Registration Dossier
Registration Dossier
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EC number: 430-740-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- RZ 97
- IUPAC Name:
- RZ 97
- Details on test material:
- Nature of substance: bright clear amber liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ML - Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- ca. 0.33
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- ca. 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- ca. 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 1 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days
- Other effects:
- Neither mortality nor adverse general clinical modifications were seen during the study.
Slight (grade 2) conjunctival redness and very slight (grade 1) chemosis were detected in all rabbits at the reading carried out 1 hour after exposure.
At the 24- and 48-hour readings conjunctival redness was the only eye change observed. It showed a decrease in degree and frequency and disappeared by the 72nd hour.
Negative results were obtained at the fluorescein staining performed 24 hours after the test article application.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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