Registration Dossier
Registration Dossier
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EC number: 203-381-3 | CAS number: 106-29-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is form peer-reviewed journal
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Food Flavorings and Compounds of Related Structure I. Acute Oral Toxicity
- Author:
- P. M. JENNER, E C. HAGAN, JEAN M. TAYLOR, E. L. COOK and O. G. FITZHUGH
- Year:
- 1 964
- Bibliographic source:
- Fd Cosmet. Toxicol Vol. 2 pp. 327-343.,1964
- Reference Type:
- publication
- Title:
- Monographs on Fragrance Raw Materials: GERANYL BUTYRATE
- Author:
- Jenner, P. M
- Year:
- 1 979
- Bibliographic source:
- A Collection of Monographs Originally Appearing in Food and Cosmetics Toxicology 1979, Pages 401
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Acut eoral toxicity study of geranyl butyrate in rats
- GLP compliance:
- not specified
- Test type:
- other: No data
- Limit test:
- no
Test material
- Reference substance name:
- Geranyl butyrate
- EC Number:
- 203-381-3
- EC Name:
- Geranyl butyrate
- Cas Number:
- 106-29-6
- Molecular formula:
- C14H24O2
- IUPAC Name:
- geranyl butyrate
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): Geranyl butyrate
- Molecular formula (if other than submission substance): C14H24O2
- Molecular weight (if other than submission substance): 224.342 g/mole
- Substance type: Organic
- Physical state: Liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:No data
- Age at study initiation:Young adult rat
- Weight at study initiation:No data
- Fasting period before study: Animals were fasted for approximately 18 hr prior to treatment.
- Housing:Animals were housed in cages
- Diet (e.g. ad libitum): ad libitum, food was replaced in cages as soon as animals received thcir respective doses.
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period:No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%):No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: To: No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Doses:
- No data available
- No. of animals per sex per dose:
- 5 male, 5 female
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal and showed weight gain
- Other examinations performed: clinical signs, body weight were examined. - Statistics:
- LDso's were computed by the method of Litchfield & Wi)coxon (1949).
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 10 660 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- > 8 020 - < 14 180
- Remarks on result:
- other: No effect on survival and clinical sign
- Mortality:
- Animals were dead after 4 days of dose administration.
- Clinical signs:
- Marked signs of depression and coma observed on higher dose value.
- Body weight:
- No data available
- Gross pathology:
- No data available
- Other findings:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Conclusions:
- LD50 was considered to be 10660 mg/kg bw (8020-14180 mg/kg) when Osborne-Mendel male and female rats were treated with Geranyl butyrate orally by gavage.
- Executive summary:
In a acute oral toxicity study, 10 Osborne-Mendel male and female rats were treated wtih Geranyl butyrate orally by gavage and observed for 14 days. Animals were dead after 4 days of dose administration. Marked signs of depression and coma observed on higher dose value. Based on the observation acute lethal dose were calculated as 10660 mg/kg bw with the 95% confidence limit of 8020-14,180 mg/kg. Therefore, LD50 was considered to be 10660 mg/kg bw (8020-14180 mg/kg) when Osborne-Mendel male and female rats were treated with Geranyl butyrate orally by gavage.
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