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EC number: 445-760-8 | 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:
- September 03 - 26, 2002
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 451-060-3
- EC Name:
- -
- Cas Number:
- 122886-55-9
- Molecular formula:
- Hill formula: C31H48N4O2 CAS formula: C31H48N4O2
- IUPAC Name:
- N,N’’-(methylenedi-4,1-phenylene)bis(N’-octylurea)
- Reference substance name:
- N-{4-[(4-{[(octadecylamino)carbonyl]amino}phenyl)methyl]phenyl}-N’-octylurea
- Cas Number:
- 117328-86-6
- Molecular formula:
- Hill formula: C41H68N4O2 CAS formula: C41H68N4O2
- IUPAC Name:
- N-{4-[(4-{[(octadecylamino)carbonyl]amino}phenyl)methyl]phenyl}-N’-octylurea
- Reference substance name:
- 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
- EC Number:
- 406-690-3
- EC Name:
- 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
- Cas Number:
- 43136-14-7
- Molecular formula:
- Hill formula: C51H88N4O2 CAS formula: C51H88N4O2
- IUPAC Name:
- N,N’’-(methylenedi-4,1-phenylene)bis(N’-octadecylurea)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): KY-EU
- Appearance: white powder
- Storage condition of test material: in darkness at room temperature
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley Rj: SD (IOPS Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approx. 6 weeks old
- Weight at study initiation: mean body weight 181 ± 6 g for the males and 175 ± 6 g for the females
- Housing: The animals were group housed in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). Each cage contained one to seven animals of the same sex during the acclimation period and three rats of the same sex and group during the treatment period. Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
- Diet (e.g. ad libitum): Free access to A04 C pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France)
- Water (e.g. ad libitum): Free access to drinking water filtered by a FG Millipore membrane (0.22 micron)
- Acclimation period: The acclimatization period was at least 5 days before the start of treatment
Sawdust is analysed by the supplier for composition and contaminant levels. Each batch of food is analysed by the supplier for composition and contaminant levels. Bacteriological and chemical analyses of water are performed regularly by external laboratories. These analyses include the detection of possible contaminants (pesticides, heavy metals and nitrosamines).
No contaminants were known to have been present in the diet, drinking water or bedding material at levels which may be expected to have interfered with or prejudiced the outcome of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 ºC
- Humidity (%): 30 - 70%
- Air changes (per hr): approximately 12 (filtered, non-recycled air)
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 03 September 2002 to 26 September 2002
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% methylcellulose
- Details on oral exposure:
- GAVAGE METHOD: metal gavage tube fitted to a 5 ml glass syringe
VEHICLE
- Justification for choice of vehicle: No data
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg (10 mL/kg) body weight.
DOSAGE PREPARATION: The test item was prepared at the chosen concentration in the vehicle. Each test item preparation was made freshly on the morning of administration by the CIT Pharmacy and any unused material was discarded that same day.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As no information on the toxic potential of the test item was available, for animal welfare reasons, the starting dose-level of 200 mg/kg bw was chosen. Three males were used in the initial step.
After the first assay, as no mortality occurred, another assay was carried out on three males at the dose-level 2000 mg/kg bw.
After the second assay, as no mortality was observed, the results were confirmed in three females at the dose-level 2000 mg/kg bw. - Doses:
- Initial step 200 mg/kg body weight.
First and second assay 2000 mg/kg body weight. - No. of animals per sex per dose:
- 200 mg/kg bw: 3 males
2000 mg/kg bw: 3 males and 3 females - Control animals:
- no
- Details on study design:
- The animals were fasted for an overnight period of approximately 18 hours before dosing. Water was available ad libitum. Food was given back approximately 4 hours after administration of the test item.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: Time of death was recorded individually, in terms of the number of hours or days after dosing.
Body weights: The animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
Clinical signs: 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.
- Necropsy of survivors performed: On day 15, all animals were killed by carbon dioxide asphyxiation. 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.
- Other examinations performed: none. - Statistics:
- No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).
Results and discussion
- Preliminary study:
- No deaths occurred in the initial step of 200 mg/kg body weight.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No clinical signs were observed in any of the treated animals.
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
- Other findings:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- KY-EU was administered by oral gavage to two subsequent groups of three male Sprague-Dawley rats at 200 and 2000 mg/kg body weight and three female rats at 2000 mg/kg body weight. The study was conducted according to OECD 423 and GLP guidelines.
The oral LD50 value of KY-EU in Sprague-Dawley rats was established to exceed 2000 mg/kg body weight.
Based on these results, KY-EU does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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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