4-methylanisole

Eye irritation

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: Guideline study with acceptable restrictions, i.e. limited observation period.

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 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Savo; Med. Versuchstierzuchten GmbH, Kisslegg, Germany
- Mean weight at study initiation: males 3.09 kg, female 2.95 kg
- Housing: individually in stainless steel cages with wire mesh walk floors (40 cm x 51 cm)
- Diet: Kliba 341, 4 mm (Klingentalmühle AG, Kaiseraugst, Switzerland), ca. 130 g per day
- Water: ca. 250 ml tap water per animal per day
- Acclimation period: at least 8 days before the beginning of the study; same housing conditions as during the study

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye of the same animal served as control

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml

Duration of treatment / exposure:

the substance was not washed out

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 (2 males and 1 female)

Details on study design:

0.1 ml of the test material was applied into the conjunctival sac of the animals. The substance was not washed out.
Reading time points were 1 h, 24 h, 48 h and 72 h after application of the test material.
The scores were calculated according to the method of Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

0.66

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24-48-72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24-48-72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24-48-72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 72 h

Any other information on results incl. tables

Table 1: Scores for eye irritation of the individual animals at different reading time points:

reading	animal	cornea	iris	conjunctiva redness	conjunctiva chemosis	symptoms
1 hour	1	0	0	2	0
	2	0	0	2	1
	3	0	0	2	1
24 h	1	0	0	1	0
	2	1	1	2	1	pupil contracted; small retractions in the eyelids
	3	0	0	1	0	pupil contracted
48 h	1	0	0	1	0
	2	0	0	1	0	pupil contracted; small retractions in the eyelids
	3	0	0	1	0	pupil contracted
72 h	1	0	0	0	0
	2	0	0	0	0	pupil contracted
	3	0	0	0	0	pupil contracted