Methyl 2-hexyl-3-oxocyclopentanecarboxylate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

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 Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

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:

Twenty-five volunteers were expoded to 2% test substance in petrolatum. The test substance is applied under occlusive dressing to the same sites on the volar forearms five 48-hour periods. Prior to each exposure, the site was pre-treated with 5% aqueous SLS under occlusion for 24 hours. Following a 10-day rest period, a challenge patch of the test substance is applied to a different site for 48 hours under occlusion. The challenge site is pre-treated for 1 hour with 10% aqueous SLS under occlusion. Observations are made immediately after removal of the challenge patch and 24 hours thereafter.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Methyl 2-hexyl-3-oxocyclopentanecarboxylate

EC Number:

253-379-1

EC Name:

Methyl 2-hexyl-3-oxocyclopentanecarboxylate

Cas Number:

37172-53-5

Molecular formula:

C13H22O3

IUPAC Name:

methyl 2-hexyl-3-oxocyclopentane-1-carboxylate

Test material form:

liquid

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 25
- Age: 21-53
- Race: White 14; Black 11

Clinical history:

- healthy

Route of administration:

dermal

Details on study design:

- Concentration: 2% in petrolatum
- Pre-test: A patch of the test material was applied to five subjects to normal sites on the backs for 48 hours under occlusion. No subject had any irritation from this material and it was decided to use SLS pre-treatment in the test.
- Maximization test: Performed according to Maximization Test (J.I.D.; vol. 47; No. 5; 363-409; 1966). The test substance is applied under occlusive dressing to the same site on the volar forearms of all subjects for five alternate-day 48-hour periods. Prior to each exposure, the site was pre-treated with 5% aqueous sodium lauryl sulfate under occlusive dressings for a 24-hour period. Following a 10-day rest period, a challenge patch of the test substance is applied to a different site for a 48-hour period under occlusion. The challenge site is pre-treated for 1 hour with 10% aqueous sodium lauryl sulfate under occlusion. Observations are made immediately after removal of the challenge patch and 24 hours thereafter.

Results and discussion

Results of examinations:

No effects were observed.