Registration Dossier

Diss Factsheets

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:
1984
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

Constituent 1
Chemical structure
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

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