Registration Dossier

Diss Factsheets

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

Constituent 1
Chemical structure
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.

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