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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 26, 2002 - December 23, 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approx. 9 weeks old
- Weight at study initiation: mean body weight was 18.0 ± 2.1 g.
- Housing: The animals were housed individually in disposable crystal polystyrene cages (22.00 cm x 8.50 cm x 8.00 cm). Each cage contained autoclaved sawdust (SICSA, Alfortville, France).
- Diet: Free access to A04 C pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France)
- Water: Free access to tap water (filtered using a 0.22 micron filter)
- Acclimation period: 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, including the detection of possible contaminants (pesticides, heavy metals and nitrosamines) are performed regularly by external laboratories. The results of these analyses are archived at CIT.
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%
The temperature and relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the study plan. This minor deviation was not considered to have compromised the validity or integrity of the study.
- Air changes (per hr): approximately 12 (filtered, non-recycled air)
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 26 November 2002 to 23 December 2002
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Preliminary test: concentrations of 0.5, 1, 2.5 and 5%
Main test: 0, 0.25, 0.5, 1, 2.5 and 5% - No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS: The test item was prepared at the concentrations of 0.5, 1, 2.5 and 5%. For three consecutive days, four animals received applications of 25 µL of the dosage form preparations to the external surface of both ears (one concentration per ear). Measurement of the ear thickness (using a micrometer) was performed each day before treatment and 24 hours after the last application.
MAIN STUDY
ANIMAL ASSIGNMENT TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: The test item was considered as a skin sensitizer when the SI for a dose group is ≥ 3. Other relevant criteria such as cellularity, radioactivity levels and ear thickness were also taken into account for the interpretation of results.
TREATMENT PREPARATION AND ADMINISTRATION:
Test substance preparation: The test item was mixed with the required quantity of vehicle and then sonicated for 30 minutes at the temperature of 30 ºC. All dosage form preparations were made freshly on the morning of administration and any unused material was discarded that same day.
Rationale for vehicle: Due to the unsatisfactory solubility of the test item in the first recommended vehicle (acetone/olive oil (4:1, v/v), dimethylformamide was chosen among the other proposed vehicle. A homogeneous dosage preparation was obtained at the maximum concentration of 5%.
Induction - Days 1, 2 and 3:
A dose volume of 25 μL of the control or dosage form preparations was applied to the dorsal surface of both ears, using a adjustible pipette fitted with a plastic tip. In order to avoid licking and to ensure an optimized application of the test materials, the animals were placed under light isoflurane anesthezia during the administration. No massage was performed but the tip was used to spread the preparation over the application sites. No rinsing was performed between each application.
Excision of the nodes - Day 6:
All animals of all groups received a single intravenous injection of 250 µL of 0.9% NaCl containing 20 μCi of 3H-TdR (specific activity of 25 Ci/mmol) via the tail vein. Approximately 5 hours later, the animals were killed by cervical dislocation and the auricular lymph nodes were excised. The lymph nodes were pooled for each experimental group.
Tissue processing for radioactivity - Day 6:
For each experimental group, a single cell suspension of auricular lymph node cells (ALNC) was prepared by mechanical dissagregation in Petri dishes with the plunger of a syringe. Cell suspensions were washed with 15 mL of 0.9% NaCl and pellets obtained were re-suspended in 0.9% NaCl for numeration of lymphocytes (cellularity) and determination of their viability by exclusion of trypan blue. Each cell suspension was then centrifuged and pellets were precipitated with 3 mL of 5% (w/v) trichloroacetic acid (TCA) in purified water at 4ºC overnight.
Radioactivity measurements - Day 7
After a last centrifugation, the pellets were precipitated with 1 mL of 5% TCA. Three mL of Ultima Gold scintillation fluid (Packard) were added in order to measure incorporation of 3H-TdR using β-scintillation counting. The results were expressed as disintegrations/mn (dpm) per group.
Observations:
Clinical signs, morbidity and mortality: The animals were observed at least once a day during the study.
Body weights: The animals were weighed individually on the first day of the study (day 1) and on the day of sacrifice (day 6).
Ear thickness measurements and recording of local reactions: On days 1, 2 and 3 (before application) and on day 6 (after sacrifice), the thickness of the left ear of each animal of the vehicle control and treated groups was measured using a micrometer. No measurement of ear thickness was carried out for animals of the reference treated group.
Any irritation reaction (erythema and oedema) was recorded in parallel. Any other observation (coloration, presence of residual test item,) was noted. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not performed.
Results and discussion
- Positive control results:
- In the positive control group give HCA at the concentration of 25%, a moderate increase in cellularity and stimulation index exceeding the threshold value of 3 (SI = 15.00) were noted. The study was therefore considered valid.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.17
- Test group / Remarks:
- 0.25%
- Key result
- Parameter:
- SI
- Value:
- 1.06
- Test group / Remarks:
- 0.5%
- Key result
- Parameter:
- SI
- Value:
- 1.52
- Test group / Remarks:
- 1%
- Key result
- Parameter:
- SI
- Value:
- 0.68
- Test group / Remarks:
- 2.5%
- Key result
- Parameter:
- SI
- Value:
- 1.21
- Test group / Remarks:
- 5%
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Mean DPM/animal values for the experimental groups treated with test substance concentrations 0.25, 0.5, 1, 2.5 and 5% were 673, 607, 871, 388 and 695 DPM respectively. The mean DPM/animal values for the vehicle control and positive control group were 574 and 8616 DPM respectively.
Any other information on results incl. tables
Results Pre-screen test:
The test item was non-irritant in the preliminary test, whatever the concentration. The highest concentration retained for the main test was therefore the maximal practicable concentration, according to the criteria specified in the International Guidelines.
Other results - main study:
Dryness of the skin was noted on day 6 in 1/4 animals at the concentration of 2.5% and in 1/4 animals at the concentration of 5%. Residual test item was recorded on day 3 in all animals of the 5% treated group.
A slight increase in ear thickness (+ 20.65%) was noted in the animals given the test item at the concentration of 5%, showing the slight irritant potential of the test item at this concentration. No noteworthy increase in ear thickness was observed in the animals of the other treated groups.
The body weight gain of the treated animals was similar to that of the control animals.
No clinical signs and no mortality were observed during the study.
The quantity of cells obtained in each group was satisfactory. The cell viability was higher than 80% in each group.
In the treated groups, the incorporation of 3H-TdR was similar to that of the vehicle control group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Assessment of contact hypersensitivity to KY-EU in the mouse (Local Lymph Node Assay, 4 females/dose) was conducted according to OECD 429 guidelines and GLP principles.
Since there was no indication that the test substance elicits an SI ≥ 3 when tested up to and including 5%, KY-EU is considered not to be a skin sensitizer.
Based on these results, KY-EU needs not to be classified and has no obligatory labelling requirement for sensitization by skin contact according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. - Executive summary:
In a mouse lymph node assay, performed according to OECD test guidelines, mouse were treated with 0, 0.25, 0.5, 1, 2.5 and 5% of KY-EU on three consecutive days by open application on the ears. Three days after the last exposure all animals were injected with 3H-methyl thymidine. Radioactivity measurements of the lymph nodes were performed.
Dryness of the skin was noted on day 6 in 1/4 animals at the concentration of 2.5% and in 1/4 animals at the concentration of 5%. Residual test item was recorded on day 3 in all animals at the concentration of 5%.
A slight increase in ear thickness (+ 20.65%) was noted in the animals given the test item at the concentration of 5%, showing the slight irritant potential of the test item at this concentration. No noteworthy increase in ear thickness was observed in the animals of the other treated groups.
The body weight gain of the treated animals was similar to that of the control animals.
No clinical signs and no mortality were observed during the study.
The SI values calculated for the substance concentrations 0.25, 0.5, 1, 2.5 and 5% were 1.17, 1.06, 1.52, 0.68 and 1.21 respectively. Since there was no indication that the test substance elicits an SI ≥ 3 when tested up to 5%, KY-EU was considered not to be a skin sensitizer.
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