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EC number: 207-940-2 | CAS number: 502-49-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Hall et al. (1974) reported results on female and male mouse fertility screenings after exposure to cyclooctanone. After 28 days of i.p. dosing of 50 mg/kg/ day thenumber of pregnancies, viable fetuses, dead in uterine and resorptions were recorded. The percentage of pregnancies was 88%, viable fetuses per litter 109% and resorption per litter 170% compared to vehicle treated control. Male mice were dosed with 10 mg/kg/day according to the methode of Coppola (1969). No effects on male fertility were observed, as male mice copulated successfully with females and mating led to viable offspring.
Link to relevant study records
- Endpoint:
- fertility, other
- Type of information:
- experimental study
- Remarks:
- publication
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- For female mouse fertility screening test, female CF1 mice were weighted and administered 50 mg/kg of the test material daily ip for a total of 28 days. On the tenth day of dosing, the females were exposed to males (two females/male) for the remaining experiment. The males were rotated every fifth day. After 28 days of dosing, females were sacrificed. The number of pregnancies, viable fetuses, dead in uterine and resorptions were recorded.
For male fertility screening test, male CF1 mice were dosed with 10 mg/kg/day according to the methode of Coppola (Coppola, J.A. (1969) An extragonadal antifertility agent. Life Sciences 8, 43-48). - GLP compliance:
- not specified
- Specific details on test material used for the study:
- The test material was suspended in 1% carboxymethylcellulose (CMC) and homogenised.
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- male/female
- Route of administration:
- intraperitoneal
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- 50 mg/kg/day test material suspended in 1% carboxymethylcellulose (CMC) administered in 0.2 cc ip.
Doses were adjusted for weight gains during the experiment. - No. of animals per sex per dose:
- 8 females for fertility screening
- Control animals:
- yes, concurrent vehicle
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- female fertility: (percentage of control)
Pregnancies: 88%
Viable fetuses per litter: 109%
Reabsorption per litter: 170%
male fertility:
no effects on male fertility (copulated successfully with fertile females resulted in viable offspring) - Remarks on result:
- not determinable due to absence of adverse toxic effects
- Conclusions:
- Based on fertility screening after intraperitoneal administration for a period of 28 days the NOAEL for cyclooctanone was set at ≥ 50 mg/kg/day in female CF1 mice. Due to no effects in male mouse fertility screen, the NOAEL for cyclooctanone was set at ≥ 10 mg/kg/day in male CF1 mice. Based on the available information, no classification for adverse effects on sexual function and fertility according to CLP Regulation (EC) No. 1272/2008 is required.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
i.p. administration of cyclooctanone to female mice for 28 days resulted in NOAEL (reproduction): ≥50 mg/kg/day
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Toxicity to reproduction: other studies
Description of key information
Harvey and Cowley (1984) investigated the effects of cyclooctanone exposure via inhalation for the first three weeks of life to female mice. The exposure to 7.3 x 10^-5 M cyclooctanone led to no differences in age of sexual maturation and no adverse effects on behavior. Cellular changes in olfactory bulbs were detected but considered to be non-adverse and of no relevance for developmental toxicity.
Link to relevant study records
- Endpoint:
- toxicity to reproduction: other studies
- Remarks:
- developmental toxicity
- Type of information:
- experimental study
- Remarks:
- publication
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Female mice were reared and observated from day 1 of life for three weeks. They were continously exposed to the odors of either cyclooctanone, adult male mouse urine or distilled water as control. Body weight, vaginal opening and first oestrus, olfactory preference, behavior and histological analysis of olfactory bulbs was recorded.
- GLP compliance:
- no
- Type of method:
- in vivo
- Specific details on test material used for the study:
- cyclooctanone crystals (Koch-Light Laboratories, Bucks)
- Species:
- mouse
- Strain:
- other: T.O. mice
- Sex:
- female
- Route of administration:
- inhalation
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- odorants were placed in petri dishes below the wire mesh floor of the living area of the observation incubators and in the path of the airflow which was fed in from outside the building by a vacuum/pressure pump with an output of approximately 1 L/min. Odorants were placed in the incubators daily.
- Duration of treatment / exposure:
- from day 1 of life for three weeks
- Frequency of treatment:
- continously
- Duration of test:
- up to 8 months
- Dose / conc.:
- 0.25 other: g
- Remarks:
- giving an average molar concentration of 7.3 x10^-5 M
- No. of animals per sex per dose:
- 23 per dose
- Control animals:
- yes, sham-exposed
- Conclusions:
- Exposure to cyclooctanone via inhalation for the first three weeks of life leads to no difference in age of sexual maturation of female mice. Exposure during neonatal period of female mice showed cellular changes in olfactory bulbs but effects were not considered adverse. Behavior was not adversely affected by exposure to cyclooctenone.
Reference
Vaginal opening: at day 26.45 (control at day 27.37)
First oestrus: at day 30.77 (control at day 30.89)
Behavior: No treatment effect on grooming; altered sniffing pattern over days but not generally increased
Histology of olfactory bulb: significantly wider olfactory bulbs, significantly greater overall number of altered mitral cells
Justification for classification or non-classification
Data on sexual function and fertility after exposure to cyclooctanone was published by Hall et al. (1974) in non-OECD screening tests. Number of pregnancies, viable fetuses and resorption per litter showed no clear evidence of reproductive toxicity on female mice. In addition, no effects on male fertility were evident.
Since no OECD study on developmental toxicity is available, the information on neonatal exposure of female mice reported by Harvey and Cowley (1984) could be considered for this endpoint. The exposure to cyclooctanone via inhalation during neonatal period of female mice showed no adverse effects no sexual maturation, behavior and histopathology of olfactory bulbs.
Based on the available infomation with limited reliability, the test item cyclooctanone requires no classification for reproductive toxicity according to CLP Regulation (EC) No. 1272/2008.
Additional information
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