Registration Dossier
Registration Dossier
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EC number: 603-266-1 | CAS number: 128286-13-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- slight variation of humidity with a minimum at 38,9% RH
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- DICOA
- IUPAC Name:
- DICOA
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Controls:
- other: the other eye is not treated
- Amount / concentration applied:
- 70 mg (0,1ml) per animal
- Observation period (in vivo):
- 1h, 24h (day 1), 48h, 72, day 7
- Number of animals or in vitro replicates:
- 6 males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- ca. 0.67
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- ca. 0.67
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- ca. 1
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- ca. 0.67
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- ca. 0.33
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- ca. 0.33
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- ca. 0.83
- Reversibility:
- not fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- ca. 0.33
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- ca. 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- ca. 0.17
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- ca. 0
- Irritant / corrosive response data:
- The lesions observed at 72h showed a total reversibility in the 6 rabbits examined on day 7.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- From the results obtained under the experimental conditions employed, application of this test article to the rabbit's eye provoked a slight irritation.
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