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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline available with which to compare the study design. Documentation insufficient for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report Date:
1964

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:
Twenty-five healthy male adults were used as subjects. Each were given a course of five 48-hour exposures of 25% Tinuvin P vaseline with one day intervals between exposures. Each site was abraded with sandpaper prior to application of the test agents An occlusive patch was used. Two weeks after the last abraded exposure, a new skin area abraded as above, was challenged using 10% Tinuvin P in Vaseline with a 48-hour occlusive patch. Readings were made at 48, 72, and 96 hours. A baseline control was also used.
GLP compliance:
no
Remarks:
Study pre-dates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tinuvin P

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
- Sex: Male
- Age: Not reported
- Race: Not reported
- Demographic information: Not reported
Clinical history:
- History of allergy or casuistics for study subject or populations: Not reported
- Symptoms, onset and progress of the disease: Not reported
- Exposure history: Not reported
- Aggravating factors both in home and workplace: Not reported
- Family history: Not reported
- Medical history (for respiratory hypersensitivity): Not reported
- Any other allergic or airway disorders: Not reported
- Smoking history: Not reported
Controls:
Vaseline
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: Not further defined
- Vehicle / solvent: Vaseline
- Concentrations: 25% (induction) and 10% (challenge)
- Volume applied: Not reported
- Testing/scoring schedule: 5 48-hour exposures with one day intervals; 2 weeks after challenged with 48 hour patch and readings made at 48, 72, and 96 hours
- Removal of test substance: each application lasting 48 hours
- Other:


EXAMINATIONS
- Grading/Scoring system: Not reported
- Statistical analysis: Not reported
- Other:

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: Not reported


NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
No individual data provided in study report. Study report states that "none of the 25 subjects became sensitized".
- Number of subjects with positive reactions: Not reported
- Number of subjects with negative reactions Not reported
- Number of subjects with equivocal reactions Not reported
- Number of subjects with irritating reactions Not reported


RESULT OF CASE REPORT: Not reported


OTHER RESULTS:

Applicant's summary and conclusion