Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 Dec 1997- 09 Jan 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
A Repeated Insult Patch Test (RIPT) was conducted to evaluate the potential of the test material, as a result of repeated applications, to induce contact dermal sensitisation in human subjects.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: clear liquid
- Analytical purity: no data

Method

Type of population:
general
Ethical approval:
other: legally valid informed consent in conformity with 21 CFR Part 50: " Protection of Human Subjects"
Subjects:
- Number of subjects exposed: 113 subjects (37 males and 76 females). 98 subjects (34 males and 64 females) completed the test.
- Age: 19-62 year old
- Other: each potential subject completed an history form, including relevant medical history and was assigned a permanent HRL identification number.
Clinical history:
No subject was used if he or she had a history of any dermatological or other medical or physical condition which would preclude topical application of the test material. No known pregnant nor nursing women were used on this study.
Controls:
No control subject
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Repeated Insult Patch Test (RIPT)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Webril / adhesive patch
- Volume applied: 0.2 mL
- Testing/scoring schedule:
Induction phase: a series of nine induction patchings were completed on the left scapular area over a period of three weeks. The patch was held in place for ~ 24 hours. A 24 hour period (48 during weekend), during which no test material was applied followed the weekday patch removals.

Rest Period: A two-week Rest Period, during which no test material was applied, followed the last Induction patching.

Challenge Phase: the original induction test site was observed and each subject queried as to whether any reaction was experienced. Challenge patch was applied on the untreated test site (right scapular area) for 24 hours.

At 48, 72 and 96 hours after challenge application subjects´ reactions were scored and recorded.

- Removal of the test substance: The test site was wiped clean with a dry Kimwipe® prior to each patching.

EXAMINATIONS
- Grading/Scoring system: simple scale from 0 to 4 for the assessment of erythema scores

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with negative reactions: 98. During the induction phase, no reactions were exhibited. The original test sites exhibited no reactions during the rest period or at challenge. At the challenge phase, no reactions were exhibited.

Applicant's summary and conclusion

Conclusions:
The test substance did not induce contact dermal sensitisation in human subjects.