4-tert-butylbenzaldehyde

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable study report which meets basic scientific principles.

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

Principles of method if other than guideline:

Human repeated insult patch test

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4-tert-butylbenzaldehyde

EC Number:

213-367-9

EC Name:

4-tert-butylbenzaldehyde

Cas Number:

939-97-9

Molecular formula:

C11H14O

IUPAC Name:

4-tert-butylbenzaldehyde

Details on test material:

- Name of test material (as cited in study report): p-tert-butylbenzaldehyde
- Analytical purity: no data given

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 60
- Sex: 26 males and 34 females
- Age: 16 - 72 years

The selection of the subjects was based on the following criteria:
Absense of any physical or dermatological condition which would preclude application of the test material

Route of administration:

dermal

Details on study design:

A. INDUCTION EXPOSURE
- Site: inner aspect of the arm or the back between scapulae and the waist (2 cm2)
- Exposure period: removal of the patch after 24 hours
- Rest period: Twenty-four hour rest periods followed the Tuesday and Thursday removals and 48 hour rest periods followed the Saturday removal.
- Frequency of applications: 10
- The test site was scored just prior to the next patch application. The choice of contact site for the second and subsequent applications depended on the condition of the previous site. Thus, if no irritation was observed at this time, the test material was reapplied to the same site . If, however, at least a 2+ reaction was observed, the test material was applied to a new site and the change in site was recorded . If a minimum of a 2+ reaction occurred in the new site, no new exposures were made.
- Concentration: 2 % (about 200 mg)
- Control group: no

B. CHALLENGE EXPOSURE
- Day(s) of challenge: ten to fourteen days after application of the last induction patch
- Exposure period: the patches remained in place for 24 hours
- Site: original contact site of the induction and a fresh, adjacent site
- Concentrations: 2 % (about 200 mg)
- Evaluation (hr after challenge): the sites were scored 24 and 48 hours after application
- Control group: no

Results and discussion

Results of examinations:

Nine subjects did not complete the test for personal reasons and not because of adverse reactions to the test product. Fifty one subjects completed the test .

The test material elicited no adverse dermal reactions from any of the subjects. It appears that the test material is not capable of inducing sensitization effects on the skin under the chosen testing conditions.