Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
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:
1960
Report Date:
1960

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
59 subjects received 24 hour patch exposures to different test materials, among these the test substance, three times weekly for three weeks, followed by a similar challenge exposure in the sixth week.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 59
- Sex: 12 men and 47 women
- Age: 9 men and 35 women between the ages of 20 and 50, 3 men and 12 women over 50
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: The test patch was a 3/4 x 7/8-inch swatch of "Webril" moistened with the test solution and held to the skin with a Duke Elastoplast Coverlet No. 330 (1-1/2 x 2-inch adhesive elastic bandage).
- Vehicle / solvent: dimethyl phthalate
- Concentrations: 0.5 %
- Volume applied: 0.5 ml
- Testing/scoring schedule: 9 applications were performed. The patch was applied to the same site each time, except that the challenge patch was applied to a fresh site immediately adjacent to the original site
- Removal of test substance: 24 hours after application


EXAMINATIONS
- Grading/Scoring system: 0 - no evidence of irritation, 1 - slight erythema, 2 - marked erythema, 3 - erythema and papules, E - erythema and edema, 4 - erythema, edema, and papules, 5 - vesicular eruption, 6 - strong reaction extending well 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: 2
- Number of subjects with negative reactions: 57
- Number of subjects with equivocal reactions: None
- Number of subjects with irritating reactions: None

OTHER RESULTS:
One female subject was hypersensitive to dimethyl phthalate as demonstrated by her reacting equally strongly to the second application of this and four dimethyl phthalate solutions of other, totally different, test materials simultaneously under test, and failing to react to a sixth sample containing no dimethyl phthalate. She was therefore dismissed as an unsuitable subject. Another female subject suffered a very strong sensitisation reaction to one of the other samples under test, and still exhibited very considerable congestion at challenge time. Although she did not have any reaction at all to the test substance, it was thought it would be unwise to continue her in the test at all. Both of these subjects reported that they had never previously experienced any sensitization reactions to anything, other than an ordinary degree of sensitivity to poison ivy.

Under the conditions of this test a 0.5 % solution of the test substance in dimethyl phthalate caused no irritation and did not sensitizse any of the subjects.

Applicant's summary and conclusion