Registration Dossier
Registration Dossier
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EC number: 410-510-9 | CAS number: 86753-82-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Observation period (in vivo):
- 9 days
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 1.3
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 1.7
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 1.7
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- conjunctivae score
- Max. score:
- 2
- Remarks on result:
- other: max. duration: 9h; Max value at end of observation period:0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 1.7
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 1
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Max. score:
- 2
- Remarks on result:
- other: Max. duration:4h; max. value at tend of observation period:0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Max. score:
- 0
- Remarks on result:
- other: Max duration: 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 72h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- ca. 0.7
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration:3 h; Max value at the end of observation period:0 (related to all animals)
- Other effects:
- Other signs of irritation were noted: eversion of the eyelids, and mucous secretions of the Harderian gland, dry secretions in the upper and lower eyelids. Fluorescein staining revealed superficial erosion of the cornes in one animal.
Maximum duration of any effect: 9 days
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- not classified.
- Executive summary:
Not classified.
Although some animals reacted to the test substance, it does not meet the criteria for classification as specified in EC No 1272/2008. The maximum duration of any effect: 9 days
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