Phenethyl acetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1970

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Three groups of three rabbits were subject to dermal application of phenyl ethyl acetate under an occlusive dressing for a period of 24 hours. After removal of the dresing the rabbits were assesed for mortality or signs of systemic toxicity.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

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

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No information
- Weight at study initiation: 1500 to 2500g
- Housing:No information
- Diet (e.g. ad libitum):No information
- Water (e.g. ad libitum):No information
- Acclimation period:No information

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

IN-LIFE DATES: From: not stated To: not stated

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: No information
- % coverage: No information
- Type of wrap if used: Saran wrap and bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was gently removed after 24 hours but no information provided for method of removal
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

Duration of exposure:

24 hours

Doses:

Three dose levels used were 6500, 10000 and 15000 mg/kg bw

No. of animals per sex per dose:

Three rabbits per dose group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: no information
- Necropsy of survivors performed: yes

Statistics:

Median lethal dose calculated

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

6 210 mg/kg bw

Based on:

test mat.

95% CL:

3 890 - 9 900

Mortality:

All three rabbits dosed at 10000 and 15000 mg/kg bw died within 30 hours of exposure (except one rabbit dosed at 10000 mg/kg bw that died approximately 70 hours after exposure).
Two rabbits dosed at 6500 mg/kg bw died. One death was delayed until Day 5 of the observation period.

Clinical signs:

other: All rabbits exhibited clinical signs including motor incoordination, dropped ears, pupillary dilation, decreased respiratory rate and generalised depression. Slight erythema was evident after bandage removal but resolved within six hours.

Gross pathology:

The macroscopic examination of decedents and the sole surviving rabbit revealed no gross lesions attributed to treatment with HSS.

Other findings:

Based on the mortality pattern for the three treatment groups a median lethal dose of 6210 mg/g bw was calculated, with confidence limits of 3890 and 9900 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 in the rabbit was found to be 6210 mg/kg bw under the conditions of this study.

Executive summary:

Three groups of three albino rabbits were treated at 6500, 10000 or 15000 mg/kg bw by topical exposure to shaved skin under an occlusive dressing for 24 hours. The degree of dermal response and rapidity of resolution indicate no biologically significant expectation of an irritant response and classification as a skin irritant is not indicated based on this assessment of systemic toxicity.

All rabbits exhibited clinical signs including motor incoordination, dropped ears, pupillary dilation, decreased respiratory rate and generalised depression. Slight erythema was evident after bandage removal but resolved within six hours. All three rabbits dosed at 10000 and 15000 mg/kg bw died within 30 hours of exposure (except one rabbit dosed at 10000 mg/kg bw that died approximately 70 hours after exposure). Two rabbits dosed at 6500 mg/kg bw died. One death was delayed until Day 5 of the observation period.

A median lethal dermal dose level of 6210 mg/kg bw was calculated based on the mortality pattern in the three groups.