Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Remarks:
Intraperitoneal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
Relation of the toxicity of some homologous esters to their rates of saponification.
Author:
Selisko
Year:
1962
Bibliographic source:
Ernahrungsforschung, 7(2), 211-215

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The median lethal dose of various esters was determined in rats after intraperitoneal injections. The animals were observed for 24 hours and the method was according to Behrens and Kärber.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyl butyrate
EC Number:
203-656-8
EC Name:
Butyl butyrate
Cas Number:
109-21-7
Molecular formula:
C8H16O2
IUPAC Name:
butyl butanoate
Test material form:
liquid

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: own breed
- Weight at study initiation: 90 +/- 5 g
- Fasting period before study: yes

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Doses:
6-7 groups up to 5000 mg/kg bw, however, not specified.
No. of animals per sex per dose:
8
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 24 hours
Statistics:
Determination of LD50 according to formula Behrens and Kärber.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
2 200 mg/kg bw
Based on:
test mat.
Mortality:
No detailed information given.
Clinical signs:
No detailed information given.

Applicant's summary and conclusion

Conclusions:
The LD50 after intraperitoneal injection was determined to be 2200 mg/kg bw.
Executive summary:

In the current study the toxicity of the test item was assessed and the median lethal dose (LD50) was determined.

The undiluted test material was administered to albino rats via intraperitoneal route. The animals were fasted before treatment and observed for 24 hours after injections. In every group there were 8 animals and for the determination of the LD50 6 -7 groups were taken.

The LD50 was determined to be 2200 mg/kg bw. No further details were given.