N-[3-(dimethylamino)propyl] amides C18-22 (even numbered)

Sensitisation data (human)

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

Test material information

Constituent 1

Reference substance name:

N-[3-(dimethylamino)propyl]docosanamide

EC Number:

262-134-8

EC Name:

N-[3-(dimethylamino)propyl]docosanamide

Cas Number:

60270-33-9

Molecular formula:

C27H56N2O

IUPAC Name:

N-[3-(dimethylamino)propyl]docosanamide

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