Registration Dossier
Registration Dossier
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EC number: 607-081-7 | CAS number: 224586-49-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 February 2004 to 12 february 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-(butan-2-yloxy)-3,5-dimethoxybenzaldehyde
- EC Number:
- 607-081-7
- Cas Number:
- 224586-49-6
- Molecular formula:
- C13H18O4
- IUPAC Name:
- 4-(butan-2-yloxy)-3,5-dimethoxybenzaldehyde
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): v175023
- Physical state: brown liquid
- Analytical purity: 99.05%
- Lot/batch No.: v175023/P8B
- Expiration date of the lot/batch: 15 Dec 2004
- Storage condition of test material: at room temperature protected from light
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 9-12 weeks
- Weight at study initiation: 2283 to 2603g
- Housing: individual in cages with perforated floors (56X44X37.5 cm)
- Diet: ca 100 g/d Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Lage, Germany
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14.8-22.7°C
- Humidity (%): 32-77%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL - Duration of treatment / exposure:
- single treatment (eyelids held for 1 second)
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after instillation
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein after 24 h scoring
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0.11
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- no findings after fluorescein staining
Any other information on results incl. tables
Animal no |
1 |
2 |
3 |
|||||||||
Observation time (h) |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
cornea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
redness |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
chemosis |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
discharge |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the eyes
- Executive summary:
The substance was installed in the eyes of 3 rabbits. Slight redness, chemosis and discharge were observed at the 1 hour observation. Thereafter no signs of irritant properties became apparent. The substance is considered not irritating to the eye.
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