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EC number: 278-928-2 | CAS number: 78491-02-8
- 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: Well reported study performed under GLP and using a standard test method.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea
- EC Number:
- 278-928-2
- EC Name:
- 1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea
- Cas Number:
- 78491-02-8
- Molecular formula:
- C8H14N4O7
- IUPAC Name:
- 1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Bodyweight 2.2-2.6 kg and checked for absence of corneal, iridial or conjunctival abnormalities pre-test.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 67 mg (0.1 ml equivalent)
- Duration of treatment / exposure:
- 3 rabbits: no removal of test substance up to 14 days post-treatment.
1 rabbit: treated eye washed with distilled water 30 seconds after treatment. - Observation period (in vivo):
- Up to day 14 post-treatment.
- Number of animals or in vitro replicates:
- 3 + 1
- Details on study design:
- One eye treated/animal: untreated eyes served as controls.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- : corneal opacity
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: Across 24, 48, and 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Score 2 also at 1h
- Irritation parameter:
- cornea opacity score
- Remarks:
- : corneal opacity
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: Across 24, 48 and 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Score 2 also at 1h
- Irritation parameter:
- cornea opacity score
- Remarks:
- : corneal opacity
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- other: Across 24, 48 and 72h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Score 0 also at 1h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: Across 24, 48 and 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Score 2 also at 1h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: Across 24, 48 and 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Score 2 also at 1h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- other: Across 24, 48 and 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Also score 2 at 1h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- other: Across 24, 48 and 72h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Score 3 at 1h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- other: Across 24, 48 and 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Also score 2 at 1h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- other: Across 24, 48 and 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Also score 2 at 1h
- Irritant / corrosive response data:
- Iridial changes were less marked that those tabulated above:
- animal 1, score 1 at 24h only
- animal 2, score 1 at 48 and 72h only
- animal 3, score 0 only.
In the one additional animal eyewashed 30 seconds after treatment, no corneal or iridial changes were observed but conjunctival redness and discharge scores were 2 up to 72h (fully recovered by Day 14).
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this study, eye irritation was evident. All lesions were reversible, but the responses were sufficient to trigger classification under the CLP Regulation.
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