Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
13 Mar - 21 Apr 2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study which meets basic scientific principles. Study report without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Method of Marzuli and Maibach.
Induction-phase: The test-substance was applied to the upper back of 56 volunteers under occlusive conditions for 48 h, 3 times a week for 3 weeks and graded for skin reactions. After a two weeks resting period, the challenge patches were applied to previously treated and unexposed sites for 48 h and analysed for dermal reactions after 48, 72 and 96 h.
GLP compliance:
no
Remarks:
GCP compliant

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): pentaisononanoate de dipentaerythritol
- Analytical purity: no data
- Lot No: 05078603

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Subjects:
- Number of subjects exposed: 56
- Sex: male and female
- Age: 18-69

Clinical history:
- History of allergy or casuistics for study subject or populations: No
- Exposure history: No
Controls:
No
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Concentrations: applied pure
- Volume applied: 0.2 mL
- Testing/scoring schedule: Occlusive patches with 0.2 mL of test substance for 48 h 3 times a week for 3 weeks. Following a two weeks resting period, the challenge patches (pure test substance) were applied to previously treated test sites on the back (original) and to previously unexposed newly defined sites (virgin) for 48 h. Scoring was performed after each application (induction scores) and after patch removal (48 h) and at 72 and 96 h after challenge.

EXAMINATIONS
- Grading/Scoring system: Accounting for erythema and edema formation according to the method of Marzuli and Maibach:
- = no reaction
? = minimal or doubtful response, slightly different from surrounding normal skin
+ = definite Erythema, no edema
++ = definite erythema, definite edema
+++ = definite erythema, definite edema and vesiculation

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: One individual showed definite erythema but no edema 72 h and 96 h after challenge. Two other subjects had minimal or doubtful, reversible, reactions 48 h or 72 h after challenge.


NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 53
- Number of subjects with equivocal reactions: 2
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:
Not sensitising, not irritating