Reaction mass of 1,2,3,4,5,6,7,8-octahydro-5,5-dimethylnaphthalene-2-carbaldehyde and 1,2,3,4,5,6,7,8-octahydro-8,8-dimethyl-2-naphthaldehyde

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:

1977

Report date:

1977

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 4% test substance in petrolatum. The test substance is applied under occlusive dressing to the same site (forearm or scapular back) for five 48-hour periods. Prior to each exposure, the site was pre-treated with 2.5% 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 5% to 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:

Reaction mass of 1,2,3,4,5,6,7,8-octahydro-5,5-dimethylnaphthalene-2-carbaldehyde and 1,2,3,4,5,6,7,8-octahydro-8,8-dimethyl-2-naphthaldehyde

EC Number:

916-807-4

Molecular formula:

C13H20O

IUPAC Name:

Reaction mass of 1,2,3,4,5,6,7,8-octahydro-5,5-dimethylnaphthalene-2-carbaldehyde and 1,2,3,4,5,6,7,8-octahydro-8,8-dimethyl-2-naphthaldehyde

Test material form:

liquid

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 25
- Sex: Male: 8; Female: 17
- Age: 18-50 (22 volunteers are between 18 and 22 years of age)
- Race: White: 24, Black 1

Clinical history:

- healthy

Route of administration:

dermal

Details on study design:

- Concentration: 4% in petrolatum
- Pre-test: A patch of the test material was applied to normal sites on the volar forearms or backs of 25 volunteers 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), " Updating The Maximization Test for Identifying Contact Allergens" - Contact Dermatitis; 1975; 1:231-239. The test substance is applied under occlusive dressing to the same site (forearm or scapular back) for five 48-hour periods. Prior to each exposure, the site was pre-treated with 2.5% 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 (scapular back) for a 48-hour period under occlusion. The challenge site is pre-treated for 1 hour with 5% to 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.