2,5-thiophenediylbis(5-tert-butyl-1,3-benzoxazole)

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1964

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Documented study with some restictions (materials and methods are described in rudimentary form).

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

Guideline:

other: Test guideline: not applicable

Principles of method if other than guideline:

The test substance was made up into 0.5% and 1 % strengths with white soft paraffin and each strength applied to the normal skin on a total of 102 people as a primary application; a second or "challenge" application was made to all of these same people after an interval of two or three weeks
(the variation in interval between applications was simply a matter of convenience of carrying out the tests).

GLP compliance:

no

Remarks:

prior to GLP

Test material

Test material information

Constituent 1

Reference substance name:

2,5-thiophenediylbis(5-tert-butyl-1,3-benzoxazole)

EC Number:

230-426-4

EC Name:

2,5-thiophenediylbis(5-tert-butyl-1,3-benzoxazole)

Cas Number:

7128-64-5

Molecular formula:

C26H26N2O2S

IUPAC Name:

5-tert-butyl-2-[5-(5-tert-butyl-1,3-benzoxazol-2-yl)thiophen-2-yl]-1,3-benzoxazole

Details on test material:

- Physical state: solid

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 102
- Sex: m/f
- Age: 13 - 76

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: patch test (epicutaneous test)
- After an interval of two or three weeks, a second application was made.

ADMINISTRATION
- Type of application: Patches fixed with plaster
- Vehicle: White soft paraffin
- Concentrations: Each powders - 1/2% and 1% strengths in white soft paraffin.
- Removal of test substance: Patches were left on for 48 hours.

EXAMINATIONS
- Other: Result listed for each proband
- Scoring: No data on scoring system.

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: Not applicable.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 102
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

RESULT OF CASE REPORT:
Out of all these test there were no positive reactions to suggest that the test substance was either primary an irritant or sensitizer, and it was concluded that the test substance was safe at these strengths.

OTHER:
Powder 1159 (test substance) made up with soft white paraffin, developed a slight bluish tinge when spread thinly on the skin or on white paper.