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EC number: 229-352-5 | CAS number: 6485-40-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Remarks:
- chronic toxicity study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Food Flavourings and Compounds of Related Structure. II. Subacute and Chronic Toxicity
- Author:
- E. C. Hagan, W. H. Hansen, O. G. Fitzhugh, P. M. Jenner, W. I. Jones, Jean M. Taylor, Eleanor L. Long, A. A. Nelson and J. B. Brouwer
- Year:
- 1 967
- Bibliographic source:
- Fd Cosmet. Toxicol. Vol 5, pp. 141-157. 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Reproductive toxicity study of carvone was performed on Osborne-Mendel rats.
- GLP compliance:
- not specified
- Limit test:
- yes
- Justification for study design:
- No data available
Test material
- Reference substance name:
- L-p-mentha-1(6),8-dien-2-one
- EC Number:
- 229-352-5
- EC Name:
- L-p-mentha-1(6),8-dien-2-one
- Cas Number:
- 6485-40-1
- Molecular formula:
- C10H14O
- IUPAC Name:
- (5R)-2-methyl-5-(prop-1-en-2-yl)cyclohex-2-en-1-one
- Details on test material:
- - IUPAC Name: L-p-mentha-1(6),8-dien-2-one
- Common Name: L-carvone
- InChI:1S/C10H14O/c1-7(2)9-5-4-8(3)10(11)6-9/h4,9H,1,5-6H2,2-3H3/t9-/m1/s1
- Smiles:C1[C@@H](CC=C (C1=O)C)C(C)=C
- Molecular formula :C10H14O
- Molecular weight :150.2196 g/mol
- Substance type:organic
- Physical state:Colorless liquid
Constituent 1
- Specific details on test material used for the study:
- - IUPAC Name: L-p-mentha-1(6),8-dien-2-one
- Common Name: L-carvone
- InChI:1S/C10H14O/c1-7(2)9-5-4-8(3)10(11)6-9/h4,9H,1,5-6H2,2-3H3/t9-/m1/s1
- Smiles:C1[C@@H](CC=C (C1=O)C)C(C)=C
- Molecular formula :C10H14O
- Molecular weight :150.2196 g/mol
- Substance type:organic
- Physical state:Colorless liquid
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing:The animals were housed individually in wire cages
- Use of restrainers for preventing ingestion (if dermal): yes/no
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS: test material soluble in corn oil.
DIET PREPARATION
- Rate of preparation of diet (frequency):Fresh diets were made and distributed weekly
- Mixing appropriate amounts with (Type of food )
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): corn oil
- Concentration in vehicle: 125.0 mg/kg bw/day
- Amount of vehicle (if gavage): 1ml of solution/kg daily
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- one year
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
Doses / concentrations
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Total:20
0 mg/kg bw/day: 5 male and 5 female
125.0 mg/kg bw/day: 5 male and 5 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: yes
DETAILED CLINICAL OBSERVATIONS: Yes
Time schedule: every week.
BODY WEIGHT: Yes
Time schedule for examinations: every week.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes Food consumption was determined every week.
Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
Time schedule for examinations: - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- SACRIFICE:At the termination of the experiments the rats were sacrificed and exsanguinated.
- Gross necropsy : yes
HISTOPATHOLOGY / ORGAN WEIGHTS: The tissues of all the rats were examined macroscopically at the time of sacrifice. The viscera
were removed and the liver, kidneys, spleen, heart, and testes were weighed. These organs, the remaining abdominal and thoracic viscera, and one hind leg, for bone, bone marrow, and muscle, were preserved in 10% buffered formalin-saline solution for histopathological examination. For routine histopathology, sections were embedded in paraffin wax and stained with haematoxylin and eosin. Tissues from rats dying during the experiment were examined for gross changes and were preserved if autolysis was not advanced. Organs were not weighed but abnormalities and the suspected reason for death were noted. - Postmortem examinations (offspring):
- No data available
- Statistics:
- No data available
- 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:
- no effects observed
- 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:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: No effects on reproductive organ weight was observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- 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)
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F2 generation
General toxicity (F2)
- Description (incidence and severity):
- The animals were housed individually in wire cages
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No Observed Adverse Effect Level (NOAEL) for reproductive toxicity was considered to 125.0 mg/kg/day, When male and female Osborne-Mendel rats were treated with carvone (6485-40-1) orally for one year .
- Executive summary:
Reproductive /chronic toxicity study of carvone(6485 -40 -1)was performed on male and female Osborne-Mendel rats.5 male and 5 female were used in each dose group. The test material soluble in corn oil were administers in dose concentration 0, 125.0mg/kg bw/day from one year by oral gavage route. Animals were checked for clinical signs, Food consumption and body weight ever week. At the termination of the experiments the rats were sacrificed and exsanguinated.The tissues of all the rats were examined macroscopically at the time of sacrifice. The viscera were removed and the liver, kidneys, spleen, heart, and testes were weighed. These organs, the remaining abdominal and thoracic viscera, and one hind leg, for bone, bone marrow, and muscle, were preserved in 10% buffered formalin-saline solution for histopathological examination. For routine histopathology, sections were embedded in paraffin wax and stained with haematoxylin and eosin. Tissues from rats dying during the experiment were examined for gross changes and were preserved if autolysis was not advanced. Organs were not weighed but abnormalities and the suspected reason for death were noted.No treatment-related clinical signs and premature deaths were observed. No relevant necropsy findings were noted. No effects on testes weight were observed .Hence No Observed Adverse Effect Level (NOAEL) for reproductive toxicity was considered to 125.0mg/kg/day,When male and female Osborne-Mendel rats were treated with carvone(6485 -40 -1)orally for one year.
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