Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline Study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24 hours exposure instead of 4 hours, occlusive instead of semi-occlusive dressing, skin examinations only at 24 and 72 hours, not at 48 hours after patch removal. Lack of details on test substance and test animals.
Principles of method if other than guideline:
Federal Hazardous Substances Labeling Act (FHSA)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Di-Butyl Sebacate
-Analytical purity: No data

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped back skin
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Unchanged test substance
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back skin
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used:
The patches consisted of two layers of light gauze cut in squares (2.5 cm x 2.5 cm). The patches were secured to the area by thin bands of adhesive tape. The material to be tested (0.5 mL) was introduced beneath the patch. The entire trunks of the animals were then wrapped in clear plastic trunk bands. The trunk bands helped to hold the patches in position an retarded evaporation of volatile substances during the 24 h exposure.
The animals were immobilized in a special holder during the 24 h exposure period.

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: average 24 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 24 hours exposure of intact skin under occlusive coonditions.
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: average 24 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 24 hours exposure of intact skin under occlusive coonditions.
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: average 24 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 24 hours exposure of intact skin under occlusive coonditions.
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: average 24 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 24 hours exposure of intact skin under occlusive coonditions.
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: average 24 and 72h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
other: 24 hours exposure of intact skin under occlusive coonditions.
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: average 24 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 24 hours exposure of intact skin under occlusive coonditions.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: average 24 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 24 hours exposure of intact skin under occlusive conditions.

Any other information on results incl. tables

The test substance was not skin irritating, as no edema and only light erythema in 1 out of 6 animals occured which was fully reversible within 72 hours, although the testing was performed according to FHSA, and therefore under more critical conditions than those required for OECD Guideline 404.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU