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Diss Factsheets
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EC number: 201-126-0 | CAS number: 78-59-1
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
- Reference Type:
- publication
- Title:
- Isophorone: Ambient water quality criteria
- Author:
- U.S. EPA (Environmental Protection Agency)
- Year:
- 1 978
- Bibliographic source:
- U.S. Department of Commerce, National Technical Information Service (NTIS), PB-296 798
Materials and methods
- Principles of method if other than guideline:
- Method: Repeated Dose Toxicity; see reference
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 3,5,5-trimethylcyclohex-2-enone
- EC Number:
- 201-126-0
- EC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Cas Number:
- 78-59-1
- Molecular formula:
- C9H14O
- IUPAC Name:
- 3,5,5-trimethylcyclohex-2-enone
- Details on test material:
- Origin: International Chemical Corp., New York, 11 Aug 1971
- clear liquid with a mild, pungent odor
- specific gravity: 0.93
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino rats of CFE strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Carworth Farms
- Age at study initiation: weanling
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
- Housing: individually in wire mesh cages elevated above the droppings
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- corn oil
- Details on oral exposure:
- - Isophorone was added directly to the basal ration and thorougly blended in an Patterson Kelly Twin Shell Blendor;
- Fresh diets were prepared each week
- isophorone in corn oil (1:2) was blended with the diet - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
750, 1500 and 3000 ppm diet: males 57.0, 102.5 and 233.8 mg/kg bw d; females 78.9, 163.8 and 311.8 mg/kg bw d
Basis:
nominal in diet
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Post-exposure period: none
- After 4 weeks, 5 animals per sex and dose group were killed for blood analysis - Positive control:
- none
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS AND FREQUENCY:
- Clinical signs: daily
- Mortality: daily
- Body weight: weekly
- Food consumption: weekly
- Water consumption: weekly
- Ophthalmoscopic examination: none
- Hematology: after 4 weeks and at end of study: determination of hemoglobin, hematocrit, erythrocyte counts, leukocyte counts, and differential
leukocyte determinations
- Biochemistry: after 4 weeks and at end of study: blood glucose, blood urea nitrogen, serum glutamic oxaloacetic transaminase, serum alkaline
phosphatase, total serum protein, total serum bilirubin, serum albumin, lactic acid dehydrogenase, cholesterol, calcium, phosphate, and uric aid
- Urinalysis: after 4 weeks and at end of study: pH, glucose, ketones, albumin, occult blood, microscopic examination of sediment - Sacrifice and pathology:
- ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Organ weights: organ-body weight ratios: heart, liver, kidney, adrenals, thyroid, brain, testes
- Macroscopic: after 4 weeks and at study termination: lungs, heart, intestines, kidneys, spleen, liver, urinary bladder; - weights: heart, liver, kidney,
adrenals, thyroid, brain, testes (males) for 10 males and 10 females of each dose level
- Microscopic: at study termination only: 5 males and 5 females each from high dose and control groups: brain, pituitary, eye, thyroid, lung, heart,
liver, kidney, adrenals, urinary bladder, mediastinal lymph node, pancreas, spleen, colon, bone marrow, skeletal muscle, testes and prostate (male),
ovary and uterus (female) 5 males and 5 females each from medium and low dose groups: liver, kidney - Other examinations:
- none
- Statistics:
- STATISTICAL METHODS: All data were evaluated statistically.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- NOAEL:
m: 1500 ppm diet (reduced body weight gain), equivalent to 102.5 mg/kg bw;
f: 3000 ppm diet, equivalent to 311.8 mg/kg bw.
ACTUAL DOSE RECEIVED BY DOSE LEVEL BY SEX mean daily compound consumption (data given in study):
- males 57.0, 102.5 and 233.8 mg/kg bw d
- females 78.9, 163.8 and 311.8 mg/kg bw d
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- Mortality and time to death: 1 m (control group), 1 f (3000 ppm)
- deaths were due to intercurrent infection
- Clinical signs: none
- Body weight gain: 3000 ppm m: significant reduced body weight gain (P < 0.01); further observed changes returned to normal in the
subsequent weeks
- Food/water consumption: no evidence of refusal
- Clinical chemistry: all values within normal limits
- Haematology: all values within normal limits
- Urinalysis: all values comparable to controls
- Organ weights: kidney, testes m: slightly increased mean organ to body weight ratio (considered not compound related by the authors;
not statistically significant)
- Gross pathology: All viscera were normal in appearance and color, no lesions were observed
- Histopathology: no evidence of significant pathology
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 102.5 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: reduced body weight gain
- Dose descriptor:
- NOAEL
- Effect level:
- >= 311.8 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: no effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
no remarks
Applicant's summary and conclusion
- Conclusions:
- In this subchronic (90 day) oral feed study with rats the only observed effect was a reduced body weight gain in male animals. The No-Observed-
Adverse-Effect-Level (NOAEL) derived from this study is 102.5 mg/kg bw/day for male and 311.8 mg/kg bw/day for female rats. - Executive summary:
In this guideline-comparable study four groups of 20 male and 20 female CFE albino rats were dosed with 750, 1000, or 3000 ppm isophorone via diet - corresponding to 57.0, 102.5, 233.8 mg/kg bw/day for males and to 73.9, 163.8 and 311.8 mg/kg bw/day for females - daily for 13 weeks.
Isophorone in corn oil (ratio 1:2) was blended with the diet; fresh diets were prepared each week. Haematology, serum chemistry and urine analyses were carried out on five animals of each sex from each group at week 4 and at termination. Comprehensive histopathological examination was confined to five animals of each sex from the control and high dose groups. The liver and kindney from five animals of the intermediate dose levels were also examined histopathologically. Under the conditions of this study, no effects on the general appearance of the test animals, on their behaviour, on body weight gain or on food consumption were observed at a dietary level of 1500 mg/kg or less. Isophorone did not alter the composition of the formed elements of the blood, nor did it interfere with the general metabolism or with liver and kidney function. No detectable gross or microscopic pathological changes were noted in any the animals examined after 28 or 90 days of feeding. Organ/body weight ratios for vital organs were not changed.
The only observed effect was a reduced body weight gain (-12 to -13 %) in male rats at 3000 ppm (during weeks 6,7,8,9,10 and 11).
Therefore, the No-Observed-Adverse-Effect-Level (NOAEL) derived from this study is 102.5 mg/kg bw/day (equivalent to 1500 ppm) for male and 311.8 mg/kg bw/day (equivalent to 3000 ppm) for female rats.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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