Decanoic acid, mixed esters with octanoic acid and pentaerythritol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non-GLP/GCP study (no data on test substance purity)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

GENERAL:
Repeat Insult Patch Test (RIPT) with 56 volunteers (55 completed). One subject dropped out for various reasons, none of which were related to the use of the test material.

INDUCTION:
Ten repeated applications of test substance to the same site (24 h application, 24 h rest period between two applications).

CHALLENGE:
A single application on the treated and at naïve site. Reading of skin alterations.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Decanoic acid, mixed esters with octanoic acid and pentaerythritol

EC Number:

270-472-2

EC Name:

Decanoic acid, mixed esters with octanoic acid and pentaerythritol

Cas Number:

68441-68-9

Molecular formula:

C23H48O8

IUPAC Name:

3-(decanoyloxy)-2,2-bis[(octanoyloxy)methyl]propyl decanoate; 3-(decanoyloxy)-2-[(decanoyloxy)methyl]-2-[(octanoyloxy)methyl]propyl decanoate; 3-(octanoyloxy)-2,2-bis[(octanoyloxy)methyl]propyl decanoate; 3-(octanoyloxy)-2,2-bis[(octanoyloxy)methyl]propyl octanoate

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 55 (initially 56, but 1 subject did not complete the study)
- Sex: male/female
- Age: 19 - 65

Clinical history:

- History of allergy or casuistics for study subject or populations: Subjects with a visible skin desease which might be confused with skin reactions from the test were excluded from the study

Controls:

no

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: 2.54 x 2.54 cm Webril pads (cotton), held in place with Dermicel tape
- Volume applied: 0.15 mL
- Concentration: 100% (undiluted)
- Test site: upper back between the scapulae was area for induction, the same site as well as volar forearm served as area for challenge
- Testing/scoring schedule:
The test substance was applied to backs of volunteers for 24 h using patches followed by a 24 h (when applied on Monday and Wednesday) or a 48 h rest period (when applied on Friday). The procedure was repeated for a total of 10 applications. After the last application, a 14 day rest period followed. A single application to the original and at naïve site was used for challenge. The volar forearm served as the virgin test site. Scoring was done 24 h and 48 h after patch removal.
- Removal of test substance: no

EXAMINATIONS
- Grading/Scoring system:
0 = no visible reaction
1+ = mild erythema
2+ = well-defined erythema
3+ = erythema and edema
4+ = erythema and edema with vesiculation and ulceration

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: none

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: none
- Number of subjects with negative reactions: 55
- Number of subjects with equivocal reactions: none
- Number of subjects with irritating reactions: none

Applicant's summary and conclusion

Conclusions:

The test substance did not cause skin sensitisation under the conditions of the study.