Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Reported 10 October 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Synopsis of results presented which is missing many of the method and results details considered necessary for a fully reliable study. However since the author of the synopsis was also responsible for validating the methods that subsequently were adopted as standard test methods, it can be presumed the assay was performed correctly.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1973
Report date:
1973

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:
Human patch test - 25 healthy male volunteers. The test material was pre-tested in five ofthe subjects for 48 hours to determine whether sodium lauryl sulphate would be required in the main study. Since no signs of irritation were observed it was concluded SLS should be applied prior to the first induction application (5% SLS under occluded bandage for 24 hours) and for an hour prior to the challenge application (10% SLS used on this occasion).

Materials were applied to the volar surface of the forearms on five alternate days for a 48 hour occluded exposure and then volunteers were challenged ten days after the last induction application by a further 48 hour occluded application to a naive site on the dorsum. Reactions were assessed immediately after removal of the bandage on each occasion and additionally 24 hours after removal of the challenge dressing.

The test method was described in J.I.D., Vol 47 No. 5, 1966. page 393-409
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexyl acetate
EC Number:
205-572-7
EC Name:
Hexyl acetate
Cas Number:
142-92-7
Molecular formula:
C8H16O2
IUPAC Name:
hexyl acetate
Details on test material:
No further details available

Method

Type of population:
other: 25 male inmate volunteers
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
- Sex: male
- Age: 21-56
- Race: 'B' or 'W'
- Demographic information: No information
Clinical history:
No information
Controls:
No data
Route of administration:
dermal
Details on study design:
25 human male volunteers used
The material was applied under occlusion to the same sites on the volar forearms of all subjects. Patch sites were pre-treated with 5% sodium lauryl sulphate to enhance penetration. The patches remained in situ for 48 hours and fresh patches were applied on alternate days to achieve 5 applications. Following a ten day rest period the volunteers were challenged by topical application to naive sites on the dorsum for a 48 hour period. challenge application was preceded by a one hour application of 10% SLS. Challenge reactions were assessed on removal of the bandage and 24 hours later.

Results and discussion

Results of examinations:
No reactions were observed following challenge application with hexyl acetate to 25 volunteer subjects.

Applicant's summary and conclusion

Conclusions:
No reactions were apparent in any of the 25 volunteers challenged with hexyl acetate. No evidence of delayed contact hypersensitivity was seen in this human patch test. It is considered unlikely hexyl acetate would elicit contact sensitisation in humans in normal use.
Executive summary:

Following induction and challenge of 25 male volunteers with hexyl acetate, using a version of the repeat insult patch test, no reactions were apparent in any of the 25 volunteers challenged with hexyl acetate. No evidence of delayed contact hypersensitivity was seen in this human patch test. It is considered unlikely hexyl acetate would elicit contact sensitisation in humans in normal use.