Diethyl sebacate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Qualifier:

no guideline followed

Guideline:

other: In vivo test on Human : patch-tests simples 48h

GLP compliance:

no

Remarks:

In vivo study (patch-tests simples 48h)

Test material

Test material information

Constituent 1

Reference substance name:

Diethyl sebacate

EC Number:

203-764-5

EC Name:

Diethyl sebacate

Cas Number:

110-40-7

Molecular formula:

C14H26O4

IUPAC Name:

diethyl sebacate

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

other: empty cup

Amount / concentration applied:

pure

Duration of treatment / exposure:

48 hours

Observation period:

24 hours after the patch is removed

Number of animals:

test on human

Details on study design:

13 volunteers came to the EUROSAFE premises on the day the test started. They were identified by a 3-letter, 2-digit code. The test product was placed in the corresponding cup. The epidermal tests were then applied to the scapular area of the volunteers' backs. An empty cup was then used as a test control. Forty-eight hours after the application of the epidermal tests, they were delicately removed by the dermatologist and their location delimited with a skin pencil. Any skin reactions were read 30 minutes after the removal of the skin tests. A second reading by the dermatologist was carried out 24 hours after the first reading if a reaction was observed.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

other:

Time point:

48 h

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

the product caused no skin reactions in the 13 volunteers. In this study, with the limitations associated with the protocol (i.e. the inclusion of the limited number of 13 volunteers), the product, in pure mode, was shown to be non-irritating.

Executive summary:

For that endpoint, one reliable study on the registered substance was performed.

In this study, the aim was to assess the local cutaneous tolerance of the "DIETHYL SEBACATE Batch 1727003" in vivo, in 13 volunteers. Tolerance was studied after a patch test carried out under occlusive conditions and lasting 48 hours.

Under the experimental conditions, sample "DIETHYL SEBACATE Batch 1727003" is considered not to be irritant nor corrosive for the skin (score=0).

The validity criteria were successful and the study was therefore regarded as acceptable for that endpoint.