Registration Dossier
Registration Dossier
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EC number: 203-306-4 | CAS number: 105-54-4
Repeated dose toxicity: oral
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:
- 1 968
- Bibliographic source:
- FAO Nutrition Meetings Report Series
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- 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 substance name:
- Ethyl butyrate
- EC Number:
- 203-306-4
- EC Name:
- Ethyl butyrate
- Cas Number:
- 105-54-4
- Molecular formula:
- C6H12O2
- IUPAC Name:
- ethyl butanoate
- 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
Constituent 1
- 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 or test system 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.
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