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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The identification of contact allergens by human assay III. The maximisation test: A procedure for screening and rating contact sensitizers
Author:
Kligman AM
Year:
1966
Bibliographic source:
J. Invest. Derm. Vol 47, 393-409
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
human maximisation test: Substances are classified according to their allergenic capabilities after five 48 hour exposures of high concentrations to inflamed skin.
GLP compliance:
no
Type of study:
other: human maximisation test
Justification for non-LLNA method:
use of available data: study from 1972

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
name in study report: Aldehyde C-6
Specific details on test material used for the study:
no details given

In vivo test system

Test animals

Species:
other: human
Sex:
male
Details on test animals and environmental conditions:
Twenty-five healthy male inmate volunteers. The volunteers were prisoners.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 %
Day(s)/duration:
48 h
Adequacy of induction:
other: non-irritant substance, but skin pre-treated with 10% SDS
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100 %
Day(s)/duration:
48 h
Adequacy of challenge:
other: challenge applications were preceded by one-hour applications of 10 % SDS under occlusion
No. of animals per dose:
25
Details on study design:
RANGE FINDING TESTS: The test item was pre-tested on five subjects in order to determine whether SDS pre-treatment was required. A patch of hexanal was applied to normal sites on the backs for 48 h under occlusion. No subject had any irritation and it was decided to use SDS pre-treatment in the test. Thus, the patch sites for the main test were pre-treated with SDS for 24 h with 5 % SDS.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: 5 d
- Test groups: 25 volunteers
- Site: volar forearm
- Frequency of applications: 5 alternate days
- Duration: 48 h
- Concentrations: 100 %

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: challenge 10 days after induction
- Exposure period: 48 h
- Test groups: 25 volunteers
- Site: fresh sites (different from induction sites) pre-treated with 4 % SDS for 24 h
- Concentrations: 100 %
- Evaluation (hr after challenge): on removal and 24 h thereafter
Challenge controls:
not specified
Positive control substance(s):
not specified

Results and discussion

Positive control results:
not specified

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
0
Group:
test group
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
not specified
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
not specified
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested
Group:
negative control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
There were no instances of contact-sensitization of hexanal in human maximisation test.
Executive summary:

Human maximisation test was performed on 25 volunteer prisoners. Induction was performed on 5 alternated days for 48 h (occlusive) on SDS pre-treated skin. Challenge was performed 10 days after induction for 48 h (occlusive) on SDS pre-treated skin. Reading was performed directly after challenge and 24 h thereafter. No volunteer was sensitized to hexanal in this test.