Registration Dossier

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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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
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
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
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
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
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
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
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
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

Applicant's summary and conclusion