Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 Oct 1999 - 3 Dec 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Repeated insult ptach test (RIPT) in 96 volunteers
GLP compliance:
not specified

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: not reported- Lot/batch No.: 0709 N

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Remarks:
in conformity with 21 CFR 50.25, Subtitle A, Protection of Human Subjects
Subjects:
- Number of subjects exposed: 106- Sex: 29 male and 77 female- Age: 18-68
Clinical history:
- History of allergy or casuistics for study subject or populations: No dermatological or other medical or physical condition which would preclude topical application of the test material. No known pregnant or nursing women were used in this study.
Controls:
None
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: The left side of the back was usually the test area for the induction phase. The subject’s skin was marked with a gentian violet surgical skin marker at the left side of the test side. The induction test side was recorded on the anatomical diagram on the back of each subject’s individual Data Form. In addition, at this time, the prospective placement of the challenge test side was also recorded. A series of nine induction patchings were completed over a period of approx. three weeks. If a subject missed a patching, it was either patched four days the following week or was re-patched at the end of the induction phase (tenth test day).The patches remained in place and were kept dry for 24 h and were removed afterwards. The test side was observed and scored 24 h afterwards using the modified scoring scale of the International Contact Dermatitis Research Group System (Fisher, Alexander A., Contact Dermatitis, Lea&Felbiger, Philadelphia, 1986: p26). The initial patch test side was than repatched until the nine induction patchings were completed.A rest period of approx 14 days followed the last induction and subjects were challenged on their previously untreated site for 24 h. The challenge site and the original test site were observed for skin reactions after 24 h and subjects reported at 48 h, 72 h and 96 h post-patching for additional observations. ADMINISTRATION- Type of application: occlusive - Description of patch: webril/adhesive patch (Kendall Healthcare Products Company Patch #4022)- Volume applied: 0.2 mL- Testing/scoring schedule: Scoring after removal of each induction patch and 24, 48, 72 and 96 h after challengeEXAMINATIONS- Grading/Scoring system: according to the international contact dermatitis research group system0 – no visible reaction± - faint, minimal erythema1 – erythema2 – intense erythema, induration3 – intense erythema, induration, vesicles4 – severe reaction with erythema, induration, vesicles pustules (may be weeping)E – edemaDR – dryness^ – HyperpigmentationC – change of test site- – no readingN9R – No 9th readingX – discontinued - Other: 10 subjects discontinued due to personal reasons

Results and discussion

Results of examinations:
SYMPTOMS- Frequency, level, duration of symptoms observed: During the induction phase, one subject exhibited a low-level reaction. No reactions were observed during rest- and challenge phase.NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION- Number of subjects with positive reactions: 1/96 (faint, minimal erythema)- Number of subjects with negative reactions 95/96- Number of subjects with equivocal reactions: 0/96- Number of subjects with irritating reactions: 0/96No sensitizing reactions were reported.

Any other information on results incl. tables

Summary of reactions (number of subjects with reaction)

Reaction Grade

Induction

Challenge

No visible reaction

101

101

100

99

96

95

96

96

0

96

95

95

94

Faint, minimal erythema

1

 

 

 

1

1

 

 

 

 

 

 

 

Erythema

 

 

 

 

 

 

 

 

 

 

 

 

 

Intense erythema, induration

 

 

 

 

 

 

 

 

 

 

 

 

 

Intense erythema, induration, vesicles

 

 

 

 

 

 

 

 

 

 

 

 

 

Severe reaction with erythema, induration, vesicles, pustules

 

 

 

 

 

 

 

 

 

 

 

 

 

Edema

 

 

 

 

 

 

 

 

 

 

 

 

 

No reading

 

 

 

 

 

 

 

 

 

 

1

1

2

No 9threading

 

 

 

 

 

 

 

 

96

 

 

 

 

Applicant's summary and conclusion

Conclusions:
The pure test substance did not induce dermal sensitization in human subjects after repeated applicatioins in this RIPT study with 106 volunteers.