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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:
supporting study
Study period:
12 Sep - 20 Oct 2005
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Repeated Insult Patch Test in Humans
- Short description of test conditions:
- Parameters analysed / observed: skin reaction after application of the test substance
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
other: volunteers
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 52
- Sex: male and female
- Age: 16 - 74 years
Clinical history:
- Other: Only males and females were chosen for the study, which had no skin disease and were not using any topical or sytemic steroids and/ or antihistamines for at least one week prior to the study initiation. In addition, they had to fill out a medical history form (no further information provided on the content of these forms).
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: clear adhesive dressing (TruMed Technologies, Inc., Burnsville, USA)
- Concentrations: 5% aquatic solution
- Volume applied: 0.2 mL, applied on 1" x 1" absorbent pad portion of the clear adhesive dressing
- Testing/scoring schedule:
Induction phase: Patches were applied 3 times per week for a total of 9 applications. The evaluation of this site was made prior to re-application. Rest periods consisted of 24 h following each removal on Tuesdays and Thursdays, and 48 h following each removal on Saturdays.
Challenge phase: 2 weeks after final induction patch application a challenge patch was applied to a test site adjacent to the induction patch site. After 24 h the patch was removed and the site was scored. An additional reading was performed after 72 h post application.
- Removal of test substance: 24 h after application
- Other: If a participant was unable to show up on the assigned test day, 1 makeup day was permitted. This day was added to the induction period.
If any test site showed a moderate reaction (scored 2) during the induction phase, the application would be moved to an adjacent area (except of the first supervised induction patch reading). Applications would be discontinued, if a moderate reaction (scored 2) was observed on the new test site aswell and/ or if marked or severe reactions (scored 3 or 4, respectively) were noted.

EXAMINATIONS
- Grading/Scoring system:
0 = no visible skin reaction
+ = barely perceptible or spotty erythema
1 = mild erythema covering most of the test site
2 = moderate erythema, possible presence of mild edema
3 = marked erythema, possible edema
4 = severe erythema, possible edema, vesiculation, bullae and/or ulceration

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/ 52
- Number of subjects with negative reactions: 52/ 52

Applicant's summary and conclusion

Conclusions:
CLP: not classified