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Diss Factsheets

Administrative data

Endpoint:
skin 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 404 (Acute Dermal 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

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, Germany
- Weight at study initiation: mean 2.81 kg
- 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

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped at least 15 hours before begin of study
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin site of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 hours
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm on upper third of back or flanks


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutol and Lutrol:water (1:1)
- Time after start of exposure: 4 h


SCORING SYSTEM:
Evaluation of erythema and edema acc. to 83/467/EEC criteria:
0 = NONE
1 = VERY SLIGHT
2 = WELL-DEFINE D
3 = MODERATE TO SEVERE
4 = SEVERE

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects

Any other information on results incl. tables

Results:

Animal1: male, 3.1 kg

Animal 2: male, 2.94 kg

Animal 3: 2.4 kg

Readings Animal Erythema Edema Additional findings
4 h 1 0 0  
2 0 0  
3 1 0  
24 h 1 0 0  
2 0 0  
3 0 0  
48 h 1 0 0  
2 0 0  
3 0 0  
72 h 1 0 0  
2 0 0  
3 0 0  
mean 24 - 72 h 1 0.0 0.0  
2 0.0 0.0  
3 0.0 0.0  
mean 24 - 72 h all animals  0.0 0.0  

Applicant's summary and conclusion