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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1994-01-17 to 1994-01-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Quinazolin-4(1H)-one
EC Number:
207-735-8
EC Name:
Quinazolin-4(1H)-one
Cas Number:
491-36-1
Molecular formula:
C8H6N2O
IUPAC Name:
4-Hydroxyquinazoline
Test material form:
solid
Specific details on test material used for the study:
Lot No.: Batch 9
Purity: Not specified

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler; Offenbach / Main, Frg
- Age at study initiation: young adult animals
- Weight at study initiation: 3.44-3.95 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2, no bedding in the cages; sawdust in the waste trays
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): about 250 mL tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL bulk volume (about 20 mg)
Duration of treatment / exposure:
72 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
- Weight determination: shortly before application of the test substance.
- Route of application: single application to the conjunctival sac of the right eyelid; the substance was not washed out.
- Readings: 1 h, 24 h, 48 h and 72 h after application.
- General observations: a check was made twice each workday and once on Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
The findings were reversible in all animals within 24 hours after application.

Any other information on results incl. tables

Animal No.

Time after

application

Cornea opacity

 

 

Iris

Conjunctivae

Redness

Chemosis

1

1 hour

0

0

2

0

24 hours

0

0

0

0

48 hours

0

0

0

0

72 hours

0

0

0

0

2

1 hour

0

0

1

0

24 hours

0

0

0

0

48 hours

0

0

0

0

72 hours

0

0

0

0

3

1 hour

0

0

1

0

24 hours

0

0

0

0

48 hours

0

0

0

0

72 hours

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions chosen and considering the described findings the test item does not give indication of an irritant property to the eye.
Executive summary:

The potential of test item to cause damage to the conjunctiva, iris or cornea was assessed in 3 white vienna rabbits in compliance with OECD405, subjected to a single ocular application of about 20 mg of the test substance on day 0.

The average score (24 to 72 hours) for irritation was calculated to be 0 .0 for corneal opacity, iris, conjunctivae redness and for chemosis .

The findings were reversible in all animals within 24 hours after application, thus the study was terminated after 72 hours.

Under the test conditions chosen and considering the described findings the test item does not give indication of an irritant property to the eye.

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