1-phenylethyl acetate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles following a protocol for the assessment of sensitisation in humans.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Kligman (1966) The Identification of Contact Allergens by Human Assay III. The Maximization Test: A Procedure for Screening and Rating Contact Sensitisers The Journal of Investigative Dermatology 47(5): 393-409

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-phenylethyl acetate

EC Number:

202-288-5

EC Name:

1-phenylethyl acetate

Cas Number:

93-92-5

Molecular formula:

C10H12O2

IUPAC Name:

1-phenylethyl acetate

Specific details on test material used for the study:

- Name of test material: 1-phenylethyl acetate- Name of test material (as cited in study report): Methyl Phenyl Carbinyl Acetate

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 25- Sex: male- Age: 21-56

Clinical history:

Volunteers were described as healthy, no further information was provided.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)ADMINISTRATION- Type of application: occlusive- Vehicle / solvent: petrolatum N.F.- Concentrations: 4%

Results and discussion

Results of examinations:

No reactions were observed in any of the subjects at either observation time.

Any other information on results incl. tables

Table 1: Grading scale results

Subject number	48 hours	72 hours
1	0	0
2	0	0
3	0	0
4	0	0
5	0	0
6	0	0
7	0	0
8	0	0
9	0	0
10	0	0
11	0	0
12	0	0
13	0	0
14	0	0
15	0	0
16	0	0
17	0	0
18	0	0
19	0	0
20	0	0
21	0	0
22	0	0
23	0	0
24	0	0
25	0	0

Applicant's summary and conclusion

Conclusions:

Under the conditions of the test, 4% test substance did not produce any cases of contact allergy in twenty-five adult males.

Executive summary:

In a pre-GLP human bioassay study conducted in line with the Maximisation test for identifying contact allergens in humans, 4% of the test material in petrolantum N.F. was applied under occlusion to the forearms of 25 male volunteers age 21 to 56 for 48hrs. After a 10 day rest period challenge patches were applied under occlusion to fresh sites on the the shoulder area of the backs for 48hrs. Reactions were read on patch removal and 24hrs after the patch removal. Under the conditions of this test, the test material, 1-phenylethyl acetate at 4% was determined not to cause contact allergy.