Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
20. Aug 1968 - 28. Aug 1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Principles of method if other than guideline:
Method: BASF test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butylal; Formaldehyddibutylacetal
- Physical state: liquid
- Analytical purity: 98-99 %

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.04 kg and 2.13 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline control.
Amount / concentration applied:
undiluted
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
Duration of treatment / exposure:
single application
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no symptoms observed
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no symptoms observed

Any other information on results incl. tables

Findings animal1/animal2:

 Time Opacity Iritis  Erythema Chemosis               
1h  1/1 0/0 2/2  0/0              
24h  1/1  0/0 1/1  0/0              
48h  0/0  0/0 0/0 0/0              
72h x  x  x              
 8d 0/0  0/0 0/0 0/0               

x: reading is missing.

Mean values over 24h, 48h (72h reading is missing):

Animal1: Opacity: 0.3; Iritis: 0; Erythema: 0.3; Chemosis: 0;

Animal2: Opacity: 0.3; Iritis: 0; Erythema: 0.3; Chemosis: 0;

The application of the test substance caused slight to moderate erythema and slight corneal opacity in the first 24 h. 48 h post application the symptoms were reversible.

The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Applicant's summary and conclusion