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EC number: 430-750-8 | CAS number: -
- 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:
- 1998-12-01 to 1999-01-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-02-10 to 1999-02-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- July 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- December 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- August 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7860 (Water Solubility Generator Column Method)
- Version / remarks:
- August 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: DIN EN 1484, "Anleitung zur Bestimmung des gesamten organischen Kohlenstoffs (TOC) und des gelösten organischen Kohlenstoffs (DOC)", Normungsausschuss Wasserwesen im Deutschen Institut für Normung e. V., August 1997.
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- other: DOC (Dissolved Organic Carbon)
- Key result
- Water solubility:
- < 1 mg/L
- Conc. based on:
- test mat. (dissolved fraction)
- Incubation duration:
- 3 d
- Temp.:
- 20 °C
- pH:
- 6
- Details on results:
- The water solubility of Urea 4 at room temperature was estimated to be < 1 g/L by visual judgement in the preliminary test. The saturation concentration of Urea 4 was analytically estimated by a simplified flask method in the preliminary test at 20 °C to be in the range of the quantification limit for the DOC-measurements (1 mg DOC/L).
- Conclusions:
- Interpretation of results: slightly soluble (0.1-100 mg/L)
The water solubility of Urea 4 was estimated to be in the range of < 1 mg/L (quantification limit of the DOC measurements) at 20 °C +/- 1 °C. Thus, Urea 4 was considered to be slightly soluble or insoluble. - Executive summary:
The water solubility of Urea 4 was determined according to EU method A.6, OECD Guideline 105, and EPA OPPTS 830.7840, EPA OPPTS 830.7860 guideline and DIN EN 1484 guideline. Because of the low solubility of the test substance in water and the low sensitivity of the analytical method available the experimental determination of the water solubility of Urea 4 was technically not feasible. Therefore, the water solubility of Urea 4 was estimated to be in the range of < 1 mg/L (quantification limit of the DOC measurements) at 20 °C +/- 1 °C. Thus, Urea 4 was considered to be slightly soluble or insoluble.
- Reason / purpose for cross-reference:
- reference to other study
Reference
- Endpoint:
- partition coefficient
- Type of information:
- calculation (if not (Q)SAR)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.8 (Partition Coefficient)
- Version / remarks:
- December 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 117 (Partition Coefficient (n-octanol / water), HPLC Method)
- Version / remarks:
- March 1989
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7570 (Partition Coefficient, n-octanol / H2O, Estimation by Liquid Chromatography)
- Version / remarks:
- August 1996
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- no
- Type of method:
- other: calculation (Leo-Hansch method)
- Partition coefficient type:
- octanol-water
- Analytical method:
- other: theoretical calculation
- Key result
- Type:
- log Pow
- Partition coefficient:
- > 6
- Temp.:
- 20 °C
- Remarks on result:
- other: calculation
- Conclusions:
- The partition coefficient of Urea 4 was estimated to be log Pow > 6 using the Leo-Hansch method.
- Executive summary:
The partition coefficient of Urea 4 was estimated according to EU method A.8 (Leo-Hansch method), OECD Guideline 117, and EPA OPPTS 830.7570 guideline. The partition coefficient of Urea 4 was estimated to be log Pow > 6 using the Leo-Hansch method. Urea 4 was not soluble in n-octanol and only slightly soluble in water. Therefore, due to the low solubility of Urea 4 in water and n-octanol and the low sensitivity of the analytical methods available the experimental determination of the partition coefficient by any analytical technique was technically not feasible.
As Urea 4 consists of several constituents, for each constituent a partition coefficient was calculated. The partition coefficients (log Pow values) of all possible constituents are > 6.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- adopted 1995-07-27
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- Directive 96/54 EEC
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 430-750-8
- EC Name:
- -
- Cas Number:
- 1266545-86-1
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Reaction product of (C8 – C18) aliphatic primary amines, ethylene diamine, p-phenetidine with 4,4’-methylenediphenyl diisocyanate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan, Winkelmann GmbH, D-33178 Borchen, Germany
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: female 150-185 g (mean: 167 g); male 201-246 g (mean: 241 g)
- Housing: Macrolon cages on Altromin saw fibre bedding
- Diet: ad libitum, Altromin 1324 totally-pathogen-free-TPF
- Water : tap water: drinking water, municipal residue control, microbiol. controlled periodically
- Acclimatisation period: 12-14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ±3 C°
- Humidity: 55 ± 10%
- Air changes: >10 x/ hour
- Photoperiod: 12/12 (light 6.30 - 18.30)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1% in aqua bidest.
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
600 mg of the test item were suspended in 1% CMC Solution to give a total volume of 20 mL.
2000 mg of the test item were suspended in 1% CMC Solution to give a total volume of 20 mL.
4.000 mg of the test item were suspended in 1% CMC Solution to give a total volume of 20 mL.
VEHICLE
- Justification for use and choice of vehicle: The vehicle was chosen due to its non-toxic characteristics
- Concentration in vehicle: CMC, 1% in aqua bidest.
- Amount of vehicle (if gavage): 5 mL/kg bw
- Lot no. : 36H0738 - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Technically not feasible. Due to the extremely low solubility in water and organic solvents test item concentrations could not be determined analytically. See section 4.7 and 4.8 for more detail.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 7 days per week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 150 mg/kg bw/day (actual dose received)
- Remarks:
- Basis: actual ingested
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Remarks:
- Basis: actual ingested
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- Basis: actual ingested
- No. of animals per sex per dose:
- 10 animals per dose (5 females and 5 males)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose selection was based on results in an acute toxicity study (see section 7.2.1). The highest dose level was chosen with the aim of inducing toxic effects but not death or severe suffering. Thereafter, a descending sequence of dose levels was selected with a perspective to demonstrate any dosage related response and no-observed-adverse effects at a certain dose level.
- Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least once a day. Mortality was observed twice a day.
BODY WEIGHT: Yes
- Time schedule for examinations: The animals were weighed prior to first application (day 0) and once a week thereafter (day 7, 14, 21, 28 or day of sacrifice, respectively).
FOOD CONSUMPTION:
- Food consumption for each animal group (females/males) was determined and calculated in g per group: Yes
FOOD EFFICIENCY:
- Body weight gain g per animal: Yes
HAEMATOLOGY AND CLINICAL CHEMISTRY : Yes
- Time schedule for collection of blood: on the day of necropsy (part of necropsy)
- Animals fasted: Yes (over night)
- How many animals: all animals
- Parameters examined: Haematocrit (Hct), Haemoglobin (Hb), Erythrocyte count (RBC), Total leucocyte count (WBC), Differential leucocyte count Platelet count, Blood clotting parameters: activated Partial Thromboplastin Time (aPTT), AST aspartate aminotransferase (GOT), ALT alanine aminotransferase (GPT), Alkaline Phosphatase (AP), Cholesterol (Chol), Total Protein (TP), Glucose (GLU), Urea, Creatinine (CREA), Albumin (ALB), Na, K;
URINALYSIS: Yes
- Time schedule for collection of urine: on the day of necropsy (part of necropsy)
- Metabolism cages used for collection of urine: No
- Animals fasted: Yes (over night)
- Parameters examined: pH, Urine GLU, Urine TP
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: once before first exposure and in the fourth exposure week
- Dose groups that were examined: all animals
- Battery of functions tested: sensory activity / grip strength / motor activity - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (All animals in the study were subjected to a full, detailed gross necropsy which included careful examination of the surface of the body, all orifices and the cranial, thoracic and abdominal cavities and their contents)
HISTOPATHOLOGY: Yes (Full histopathology was carried out on the preserved organs and tissues of all animals) - Statistics:
- For statistical analysis one-way analysis of variance (ANOVA) was carried out, followed by Student's t-test to reveal any differences between control and test groups. In the evaluation of laboratory parameters all values within a range of the mean value ± the two fold Standard deviation (x ± 2s) are considered to be „normal" values within a „normal" population.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Some borderline deviations were found (weight gain, organ weight, Na - values) without clear dose dependency or toxicological Compound related relevance.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects No toxicological relevant effects were observed in any of the dosed animals
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL of the test item was determined to be >= 1000 mg/kg bw/day.
- Executive summary:
The test substance Urea 4 was tested in a repeated dose 28 -day oral toxicity study in rats according to EU method B.7 and OECD Guideline 407. The test item was administered in doses of 150, 500 and 1000 mg/kg bw once a day, for a period of 28 days, to three groups of 5 male and 5 female Wistar rats by oral gavage. A control group of 5 male and 5 female rats was dosed with the vehicle, (CMC) 1% in aqua bidest. Clinical and behaviour/ functional observations were carried daily and examination of body weight was performed throughout the study. Blood and urine samples, collected during necropsy, were used to perform a detailed haematology analysis and urinalysis. A detailed gross necropsy was performed as well as histopathological and organ weight examination. In comparison to the untreated control group, several borderline deviations were observed for few parameters examined in the treated groups. However, a clear dose dependency or toxicological compound related relevance could not be established. All rats treated with the test item Urea 4 survived the testing period without showing compound related toxic effects. Thus the NOAEL value determined was >= 1000 mg/kg bw/day.
See cross-ref. for limitations on solubility and analytics.
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