Registration Dossier
Registration Dossier
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EC number: 218-577-4 | CAS number: 2186-92-7
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: Test protocol equivalent to current test guidelines; non-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- p-(dimethoxymethyl)anisole
- EC Number:
- 218-577-4
- EC Name:
- p-(dimethoxymethyl)anisole
- Cas Number:
- 2186-92-7
- Molecular formula:
- C10H14O3
- IUPAC Name:
- 1-(dimethoxymethyl)-4-methoxybenzene
- Details on test material:
- - Name of test material (as cited in study report): p-(dimethoxymethyl)anisole
(Anisacetal KW 7056469-1)
- Substance No.: 84/102
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, Germany
- Weight at study initiation: mean 2.66 kg (male), 2.53 kg (female)
- Housing: single in stainless steel cages with wire mesh walk floors, floor area: 40 x 51 cm
- Diet (e.g. ad libitum): Solikanin 4MM (about 130 g per animal per day)
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: for 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:
- other: untreated other eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- one application, no washing
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
Acc. to 83/467/EEC:
SCORING FOR OCULAR LESIONS :
CHEMOSIS ( SW) AND CORNEA (OP) (OPACITY-DEGREE OF DENSITY) :
0 = NONE
1 = SLIGHT
2 = WELL-DEFINED
3 = SEVERE
4 = VERY SEVERE
CONJUNCTIVAE REDNESS (RED) :
0 = NORMAL
1= SLIGHT
2 = WELL-DEFINED
3 = SEVERE
IRIS :
0 = NORMAL
1 = CIRCUM-CORNEAL INJECTION
2 = IRITIS
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
Any other information on results incl. tables
Results:
Animal 1: male, 2.66 kg
Animal 2: female, 2.52 kg
Animal 3: female, 2.53 kg
| Readings | Animal | Cornea | Iris | Conjunctival | Symptoms | |
| Erythema | Chemosis | |||||
| 1h | 1 | 0 | 0 | 2 | 1 | |
| 2 | 0 | 0 | 2 | 0 | ||
| 3 | 0 | 0 | 2 | 1 | ||
| 24 h | 1 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 1 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | ||
| 48 h | 1 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | ||
| 72 h | 1 | 0 | 0 | 0 | 0 | |
| 2 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | ||
| mean 24 - 72 h | 1 | 0.0 | 0.0 | 0.0 | 0.0 | |
| 2 | 0.0 | 0.0 | 0.3 | 0.0 | ||
| 3 | 0.0 | 0.0 | 0.0 | 0.0 | ||
| mean | 1 | 0.0 | 0.0 | 0.1 | 0.0 | |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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