Registration Dossier

Diss Factsheets

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971
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 wheter the substance has allergenic potentialities and to what degree
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Undecanal
EC Number:
203-972-6
EC Name:
Undecanal
Cas Number:
112-44-7
Molecular formula:
C11H22O
IUPAC Name:
undecanal
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: 24 h with 5% aqueous sodium lauryl sulfate
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:
- Other:

EXAMINATIONS
- Grading/Scoring system: system as stated in Kligman, 1966 (see table below):
- Statistical analysis:
- Other:

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT 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
- Number of subjects with irritating reactions

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 (71-5-15 - aldehyde C-11 undecylic, liquid, purity: not stated). The 15 days induction phase (24 h treatment with 5% aqueous sodium lauryl sulfate and subsequent 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 istem is considered to have no skin sensitisation potential (Kligman, 1971).

This study is judged to be reliable with restrictions (RL2).

This result can be transferred to the registered n-/iso-undecanal. Refer to the discussion field of the endpoint summary for detailed justification of read across.

Categories Display