Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Proctor and Gamble sponsored study. Acquired via secrecy agreement. The study is acceptable and well documented, which meets basic scientific principles. Basic data given are comparable to guidelines with acceptable restrictions.
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:
1988
Report Date:
1988

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Repeat human patch test method
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
82 human volunteers
Route of administration:
dermal
Details on study design:
Route of induction exposure: epicutaneous, occlusive
Route of challenge exposure: epicutaneous, occlusive
Concentration used - 0.4 ml of test substance (unchanged, no vehicle)
Induction: Each individual received an occluded patch containing 0.4 ml of DPnB on Monday, Wednesday and Friday for 24 hours on upper arm. The induction period is 3 weeks.
Challenge: 17 days after the last induction application, duplicate challenge patches were applied for 24 hours.
Scoring of the test sites were conducted after a 24-hour resting period and immediately before the next patch application. Challenge sites were evaluated 48 and 96 hours after application.
Challenge controls: not used
Positive control: not used

Results and discussion

Results of examinations:
The test material showed no evidence of skin sensitization to human volunteers.

Applicant's summary and conclusion

Conclusions:
The test material showed no evidence of skin sensitization to human volunteers.
Executive summary:

A volume of 0.4 ml of DPnB was applied to a Webril disc with a diameter of 24 mm. The Webril disc, providing an occluded
patch was supplied to the upper arm of 82 volunteers nine times over a period of three weeks. During this induction
period each patch was left in place for 24 hours and then removed. Seventeen days after the last induction application, duplicate challenge patches were applied for 24 hours.

The test material showed no evidence of skin sensitization to human volunteers.