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EC number: 451-060-3 | CAS number: 122886-55-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 September, 2003 - 18 September, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 451-060-3
- EC Name:
- -
- Cas Number:
- 122886-55-9
- Molecular formula:
- C31H48N4O2
- IUPAC Name:
- 3-octyl-1-[4-({4-[(octylcarbamoyl)amino]phenyl}methyl)phenyl]urea
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): KY-UN
- Stability under test conditions: not stated
- Storage condition of test material: at room temperature and protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley Rj: SD (lOPS Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France.
- Age at study initiation: Young adult animals (approx. 8 weeks old)
- Weight at study initiation: males: 274 ± 3 g; females: 214 ± 4 g
- Fasting period before study: overnight of approximately 18 hours before dosing
- Housing: Group housing of 3 animals of the same sex per cage in polycarbonate cages with stainless steel lid
- Diet: Free access to A04 C pelleted diet (SAFE, Villemoisson, Epinay-sur-Orge, France)
- Water: Free access to drinking water filtered by a FG Millipore membrane (0.22 micron)
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% aqueous suspension of methylcellulose in purified water
- Details on oral exposure:
- GAVAGE METHOD: metal gavage tube fitted to a 5 mL glass syringe.
Frequency: single dosage, on Day 1.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight.
DOSAGE PREPARATION: On the day of treatment, the test item was ground to a fine powder using a mortar and pestle, and was prepared at the chosen concentration in the vehicle. The test item preparation was made freshly on the morning of administration and any unused material was discarded that same day. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs and mortality: The animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day.
Body weights: The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15. The body weight gain of the treated animals was compared to that of CIT control animals with the same initial body weight.
- Necropsy of survivors performed: All study animals were subjected to a macroscopic examination as soon as possible after death. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: No clinical signs were observed.
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- In an acute oral toxicity study with KY-UN with male and female rats, performed according to OECD 423 test guideline and GLP principles, an LD50 >2000 mg/kg bw was determined.
- Executive summary:
KY-UN was tested in an acute oral toxicity study with male and female rats, performed according to OECD 423 test guideline and GLP principles. No deaths occurred and no clinical signs were observed. Macroscopic examination of the main organs of the animals revealed no apparent abnormalities. The overall body weight gain of the other animals was not affected by treatment with the test item. Based on the results an LD50 >2000 mg/kg bw was determined and KY-UN does not have to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.
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