Isobutyl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study is in accordance with OECD TG 401; restriction: poor information on test substance

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1962

Report date:

1962

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

no fasted animals, limited reporting

GLP compliance:

no

Remarks:

pre-GLP study

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isobutyl acetate

EC Number:

203-745-1

EC Name:

Isobutyl acetate

Cas Number:

110-19-0

Molecular formula:

C6H12O2

IUPAC Name:

isobutyl acetate

Details on test material:

- Name of test material (as cited in study report): Acetic acid, isobutyl ester
- Analytical purity: no data (but as iso-butyl acetate is usually available as high quality / purity, it can probably be assumed that test item purity was high)
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

rat

Strain:

other: Carworth-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: own breeding
- Age at study initiation: 4 to 5 weeks
- Weight at study initiation: 90 to 120 g
- Fasting period before study: no
- Housing: no data
- Diet (e.g. ad libitum): Rockland rat diet, complete

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

Dosages are arranged in a logarithnic series differing by a factor of two.
no data on individual doses.

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data

Statistics:

LD50 values were calculated by the method of Thompson (Thompson WR (1947), Bacteriol Rev 11: 115) using the Tables of Weil (Weil GS (1952), Biometrics 8: 249) . The figures in parentheses show the limits of +/- 1.96 standard deviations.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

13 413 mg/kg bw

Remarks on result:

other: 10888-16636 mg/kg bw (+/- 1.96 standard deviations)

Any other information on results incl. tables

The acute oral LD50 was reported as 15.4 (12.5 - 19.1) mL/kg bw. The figures in parentheses show the limits of +/- 1.96 standard deviations. Using a density of 0.871 g/mL (Sect. 4.4), the LD50 calculates to 13413 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 oral LD50 was 13413 mg/kg bw in male rats. No classifcation required according to EU legislation.

Executive summary:

The acute oral toxicity of isobutyl acetate was determined in groups of 5 male Carworth-Wistar rats receiving the test material by oral gavage. The dosages were spaced by a factor of 2 (logarithmically). The observation period was 14 days. The LD50 and a range of +/- 1.96 SD was calculated according to the method of Thomson (1947). Overall the study was conducted in accordance with the recently replaced OECD test guideline 401.

The acute oral LD50 was 13413 mg/kg bw in rats (Smyth et al., 1962).