Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Guideline:
other: No guideline followed
Principles of method if other than guideline:
200 men were dermally exposed to a 10% preparation of the substance for 1 week. After a 10 day rest period the volunteers were re-exposed in the same manner for a further week. Those who reacted were further exposed to a 1% preparation to rule out simple irritation.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Ointment
Details on test material:
The substance was tested under the name of D-250

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 200
- Sex: Male
Controls:
No controls were used. However a total of 6 substances were tested in this study and 3 of these gave zero responses.
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: Webril patch, 2 square inches
- Vehicle / solvent: Hydrophilic
- Concentrations: 10% (induction and challenge)
- Removal of test substance: After one week

EXAMINATIONS
- Grading/Scoring system: Not reported

Results and discussion

Results of examinations:
NO. OF PERSONS WITH REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 41



Applicant's summary and conclusion

Conclusions:
The substance gave rise to sensitisation responses in 41 out of 200 men tested. The authors conclude that the substance is a sensitiser.