Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

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: Acceptable study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1963

Report date:

1963

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

EC Number:

218-216-0

EC Name:

Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Cas Number:

2082-79-3

Molecular formula:

C35H62O3

IUPAC Name:

octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate

Details on test material:

- Physical state: white powder

Method

Type of population:

general

Subjects:

- Number of subjects exposed: 58
- Sex: 15 males and 43 females
- Age: 16-73 years

Controls:

no data

Route of administration:

dermal

Details on study design:

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

ADMINISTRATION
- Type of application: occlusive
- Description of patch: test patch was a 3/4 x 7/8-inch swatch of Webril moistened with 0.5 ml of the test solution and held to the skin with a Duke Elastoplast Coverlet.
- Vehicle / solvent: dimethyl phthalate
- Concentrations: 0.5 gm per 100 ml
- Volume applied: 0.5 ml
- Testing/scoring schedule: 9 applications were performed. For the challenge duplicate patches were applied, one to the original test site and the second to an area not previously exposed to the test solution.
- Removal of test substance: 24 h after application

EXAMINATIONS
- Grading/Scoring system: Reactions were scored on the following scale:
0 No evidence of irritation
1 Slight erythema
2 Marked erythema
3 Erythema and papules
4 Erythema and edema
5 Erythema, edema and papules
6 Vesicular eruption
7 Strong reaction extending beyond test area

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 57
- Number of subjects with irritating reactions: 0/57, 5/52, 7/50, 4/53, 9/48, 2/55, 7/50, 5/49, 5/47 persons exhibited irritation responses (with score 1/ total tested) after 1, 2, 3 ,4, 5, 6, 7, 8 and 9 applications, respectively. 1/50 and 1/49 exhibited score 3 after 7 and 8 applications, respectively.

Any other information on results incl. tables

Only 1 subject, a 16-year-old girl, exhibited a grade 6 reaction centered on the test site with an area of edema and induration extending several inches in each direction. During the following week this became still more severe, involving most of the arm, with vesicles over some areas. She responded to topical and internal medication, and when last seen exhibited only some residual erythema on and around the test site. She had reported an earlier dermatitis following use of Cuticura, otherwise her dermatological history was negative.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this test 0.5% test substance in dimethyl phthalate causes little irritation. One of 58 subjects became sensitive to the test material during the test.