Registration Dossier
Registration Dossier
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EC number: 222-359-4 | CAS number: 3445-11-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- according to Federal Register, Vol. 29, No. 182, p 13009, 17 Sept 1964
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-(2-hydroxyethyl)pyrrolidin-2-one
- EC Number:
- 222-359-4
- EC Name:
- 1-(2-hydroxyethyl)pyrrolidin-2-one
- Cas Number:
- 3445-11-2
- Molecular formula:
- C6H11NO2
- IUPAC Name:
- 1-(2-hydroxyethyl)pyrrolidin-2-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The other eye, remaining untreated, seves as a control. The eyes are not washed following instillation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals 1-6
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no corneal effects observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals 1-6
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: iris was not affected in any animal
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animals 1-6
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: one day
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animals 1-6
- Time point:
- other: 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: no conjuctival effects observed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals 1-6
- Time point:
- other: 24 hours
- Score:
- 0.16
- Max. score:
- 4
- Reversibility:
- fully reversible within: one day
- Remarks on result:
- other: one animal affected grade 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animals 1-6
- Time point:
- other: 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no chemosis observed
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: no discharge observed at any time point
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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