Registration Dossier
Registration Dossier
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EC number: 237-457-2 | CAS number: 13811-50-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline compliant but not GLP compliant study but nevertheless well documented and scientifically acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 12 May 1981
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,3-divinylimidazolidin-2-one
- EC Number:
- 237-457-2
- EC Name:
- 1,3-divinylimidazolidin-2-one
- Cas Number:
- 13811-50-2
- Molecular formula:
- C7H10N2O
- IUPAC Name:
- 1,3-diethenylimidazolidin-2-one
- Details on test material:
- Name of the test substance used in the study report: Divinylethylenharnstoff
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/ Main, Germany
- Weight at study initiation: males 3.21 kg, female 3.12 kg
- Housing: One animal per cage (type: stainless steel with wire mesh walk floors, floor area 40 x 51 cm); they were identified via ear tattoo.
- Diet: standardized animal laboratory diet (about 130 g/animal/day)
- Water: tap water (about 250 ml/animal/day)
- Acclimation period: at least 8 days before study start
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30 - 70%
- Air changes: fully air-conditioned rooms
- Photoperiod: 12 h light and 12 h dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 ml bulk volume (about 54 mg of the comminuted test substance)
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Single application to the conjunctival sac of the right eyelid; the test substance was not washed out.
Readings: 1 h, 24 h, 48 h, 72 h, 8 d
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 24/48/72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- other: 24/48/72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- other: 24/48/72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 24/48/72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- other: 24/48/72 hours
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- other: 24/48/72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- other: 24/48/72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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