Acetic acid, C11-14-isoalkyl esters, C13-rich

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

25 July 1979 to 29 August 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize Repeated Insult Patch Test

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, C11-14-isoalkyl esters, C13-rich

EC Number:

283-740-9

EC Name:

Acetic acid, C11-14-isoalkyl esters, C13-rich

Cas Number:

84712-50-5

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)

IUPAC Name:

Acetic acid, C11-14-isoalkyl esters, C13-rich

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: PA-279-3
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: no data
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: undiluted test substance

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 50
- Sex: male and female
- Age: no data
- Race: no data
- Demographic information: no data

Clinical history:

- History of allergy or casuistics for study subject or populations: no data
- Symptoms, onset and progress of the disease: no data
- Exposure history: no data
- Aggravating factors both in home and workplace: no data
- Family history: no data
- Medical history (for respiratory hypersensitivity): no data
- Any other allergic or airway disorders: no data
- Smoking history: no data

Controls:

no data

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION AND EXAMINATION
0.2 g of the test material was applied onto the arms of 50 volunteers (9 male and 41 female). The subjects ranged from 16 to 74 years of age. The samples were covered with a semi-occlusive covering of gauze and loosely applied Dermicel tape. The patches remained in place for 24 hours, after which the patches were removed. The excess material was wipes off and the test sites were examined.
The subjects were rested for another 24 hours after which the skin sited were again examined. The test substance was then applied second time, repeating the application procedure. This procedure was repeated 3 times a week for 3 weeks for a total of 9 applications. Two weeks later, challenge application was applied in the same manner to the same skin sites as well as to previously untreated sites on the same arm. The challenge applications were removed after 24 hours and the treated sites were examined for signs of skin irritation or sensitisation. The sites were re-examined at 48 and 72 hours after patch removal.

A subset of 20 volunteers (5 males and 15 females) were simultaneously studied by treating an identical site on the other arm with 0.2 g of the test material. These test sites were irradiated simultaneously. A 15-minute exposure period was utilized. The exposure distance was 15 inches from the lamp. The samples were covered with a semi-occlusive covering of gauze and loosely applied Dermicel tape. The patches remained in place for 24 hours, after which the patches were removed. The excess material was wipes off and the test sites were examined. 24 hours later the test sites were examined again. The experimental material was applied one more time to the same sites previously used. The irradiation procedure was applied at applications 1, 4, 7 and 9 and at the challenge application. The original and virgin sites were irradiated at challenge. The challenge applications were removed after 24 hours and the sites were examined at the time of patch removal, then at 48 and 72 hours post-exposure.

Results and discussion

Results of examinations:

Based on the results obtained, the test substance was not a primary skin irritant or a fatiguing agent. No sensitisation reactions were noted. Exposure to UV-A light does not appear to initiate or increase the incidence or severity of irritation, fatigue or sensitisation.

Applicant's summary and conclusion

Conclusions:

Based on the results obtained, the test substance was not a primary skin irritant or a fatiguing agent. No sensitisation reactions were noted. Exposure to UV-A light does not appear to initiate or increase the incidence or severity of irritation, fatigue or sensitisation.