Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
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:
- 20.11.2012 to 23.11.2012
- 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 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- (2004)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Fraunhofer Institute for Molecular Biology and Applied Ecology (IME), Auf dem Aberg 1, 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
- Reference substance name:
- Urea, N,N,N',N'-tetrabutyl-
- IUPAC Name:
- Urea, N,N,N',N'-tetrabutyl-
- Details on test material:
- - Name of test material (as cited in study report): Tetrabutyl urea
- 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
Constituent 2
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Freshly prepared test solutions at the beginning of the test and pooled samples of the test media at the end of the test were analysed for the test item using LC-MS/MS (duplicate samples of ca. 20 mL).
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The highest test concentration was prepared by dissolving 4.30 mg of the test item in 1000 mL of sterile water and stirring for 2 hours at room temperature. The remaining four concentrations were prepared by dilution of the stock solution by a factor of 2.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Strain: Daphnia magna Straus
- Source: German Federal Environment Agency, Institut für Wasser-, Boden- und Lufthygiene
- Age at study initiation (mean and range, SD): <24 h
- Method of breeding: Adult Daphnia, at least 3 weeks old, were separated from the stock population by sieving. Batches of 30 - 50 animals were held at room temperature in ca. 1.8 L of dilution water for one week. During this week, the daphnids were fed daily with an algal suspension (Desmodesmus subspicatus) and feedingstuff Artemio® Fluid (JBL). Algae growing in the log-phase were centrifuged and the pellet was re-suspended in a few mL of medium. Thirty millilitres of this suspension was given to 1 L of medium. The water was changed once per week. New born Daphnia (between 4 - 23 h old) were removed by wide-bore pipette (to avoid damage) and isolated in fresh dilution water for at least 1 h prior to being added randomly to the test vessels containing the appropriate test or control media.
- Feeding during test: no
ACCLIMATION
- Acclimation period: not necessary
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: daphnids were fed daily with an algal suspension (Desmodesmus subspicatus) and feedingstuff Artemio® Fluid (JBL). Algae growing in the log-phase were centrifuged and the pellet was re-suspended in a few mL of medium. Thirty millilitres of this suspension was given to 1 L of medium.
- Feeding frequency: daily
- Health during acclimation (any mortality observed): not applicable
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Test temperature:
- 20.8°C
- pH:
- test start: 7.63-8.14 (in all test vessels)
test end: 7.72-8.34 (in all test vessels) - Dissolved oxygen:
- test start: 6.8-9.1 mg O2/L (in all test vessels)
test end: 8.4-8.7 mg O2/L (in all test vessels) - Nominal and measured concentrations:
- control, 0.269, 0.538, 1.075, 2.15, and 4.30 mg/L nominal
control, 0.25, 0.55, 1.26, 2.25, and 4.76 mg/L geometric mean measured - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass beaker
- Type (delete if not applicable): the test vessels were covered with a glass pane
- Material, size, headspace, fill volume: glass/60 mL/10 mL/50 mL
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): test conducted under static conditions
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Alkalinity: 1.6 mmol/L
- Conductivity: 239.4 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: regularly (not further specified)
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8 h light/dark cycle
- Light intensity: 488-489 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobilisation, appearance, behaviour
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: conducted
- Test concentrations: 0, 0.1, 1.0, and 10 mg/L nominal
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.85 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- 24 h EC50=1.03 mg/L
- Reported statistics and error estimates:
- Determination of ECx-values were performed by probit analysis. The computer software ToxRat Solutions was used for the statistical evaluations.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a study conducted according to OECD Guideline 202, the acute toxicity (48 h EC50) of tetrabutylurea to Daphnia magna was determined to be 1.85 mg/L based on the geometric mean measured concentrations.
- Executive summary:
The acute toxicity of tetrabutylurea to Daphnia magna was investigated in a study conducted according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test; 2004). In this static test, 20 daphnids per concentration were exposed to nominal concentrations of 0, 0.269, 0.538, 1.075, 2.15, and 4.30 mg TBU/L for 48 h. The concentrations of tetrabutylurea in the test media were assessed by chemical analyses (LC/MS/MS). As the recovered tetrabutyl urea concentrations exceeded the 20 % range at the beginning of the test and decreased more than 20 % from the initial values during the test, the geometric mean for each test concentration was calculated resulting in actual concentrations of 0.25, 0.55, 1.26, 2.25 and 4.76 mg/L. The 48 h EC50 was determined to be 1.7 mg/L and 1.85 mg/L based on the nominal and geometric mean measured concentrations, respectively.
This study is classified as reliable without restriction and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.
Results Synopsis
Test organism: Daphnia magna (<24 h old)
Test type: static
48 h EC50=1.85 mg/L based on geometric mean measured concentrations
Endpoint(s) effected: immobilisation
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.