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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
27 Jan 1997 - 7 Mar 1997
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference Type:
study report
Report date:

Materials and methods

Type of sensitisation studied:
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


Type of population:
Ethical approval:
confirmed and informed consent free of coercion received
consent in conformity with: 21 CFR Part 50: "Protection of Human Subject" was secured from each subject
- 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
Not reported
Route of administration:
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

- 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.

- 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:
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      
-                       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

Not sensitizing