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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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- 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
- Remarks:
- Restriction: one dose only
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Reference Type:
- other: OECD SIDS
- Title:
- 3,5,5-Trimethylcyclohex-2-enone (Isophorone), CAS No. 78-59-1
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 16
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Four groups of male and female albino rats (10 per sex and dose) were exposed to the test substance (as vapour) in filtered room air at a concentration of 0.25 mg/L air for 6h per day, on 5 days per week, for a duration of 4 weeks. The animals were observed at frequent intervals for signs of irritation. At the end of the 4-week study period, hematological dererminations were carried out in 5 animals per sex per group. Terminal body weights were recorded and the animals were necropsied. Lung, liver, kidneys, adrenal and spleen were examined histopathologically in 3 animals per sex per dose.
- GLP compliance:
- no
- Limit test:
- yes
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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River Caesarian-derived albino rats
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 1000 L stainless steel and glass exposure chambers
- Method of holding animals in test chamber: not specified
- Source and rate of air: Air flow through the chamber was maintained by a positive pressure rotary pump located at the exhaust side of the chamber.
- Method of conditioning air: not specified
- System of generating particulates/aerosols: The vapours were generated by metering the liquid into a positive pressure spray nozzle with a Harvard infusion pump. The resultant aerosol was introduced into a large, triple necked distilling flask. A heating mantle was used to maintain the flask at a temperature adequate to vaporize the entering aerosol.
- Temperature, humidity, pressure in air chamber: not specified
- Air flow rate: The air flow rate was monitored by a rotameter
- Air change rate: not specified
- Treatment of exhaust air: not specified
TEST ATMOSPHERE
- Brief description of analytical method used: The analytical concentration of the chamber was determined daily by analysis of samples with a Beckman BD spectrometer. Each sample was obtained by drawing a known volume of the chamber atmosphere through a scrubber containing methanol as absorbent. The concentration of test material in each sample was ascertained from a standard curve which was prepared by plotting known concentrations of standard solution against percent transmission of the solutions. The concentration of the experimental atmosphere was calculated from the volume of chamber atmosphere which had been passed through the scrubber and the total liquid volume of the sample.
- Samples taken from breathing zone: not specified
VEHICLE (if applicable)
- filtered room air - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 d
- Frequency of treatment:
- 6 hours/day; 5 days/week
Doses / concentrations
- Dose / conc.:
- 0.25 mg/L air (nominal)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Post-exposure period: none
Examinations
- Observations and examinations performed and frequency:
- - Clinical signs: at frequent intervals
- Mortality: at frequent intervals
- Body weight: at study initiation and termination
- Haematology: at study initiation and termination, identical 50 % of animals of each group - Sacrifice and pathology:
- ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Macroscopic: brain, pituitary, trachea, thyroid, parathyroid, lungs, heart, liver, spleen, stomach, small intestine, large intestine, adrenals, kidneys, urinary bladder, gonads, femur
- organ weights: lungs, liver, kidneys, adrenal, spleen
- Microscopic: lungs, liver, kidneys, adrenal, spleen for three males and three females of each group - Statistics:
- performed on body and organ weights
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Slight nasal bleeding on day 3, reddish-brown discoloration of the fur surrounding the nasal regions on days 6 through 8
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight only of male rats was significantly reduced compared to control.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Differential blood count: increase of the percentage of lymphocytes (pre-exposure: 81.6 and 80.2 % among males and females, respectively; post-exposure: 84.6 and 86.0 %, respectively), decrease in the percentage of segmented neutrophiles (pre-exposure: 17.4 and 18.2 % among males and females, respectively; post-exposure: 14.6 and 13.3 %, respectively).
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Absolute and relative liver weight only of male rats were significantly reduced compared to control.
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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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