Phenethyl isobutyrate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 Dermal Toxicity Study

Author:

Shelanski, M. V.

Year:

1971

Bibliographic source:

Unpublished report to RIFM. Report 2031.

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

Method described under Section 191.10 of the Final Order, Enforcement Regulations, Federal Register, Vol 26, No 155, p 7336, 12 August 1961.

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:

rabbit

Strain:

other: albino

Sex:

not specified

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST MATERIAL
- Amount applied: 5 g/kg bw

Duration of exposure:

no data

Doses:

no data

No. of animals per sex per dose:

3 animals with intact skin and 3 animals with abraded skin were tested.

Control animals:

not required

Statistics:

The LD50 was calculated based on the test results.

Results and discussion

Effect levels

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

1 animals of the intact skin group and 1 animal of the abraded skin group died on day 1.

Clinical signs:

other: no data

Gross pathology:

no data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was found to be greater than 5000 mg/kg bw.

Executive summary:

An acute dermal toxicity study was conducted on 6 rabbits. The test material was applied in one (limit) concentration of 5000 mg/kg bw to the intact skin of 3 of the test animals, test sites on the other animals were abraded before application. As a result, 2 rabbits died (one of the intact-skin test group and one of the abraded-skin test group). Morbidity, prostration and coma were observed before death. Based on the available data, the LD50 was determined to be greater than 5000 mg/kg bw.