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Toxicological information

Skin irritation / corrosion

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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: Guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): p-Methylanisol
- Analytical purity: > 99.5 %
- Lot/batch No.: P 16

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Mean weight at study initiation: males: 2.75 kg, female 2.4 kg
- Housing: stainless steel cage with wire mesh walk floor, floor area ca. 40 cm x 51 cm without bedding
- Diet: Kliba 341, 4 mm (Klingentalmühle AG, Kaiseraugst, Switzerland), ca. 130 g per animal per day
- Water: ca. 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study
- Clipping of the fur: at least 15 h before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70 %
- Air changes per hr: fully air-conditioned rooms
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated skin sites of the same animal served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml on a 2.5 cm x 2.5 cm test patch
- Concentration: unchanged
- Application site: upper third of the back or flanks
Duration of treatment / exposure:
4 hours
Observation period:
15 days
Number of animals:
3 (2 males and 1 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: test patches were secured in position with a porous dressing (four layers of absorbent gauze and porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing: at the end of the observation period with lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 hours

READINGS
30-60 min after patch removal and 24 h, 48 h, 72 h, 8 d and 15 d after the beginning of the application

SCORING SYSTEM:
Edema/erythema scores according to the method of Draize; evaluation: none (0) - very slight (1) - well-defined (2) - moderate (3) - severe to very severe (4)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Any other information on results incl. tables

Table 1: Results on skin irritation, expressed as individual Draize scores at different reading time points:

Reading

animal

erythema

edema

symptoms

4 h

1

2

2

erythema and edema extending beyond the area of exposure

2

2

2

erythema and edema extending beyond the area of exposure

3

2

2

erythema and edema extending beyond the area of exposure

24 h

1

3

1

erythema and edema extending beyond the area of exposure

2

3

1

erythema and edema extending beyond the area of exposure

3

3

0

erythema extending beyond the area of exposure

48 h

1

3

0

erythema extending beyond the area of exposure

2

3

1

erythema and edema extending beyond the area of exposure

3

3

0

erythema extending beyond the area of exposure

72 h

1

2

0

erythema extending beyond the area of exposure

2

3

1

erythema and edema extending beyond the area of exposure

3

2

0

 

8 d

1

1

0

erythema extending beyond the area of exposure

2

1

0

erythema and scaling extending beyond the area of exposure

3

1

0

scaling

15 d

1

0

0

 

2

1

0

erythema extending beyond the area of exposure

3

1

0

scaling

Applicant's summary and conclusion