Phenethyl phenylacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001-02-28 to 2001-03-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8 weeks of age
- Weight at study initiation: Males weighed 211 to 235g and the females 201 to 227g.
- Housing: Suspended polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet: Free access to Rat and Mouse SQC Expanded Diet No. 1, Special Diets Services Limited, Witham, Essex, UK)
- Water: Free access to mains drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes: fifteen changes per hour
- Photoperiod: twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: area of shorn skin
- % coverage: 10 %
- Type of wrap if used: surgical gauze

REMOVAL OF TEST SUBSTANCE
- Washing: Distilled water
- Time after start of exposure: After 24 hours

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw (undiluted application)

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1/2, 1, 2 and 4 hours after dosing, daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, gross pathological examinations, external examination and opening of the abdominal and thoracic cavities, appearance of any macroscopic abnormalities

Statistics:

Data evaluations included the relationship, if any, between the exposure of the animal to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects. Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test material was made.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Skin Irritation. There were no signs of dermal irritation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal toxicity was determined in a study according to OECD guideline 402. The LD50 of the test material in the Sprague- Dawley strain rat was found to be greater than 2000 mg/kg bodyweight.

Executive summary:

The study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley strain rat. The method was designed to meet the requirements of the following:

OECD Guidelines for the Testing of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24 February 1987)

Commission Directive 92/69/EEC Method B3 Acute Toxicity (Dermal) Method.

A group of ten animals (five males and five females) was given a single, 24 -hour, semioccluded dermal application of undiluted test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. Mortality: There were no deaths. Clinical Observatians: There were no signs of systemic toxicity. Skin Irritation: There were no signs of dermal irritation. Bodyweight: All animals showed expected gains in bodyweight over the study period. Necropsy: No abnormalities were noted at necropsy. Conclusion. The acute dermal median lethal dose (LD50) of the test material in the Sprague- Dawley CD (Cr1: CD® (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight.

The test material does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with EU labelling regulations.