Registration Dossier
Registration Dossier
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EC number: 402-950-5 | CAS number: 81541-12-0 CLEARLITE NU 005; DISORBENE M; GENISET MD; GLC NU 005; MILLAD 3940; NU 005
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: Guideline study without detailed documentation. Study accepted by competent national authorities (ELINCS substance) from EU member states. Reference see section 13 Assessment Reports, ECHA derogation statement.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol
- EC Number:
- 402-950-5
- EC Name:
- 1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol
- Cas Number:
- 81541-12-0
- Molecular formula:
- C22H26O6
- IUPAC Name:
- 1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol
- Details on test material:
- Nature of the subsance: 0.1ml powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
Test system
- Vehicle:
- not specified
- Amount / concentration applied:
- ca. 30mg
- 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
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- readness
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0
- 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:
- 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:
- 0.3
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72h
- Score:
- 0.3
- 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
- Other effects:
- At 1 hour post-dose, scores of 2 in two rabbits and 1 in the other were seen for conjunctival redness
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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