Registration Dossier
Registration Dossier
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EC number: 601-639-3 | CAS number: 119851-28-4
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: GLP-study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-[2-chloro-4-(4-chlorophenoxy)phenyl]ethanone
- EC Number:
- 601-639-3
- Cas Number:
- 119851-28-4
- Molecular formula:
- C14H10Cl2O2
- IUPAC Name:
- 1-[2-chloro-4-(4-chlorophenoxy)phenyl]ethanone
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye of the rabbits remained untreated and served as a control
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3 males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- control eye
- Time point:
- other: 24 -72 hrs. (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- treated eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- control eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- treated eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness/chemosis
- Basis:
- animal #1
- Remarks:
- control eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- treated eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- treated eye
- Time point:
- other: 24-72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- control eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- treated eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- control eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- treated eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness/chemosis
- Basis:
- animal #2
- Remarks:
- control eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- treated eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- treated eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- control eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- treated eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- control eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- treated eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- treated eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: redness animal #3 control eye - score 0; max. score 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- treated eye
- Time point:
- other: 24 - 72 hrs (mean)
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: chemosis animal #3 control eye - score 0; max. score 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Because the mean values of the readings 24 to 72 hours after instillation are below the threshold of significance, the TS can be classified as non-irritant.
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