2-(2H-benzotriazol-2-yl)-p-cresol

Sensitisation data (human)

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

Test material information

Constituent 1

Reference substance name:

2-(2H-benzotriazol-2-yl)-p-cresol

EC Number:

219-470-5

EC Name:

2-(2H-benzotriazol-2-yl)-p-cresol

Cas Number:

2440-22-4

Molecular formula:

C13H11N3O

IUPAC Name:

2-(2H-1,2,3-benzotriazol-2-yl)-4-methylphenol

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: