4-methylanisole

Skin irritation / corrosion

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-methylanisole

EC Number:

203-253-7

EC Name:

4-methylanisole

Cas Number:

104-93-8

Molecular formula:

C8H10O

IUPAC Name:

1-methoxy-4-methylbenzene

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 or test system 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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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