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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
- 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- 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:
- Purity > 90%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Vehicle: no vehicle.
Concentrations: 0, 25, 50, 115 ppm (corresponds to 0.144, 0.289, 0.664 mg/L; low mid and high dose).
Type or preparation of particles: vapor.
Pregnant rats were dosed on days 6 through 15 of gestation (G). - Analytical verification of doses or concentrations:
- yes
- Details on mating procedure:
- - Impregnation procedure: cohoused
- Length of cohabitation: until confirmed to have mated
- Proof of pregnancy: vaginal plug or sperm in vaginal smear - Duration of treatment / exposure:
- gestation day 6 - gestation day 15
- Frequency of treatment:
- 6 hours/day
- Duration of test:
- Section on gestation day 20
Doses / concentrationsopen allclose all
- Dose / conc.:
- 25 ppm
- Remarks:
- corresponds to 0.144 mg/L
- Dose / conc.:
- 50 ppm
- Remarks:
- corresponds to 0.289 mg/L
- Dose / conc.:
- 115 ppm
- Remarks:
- corresponds to 0.664 mg/L
- No. of animals per sex per dose:
- 22 mated female rats per dose level
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: based on results of preliminary study
Examinations
- Maternal examinations:
- PARAMETERS ASSESSED DURING STUDY
Body weight gain: each 3rd day.
Food consumption: 3 day intervals.
Clinical observations: each 3rd day. - Ovaries and uterine content:
- PARAMETERS ASSESSED DURING STUDY
Examination of uterine content: identified as live fetuses, dead fetuses, late resorptions, and early resorptions at the end of the study (day 20 of gestation). The uterus of each animal was stained in 10 % aqueous ammonium sulfide and further examined for confirmation of implantation sites. Corpora lutea were counted. - Fetal examinations:
- PARAMETERS ASSESSED DURING STUDY
Examination of fetuses: Live and dead fetuses were weighed, examined externally for gross abnormalities, and crown-rump distances were determined.
Further examinations: skeletal malformations and ossification variations. - Statistics:
- Bartlett's test of homogeneity of variance: body weight, body weight change, food consumption, number of implantation sites, ratio of live fetuses to implantation sites, ratios of resorptions to implant sites, malformations per litter. Kruskal-Wallis test if variances were not equivalent. Standard nested analysis of variance for fetal weights.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- dose related increases in alopecia and staining of the cervical and anogenital areas
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- reduced on gestation days 12 (-6.1 %) and 15 (-6.8 %) in high dose group
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- reduced food consumption in high dose group (days 6-20 and 0-20)
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- 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:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Number of abortions:
- not examined
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- not examined
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- No statistically significant differences between treated and control groups: Number of resorptions, number of implantations, number of corpora lutea, duration of pregnancy.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEC
- Effect level:
- 0.289 mg/L air
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- not examined
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- No statistically significant differences between treated and control groups:
Litter size and weights, number viable, sex ratio, grossly visible abnormalities, external abnormalities, soft tissue abnormalities, skeletal abnormalities.
During the conduct of the study there was one instance of exencephaly noted in a rat fetus. Based on the observations made in this study the authors do not believe that this anomaly was related to the test material.
Effect levels (fetuses)
- Dose descriptor:
- NOAEC
- Effect level:
- 0.664 mg/L air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed up to and including the highest tested concentration
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The test material elicited a clinical effect in the pregnant dams in the form of decreased food consumption, lower body weights and dose related increases in alopecia and staining of the cervical and anogenital areas.
Within the framework of the dose levels and test methods used, the test material was not teratogenic or fetotoxic.
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