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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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