Phenethyl phenylacetate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given, acceptable, well documented publication, no guideline and no GLP study.

Data source

Reference

Reference Type:

publication

Title:

Appraisal of Sensitizing Potential of Four Products By Maximization Testing

Author:

Kligman, A

Year:

1971

Bibliographic source:

Unpublished report to RIFM. Report 1805

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

After pre-testing the Maximization Test was conducted according to Journal of Investigative Dermatology 47 (5): 393-409 (1966).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Phenethyl phenylacetate

EC Number:

203-013-1

EC Name:

Phenethyl phenylacetate

Cas Number:

102-20-5

Molecular formula:

C16H16O2

IUPAC Name:

2-phenylethyl phenylacetate

Method

Type of population:

general

Ethical approval:

not applicable

Subjects:

- Number of subjects exposed: 25
- Sex: male
- Age: Adult

Clinical history:

- Other: Healthy males

Controls:

None

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Vehicle: Sodium lauryl sulfate
- Concentration: PPA, 2 %
Occlusive pretreatment: with 5 % aqueous sodium lauryl sulfate
Challenge application: with 10 % aqueous sodium lauryl sulfate
- Testing/scoring schedule: exposure time testing: patches were applied for five alternate-day 48 hour periods; Each test application was preceded by 24 h occlusive pretreatment of the patch site with 5 % aqueous sodium lauryl sulfate. Challenge patches were applied after a 10 day rest period, exposure time challenge patch: 48 h. Challenge applications were preceded by one-hour pretreatment with 10 % sodium lauryl sulfate.

EXAMINATIONS
- Grading/Scoring system: no data

Results and discussion

Results of examinations:

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with negative reactions: 25

Applicant's summary and conclusion

Conclusions:

In a human maximization test no sensitizing potential of the test item could be found in 25 healthy adult males tested.

Executive summary:

A Maximization Test was conducted on 25 healthy male humans to determine the contact sensitizing potential of the test item, applicated in diluted form of 2 %. The test substance was applied under occlusion to the volar forearms for five alternate-day 48 hour periods. The patch sites were pretreated for 24 hours with 5 % aqueous sodium lauryl sulfate under occlusion. Following a ten-day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by one-hour applications of 10 % aqueous sodium lauryl sulfate under occlusion. The challenge sites were read on removal of the patch and 24 hours thereafter. As no skin reactions were observed, the Maximization test results did not indicate a sensitizing effect of the test substance to the skin.