Registration Dossier

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

Constituent 1
Chemical structure
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.