Registration Dossier
Registration Dossier
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EC number: 403-800-1 | CAS number: 103597-45-1 EVERSORB 78; LOWILITE 36; LS.BT.620; MIXXIM BB/100; TINUVIN 360
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:
- other: GLP compliance and OECD method
Data source
Reference
- Reference Type:
- other: ECHA inquiry result
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EWG,B.5;OECD 405
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2'-methylenebis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)
- EC Number:
- 403-800-1
- EC Name:
- 2,2'-methylenebis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol)
- Cas Number:
- 103597-45-1
- Molecular formula:
- C41H50N6O2
- IUPAC Name:
- 2-(2H-1,2,3-benzotriazol-2-yl)-6-{[3-(2H-1,2,3-benzotriazol-2-yl)-2-hydroxy-5-(2,4,4-trimethylpentan-2-yl)phenyl]methyl}-4-(2,4,4-trimethylpentan-2-yl)phenol
- Details on test material:
- Nature of the substance: solid substance
Constituent 1
Test animals / tissue source
- Species:
- other: rbt,New Zealand White Chbb:NZW
Test system
- Amount / concentration applied:
- 60 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 72h
- Score:
- 0.67
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0.67
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 1
- Remarks on result:
- other: Max. duration:7h;Max.value at end of observation period:(related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration:24h;Max.value at end of ovservation period:(related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- 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
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- iris score
- Max. score:
- 0
- Remarks on result:
- other: Max.duration:h;Max.value at end of ovservation period;(related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
- Other effects:
- Effects wre observed by the end of the seven day observation period
Applicant's summary and conclusion
- Interpretation of results:
- other: not claiisified
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