Registration Dossier
Registration Dossier
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EC number: 240-457-5 | CAS number: 16409-43-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: according to guideline, limited documentation, non-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted May 12th, 1981
- GLP compliance:
- no
Test material
- Reference substance name:
- Tetrahydro-2-isobutyl-4-methyl-2H-pyran
- EC Number:
- 236-770-1
- EC Name:
- Tetrahydro-2-isobutyl-4-methyl-2H-pyran
- Cas Number:
- 13477-62-8
- Molecular formula:
- C10H20O
- IUPAC Name:
- Reaction mass of 2H-Pyran, tetrahydro-4-methyl-2-(2-methylpropyl)-, (2R,4R)-rel- and 2H-Pyran, tetrahydro-4-methyl-2-(2-methylpropyl)-, (2R,4S)-rel-
- Details on test material:
- - Name of test material (as cited in study report): Dihydrorosenoxyd
no further data provided
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; 6050 Offenbach/Main, Germany
- Weight at study initiation: 3.31 kg, 2.95 kg, 2.80 kg
- Housing: single
- Diet: 130 g per animal per day (Ovator Solikanin 4mm)
- Water: daily 250 mL
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single treatment
- Observation period (in vivo):
- 1, 24, 48, 72 hours and 8 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 1-3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
Any other information on results incl. tables
| Cornea | Iris | Conjunctiva | ||||||
| Readings | Animal | Opacity | Area involved | Redness | Swelling | Discharge | Further findings | |
| 1h | 1 | 0 | 0 | 0 | 2 | 1 | 1 | |
| 2 | 0 | 0 | 0 | 2 | 1 | 1 | ||
| 3 | 0 | 0 | 0 | 2 | 1 | 1 | ||
| 24h | 1 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 1 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 1 | 0 | 0 | ||
| 48h | 1 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 1 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 1 | 0 | 0 | ||
| 72h | 1 | 0 | 0 | 0 | 1 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 1 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 1 | 0 | 0 | ||
| 8d | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| Mean (24h-72h) | 1 | 0,0 | 0,0 | 0,0 | 1,0 | 0,0 | 0,0 | |
| 2 | 0,0 | 0,0 | 0,0 | 1,0 | 0,0 | 0,0 | ||
| 3 | 0,0 | 0,0 | 0,0 | 1,0 | 0,0 | 0,0 | ||
| Mean (24h-72h) | all animals | 0,0 | 0,0 | 0,0 | 1,0 | 0,0 | 0,0 |
Applicant's summary and conclusion
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