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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 08, 2002 - October 13, 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 months old
- Weight at study initiation: 2.7 ± 0.3 kg
- Housing: The animals were individually housed in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
- Diet (e.g. ad libitum): Free access to 110 pelleted diet (UAR, Villemoisson, Epinay-sur-Orge, France).
- Water (e.g. ad libitum): Free access to 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.
Food was analysed regularly by the supplier for composition and contaminant levels. Bacteriological and chemical analyses of water were 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 or drinking water at levels which may be expected to have interfered with or prejudiced the outcome of the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 - 70
The 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 the validity or integrity of the study.
- Air changes (per hr): approximately 12
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: October 08, 2002 to October 13, 2002
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped using electric clippers
- Vehicle:
- other: The test substance was moistened with purified water.
- Controls:
- other: The untreated skin of each animal served as controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams - Duration of treatment / exposure:
- Single application.
- Observation period:
- 4 days.
- Number of animals:
- 3 males.
- Details on study design:
- STUDY DESIGN
As no information was available on the irritant properties of the test item, in the first instance, the test item was evaluated on a single animal. The duration of exposure was 3 minutes on one flank and 4 hours on the other flank.
Since the test item was not corrosive/severely irritant on this first animal, it was than applied for 4 hours to two other animals.
TEST SITE
The day before treatment, both flanks of each animal were clipped using electric clippers and the skin of each animal was examined. Only animals with healthy intact skin were used. Clipping was repeated thereafter on day 2 or 3.
Doses of 500 mg of the test item in its original form were placed on a moistened gauze pad, which was then applied to the right flank (application for 4 hours) or the left flank (application for 3 minutes) of the animals.
The test item and the gauze pad were held in contact with the skin by means of an adhesive hypoallergic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
After removal of the dressing, any residual test item was wiped off by means of a moistened or dry cotton pad.
OBSERVATIONS
- Mortality/Viability: No data
- Toxicity: No data
- Body Weight: No data
- Necropsy: No data
- Irritation:
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressing and test substance. The irritation scores were recorded.
SCORING SYSTEM:
The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:
Erythema and eschar formation:
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Oedema formation:
0: No oedema
1; Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well-defined by definite raising)
3: Moderate oedema (raised approximately 1 millimeter)
4: Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No cutaneous reactions were observed during the study.
Tables containing individual and mean irritation scores are specified in the attached table.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A primary skin irritation/corrosion study with KY-EU in the rabbit (4-hour semi-occlusive application, 3 males) was conducted according to OECD 404 and GLP guidelines. No skin irritation was observed, and based on these results KY-EU does not have to be classified and has no obligatory labelling requirement for skin irritation.
- Executive summary:
In a skin irritation study performed according to OECD 404 and GLP principles, three male rabbits were exposed to 0.5 g of substance semi-occlusively for 4 hours. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.
No cutaneous reactions were observed during the study. No oedema was noted in any of the animals. Systemic effects were not described or recorded. KY-EU is considered to be not skin irritating.
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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