Ethyl phenylacetate

Exposure related observations in humans: other data

Administrative data

Endpoint:

exposure-related observations in humans: other data

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1972

Materials and methods

Endpoint addressed:

skin irritation / corrosion

Principles of method if other than guideline:

Human patch test on compounded perfumes for toilet goods.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl phenylacetate

EC Number:

202-993-8

EC Name:

Ethyl phenylacetate

Cas Number:

101-97-3

Molecular formula:

C10H12O2

IUPAC Name:

ethyl phenylacetate

Method

Ethical approval:

not specified

Details on study design:

TYPE OF TEST USED: Closed patch test

Vehicle used
Condition 1: Vaselinum Aldum, Unguentum Hydrophilicum
Condition 2: Unguentum Simplex, Ungeuntum Hydrophilicum

Concentrations:
Condition 1: 3 -20 %
Condition 2: 0.2-2 %

Number of subjects:
Condition 1: 1763 subjects
Condition 2: 1830 subjects

Details on exposure:

TYPE OF EXPOSURE: Closed human patch test
Condition 1: Small of back
Condition 2: Upper inside of arm

Exposure period: Condition 1: 48 hours
Condition 2: 24-72 hours

Results and discussion

Results:

The test item showed no irritation potential in the two test conditions.

Applicant's summary and conclusion

Conclusions:

In this human patch test healthy male and female subjects were tested under 2 different conditions. No irritation potential could be found in this test.

Executive summary:

In a closed human patch study the skin irritation potential of the test item was tested. 1763 healthy male and female subjects were tested in condition 1 and 1830 subjects in condition 2. The following application way was chosen: In condition 1 the site of application was the small of back in condition 2 the upper inside of arm. Vaselinum Aldum, Unguentum Hydrophilicum were used as vehicle in condition 1 and Unguentum Simplex, Unguentum Hydrophlicum were used as vehicle in condition 2. The test item was applicated in a concentration of 3 -20 % and in a concentration of 0.2 -2 %. No irritation reactions were observed in 30 subjects.