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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
The experimental data is presented in a WHO report.

Data source

Reference
Reference Type:
secondary source
Title:
Short-term studies on rats.
Author:
WHO
Year:
1968
Bibliographic source:
FAO Nutrition Meetings Report Series

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Refer below principle
Principles of method if other than guideline:
Short-term study of the given test chemical in rats was evaluated for its toxic nature upon repeated exposure.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Ethyl butyrate
- Molecular formula : C6H12O2
- Molecular weight :116.16 g/mol
- Smiles notation : C(=O)(CCC)OCC
- InChl : 1S/C6H12O2/c1356(7)842/h35H2,12H3
- Substance Type: Organic
- Physical State: Liquid
Specific details on test material used for the study:
- Name of test material: Ethyl butyrate
- Molecular formula : C6H12O2
- Molecular weight : 116.16 g/mol
- Smiles notation : C(=O)(CCC)OCC
- InChl : 1S/C6H12O2/c1356(7)842/h35H2,12H3
- Substance Type: Organic
- Physical State: Liquid

Test animals

Species:
rat
Strain:
not specified
Details on species / strain selection:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
not specified

Administration / exposure

Route of administration:
oral: feed
Details on route of administration:
not specified
Vehicle:
other: Diet
Details on oral exposure:
PREPARATION OF DOSING SOLUTIONS: The test substance was mixed with diet before feeding study was initiated.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Diet
- Concentration in vehicle: 14.4 mg/kg bw
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
12 weeks
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations: 14.4 mg/kg bw
No. of animals per sex per dose:
15 males and 15 females
Control animals:
not specified
Details on study design:
not specified
Positive control:
not specified

Examinations

Observations and examinations performed and frequency:
not specified
Sacrifice and pathology:
not specified
Other examinations:
not specified
Statistics:
not specified

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified
Details on results:
No adverse effects were noted in test chemical-treated rats.

Effect levels

Dose descriptor:
NOAEL
Effect level:
14.4 other: mg/kg bw
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse effects were observed.
Remarks on result:
other: No adverse toxic effect were observed on treated rats

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The given test chemical was observed for its toxic effect in rats. The No Observed Adverse Effect Level (NOAEL) was considered to be 14.4 mg/kg bw, when male and female rats were exposed to the given test chemical for 12 weeks.
Executive summary:

In a repeated oral toxicity study, 15 male and 15 female rats were administered 14.4 mg/kg bw of the given test chemical in diet for 12 weeks. No adverse effects were noted in the animals at the mentioned dose level. The No Observed Adverse Effect Level (NOAEL) was considered to be 14.4 mg/kg bw when male and female rats were exposed to the given test chemical for 12 weeks.