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Diss Factsheets
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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 OECD TG 402
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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- EXP 3982 N-2-Hydroxyethylurea
- IUPAC Name:
- EXP 3982 N-2-Hydroxyethylurea
- 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 Spargue Dawley Inc.
- Age at study initiation: 11 weeks
- Weight at study initiation: males: 330-365 g, females: 211 - 243 g
- Fasting period before study: No
- 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 (%): 36 -45
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure:
- % coverage: 10% of body surface area
- Type of wrap if used: gauze dressing backed with a plastic wrap, elastic wrap over trunk and test area
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test article removes using gauze moistened with deionized waster followed by dry gauze
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3473 mg/kg (corresponding to 2000 mg/kg active ingredient)
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- 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 and weighing: daily examinations for erythema and edema, daily clinical observations, twice daily mortality check, weighing on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights
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 the limit test.
- Clinical signs:
- other: Few faeces, dark material around the facial area, dermal irritation at site of test material application
- Gross pathology:
- No significant gross internal findings at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test, the acute dermal LD50 was estimated to be greater than 3473 mg for the aqueous solution EXP 3982 N-2-hydroxyethylurea per kg in the rat. This corresponds to a LD50 of > 2000 mg/kg for hydroxyethyl urea.
- Executive summary:
The single-dose dermal toxicity of the test substance EXP 3982 N-2-hydroxyethylurea containing 57.58% of the active ingredient hydroxyethyl urea was evaluated in rats in accordance with OECD TG 402. The study was performed under GLP.
A limit test was performed in which one group of five male and five female rats received a single dermal administration of the test substance at a dose of 3573 mg/kg formulation (2000 mg/kg active ingredient). Following dosing, the test animals were observed daily and weighed weekly. A gross necropsy examination was performed on all animals at the time of scheduled euthanasia (day 14).
No mortality occurred during the limit test. Clinical abnormalities observed during the study included few faeces and dark material around the facial area. Dermal irritation was noted at the site of test article application. A slight body weight loss was noted for one male and one female during the day 0 to 7 body weight interval. Body weight gain was noted for all other animals during the test period. No significant gross internal findings were observed at necropsy on study day 14.
Under the conditions of this test, the acute dermal LD50 of EXP 3982 N-2-hydroxyethylurea was estimated to be greater than 3473 mg/kg in the rat. This corresponds to a LD50 of > 2000 mg/kg for hydroxyethyl urea. 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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