Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin 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:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
Method: other: BASF-Test, see details in the section "Any other information on materials and methods incl. tables".
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

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation/exposure time: 2.87 kg/5 min, 3.01 kg/1 hr, 2.99 kg/4 hrs (average weight)

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Remarks:
The liquid test substance was applied in unaltered form to the intact skin under occlusive conditions.
Controls:
other: untreated skin of the same animals served as control.
Duration of treatment / exposure:
5 min, 1 hour or 4 hours
Observation period:
8 days
Number of animals:
- 2 (5 min exposure time)
- 4 (1 h exposure time), 1 Male, 3 Females
- 4 (4 h exposure time), 2 Males, 2 Females
Details on study design:
TEST SITE
- Area of exposure: 2.0 x 2.0 cm

REMOVAL OF TEST SUBSTANCE
- Washing: conc. Lutrol and 50 % Lutrol solution
- Time after start of exposure: 1, 5 or 15 min post exposure

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
, exposure 5 min
Time point:
other: 24, 48 h (mean)
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: score = 1 after 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
, exposure 5 min
Time point:
other: 24, 48 h (mean)
Score:
1.5
Max. score:
4
Reversibility:
fully reversible
Remarks:
8 days
Remarks on result:
other: after 8 days: scale formation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
, exposure 5 min
Time point:
other: 24, 48 h (mean)
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
, exposure 5 min
Time point:
other: 24, 48 h (mean)
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
, exposure 1 hour
Time point:
other: 24, 48 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: after 8 days: scale formation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
, exposure 1 hour
Time point:
other: 24, 48 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: after 8 days: superficial necrosis
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
, exposure 1 hour
Time point:
other: 24, 48 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
, exposure 1 hour
Time point:
other: 24, 48 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
, exposure 1 hour
Time point:
other: 24, 48 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
, exposure 1 hour
Time point:
other: 24, 48 h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: score = 2 after 8 days
Irritation parameter:
edema score
Basis:
other: animal #3, #4, exposure 1 hour
Time point:
other: 24, 48 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
, exposure 4 hours
Time point:
other: 24, 48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: after 8 days: superficial necrosis
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
, exposure 4 hours
Time point:
other: 24, 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: score = 1 after 8 days, scale formation
Irritation parameter:
erythema score
Basis:
other: animal #3, #4, exposure 4 hours
Time point:
other: 24, 48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: necrosis observed after 1 day; score = 4 after 8 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
, exposure 4 hours
Time point:
other: 24, 48 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: score = 2 after 8 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
, exposure 4 hours
Time point:
other: 24, 48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
, exposure 4 hours
Time point:
other: 24, 48 h (mean)
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: score = 2 after 8 days
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
, exposure 4 hours
Time point:
other: 24, 48 h (mean)
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: score = 2 after 8 days
Irritant / corrosive response data:
- After 1 hour of exposure one animal developed a superficial necrosis after 8 days.
- After 4 hours of exposure 3 of 4 animals developed superficial, soft and papyraceous necroses, respectively at different times after exposure (4 hours to 8 days).
- One animal developed a full thickness necrosis after 4 hours of exposure and 8 days of observation.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: corrosive (causes burns)