N-butyl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Was not conducted under GLP but has sufficient data for interpretation of results.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

(too many animals per dose group; doses tested choosen too high)

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-butyl acetate

EC Number:

204-658-1

EC Name:

N-butyl acetate

Cas Number:

123-86-4

Molecular formula:

C6H12O2

IUPAC Name:

butyl acetate

Details on test material:

- Name of test material (as cited in study report): N-Butyl Acetate
- Physical state: liquid
- Analytical purity: as n-butyl acetate is usually available as high quality / purity, it can probably be assumed that test item purity was high

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200 to 300 g
- Fasting period before study: overnight before dosing
- Diet: commercial available diet, ad libitum
- Water: municipal water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

males: 16.0, 11.3 & 8.0 ml/kg.
females: 16.0, 11.3, 8.0 & 4.0 ml/kg.

No. of animals per sex per dose:

5 rats per sex at 16.0, 11.3, 8.0 ml/kg.
2 rats (female only) at 4.0 ml/kg.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology:

Statistics:

LD50's and the estimated LD50 slopes are calculated by the moving average method (Thompson, 1947; Weil, 1983).

Results and discussion

Preliminary study:

none.

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

14.5 mL/kg bw

95% CL:

9.3 - 22.7

Remarks on result:

other: LD50 (calculated 12789 mg/kg, based on specific gravity of 0.882)

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

12.2 mL/kg bw

95% CL:

9.2 - 16.1

Remarks on result:

other: LD50 (calculated 10760 mg/kg, based on specific gravity of 0.882)

Mortality:

16.0 ml/kg: 3 of 5 males, 4 of 5 females
11.3 ml/kg: 1 of 5 males, 2 of 5 females

Clinical signs:

other: 16.0 ml/kg male: Sluggishness at 30 min; moribund appearance at 2 hr. Survivors recovered at 1 day. 16.0 ml/kg female: Sluggishness at 30 min to 1 hr; prostration in 2 at 1 hr; moribund appearance in 1 at 2 hr. Death of 2 at 3 hr. Survivor recovered at 1

Gross pathology:

16.0 ml/kg male: In victims, ventral surface of liver of 1 pale tan; stomachs tan or red, liquid or gas-filled. In survivors, nothing
remarkable.
16.0 ml/kg female: In victims, ventral surface of livers of 2 pale tan; stomachs of 2 filled with clear liquid. In survivor, nothing remarkable.
11.3 ml/kg male: In victim, stomach tan and red, distended, gas-filled. In survivors, lungs of 2 mottled light and dark red; kidneys of 2 mottled tan and brown.
11.3 ml/kg female: In victims, ventral surface of liver of 1 pale tan; stomachs distended, gas-filled. In survivors, lungs of 2 dark red.

Other findings:

None.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

N-Butyl Acetate was slightly toxic following its administration by single peroral intubation. The acute oral LD50 for n-Butyl Acetate in male rats is 14.5 ml/kg bwt (9.3 - 22.7 ml/kg; calculated 12789 mg/kg, based on specific gravity of 0.882). The acute oral LD50 for n-Butyl Acetate in female rats is 12.2 ml/kg bwt (9.2 - 16.1; ml/kg; calculated 10760 mg/kg, based on specific gravity of 0.882 .

Executive summary:

N-Butyl Acetate was tested for acute oral toxicity in 5 male rats/dose at doses of 16.0, 11.3 and 8.0 ml/kg. Male dosing killed 3 out of 5 rats at 16.0 ml/kg, 1 of 5 at 11.3 ml/kg and 0 of 5 at 8.0 ml/kg. Acute oral toxicity in 5 female rats/dose at doses of 16.0, 11.3, 8.0 and 4.0 ml/kg resulted in 4 of 5 deaths at 16.0 ml/kg, 2 of 5 at 11.3 ml/kg, 0 of 5 at 8.0 ml/kg and 0 of 2 at 4.0 ml/kg.

Based on the results obtained, the LD50 was 14.5 ml/kg for male rats (calculated 12789 mg/kg, based on specific gravity of 0.882) and 12.2 ml/kg for female rats (calculated 10760 mg/kg) under the study conditions (Myers et al., 1987).

This study was judged to be reliable (RL2) and therefore was selected as key study.