N-butyl acetate

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well described study

Qualifier:

according to guideline

Guideline:

other: "the moving average method" (Weil, 1983)

Principles of method if other than guideline:

Female Sprague-Dawley rats (200-300 grams) received 4.0, 8.0, 11.3, or 16.0 ml/kg (3520, 7040, 9944, and 14080 mg/kg) of n-butyl acetate by gavage. The rats were fasted overnight prior to dosing. The group size at each dose level was 5 animals/group. The LD50 value was calculated by the moving average method (Weil, 1983) after the animals had been observed for 14 days for clinical signs and survival. A gross pathology exam was conducted on animals found dead or at sacrifice.

GLP compliance:

no

Test type:

other: "the moving average method" (Weil, 1983)

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Route of administration:

oral: gavage

Doses:

Female Sprague-Dawley rats (200-300 grams) received 4.0, 8.0, 11.3, or 16.0 ml/kg (3520, 7040, 9944, and 14080 mg/kg) of n-butyl acetate by gavage.

Sex:

female

Dose descriptor:

LD50

Effect level:

10 736 mg/kg bw

Based on:

test mat.

Gross pathology:

A gross pathology exam was conducted on animals found dead or at sacrifice.

Two of five female rats were found dead on the day of dosing and two more on the day following dosing with 16.0 ml/kg. Weight gain in the surviving animal from the 16.0 ml/kg was normal. Clinical signs in the 16.0 ml/kg group included sluggishness at 30 minutes, prostration (2/5 animals) at one hour and moribund appearance (1/5 animals) at 2 hours post-dosing. The two animals were found dead at three hours post-dosing. The surviving animal was normal in appearance on the day following dosing. There were no remarkable gross pathology findings in any animals at this dose level. Two of five female rats were found dead (1/5 on Day 1 and 1/5 on Day 3) following dosing with 11.3 ml/kg. Weight gain in the surviving animals from the 11.3 ml/kg was normal. Clinical signs in the 11.3 ml/kg group included sluggishness (1/5 animals) and prostration (5/5 animals) at 30 minutes post-dosing, and moribund appearance (2/5 animals) at 2 hours (continuing to Day 1). The surviving animals were normal in appearance within one day following dosing. There were no remarkable gross pathology findings in any animals at this dose level. No rats died following dosing with either 4.0 or 8.0 ml/kg. No abnormal clinical signs or changes in weight gain were noted following dosing or upon gross pathology exam at termination in either the 4.0 or 8.0 ml/kg group animals. 

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 is 10736 mg/kg

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 736 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
oral 001 and oral 002 are the most reliable studies - it is the same study but data for males and females are presented seperately. The endpoint for the study concerning females is chosen as it has the lowest effect level.