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EC number: 215-304-0 | CAS number: 1320-51-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study in accordance with OPPTS 870.1100 and OECD TG
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- version 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- EXP 3982 N-2-hydroxethylurea
- IUPAC Name:
- EXP 3982 N-2-hydroxethylurea
- Details on test material:
- - Name of test material (as cited in study report): EXP 3982 N-2-hydroxyethylurea
- Physical state: clear yellow liquid
- Analytical purity: aqueous solution containing 57.58 % hydroxyethyl urea
- Impurities (identity and concentrations): not reported
- Composition: aequeous solution containing 57.58 % hydroxyethyl urea
- Purity test date: not reported
- Lot/batch No.: 84714
- Expiration date of the lot/batch: 15 July 2001
- Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley Inc.
- Age at study initiation: males were about 10 to 11 weeks old; females were about 10 weeks old
- Weight at study initiation: males weighed 298-335 g; females weighed 187-226 g
- Fasting period before study: yes, overnight fasting
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Rodent Chow #5002 (Purina Mills Inc) ad libitum
- Water (e.g. ad libitum): municipal tap water treated by reverse osmosis ad libitum
- Acclimation period: acclimated to the laboratory conditions for a minimum of five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24
- Humidity (%): 30-45
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 3.05 mL/kg
- Doses:
- 3473 mg/kg corresponding to 2000 mg/kg active ingredient
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: clinical observations were made two times on the day of administration and once per day thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: bodyweight was determined on the day of administration, on day 7 and day 14 - Statistics:
- Not applicable
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 473 mg/kg bw
- Based on:
- test mat.
- Remarks:
- aqueous solution containing 57.58 % of the registration item
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No mortality occurred during after oral administration or during the 14-day observation period.
- Clinical signs:
- other: Transient incidences of fecal stain, mucoid stools and dark material around the nose
- Gross pathology:
- No significant findings; one isolated incidence of foci on the thymus of one animal was observed that was considered to be not related to treatment
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was not acutely toxic to rats after single oral administration and the LD50 was greater than 3473 mg/kg (> 2000 mg/kg for hydroxyethyl urea).
- Executive summary:
The acute oral toxicity of the test substance EXP 3982 N-2-hydroxyethylurea containing 57.58% of the active ingredient hydroxyethyl urea was studied under GLP in a study according to OECD TG 401. After a preliminary study with doses ranging from 868 to 3473 mg/kg (corresponding to 500 to 2000 mg/kg active ingredient), a final limit test was conducted with a single dose of 3473 mg/kg corresponding to 2000 mg/kg active ingredient. Five male rats (10 to 11 weeks old, weighing 298 to 335 g) and five female rats (10 weeks old, weighing 187 to 226 g) of the Sprague-Dawley strain were fasted overnight and received a single oral dose of the test material by gavage at a volume of 3.05 mL/kg. Animals were housed individually in suspended cages and observed for a period of 14 days. Animals received food and drinking water ad libitum. At the end of the observation period the animals were sacrificed and a gross necropsy was performed on all animals. No mortality occurred after dosing or during the 14-day observational period. No significant clinical observations and findings at necropsy were made. Bodyweight development was normal. The LD50 value was greater than 3473 mg/kg for the formulation, which corresponds to >2000 mg/kg for the active ingredient.
Based of the lack of any significant toxicity at 2000mg/kg, hydroxyethyl urea is not classified for acute dermal toxicity according to GHS.
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