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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study performed under GLP
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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN
- Age at study initiation: males: 14-15 weeks, females: 15 weeks
- Weight at study initiation: males: 3.0 - 3.2 kg, females: 3.1 - 3.5 kg
- Housing: individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Rabbit Chow #5322 (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): 21-22
- Humidity (%): 26-56
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye of each rabbit remained untreated and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 1, 24, 48 and 72 h and up to 7 days after dosing
- Number of animals or in vitro replicates:
- 3 males, 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Following macroscopic observations at the 24-h scoring interval, any residual test article was gently rinsed from the eye using physiological saline.
- Time after start of exposure: 24 h
SCORING SYSTEM:
CORNEAL OPACITY-DEGREE OF DENSITY (AREA MOST DENSE TAKEN INTO ACCOUNT)
0: No ulceration or opacity
1: Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible
2: Easily discernible translucent area,, details of iris slightly obscured
3: Nacreous (opalescent) area, no details of iris visible, size of pupil barely discernible
4: Opaque cornea, iris not discernible through opacity
AREA OF CORNEA INVOLVED (TOTAL AREA EXHIBITING ANY OPACITY, REGARDLESS OF DEGREE)
0: No ulceration or opacity
1: One quarter (or less) but not zero
2: Greater than one quarter, but less than half
3: Greater than half, but less than three quarters
4: Greater than three quarters, up to whole area
IRITS
0: Normal
1: Markedly deepened rugae (folds above normal), congestion, swelling, modarate circumcorneal hyperemia or injection, any or all of these or combination of any thereof, iris is still reacting to light (sluggish reaction is positive)
2: No reaction to light, hemorrhage, gross destruction (any or all of these)
CONJUNCTIVAL REDNESS (REFERS TO PALPEBRAL AND BULBAR CONJUNCTIVAE EXCLUDING CORNEA AND IRIS
0: Blood vessels normal
1: Some blood vessels definitely hyperemic (injected) above normal (slight erythema)
2: Diffuse, crimson color, individual vessels not easily discernible (moderate erythema)
3: Diffuse beefy red (marked erythema)
CONJUNTIVAL SWELLING (LIDS AND/OR NICTITATING MEMBRANE)
0: No swelling
1: Any sweliing above normal (includes nictitating membrane, slightly swollen)
2: Obvious sewlling with partial eversion of lids
3: Swelling with lids about half closed
4: Swelling with lids more than half closed
CONJUNCTVAL DISCHARGE
0: No discharge
1: Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2: Discharge with moistening of the lids and hairs just adjacent to lids
3: Discharge with moistening of the lids and hairs and considerable area around the eye
TOOL USED TO ASSESS SCORE: auxiliary light source/ fluorescein (before start of test and after 24 h)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 0.056
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 0.56
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of scores at 24, 48 and 72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
Any other information on results incl. tables
Individual scores at 1 h
Cornea score: 0 for all animals
Iris score: 0 in three males, 1 in three females
Conjunctivae score: 1 in all animals
Chemosis score: 1 in all animals
Individal mean scores at 24, 48 and 72 h
Cornea score: 0 for all animals
Iris score: 0 in three males and two females, 1/3 in one female
Conjunctivae score: 1/3 in two males and one female, 2/3 in two females, 1 in one male
Chemosis score: 0 in one male and one female, 1/3 in two males and two females
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of the test, the test item is considered to be a mild irritant to the ocular tissure of the rabbit. EXP 3982 N-2-hydroxyethylurea does not have to be classified for eye irritation according to Regulation (EC) 1272/2008 (CLP).
- Executive summary:
The potential irritant and/or corrosive effects of the aqueous solution EXP 3982 N-2-hydroxyethylurea containing 57.58 % of the active ingredient hydroxyethyl urea were evaluated under GLP on the eyes of New Zealand White rabbits in accordance with OECD TG 405. Each of six rabbits received a 0.1 mL dose of the aqueous solution in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 7 days following dosing.
Exposure to the test article produced iritis in 3/6 test eyes at the 1-hour socring interval which resolved completely in all test eyes by the 48-hour scoring interval. Effects on the conjunctivae (redness, swelling and/or discharge) were noted in 6/6 test eyes at the 1-hour scoring interval. The conjunctival irritation resolved completely in all test eyes by study day 7.
EXP 3982 N-2-hydroxyethylurea is considered to be a mild irritant to the ocular tissue of the rabbit. It does not have to be classified for eye irritation according to Regulation (EC) 1272/2008 (CLP) /GHS.
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