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:
other: The test preparation is a composite of two pigments, the exact dose of the test substance is not known.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
To determine if the test material is capable of irritating the skin of humans under controlled test conditions; and, if so, to classify the test material as a primary irritant, fatiguing agent, and/or sensitizer on the basis of visible clinical responses, the test material was applied under occlusion for a series of effective contact periods of two days duration. The patches were then removed, the contact sites examined, and the reactions, if any, were graded and recorded. The following scoring, system was used to grade skin reactions: 0 = No reactions; 1+ = Slight erythema; 2+ = Marked erythema; 3+ = Marked erythema, edema, with or without a few vesicles; 4+ = Marked erythema, edema, with vesicles and oozing. If no reactions occurred, the test material was re-applied immediately for another forty-eight-hour period, and the cycle repeated for 3 more weeks, so that a series of 8 48-hour applications were completed. A challenge was then performed 2 week later and the skin reaction examined 24 and 48 hours thereafter.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No details provided

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Subjects:
- Number of subjects exposed: 200
Clinical history:
A group of 200 individuals who qualified were selected from a local population. The criteria for qualifying were:
1. General well-being.
2. Absence of any skin disease which might be confused with skin reactions from the test material.
3. Willingness to cooperate.
4. Dependability and intelligence in following directions.
5. Reading, understanding, and signing an informed-consent contract (in the case of minors, parental consent was obtained).
Controls:
Untreated skin sites
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
A. INDUCTION EXPOSURE
- No. of exposures: 8
- Exposure period: 48 hours per exposure
- Test groups: 20% test substance in a composite
- Site: 3 cm x 3 cm
- Frequency of applications: twice a week
- Duration: 4 weeks (patch on Mondays, scoring following by a new patch on Wednesdays, scoring on Fridays following by resting until the following Monday, when the procedure is repeated). New patches were applied only if no reactions occurred and the volunteers were instructed to call in case of any discomfort.

B. CHALLENGE EXPOSURE
- No. of exposures: once
- Day(s) of challenge: at least 2 weeks after the last induction
- Exposure period: 48 hours
- Test groups: 20% test substance in a composite
- Site: same as induction
- Evaluation (hr after challenge): 0, 24 and 48 hours after challenge

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 200

Any other information on results incl. tables

- 1). Skin changes accompanying application No. 1: no visible skin changes signifying reaction to injury were observed in any of the 200 subjects.

- 2). Skin changes accompanying application Nos. 2 through 8: visible skin changes signifying reaction to injury were observed in 1 out of 200 subjects.

- 3). Skin changes accompanying challenge Application: no visible skin changes signifying reaction to injury were observed in any of the 200 subjects.

Applicant's summary and conclusion