Butyl 2,3-epoxypropyl ether

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 1

Reference Type:

publication

Title:

Threshold for Classification as a Skin Sensitizer in the Local Lymph Node Assay: a Statistical Evaluation

Author:

Basketter D.A., Lea L.J., Cooper K., Stocks J., Dickens A., Pate I., Dearman R.J., Kimber I.

Year:

1999

Bibliographic source:

Food and Chemical Toxicology 37 (1999) 1167 - 1174

Reference 2

Reference Type:

publication

Title:

The indentification of contact allergens by human assay - III. The Maximization Test: A procedure for screening and rating contact sensitizers

Author:

Kligman A.M.

Year:

1966

Bibliographic source:

The Journal of Investigative Dermatology, Vol. 47, No. 5

Materials and methods

Type of sensitisation studied:

skin

Principles of method if other than guideline:

The Maximization Test was performed according to the method of Kligman (1966) in a panel of 25 healthy adult subjects (volunteering inmates from Holmesburg Prison).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butyl 2,3-epoxypropyl ether

EC Number:

219-376-4

EC Name:

Butyl 2,3-epoxypropyl ether

Cas Number:

2426-08-6

Molecular formula:

C7H14O2

IUPAC Name:

2-(butoxymethyl)oxirane

Test material form:

liquid

Method

Type of population:

other: prison inmates

Ethical approval:

no

Subjects:

A panel of 25 healthy adult subjects (volunteering inmates from Holmesburg Prison).

Clinical history:

Subjects are healthy.

Route of administration:

dermal

Details on study design:

Induction Procedure:
The sensitizing patches are applied to an extremity, either the forearm or the lower leg in the calf region. The entire series of patches is applied to exactly the same site. The procedure has the following basic structure for non-irritating substances:
1. 1.0 mL of 5% aqueous sodium lauryl sulphate (SLS) to a 1.5" square of Webril is delivered fastened occlusively to extremity for 24 hours. This treatment produces a moderate inflammatory reaction which promotes sensitization.
2. To the same site a 48 hour occlusive patch is applied with the test material (10 %).
3. This sequence of alternating 24 hour irritant and 48 hour allergen patches is repeated for a total of five exposures. The procedure therefore consists of five 48 hour exposures, each one preceded by a 24 hour pre-treatment with 5% SLS. The inflammation tends to increase somewhat with each SLS exposure, reaching a maximum by the third or fourth time. The SLS pre-treatments are eliminated if at any time the skin becomes too inflamed. The aim is to keep the skin moderately inflamed during the exposures. Usually the subjects tolerated the procedure with little complaint.

Instead of 24 hour pre-treatments with sodium lauryl sulphate, the surfactant may be incorporated into the test mixture at 5% concentration, provided there is certainty of chemical compatibility. The procedure then involves five 48 hour combined allergen-irritant exposures with one day intervals of complete rest. However, a chemical reaction between the allergen and the surfactant may inactivate one or both, spoiling the test completely. Irritating substances require no pre-treatment with SLS.

Challenge Tests: —The SLS provocative patch test:
The provocative test consists of pre-treating the skin occlusively with 0.4 mL of 10% SLS on a 1.0" Webril square for one hour. This produces sub-clinical inflammation in 48 hours. Liquids may be used undiluted if non-irritating. Non-irritating solids are routinely tested at 10% in petrolatum. Liquids may be used at the highest non-irritating concentration on normal skin or on SLS pre-treated skin if non-aggravating. The test substance was tested at 10% concentration.
Irritancy is established by pilot testing of no less than 10 subjects. One may expect great individuality in irritability. A 1% concentration is generally a safe concentration with which to begin range finding. The challenge reaction is read immediately after removal of the 48 hour patch and again in another two days. Subjects are asked to return if reactions develop still later, an unusual but not rare event. An evident erythema is the minimum positive response. The reliability of this response has been verified histologically, though of course, erythema is certainly not a specific sign of allergic response. Marginal erythematous reactions are operated one week later.
A control patch is necessary for the provocative test consisting of petrolatum applied for 48 hours to a site pre-treated for one hour with 10% aqueous sodium lauryl sulphate. The control site will usually show no reaction, or occasionally a very mild erythema may be present. The mild inflammatory reaction induced by SLS is mainly discernible at the microscopic level. The allergen treated site is not regarded as positive unless it is clearly more inflammatory than the control site.

Results and discussion

Results of examinations:

19 out of 24 subjects were found to be sensitized to the test substance.