Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979 - 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable and well documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
Method: Draize Test
GLP compliance:
no
Remarks:
study was performed prior to GLP implementation

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-dimethyloxirane
EC Number:
209-193-8
EC Name:
2,2-dimethyloxirane
Cas Number:
558-30-5
Molecular formula:
C4H8O
IUPAC Name:
2,2-dimethyloxirane
Details on test material:
Please refer to the section "confidential details on test material" below.

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation/Gender: 2.82 kg/Males (average weight), 3.19 kg/Female

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye served as saline control.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 µL
Duration of treatment / exposure:
continous
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none, the test substance was applied in unaltered form.

SCORING SYSTEM: Draize (test was performed according to: Federal Register 38, no. 187, §1500.42, p. 27019; 27.09.1973)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h (mean)
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 h (mean)
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 h (mean)
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
other: Eye discharge
Basis:
mean
Remarks:
(all animals)
Time point:
other: 24, 48, 72 h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 8 days

Any other information on results incl. tables

Findings animal #1/animal #2/animal #3 (100 µL):

 Time  Opacity (cornea score)  Iritis(iris score)  Erythema (conjunctivae score)  Chemosis (chemosis score)  cornea score -area  Eye discharge
24 h 1/1/1 0/0/0 2/2/2 1/1/2  3/3/4  2/2/2
48 h 1/1/1 0/0/0 2/2/2 1/0/2  3/3/4  2/1/2
72 h 1/1/1 0/0/1 1/1/2 1/0/2  2/2/4

 1/1/2

 8 d 0/0/0 0/0/0 0/0/1 0/0/0  0/0/0

 0/0/0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
Classification: irritating