2-ethylhexyl acetate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Secondary source

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Monographs on fragrance raw materials.

Author:

Opdyke DL

Year:

1979

Bibliographic source:

Food Cosmet. Toxicol. V, 779, 1979

Reference 2

Reference Type:

secondary source

Title:

Report to RIFM

Author:

Epstein WL

Year:

1976

Bibliographic source:

RIFM no. 76-103, 20 December

Reference 3

Reference Type:

secondary source

Title:

The identification of contact allergens by human assay. III. The maximization test. A procedure for screening and rating contact sensitizers

Author:

Kligman, AM

Year:

1966

Bibliographic source:

J. invest Derm. 47, 393

Reference 4

Reference Type:

secondary source

Title:

Updating the maximization test for identifying contact allergens

Author:

Kligman, AM & Epstein, W

Year:

1975

Bibliographic source:

Contact Dermatitis 1, 231-9

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Maximization test with human volunteers as described in Kligman, AM: The identification of contact allergens by human assay. III. The maximization test. A procedure for screening and rating contact sensitizers, J. invest Derm. 47, 393, 1966 and Kligman, AM & Epstein, W: Updating the maximization test for identifiying contact allergens, Contact Dermatitis 1, 231-9, 1975.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl acetate

EC Number:

203-079-1

EC Name:

2-ethylhexyl acetate

Cas Number:

103-09-3

Molecular formula:

C10H20O2

IUPAC Name:

2-ethylhexyl acetate

Details on test material:

RIFM no . 76-103

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 29

Clinical history:

no data

Controls:

no data

Route of administration:

dermal

Details on study design:

Maximization test with human volunteers as described in Kligman, AM: The identification of contact allergens by human assay. III. The maximization test. A procedure for screening and rating contact sensitizers, J. invest Derm. 47, 393, 1966 and Kligman, AM & Epstein, W: Updating the maximization test for identifiying contact allergens, Contact Dermatitis 1, 231-9, 1975.

Results and discussion

Results of examinations:

A human maximization study was conducted on 29 healthy subjects. Test materials were applied under occlusion to the same site on the volar forearms of all subjects for 5 alternate day 48 hour periods. Patch sites were pre-tested for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of all materials were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right and labeled site 5. Vehicle was petrolatum. Questionable reactions were biopsied and followed on a daily basis for 1 week with retest at a separate site at a later time. 4 % 2-ethylhexyl acetate in petrolatum did not produce any skin sensitization reactions.

Any other information on results incl. tables

4 % 2-ethylhexyl acetate in petrolatum did not produce any skin sensitization reactions.