Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol

Sensitisation data (human)

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

Test material information

Constituent 1

Reference substance name:

84418-63-3 (UVCB)

IUPAC Name:

84418-63-3 (UVCB)

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