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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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