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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Study period:
27 Jan 1997 - 7 Mar 1997
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:
1997
Report Date:
1997

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Repeated insult patch test (RIPT) with 100 subjects
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Ethical approval:
confirmed and informed consent free of coercion received
Remarks:
consent in conformity with: 21 CFR Part 50: "Protection of Human Subject" was secured from each subject
Subjects:
- Number of subjects exposed:
- Sex: 29 male, 84 female
- Age: 18 - 65 years
Clinical history:
- History of allergy or casuistics for study subject or populations: no subject had a history of any dermatological or other medical or physical condition which would preclude from topical testing
- Exposure history: a period of at least six weeks ahd elapsed since a subject was patched RIPT of Photoallergy Test before he was used in this RIPT
Controls:
Not reported
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/adhesive patch (Kendall Healthcare Products Company Patch #4022)
- Concentrations: 100%
- Volume applied: 0.2 mL was applied to each patch
- Test site: left scapular area for induction, right scapular area for challenge
- Testing/scoring schedule: nine induction patches (24 h each) within three weeks, followed by a apprx. two week rest period. The challenge consist of a 24 h patch scored 24, 48, 72 ahnd 96 h after after patching.

EXAMINATIONS
- Grading/Scoring system: modified scoring scale of the International Contact Dermatitis Research Group System: Fisher, Alexander a., Contact Dermatitis, Lea & Febiger, Philadelphia, 1986: p26:

0 - no visible reaction
± - faint, minimal erythema
1 - erythema
2 - intense erythema, induration
3 - intense erythema, induration, vesicles
4 - severe reaction with erythema, induration, (may be weeping) pustules
E - indicates edema
DR - dryness

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
A total of 98 of initial 113 subjects, 27 male and 71 female completed the study. 15 subjects discontinued the study, none of them due to test material reaction:
- Number of subjects with positive reactions: 0/98
- Number of subjects with negative reactions: 98/98
- Number of subjects with equivocal reactions: 0/98
- Number of subjects with irritating reactions: 0/98

During the induction phase, no reactions were exhibited.
The original tests sites exhibited no reactions during the rest period or challenge phase.
At the challenge, one subject exhibited a low-level (±) reaction.

Any other information on results incl. tables

Summary of reactions:

Reaction grade* Induction Readings Challenge Readings (h)
1 2 3 4 5 6 7 8 9 24 48 72 96
0 106 105 103 101 101 100 99 99 99 97 98 96 94
±                   1      
1                          
2                          
3                          
4                          
-                       2 4
Number of subjects 106 105 103 101 101 100 99 99 99 98 98 98 98

* Scoring system:

0: no visible reaction

±: faint, minimal erythema

1: erythema

2: intense erythema, induration

3: intense erythema, induration, vesicle

4: severe reaction with erythema, induration, (may be weeping) pustules

-: no site reading

Applicant's summary and conclusion

Conclusions:
Not sensitizing