Phenethyl isobutyrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Acute Oral Toxicity Study

Author:

Skelanski, M.V.

Year:

1971

Bibliographic source:

Unpublished report to RIFM. Report 2030

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phenethyl isobutyrate

EC Number:

203-116-1

EC Name:

Phenethyl isobutyrate

Cas Number:

103-48-0

Molecular formula:

C12H16O2

IUPAC Name:

2-phenylethyl 2-methylpropanoate

Test animals

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: mortalities were recorded daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Statistics:

The number of deaths were used to calculate the LD50 value.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

3 males died on day 1,
1 female died on day 2.

Clinical signs:

other: Diuresis, crawling on stomach, slowed coordination, pilo erection, prostration, coma and death were observed. The surviving animals showed signs of recovery on the 3rd day.

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study the LD50 value was determined to be >5000 mg/kg bw.

Executive summary:

An acute oral toxicity study was conducted on 10 rats (5 male and 5 female animals). The test material was applied in one (limit) concentration of 5000 mg/kg bw by gavage. The animals were observed for a period of 14 days. Symptoms that were observed during this period were diuresis soon after dosing, crawling, slowed coordination, pilo erection, morbidity, prostration, coma and death. 3 males died on day 1, one female died on day 2. The surviving animals showed signs of recovery on the third day of observation.