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Toxicological information

Acute Toxicity: oral

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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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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

Constituent 1
Chemical structure
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 levelsopen allclose all
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)
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:
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 day.
11.3 ml/kg male: Sluggishness in 1, marked slugishness in 1 at 30 min; prostration at 30 min. Survivors recovered at 1 to 2 days.
11.3 ml/kg female: Sluggishness in 1 at 30 min; prostration at 30 min; moribund appearance in 2 at 2 hr or 1 day. Survivors recovered at 1 day.
Body weight:
No body weight effects.
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.