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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- sept 2002-febr 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- Neurological investigations were based on OECD 424 and EPA 799, 9620-62-158
- Deviations:
- no
- GLP compliance:
- yes
- 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:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, l'Arbresle, France
- Age at study initiation:6 weeks
- Weight at study initiation: males: 199 g (range 164-214 g); females: 166 g ( range 156-175 g)
- Fasting period before study: no
- Housing: individually in suspended wire-mesh cages.
- Diet: ad libitum A04 C pelleted maintenance diet, distributed weekly
- Water: free access to filtered tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 20
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 08 November 2002 To: 11 December 2002
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% (w/w) aqueous methylcellulose solution
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test item was ground to a fine powder, using a mortar and pestle, and then mixed with the required quantity of vehicle in order to achieve the concentrations of 30, 90 and 200 mg/mL. The test item dosage forms (suspension in vehicle) were prepared on a weekly basis and were stored at 4°C prior to use.
VEHICLE
- Lot/batch no.: 81K0299 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Homogenity of the dosage forms was tested before the treatment period (lowest concentration and highest concentration) and analyzed by HPLC with UV detection. Each dosage form prepared for homogenity was analysed for stability after 0, 4, 5 and 7 days storage at 4°C (HPLC with UV detection). The concentration of samples taken from each dosage form (including the control) prepared for use in weeks 1 and 4 was determined.
- Duration of treatment / exposure:
- 29 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 150, 450, 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The dose levels were selected on the basis of the results of a 7-day range-finding toxicity study by oral route performed in the same species (CIT/Study No. 24561 TSR), in which no signs of toxicity were observed at the dose levels of 150, 450 and 1000 mg/kg bw/day. Consequently, the same dose-levels were used for the main study.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: at least twice a day
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: before the beginning of the treatment period and once a week thereafter
BODY WEIGHT: Yes
- Time schedule for examinations: at least once before allocation of the animals to groups, on the first day of treatment, and then once a week until the end of the study.
FOOD CONSUMPTION:
- recorded once a week, recorded over 7-day period during the study. Food consumption was calculated per animal and per day.
WATER CONSUMPTION: not determined
OPHTHALMOSCOPIC EXAMINATION: not determined
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at the end of the treatment period.
- Anaesthetic used for blood collection: Yes (isoflurane anesthesia)
- Animals fasted: Yes, for at least 14 hours
- How many animals: all
- Parameters checked: according to guideline
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at the end of the treatment period.
- Animals fasted: Yes, for at least 14 hours
- How many animals: all
- Parameters checked: according to guideline
URINALYSIS: not detremined
NEUROBEHAVIOURAL EXAMINATION: Yes, FOB
- Time schedule for examinations: at the end of the treatment period.
- Dose groups that were examined: all
- Battery of functions tested: FOB
ORGAN WEIGHTS
- organ weight at the end of the treatment (aorta, brain, epididimydes, heart, kidneys, liver, ovaries, spleen, testes, thymus, thyroids with parathyroids) - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, according to guideline
HISTOPATHOLOGY: Yes, according to guideline - Statistics:
- Statistical analysis was performed on body weight, food consumption, hematology, blood chemistry and organ weight data (number of animals/sex >3 in each group). Normality of data distribution was tested with Kolmogorov-Lilliefors test, followed by Bartlett test, Fisher test, Dunn test, Student test, Dunett test or Mann-Whitney/Wilcoxon test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- slighly lower body weight gain observed in high dose males
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- changes in plasma Na and Cl (males) and K (females)
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- slightly increased kidney weight in high dose males.
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- BODY WEIGHT AND WEIGHT GAIN: body weight of high dose males were slightly lower at days 22 and 29 of the treatment period, and slightly lower bodyweight gain (13%) in high dose males.
CLINICAL CHEMISTRY: increased levels of sodium and chloride in mid and high dose males, and increased levels of potassium in high dose females. No historical control data were included. Relative kidney weight was slightly increased (11%) in high dose males. No historical control data were included. Based on the present available information, the effects on plasma ions are considered toxicologically relevant in the high dose group.
ORGAN WEIGHT: Relative kidney weight was slightly increased (11%) in high dose males.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 450 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Higher levels of plasma Na and Cl and increased relative kidney weight in high dose males. In high dose animals slightly lower body weight gain was observed in males, whereas females showed higher plasma potassium levels.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In an oral 28-day repeated dose toxicity study with rats, at 1000 mg/kg bw/day, males showed slightly lower body weight gain, slightly increased plasma levels of sodium and chloride, and higher relative kidney weight. High dose females showed slightly increased levels of plasma potassium. Based on the effects observed in high dose animals, the NOAEL for systemic effects in this study is set at 450 mg/kg bw/day.
- Executive summary:
KY-EU was given by oral administration (gavage) to male and female rats at dose levels of 0, 150, 450 and 1000 mg/kg bw/day for 29 days. The study was performed according to EU guidelines for repeated dose toxicity testing. In high dose males a slightly lower body weight gain was observed, together with slightly increased levels of plasma sodium and chloride and increased relative kidney weight. In high dose females, plasma levels of potassium were slightly increased. Based on the effects observed in high dose animals, the NOAEL for systemic effects in this repeated dose toxicity study is set at 450 mg/kg bw/day.
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