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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 430-750-8 | CAS number: -
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Bacterial reverse mutation test
The test item Urea 4 was investigated for its mutagenic potential in a bacterial reverse mutation test according to EU Method B.13/14, OECD Guideline 471 and EPA OPPTS 870.5265. Five S. typhimurium strains (TA 1535, TA 1537, TA 98, TA 100 and TA 102) were tested with and without metabolic activation. A plate incorporation test and a pre-incubation test were performed independently and the following concentrations of the test item, tested in triplicate, were used in both experiments: 33.3; 100.0; 333.3; 1000.0; 2500.0 and 5000.0 µg/plate.
Precipitation of the test item was observed on the agar plates at concentrations >= 333.3 µg/plate. Cytotoxic effects of the test item were not observed. Reference mutagens showed a distinct increase of induced revertant colonies.
No substantial increase in the revertant colony numbers of any of the five test strains was detected at any dose level of the test item either with or without metabolic activation in both independently performed experiments. Thus, Urea 4 was considered non-mutagenic in this bacterial reverse mutation assay.
In vitro mammalian cell chromosome aberration test
An in vitro mammalian chromosome aberration test was performed with the test item Urea 4 according to EU Method B.10, OECD Guideline 473 and EPA OPPTS 870.5375. The test item potential to induce structural chromosome aberrations in V79 Chinese hamster cells was investigated in two independent experiments. In the two independent experiments the chromosomes were prepared 20 h after start of treatment with the test item. Experiment I was performed with and without S9 mix using a treatment interval of 4 h and a preparation interval of 20 h. Experiment II was performed only without metabolic activation with a treatment and preparation interval of 20 h. Two parallel cultures were set up per test group. Per culture 100 metaphases were scored for structural chromosomal aberrations. The following concentrations were evaluated (higher concentrations could not be evaluated due to the solubility characteristics of the test item):
Experiment I: 4 h treatment, 20 h preparation interval:
with and without metabolic activation (S9 mix) and test item concentrations: 25, 250, 500 µg/mL
Experiment II: 20 h treatment and preparation interval:
without metabolic activation (S9 mix) and test item concentrations: 10, 25, 50 µg/mL
Reference mutagens as positive controls were tested in parallel to the test item and showed an expected distinct increase in cells with structural chromosome aberrations.
Treatment of the cells with the test item in both experiments did not lead to a relevant decrease of the relative mitotic index or of the cell density.
When compared to the corresponding solvent control no biologically relevant increase in aberrant cells was obtained with and without metabolic activation in both independent experiments. No biologically relevant increase in the frequencies of polyploidy metaphases was found after treatment with the test item if compared to the frequencies of the controls.
It was concluded that the test item did not induce structural chromosome aberrations with and without metabolic activation. Thus, Urea 4 was considered non-mutagenic in this chromosome aberration test.
The in vitro mammalian cell gene mutation test
A study according to OECD guideline 476 has been commissioned and the data will be submitted to ECHA as soon as the results of the study become available. Results of the HPRT study should be available in mid of 2016.
Justification for selection of
genetic toxicity endpoint
Two GLP and guideline conform studies investigating gene mutations
in bacteria and chromosome aberrations in vitro.
Short description of key information:
The test substance was tested for in vitro mutagenic/ genotoxic
activity in a bacterial reverse mutation test (Ames test) and in an in
vitro mammalian chromosome aberration test according to OECD Guideline
471 and OECD 473 Guideline, respectively. The in vitro mammalian cell
gene mutation test (OECD 476) has bee commissioned.
The test item did not induce point or frameshift mutations in the
bacterial reverse mutation test performed with five strains of S.
typhimurium with and without metabolic activation. Therefore, the test
item was considered non-mutagenic in the Ames test performed. The test
item did not induce structural chromosome aberrations in the in vitro
chromosome aberration test performed with Chinese hamster V79 cells in
the presence and absence of metabolic activation. Therefore, the test
item is not considered clastogenic in this chromosome aberration test.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available in vitro studies, the test item was not classified and labelled as mutagenic according to Regulation (EC) No 127272008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.
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.