Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From April 1 to May 5, 1981
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Modification of the usual Draize Repeated Insult Patch Test as described in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): MT-112 (4 %)

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 50 for RIPT, including 20 also tested for photosensitization
- Sex: 9 males and 41 females (including 4 males and 16 females also tested for photosensitization)
- Age: 16 to 71 years
Clinical history:
Not specified
Controls:
None
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Patch test (epicutaneous test)

ADMINISTRATION - RIPT
- Type of application: Semiocclusive
- Application site: Upper arms for induction; same site + untreated skin sites for challenge
- Description of patch: gauze and loosely applied Dermicel tape, remained in place for 24 hours.
- Vehicle / solvent: None
- Concentrations: Undiluted
- Volume applied: 0.2 g
- Testing schedule: 3 times a week for 3 weeks for a total of 9 applications. Challenge application was done after a two-week rest period.
- Scoring schedule: 24 h after induction patch removal; 24, 48 and 72 h after challenge patch removal
- Removal of test substance: Excess material was wiped off after 24 hours

ADMINISTRATION - Photosensitization study
- Application site: Opposite arm
- Vehicle / solvent: None
- Concentration: Undiluted
- Volume applied: 0.2 g
- Irradiation: Spectroline Model B-100, Black Light flood lamp (365 nm, 1680 microwatts/cm²). 15 minute exposure. Exposure distance: 15 inches from the lamp. Irradiation at applications 1, 4, 7 and 9 and at the challenge application.
- Type of application: After the irradiation, test site were covered with a semi-occlusive covering of gauze and loosely applied Dermicel tape.
- Testing schedule: 3 times a week for 3 weeks for a total of 9 applications. Challenge application was done after a two-week rest period.
- Scoring schedule: 24 h after induction patch removal; 24, 48 and 72 h after challenge patch removal
- Removal of test substance: Excess material was wiped off after 24 hours

EXAMINATIONS
- Grading/Scoring system: No data
- Statistical analysis: None

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 50
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
The test material (4 %) does not appear to be a primary skin irritant or fatiguing agent. No sensitization reactions were noted. Exposure to UV-A light does not appear to initiate or increase the incidence and severity of irritation, fatigue or sensitization.
Executive summary:

A panel of 50 male and female human volunteers participated in a repeat insult patch test in which the test material (4 %) was applied to the upper arms of the subjects under semi-occlusive patches. During the induction phase nine patches were applied, separated by a 48-hour interval. The patches were removed 24 hours after application. Following a 14-day rest period, a challenge patch was applied and the sites scored 24, 48 and 72 hours after application. A subset of 20 subjects selected from the group of 50 subjects was simultaneously studied for photosensitization. 15 minute irradiation period were applied at application 1, 4, 7, 9 and at challenge application on the opposite arms.

The test material does not appear to be a primary skin irritant or fatiguing agent. No sensitization reactions were noted. Exposure to UV-A light does not appear to initiate or increase the incidence and severity of irritation, fatigue or sensitization.