Phenethyl acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 October 1979 to 20 November 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Standard test method but conducted prior to adoption of standard test guidelines and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The test material, phenylethyl acetate, and appropriate standards, were applied to the clipped dorsum of groups of 8 rabbits for 4 hours under individual semi-occlusive patches (8-ply gauze). After removal of the patches, the treated areas were wiped and examined for evidence of irritation. Assessments were made at removal of the dressing, 24, 48 and 72 hours after treatment.

GLP compliance:

no

Remarks:

:study pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

Phenethyl acetate

EC Number:

203-113-5

EC Name:

Phenethyl acetate

Cas Number:

103-45-7

Molecular formula:

C10H12O2

IUPAC Name:

2-phenylethyl acetate

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no details
- Age at study initiation: 9-12 weeks
- Weight at study initiation: no details
- Housing: no details
- Diet (e.g. ad libitum): no details
- Water (e.g. ad libitum): no details
- Acclimation period: no details

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no details
- Humidity (%): no details
- Air changes (per hr): no details
- Photoperiod (hrs dark / hrs light): no details

IN-LIFE DATES: From: 23 October 1979 To: 26 October 1979

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: various positive control tested groups included

Amount / concentration applied:

0.5 ml for each test solution and the standard solutions (diethyl phthalate, cyclamen aldehyde and geraniol) or 0.2g for solid samples.

Duration of treatment / exposure:

4 hours under a semi-occlusive dressing

Observation period:

The test material, phenylethyl acetate, and appropriate standards, were applied to the clipped dorsum of groups of 8 rabbits for 4 hours under individual semi-occlusive patches (8-ply gauze). After removal of the patches, the treated areas were wiped and examined for evidence of irritation. Assessments were made at removal of the dressing, 24, 48 and 72 hours after treatment.

Number of animals:

8 New Zealand White rabbits, aged 9-12 weeks were used for each test. The whole dorsal surface was clipped 3-4 days before the test commenced, animals in the telogen phase of hair growth were selected.

Details on study design:

Occlusive patches were prepared by attaching a piece of thin flexible polythene 3cm x 3cm to a piece of zinc oxide plaster 9cm x 2.5cm. A 2.5cm square of cotton gauze (8 ply folded in two) was laid on the polythene such that the edges of the pad are attached to the zinc oxide plaster. Test solutions (0.5ml) were applied to the dry patch. (Test solids (0.2g) were applied to a moistened patch.) {Aerosol preparations were applied directly to the skin with two 1-second bursts and the patches were saturated with spray which acted as a reservoir.}

The patches were firmly attached to ensure good contact between the skin and test substance. The animals were immobilised in a canvas body sleeve for 4 hours after application of the patch. When the patches were removed, the treatment sites were wiped clean of excess material. The positions of treatment sites were randomised

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: marginal reactions recorded, wich resolved within the observation period, and which were much less distinct than these elicted by the positive control standards

Irritant / corrosive response data:

For phenylethyl acetate erythema and oedema reactions were marginal, very slight or slight predominantly at the 4 and 24 hour assessments with amelioration and resolution by the 48 and 72 hour assessments.

Other effects:

No dermal reactions other than marginal to slight erythema and oedema

Any other information on results incl. tables

No further details

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

For phenylethyl acetate erythema and oedema reactions were marginal, very slight or slight predominantly at the 4 and 24 hour assessments with amelioration and resolution by the 48 and 72 hour assessments.

Executive summary:

 Skin irritation to the rabbit. A study was conducted to investigate the irritation effects of test materials (including phenylethyl acetate) when applied once to intact skin under a semi-occlusive dressing. A 4-hour semi-occlusive patch test was conducted on eight New Zealand white rabbits, 9 - 12 weeks old.  The dorsal region was clipped 3-4 days before the beginning of the study. A 0.5-ml aliquot of the undiluted test material, and appropriate standards, were applied to gauze pads attached to strips of adhesive tape. The patches were placed on the clipped dorsum of animals, and the animals were then immobilized in body sleeves for 4 hours. After removal of the patches, the sites were wiped clean of the excess test material. Reactions were graded immediately and at 24, 48 and 72 hours after patch removal. For phenylethyl acetate erythema and oedema reactions were marginal, very slight or slight predominantly at the 4 and 24 hour assessments with amelioration and resolution by the 48 and 72 hour assessments. The results of this study indicate that phenylethyl acetate does not require classification as a skin irritant according to the CLP Regulation.