Registration Dossier
Registration Dossier
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EC number: 451-540-2 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - 3 male rabbits used – 1 treated group
- Age/Bodyweight at start: 2 to 4 month-old; 3.0 +/-0.1kg
- Temperature: 18+/-3°C; RH: 30-70%; Light/dark cycle: 12h/12h; ventilation: Approx. 12 cycles/h
- Caging: 1 rabbit/cage
- Food and water ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 100 mg/animal
- Duration of treatment / exposure:
- - Application directly in the conjunctival sac of 1 eye
- No rinsing after application
- The controlateral eye served as control. - Observation period (in vivo):
- eye examination at 1, 24, 48, 72 hours after the treatment
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Control animals
not required (the contro-lateral eye served as control)
At each time of examination, individual scoring for conjunctival reactions, iritis and corneal opacification
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: chemosis
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: chemosis
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: chemosis
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: conjunctiva redness
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: conjunctiva redness
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: conjunctiva redness
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: iris
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: iris
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: iris
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: corneal opacity
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: corneal opacity
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: corneal opacity
- Other effects:
- Observation: Whitish purulent discharge in 1 animal on day 2. Fully reversible.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information fully reversible Criteria used for interpretation of results: EU
- Conclusions:
- Classification is not required.
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