Registration Dossier
Registration Dossier
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EC number: 413-110-2 | CAS number: 135861-56-2
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:
- other: see 'Remark'
- Remarks:
- The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. However the reliability is estimated to be at level 1: Study conducted in accordance with generally accepted scientific principles. Possible deficiencies do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 413-110-2
- EC Name:
- -
- Cas Number:
- 135861-56-2
- Molecular formula:
- C24H30O6
- IUPAC Name:
- (1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 41 mg
- Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- No data
- 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:
- 0.7
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: max. duration: 48 h; 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 72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: max. duration: 24 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:
- 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Max. score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: max. duration: h; Max. value at end of observation period: (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks:
- 3 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Max. score:
- 0
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: max. duration: h; Max. value at end of observation period:(related to all animals)
- Other effects:
- Conjunctival redness and chemosis were observed at 1 hour reading (mx grade 2)
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
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