Registration Dossier
Registration Dossier
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EC number: 405-040-6 | CAS number: 63500-71-0 CIS/TRANS-TIMO; FLOROL; FLOROSA
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
- EC Number:
- 405-040-6
- EC Name:
- A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
- Cas Number:
- 63500-71-0
- Molecular formula:
- C10 H20 O2
- IUPAC Name:
- 4-methyl-2-(2-methylpropyl)oxan-4-ol
- Details on test material:
- - Analytical purity: >99%
- Lot/batch No.:S1943401
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml - Observation period (in vivo):
- examination of the eyes after 1 hour and 1, 2, 3, 4, 7, 14 and 21 days after instillation
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0.11
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 1.44
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24+48+72h
- Score:
- 0.89
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
|
time |
animal 1 |
animal 2 |
animal 3 |
corneal opacity |
24 h |
1 |
2 |
1 |
48 h |
1 |
2 |
1 |
|
72 h |
1 |
1 |
2 |
|
iris |
24 h |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
1 |
|
conjunctivae |
24 h |
1 |
2 |
2 |
48 h |
1 |
1 |
1 |
|
72 h |
1 |
2 |
2 |
|
chemosis |
24 h |
1 |
2 |
1 |
48 h |
0 |
1 |
1 |
|
72 h |
0 |
1 |
1 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Single instillation into the eye elicited corneal opacities in all 3 animals accompanied by temporary iritis in one animal and conjunctival irritation in all 3 animals. All reactions had resolved 21 days after instillation.
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