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EC number: 203-837-1 | CAS number: 111-13-7
Toxicological information
Toxicity to reproduction
Currently viewing:
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Cycloalkanones. 7.' Hypocholesterolemic Activity of Aliphatic Compounds Related to 2,8-Dibenzylcyclooctanone
- Author:
- G. L. Carlson,* I. H. Hall, and C. Piantadosi
- Year:
- 1 975
- Bibliographic source:
- Journal of Medicinal Chemistry, Vol. 18, No. 10 pp 1024-1026
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: No data
- Principles of method if other than guideline:
- To evaluate the reproductive toxicity of 2-Octanone in female Sprague-Dawley Rats by Uterotropic Activity
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-Octanone
- IUPAC Name:
- 2-Octanone
- Reference substance name:
- Octan-2-one
- EC Number:
- 203-837-1
- EC Name:
- Octan-2-one
- Cas Number:
- 111-13-7
- Molecular formula:
- C8H16O
- IUPAC Name:
- octan-2-one
- Test material form:
- other: Colourless liquid
- Details on test material:
- - Name of test material:Octan-2-one
- Molecular formula: C8H16O
- Molecular weight: 128.21 g/mol
- Substance type: Organic
- Physical state:Liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material: 2-octanone
- IUPAC name: octan-2-one
- Molecular formula: C8H16O
- Molecular weight: 128.2134 g/mol
- Substance type: Organic
- Physical state: Liquid
- Impurities (identity and concentrations): No data available
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zivic Miller, Allison Park, Pa.
- Age at study initiation: No data available.
- Fasting period before study: No data available.
- Housing: No data available.
- Diet (e.g. ad libitum): Purina lab chow ad libitum
- Water (e.g. ad libitum): water ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- DOSAGE PREPARATION (if unusual): Test compound was suspended in 1% carboxymethylcellulose- H20 (1% CMC) and homogenized
VEHICLE
- Concentration in vehicle:10 mg/kg
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: 1% carboxymethylcellulose- H20 (1% CMC)
- Lot/batch no. (if required):
- Purity: - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 3 days
- Frequency of treatment:
- Daily
- Details on study schedule:
- A fertility test was conducted on Ovariectomized female Sprague-Dawley Rats by Uterotropic Activity for 3 days, The dose were administrated by oral gavage.
Doses / concentrations
- Dose / conc.:
- 10 mg/kg diet
- No. of animals per sex per dose:
- Total no of animals-42 females
0 mg/kg/day-21 female rats
10 mg/kg/day-8 female rats
10 µg /k (positive contro)-13 female rats - Control animals:
- yes, concurrent vehicle
- Positive control:
- 17-Ethinylestradiol
Examinations
- Parental animals: Observations and examinations:
- Clinical sign and Body weight was observed daily.
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- The necropsy was performed after 3 days. The uterus was removed, trimmed, and weighed.
- Postmortem examinations (offspring):
- No data available
- Statistics:
- yes, Student's t test and standard deviation were measured.
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- 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:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No uterotropic activities and change in uterus weight were observed in treated rats as compare to control
Details on results (P0)
Organ weight- No significant change was observed at dose level 10 mg/kg/day in treated group compare to control.
No uterotropic activities and change in uterus weight were observed in treated rats as compare to control
No uterotropic activities and change in uterus weight were observed in treated rats as compare to control
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- organ weights and organ / body weight ratios
- reproductive performance
- Remarks on result:
- other: not specified
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- 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
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P1)
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
Target system / organ toxicity (P1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- other: not specified
- Generation:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- no
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 10 mg/kg bw /day for P generation when Sprague-Dawley female rat were treated with octan-2-one daily for 3 days.
- Executive summary:
In an uterotropic activity study,Sprague-Dawley female rat were treated with octan-2-one in the concentration of 10 mg/kg in 1% carboxymethylcellulose- H20 (1% CMC) and homogenized and administrated orally by gavage dailyfor days which were ovariectomized before dosing. No toxic clinical sign and change in body weight were observed in treated female rats at 10 mg/kg as compared to control. In addition, no uterotropic activities and change in uterus weight were observed in treated rats as compare to control. Therefore, NOAEL was considered to be 10 mg/kg bw /day for P generation when Sprague-Dawley female rat were treated with octan-2-one daily for 3 days.
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