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Diss Factsheets
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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
Description of key information
The test substance Urea 4 was tested for repeated oral toxicity in a 28-day study in rats, according to OECD Guideline 407. Based on the results of this study, a NOAEL of 1000 mg/kg bw/day was determined. The tests for repeated dose toxicity by the inhalation and the dermal routes were waived according to REACH Regulation No. 1907/2006, Annex VIII, 8.6.1.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- GLP and guideline conform study.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: oral
The test substance Urea 4 was tested in a repeated dose 28 -day oral toxicity study in rats according to EU method B.7 and OECD Guideline 407. The test item was administered in doses of 150, 500 and 1000 mg/kg bw once a day, for a period of 28 days, to three groups of 5 male and 5 female Wistar rats by oral gavage. A control group of 5 male and 5 female rats was dosed with the vehicle, (CMC) 1% in aqua bidest.
Clinical and behaviour/ functional observations were carried daily and examination of body weight was performed throughout the study. Blood and urine samples, collected during necropsy, were used to perform a detailed haematology analysis and urinalysis. A detailed gross necropsy was performed as well as histopathological and organ weight examination. In comparison to the untreated control group, several borderline deviations were observed for few parameters examined in the treated groups. However, a clear dose dependency or toxicological compound related relevance could not be established. All rats treated with the test item Urea 4 survived the testing period without showing compound related toxic effects. Thus the NOAEL value determined was >= 1000 mg/kg bw/day.
Repeated dose toxicity: inhalation and dermal
The tests for repeated dose toxicity by the dermal and the inhalation routes were waived as a repeated dose oral toxicity study was performed. According to the REACH Regulation No. 1907/2006, Annex VIII, 8.6.1 only one repeated dose toxicity study is required, with test item administration via the most appropriate route.
Justification for selection of
repeated dose toxicity via oral route - systemic effects endpoint:
Only one reliable study available.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on repeated dose toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (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.
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