Registration Dossier
Registration Dossier
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EC number: 438-670-5 | CAS number: 87199-17-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- May, 2017. Because of in the NDA 01-04-1385-00 carried out by Germany was not requested to indicate the endpoint study record, considering the data inserted in the course of the assessment to be correct and exhaustive the proper “Adequacy of study” has been selected.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/62/EWG, B.5
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 438-670-5
- EC Name:
- -
- Cas Number:
- 87199-17-5
- Molecular formula:
- Hill formula: C7H7BO3 CAS formula: C7H7BO3
- IUPAC Name:
- (4-formylphenyl)boronic acid
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Amount / concentration applied:
- 100 MG
- 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
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 96 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.7
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.7
- Irritation parameter:
- chemosis score
- Max. score:
- 4
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Irritation parameter:
- cornea opacity score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 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 5 days
- Other effects:
- 1 h p.a. wurde Tränenfluss festgestellt, der bei einem Tier
bis 48 h p.a. anhielt.
"ENGLISH"
At 1-hour reading slight tear secretion was observed in all
three rabbits. At the reading 48 hours after the
installation of the substance one rabbit showed signs of
slight tear secretion. No teat secretion in the other
animals was observed at the later readings.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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