Registration Dossier
Registration Dossier
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EC number: 272-249-5 | CAS number: 68784-47-4
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Annex V
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 410-660-5
- EC Name:
- -
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Amount / concentration applied:
- 0.1 ml
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.5
- Max. score:
- 0.6
- Reversibility:
- fully reversible within: 3d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.3
- Max. score:
- 0.3
- Reversibility:
- fully reversible within: 3d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days
- Other effects:
- Grade 1 conjunctival redness and chemosis was observed in
all three rabbits at 1 and 24 hours post-application.
Slight
discharge was also noted in all three rabbits at one hour.
Grade 1 conjunctival redness was also observed in 2 rabbits
at 48 hours. No reactions were seen at 72 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Slight effects observed, but not sufficiently severe for classification
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