Undecanal

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report which meets basic scientific principles

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1966

Report date:

1966

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

maximization test on humans to establish whether the substance has an allergenic potential and to what degree

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Undecanal

EC Number:

203-972-6

EC Name:

Undecanal

Cas Number:

112-44-7

Molecular formula:

C11H22O

IUPAC Name:

undecanal

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): 71-5-15 - aldehyde C-11 undecylic
- Physical state: liquid

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 25
- Sex: male
- Age: 21 to 44
- Race: black americans
- Other: healthy inmates

Clinical history:

no data

Controls:

not required

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch:
induction: ~ 14.5 cm² Webril patch (non-woven, highly absorbent, cloth) placed on the forearm or calf
challenge: ~10 cm² Webril patch placed on the lower back
- Concentrations: undiluted
- Volume applied:
induction: 1.0 mL
challenge: 0.4 mL
- Testing schedule:
Pre-treatment: none (treatment with 5% aqueous sodium lauryl sulfate omitted)
Induction phase: 48 h with test item
Repeat this pre-treatment and induction 5 times (total induction phase: 15 d)
Rest: 10 d
Challenge phase: 48 h with test item
- Scoring schedule:
- Removal of test substance:

EXAMINATIONS
- Grading/Scoring system: system as stated in Kligman, 1966 (see table below):
- Statistical analysis: not needed

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/WITHOUT REACTIONS COMPARED TO STUDY POPULATION

- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 25
- Number of subjects with equivocal reactions: 0

Applicant's summary and conclusion

Conclusions:

Under the conditions tested, the test item did not reveal any skin sensitisation potential in humans.

Executive summary:

25 healthy male black american inmates completed this human maximization test using the undiluted test item (name in the report:71-5-15 - aldehyde C-11 undecylic, liquid, purity: not stated). The 15 days induction phase (48 h treatment with test material, repeated 5 times under occlusive conditions) was followed by a 10 days rest period and a final challenging phase (48 h treatment with test material under occlusive conditions). Scoring was made after the patch was removed and 24 h thereafter. None of the subjects revealed any reaction following this treatment, therefore the test item is considered to have no skin sensitisation potential (Kligman, 1971).

This study is judged to be reliable with restrictions (RL2). Essentially the study followed the methodology described in a separate publication (Kligman, 166).