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EC number: 204-820-1 | CAS number: 127-06-0
- 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
Carcinogenicity
Administrative data
Description of key information
The substance was reported to give a carcinogenic response in male rats.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Numerous deficiencies in the conduct of the study. For example the study had only one dose group and the group size was too small. The control group was non-concurrent. The study was not conducted to any guideline and there is no data regarding GLP. The study is only very briefly reported.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Substance tested by administration in the drinking water to male and female outbred MRC-Wistar rats. The dose of 1.0 g/L was administered 5 days/week for 18 months.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: drinking water
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 18 months
- Frequency of treatment:
- 5 days per week
- Remarks:
- Doses / Concentrations:
1000mg/l
Basis:
nominal in water
Total dose = 7g/rat (males) and 6.2 g/rat (females) - No. of animals per sex per dose:
- 15 males and 16 females
- Control animals:
- other: The control animals were given no treatment. The controls and treated animals were started 8 months apart since the former also served as controls for other studies
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: Monthly
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: For selected cages, over 24 hr periods every month - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Not reported
- Body weight and weight changes:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- not specified
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- Liver tumors were present, chiefly in the male rats [80% incidence (93 wk)] but also in the females [17% incidence (111 wk)J. For males only, the liver tumor incidence was significantly greater than the 0% incidence in the controls. All rats with liver tumor had hepatocellular adenomas, mostly 1-4 cm in diameter. These were composed of circumscribed masses of cells, having abundant cytoplasm and small, round nuclei. All these tumors had benign histologic criteria despite occasional differences in nuclear size, except in 1 male rat in which focal malignant degeneration was noted. Three rats (including 2 males) had liver hemangiomas in addition to the adenomas.
- Dose descriptor:
- LOAEL
- Effect level:
- <= 1 000 mg/L drinking water
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Incidence of liver tumours
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- LOAEL
- Effect level:
- > 1 000 mg/L drinking water
- Based on:
- test mat.
- Sex:
- female
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- Acetone oxime was a liver carcinogen to male rats in this study. However there were numerous deficiencies in the conduct of this study. For example the study had only one dose group and the group size was too small. The control group was non-concurrent. The study was not conducted to any guideline and there is no data regarding GLP. The study is also only very briefly reported. Hence the study has been assessed as unreliable.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- This study is in excess of requirements however is included as available data.
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Whilst the available carcinogenicity study gave a positive result, the study design and reporting means that it is assessed as unreliable. Hence of itself this study would not justify classification. However the structurally related substance butanone oxime (CAS No. 96-29-7) has been tested in chronic studies in both rats and mice and also gave rise to liver carcinogenicity in male animals only, in both species. Butanone oxime is classified as a Carcinogen, category 2. Given the close structural similarity between the two substances and the similarity of findings between the available chronic data, the registrant proposes a precautionary approach to classify acetone oxime as a Carcinogen, category 2, H351.
Additional information
The substance was dosed to rats in drinking water for 18 months.Liver tumors were present, chiefly in the male rats [80% incidence (93 wk)] but also in the females [17% incidence (111 wk)J. For males only, the liver tumor incidence was significantly greater than the 0% incidence in the controls. All rats with liver tumor had hepatocellular adenomas, mostly 1-4 cm in diameter. These were composed of circumscribed masses of cells, having abundant cytoplasm and small, round nuclei. All these tumors had benign histologic criteria despite occasional differences in nuclear size, except in 1 male rat in which focal malignant degeneration was noted. Three rats (including 2 males) had liver hemangiomas in addition to the adenomas. However there were numerous deficiencies in the conduct of this study. For example the study had only one dose group and the group size was too small. The control group was non-concurrent. The study was not conducted to any guideline and there is no data regarding GLP. The study is also only very briefly reported. Hence the study is assessed as unreliable and the validity of the results is uncertain.
Justification for selection of carcinogenicity via oral route endpoint:
It is the only available carcinogenicity study however it is an unreliable study.
Carcinogenicity: via oral route (target organ): digestive: liver
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