m-phenylenediamine

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1962

Materials and methods

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Fabric made from HT-1 fibers was applied to arms and legs. Held in place with adhesive tape.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

m-phenylenediamine

EC Number:

203-584-7

EC Name:

m-phenylenediamine

Cas Number:

108-45-2

Molecular formula:

C6H8N2

IUPAC Name:

m-phenylenediamine

Details on test material:

- Name of test material (as cited in study report): Fibers
HT-1 Fiber - Sample P1283-50A - prepared from isophthaloyl chloride and m-phenylenediamine
HT-1 Fiber (2) - Sample P1283 - 50B - prepared from isophthaloyl chloride and m-phenylenediamine
Physical state: Taffeta-type fabric; fibers were pulverized in hammer mill and washed with water and acetone.

Method

Ethical approval:

not specified

Subjects:

- Number of subjects exposed:
- Sex: Male and female
- Age: not reported
- Race: not reported
- Demographic information: not reported

Clinical history:

not reported

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

A. ADMINISTRATION (INDUCTION EXPOSURE)
- Type of application: semiocclusive
- Description of patch: test material held in place with adhesive tape.
- Vehicle / solvent: none (unchanged)
- Concentrations: 1-inch square fabric made from HT-1
- Volume applied: 1-inch square fabric made from HT-1
- No. of exposures: 203 (1 for each test subject)
- Exposure period: 6 days
- Test groups: 1 male and 1 female
- Control group: no data
- Site: Arms of males and arms/legs of females
- Frequency of applications: 1x
- Duration: 6 days

A. ADMINISTRATION (CHALLENGE EXPOSURE)
- Type of application: semiocclusive
- Description of patch: test material held in place with adhesive tape.
- Vehicle / solvent: none (unchanged)
- Concentrations: 1-inch square fabric made from HT-1
- Volume applied: 1-inch square fabric made from HT-1
- No. of exposures: 203 (1 for each test subject)
- Exposure period: 24 hours
- Test groups: 1 male and 1 female
- Control group: no data
- Site: Arms of males and arms/legs of females
- Frequency of applications: 1x
- Evaluation (hr after challenge): 24 hours

OTHER: 10 day rest period between initial and challenge test.

- Other:

Results and discussion

Results of examinations:

Results: 1st reading, 0 hours after challenge, test group, dose level was 1-inch square fabric made from HT-1, 1 had a positive reaction our of 203 total number in group. The clinical observations was that this was a questionable reaction.


One questionable reaction was observed after the initial 24 hour application. The subject showed no response after 6 days or after the challenge test, and the reaction was considered non-specific

Applicant's summary and conclusion

Executive summary:

On the basis of the test, fabric made from HT-1 fiber should pose no problems when in contact with human skin. It should be pointed out, however, that m-phenylenediamine is a skin sensitizer and care must be taken to see that the fiber is free of this material.