Bis(2-ethylhexyl) sebacate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 Feb - 18 Feb 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions. No experimental 48 h reading performed.

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

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:

Draize test conducted according to the Federal Hazardous Substances Labeling Act (FHSA)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) sebacate

EC Number:

204-558-8

EC Name:

Bis(2-ethylhexyl) sebacate

Cas Number:

122-62-3

Molecular formula:

C26H50O4

IUPAC Name:

bis(2-ethylhexyl) sebacate

Details on test material:

- Name of test material (as cited in study report): Di-Octyl Sebacate
- Analytical purity: No data

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

Albino rabbits were used for testing.
no further information provided

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

24 h

Observation period:

72 h
Reading time points: 24 and 72 h

Number of animals:

3 females
3 males

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 scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: *no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Remarks on result:

other: *no 48 h data are available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h)

Irritant / corrosive response data:

The test substance was not skin irritating, as no oedema or erythema occurred, although the testing was performed according to the Draize test as recommended by the FHSA, and therefore under more critical conditions (24 h occlusive exposure) than those required for OECD Guideline 404. In addition, when tested on abraded skin the test substance produced only mild erythema (grade 1) after 24 hours in 2/6 rabbits which were fully reversible within 72 h.

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