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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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