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Toxicological information

Sensitisation data (human)

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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

Referenceopen allclose all

Reference Type:
publication
Title:
Monographs on fragrance raw materials.
Author:
Opdyke DL
Year:
1979
Bibliographic source:
Food Cosmet. Toxicol. V, 779, 1979
Reference Type:
secondary source
Title:
Report to RIFM
Author:
Epstein WL
Year:
1976
Bibliographic source:
RIFM no. 76-103, 20 December
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 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

Constituent 1
Chemical structure
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.

Applicant's summary and conclusion