Registration Dossier
Registration Dossier
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EC number: 223-032-9 | CAS number: 3699-54-5
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- other: Guideline study, available as unpublished report, fully adequate for assessment.
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)
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-(2-hydroxyethyl)imidazolidin-2-one
- EC Number:
- 223-032-9
- EC Name:
- 1-(2-hydroxyethyl)imidazolidin-2-one
- Cas Number:
- 3699-54-5
- Molecular formula:
- C5H10N2O2
- IUPAC Name:
- 1-(2-hydroxyethyl)imidazolidin-2-one
- Details on test material:
- - Name of test material: Hydroxyethylethylene urea
- CAS No.: 3699-54-5
- Appearance: white, solid, crystalline melt
- Purity: > 98%
- Impurities: urea < 1%, water < 1%
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, FRG
- Weight at study initiation: male (mean): 2.69 kg; female (mean): 2.75 kg
- Housing: Cages made of stainless steel with wire mesh walk floors; floor area: 40 cm x 51 cm.
- Diet: Kliba 341, 4 MM, Firma Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 8 days, same housing condintions as during the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml (unchanged) after heating at about 100°C - Duration of treatment / exposure:
- single application, no washing was performed
- Observation period (in vivo):
- 1, 24, 48, 72 hours after application
- Number of animals or in vitro replicates:
- 2 males and 1 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Chemosis (score 1) was observed in two animals 1 hour after application.
Conjunctivae discharge (score 2) was observed in all animals 1 after application.
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
