Hexanal

Skin sensitisation

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

Reference

Reference 1

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 2

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

Test material information

Constituent 1

Reference substance name:

Hexanal

EC Number:

200-624-5

EC Name:

Hexanal

Cas Number:

66-25-1

Molecular formula:

C6H12O

IUPAC Name:

hexanal

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)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

0

Group:

test chemical

Dose level:

100 %

No. with + reactions:

0

Total no. in group:

25

Clinical observations:

not specified

Remarks on result:

no indication of skin sensitisation

Results 2

Key result

Reading:

2nd reading

Hours after challenge:

24

Group:

test chemical

Dose level:

100 %

No. with + reactions:

0

Total no. in group:

25

Clinical observations:

not specified

Remarks on result:

no indication of skin sensitisation

Results 3

Group:

positive control

Remarks on result:

not measured/tested

Results 4

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.