Registration Dossier
Registration Dossier
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EC number: 403-360-0 | CAS number: 42405-40-3 BONTRON E-84; E-84
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study, only basic data available from SNIF (ECHA)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 94/449/EEC, Method B5 OECD Guideline No. 405
- GLP compliance:
- yes
Test material
- Reference substance name:
- 610-025-4
- EC Number:
- 610-025-4
- IUPAC Name:
- 610-025-4
- Reference substance name:
- Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc
- EC Number:
- 403-360-0
- EC Name:
- Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc
- Cas Number:
- 42405-40-3
- Molecular formula:
- C30H42O6Zn
- IUPAC Name:
- bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc
- Details on test material:
- Nature of substance: Powder
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- other: Rabbit, New Zealand white
Test system
- Amount / concentration applied:
- 65 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:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- Mean score 2
- Time point:
- other: Overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- Mean score 3
- Time point:
- other: Overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 1 h; Max. value at the 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
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- Mean score 2
- Time point:
- other: Overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- Mean score 3
- Time point:
- other: Overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis 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
- Remarks:
- Mean score 1
- Time point:
- other: Overall at 24, 48 and 72 h
- Score:
- 0
- 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
- Irritation parameter:
- cornea opacity 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:
- 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: h; Max. value at end of observation period: 0 (related to all animals)
- Other effects:
- Very slight transient conjunctival reactions were observed at one hour reading only
Any other information on results incl. tables
Reversibility of any observed effect: Changes fully reversible within 1 day
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
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