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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 Feb - 18 Feb 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline Study with acceptable restrictions (24 h exposure period, occlusive conditions, no 48 h reading, limited documentation)

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
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.
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substances Labeling Act (FHSA)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Diisopropyl sebacate
EC Number:
231-306-4
EC Name:
Diisopropyl sebacate
Cas Number:
7491-02-3
Molecular formula:
C16H30O4
IUPAC Name:
1,10-bis(propan-2-yl) decanedioate
Details on test material:
- Name of test material (as cited in study report): Di-Isopropyl Sebacate
-Analytical purity: no data

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped and abraded back skin
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated site of the same animal served as control
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
Reading time points: 24 and 72 h
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: back skin (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 and 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 scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24 and 72h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24 and 72h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24 and 72h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: mean over 24 and 72h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean over 24 and 72h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean over 24 and 72h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: mean over 24 and 72h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Slight erythema in 2 out of 6 animals that were fully reversible within 72 h were the only effects observed.

Any other information on results incl. tables

Only values for intact skin are taken into account for calculation of mean scores. The test substance was not skin irritating, as no edema and only slight erythema in 2 out of 6 animals occurred which were fully reversible within 72 hours, although the testing was performed according to FHSA, and therefore under more critical conditions than those required according to current OECD Guideline 404.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified