Registration Dossier
Registration Dossier
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EC number: 906-083-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to OECD guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Neryl acetate
- EC Number:
- 205-459-2
- EC Name:
- Neryl acetate
- Cas Number:
- 141-12-8
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 3,7-dimethylocta-2,6-dien-1-yl acetate (Z)-
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Nerylacetat
- Lot/batch No.: 50547891
- Physical state: colourless liquid
- Analytical purity: 94.2 %
- Storage condition of test material: cool and dry
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: SPF albino - Chbb:HM(SPF) Littlerussian
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BI Pharma KG, 88397 Biberach
- Weight at study initiation: 2.5 - 2.9 kg
- Housing: individually in PPO cages with perforated floor
- Diet (e.g. ad libitum): pelleted complete rabbit diet "Altromin 2123" was available, ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5, ad libitum
- Acclimation period: at least 1 w
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 40 - 60
- Air changes (per hr): 10x
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- single treatment (washed out after 24h)
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- SCORING SYSTEM:
according to OECD guideline
TOOL USED TO ASSESS SCORE: fluorescein after 24 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1-4
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 1-4
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1-4
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 1-4
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
Any other information on results incl. tables
| Cornea | Iris | Conjunctiva | |||
| Readings | Animal | Opacity | Redness | Swelling | |
| 1h | 1 | 0 | 1 | 1 | 1 |
| 2 | 0 | 0 | 1 | 0 | |
| 3 | 0 | 0 | 1 | 1 | |
| 4 | 0 | 0 | 1 | 1 | |
| 24h | 1 | 0 | 0 | 1 | 0 |
| 2 | 0 | 0 | 1 | 1 | |
| 3 | 0 | 0 | 1 | 1 | |
| 4 | 0 | 0 | 1 | 1 | |
| 48h | 1 | 0 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 0 | |
| 4 | 0 | 0 | 1 | 1 | |
| 72d | 1 | 0 | 0 | 0 | 0 |
| 2 | 0 | 0 | 0 | 0 | |
| 3 | 0 | 0 | 0 | 0 | |
| 4 | 0 | 0 | 0 | 0 | |
| Mean (24h-72h) | 1 | 0,0 | 0,0 | 0,3 | 0,0 |
| 2 | 0,0 | 0,0 | 0,3 | 0,3 | |
| 3 | 0,0 | 0,0 | 0,3 | 0,3 | |
| 4 | 0,0 | 0,0 | 0,7 | 0,7 | |
| Mean (24h-72h) | all animals | 0,0 | 0,0 | 0,4 | 0,3 |
Applicant's summary and conclusion
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