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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11.02.2013 to 15.02.2013
- 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
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- (1992)
- GLP compliance:
- yes (incl. QA statement)
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, 1,1,3,3-tetrabutyl-
- IUPAC Name:
- urea, 1,1,3,3-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, sulfur, Cl
- Composition of test material, percentage of components: dibutylamine: 0.04%, water: 0.04%, sulfur: <1 ppm, Cl: 0.8 ppm
- Purity test date: 04.06.2012
- Lot/batch No.: 2011-11-4
- Expiration date of the lot/batch: 03.11.2013
- Storage condition of test material: test material stored dry at room temperature (15-25°C) in the dark
Constituent 1
Constituent 2
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The concentrations of tetrabutyl urea in the test matrix were determined by liquid chromatography tandem mass spectrometry (LC-MS/MS). All test concentrations were measured at test start, after 48 hours (aged and fresh test matrix) and at the end of the test (after 96 h). The samples were analysed immediately on the sampling day.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test media solutions were prepared by dilution of stock solutions. The stock solutions were prepared by dissolving the test item in an appropriate volume of dilution water, followed by stirring for ca. 2 hours at room temperature.
- 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):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Source: own breeding
- Age at study initiation (mean and range, SD): not reported
- Length at study initiation (length definition, mean, range and SD): mean: 2.3 cm (range: 2.2-2.5 cm)
- Weight at study initiation (mean and range, SD): mean: 0.08 g (range: 0.07-0.10 g)
- Method of breeding: The fish were held in water of the same quality as used in the test (purified drinking water) until the start of the test.
- Feeding during test: no
ACCLIMATION
- Acclimation period: >=12 d
- Acclimation conditions (same as test or not): same
- Type and amount of food: fish were fed ad libitum with live brine shrimp nauplii and ground flake food TetraMinR; feeding was stopped 24 h before test start
- Feeding frequency: once daily
- Health during acclimation (any mortality observed): mortality <5%
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
Test conditions
- Hardness:
- total hardness of dilution water: 1.0 mmol/L
- Test temperature:
- temperature throughout the test: 23-23.1°C
- pH:
- pH values throughout the test: 7.9-8.3
- Dissolved oxygen:
- oxygen saturation throughout the test: 92-107%
- Nominal and measured concentrations:
- nominal concentrations: 0.269, 0.538, 1.08, 2.15, and 4.3 mg/L
geometric mean measured concentrations (0-96 h): 0.172, 0.365, 1.0, 1.75, and 2.59 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass aquaria
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume: glass/12 L/-/ca. 5.6 L
- Aeration: yes
- Type of flow-through (e.g. peristaltic or proportional diluter): test conducted under semi-static conditions
- Renewal rate of test solution (frequency/flow rate): A complete renewal of test media was performed once during the test after 48 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates):
- Biomass loading rate: 0.1 g/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Chlorine: <0.02 mg/L (total residual chlorine)
- Alkalinity: 1.3 mmol/L
- Ca/Mg ratio: according to guideline
- Conductivity: 203.7 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: Temperature, pH and oxygen concentration of the water were measured in each vessel directly before adding the fish and afterwards daily
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 12/12 h light/dark cycle
- Light intensity: not reported
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and clinical signs were recorded at 3 h, 24, h, 48 h, 72 h, and 96 h after the addition of fish to the test vessels
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: performed
- Test concentrations: 0.5, 1.0, and 4.3 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.365 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- other: mortality and clinical signs
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1.4 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: 95% c.i.: 1.0-1.8 mg/L (geom. mean measured)
- Reported statistics and error estimates:
- LC10 and LC50 values were determined together with 95 % confidence intervals using Probit-analysis assuming log-normal distribution of the values by using the ToxRat® software. Additionally, the highest tested concentration of the test item at which no lethal or other effect was observed (NOEC) was reported.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of tetrabutyl urea to Danio rerio was investigated in a study conducted according to OECD Guideline 203. The 96 h LC50 was determined to be 1.4 mg/L based on geometric mean measured concentrations.
- Executive summary:
The acute toxicity of tetrabutyl urea to Danio rerio was investigated in a study conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test; 1992). In this semi-static test, 7 fish per concentration were exposed to nominal concentrations of 0, 0.269, 0.538, 1.075, 2.15, and 4.30 mg TBU/L for 96 h. The concentrations of tetrabutylurea in the test media were assessed by chemical analyses (LC/MS/MS). Analysis of test media revealed tetrabutyl urea concentrations between 60.3 and 92.2% of nominal. Therefore, the geometric mean for each test concentration was calculated resulting in actual concentrations of 0.172, 0.365, 1.0, 1.75 and 2.59 mg/L. The 96 h LC50 was determined to be 1.7 mg/L and 1.4 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 fish.
Results Synopsis
Test organism: Danio rerio
Test type: semi-static
96 h LC50=1.4 mg/L based on geometric mean measured concentrations
Endpoint(s) effected: mortality
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.