Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Register 38, No. 187 § 1500.41, p. 27019, Sept. 27, 1973
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Iso-Butyl-Tert-Butylether.

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male: 2.71 kg; female: 2.63, 3.02 kg
- Diet (e.g. ad libitum): Ssniff; ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and scarified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): 100%
Duration of treatment / exposure:
one application
Observation period:
7 d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal skin of animals

SCORING SYSTEM:
acc. to Draize, J.H. (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.6
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 2, 48, 72 h
Score:
1.7
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
2.6
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: scarified skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.9
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: scarified skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 72 h
Score:
4.1
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Findings for the intact skin sites:
At the 24-h reading slight spreading erythema was found in two animals and severe spreading erythema in one animal. At the 72-h reading one animal showed an increase to severe spreading erythema, the findings for the two other animals remained the same. At the 8-d reading very slight to slight erythema and spreading desquamation was seen in the three animals. Regarding edema development, one animal showed slight edema at the 24 and 48-h readings, which was reversibel within 8 days. One animal showed severe edema at the 24-h reading and slight edema at the 48-h and the 8-d reading, whereas the third animal did not show signs of edema until and including the 8-d reading time point.
Findings for the abraded skin sites:
With the exception of one animal showing severe spreading desquamation, findings for erythema were the same as on the intact skin sites. Slight to severe edema was seen in two animals at the 24-reading. At the 72-h reading all three animals showed edema (very slight-slight). In one animal this finding was reversible within 8 days, whereas in another animal it remained slight and in the third one it declined to very slight. The primary irritation value calculated was ca. 4.1

Any other information on results incl. tables

Results:

Body weights:

Animal 1: female, 3.02 kg (d0), 3.04 kg (d7)

Animal 2: female, 2.63 kg (d0), 2.69 kg (d7)

Animal 3: male, 2.71 kg (d0), 2.66 kg (d7)

Readings:

Readings Animal Intact skin Scarifed skin
Erythema Edema Additional findings Erythema Edema Additional findings
24 h 1 2 2   2 2  
2 2 0   2 0  
3 3 3   3 3  
48 h 1 3 2   3 2  
2 2 1   2 2  
3 3 3   3 3  
72 h 1 3 2   3 2  
2 2 0   2 1  
3 3 2   3 2  
6 d 1 2 1   2 1  
2 1 0 d 1 0 d
3 2 2 d 2 2 d
7 d 1 2 0   2 1  
2 1 0 d 1 0 d
3 1 2 d 2 2 d
Mean 24 - 72 h 1 2.7 2.0   2.7 2.0  
2 2.0 0.3   2.0 1.0  
3 3.0 2.7   3.0 2.7  
Mean 2.6 1.7   2.6 1.9  

d: desquamation

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU