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EC number: 204-846-3 | CAS number: 127-51-5
- 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: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- 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
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Fragrance material review on alpha-iso-methylionone
- Author:
- A. Lapczynski
- Year:
- 2 007
- Bibliographic source:
- Food and Chemical Toxicology
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: see Principles below
- Principles of method if other than guideline:
- A 90 days Subchronic dermal toxicity study was conducted on rats to evaluate the toxic nature of test substance.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one
- EC Number:
- 204-846-3
- EC Name:
- 3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one
- Cas Number:
- 127-51-5
- Molecular formula:
- C14H22O
- IUPAC Name:
- 3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: No data available
TEST SITE
- Area of exposure: Clipped backs
- % coverage: No data available
- Type of wrap if used: No data available
- Time intervals for shavings or clipplings: No detailed data available
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available
- Time after start of exposure: No data available
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data available
- Concentration (if solution): 0, 50, 170, 580 or 2000 mg/kg/day
- Constant volume or concentration used: No data available
- For solids, paste formed: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data available
- Amount(s) applied (volume or weight with unit): No data available
- Concentration (if solution): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available
USE OF RESTRAINERS FOR PREVENTING INGESTION: No data available - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations: 0, 50, 170, 580 or 2000 mg/kg/day
- No. of animals per sex per dose:
- 15/sex/dose
- Control animals:
- yes
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data available
DETAILED CLINICAL OBSERVATIONS: No data available
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: No data available
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes
FOOD EFFICIENCY: Yes
WATER CONSUMPTION: No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes
URINALYSIS: Yes
NEUROBEHAVIOURAL EXAMINATION: No data available
OTHER: Organ weight - Sacrifice and pathology:
- GROSS PATHOLOGY: No data
HISTOPATHOLOGY: Yes - Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- Erythema, edema, and eschar formation was observed in all dosage groups
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 580 and 2000 mg/kg: Reduced body weight gain in females and in males.
- Food consumption and compound intake (if feeding study):
- not specified
- Description (incidence and severity):
- 580 and 2000 mg/kg: Food consumption elevations in females, lower efficiency food utilization in both male and females.
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- 580 and 2000 mg/kg: lower efficiency food utilization in both male and females.
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 170 mg/kg: Changes in hematology parameters in both sexes.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 580 and 2000 mg/kg: Serum glucose levels were depressed in males at week 7 and in both sexes at termination. BUN levels increased with dose in males.
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 170, 580 and 2000 mg/kg: Urine albumin levels were significantly increased in male groups at termination.
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- 50 mg/kg: Dose related increase in liver weight and.
170, 580 and 2000 mg/kg: Increases in the absolute and relative weights in the liver and kidneys in both sexes. - Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Severe tissue destruction and infection in the skin may have combined to elicit increased kidney weight at higher doses and epithelial eosinophilic globules in the convoluted tubules of the outer cortex. To determine if these effects were specific to male rat nephropathy, a review of the histopathology of kidney from rats in this study was conducted. This lesion occurred in a dose-responsive fashion in males only and was seen
also in male control rats. It was accompanied by interstitial nephritis in control and treated rats. The findings suggest an endogenous disease process which was exacerbated by the application of the irritating test material and marked skin necrosis. - Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- On the basis of the review of the kidney histopathology data and considering the dermal inflammation and infection in these animals, the results of this study are concluded to show a systemic NOAEL of topical alpha-isomethyl ionone of 50 mg/kg. Since erythema and eschar formation
occurred in all treatment groups, a NOAEL for this effect could not be established
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- histopathology: non-neoplastic
- other: On the basis of the review of the kidney histopathology data and considering the dermal inflammation and infection in the animals
- Remarks on result:
- other: No toxic effects were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- On the basis of the review of the kidney histopathology data and considering the dermal inflammation and infection in the rats, the results of this study are concluded to show a systemic NOAEL of topical test substance of 50 mg/kg.
- Executive summary:
A dermal subchronic study was conducted on Sprague-Dawley rats (15/sex/dose). An open application of test substance at a dose of 50, 170, 580 or 2000 mg/kg was made to the clipped backs, once daily for 90 days. The controls (60 rats/sex) were not treated with the test material. Observations for signs of toxicity including erythema and eschar formation, were performed daily. Body weight and food consumption data were measured weekly. Selective hematology, clinical chemistry and urinalysis assessment were conducted at weeks 7 and 13 of the study. A complete gross necropsy on all animals and a microscopic examination of tissues in the control and high dose animals were conducted at sacrifice. No treatment related deaths occurred. On the skin at the application site there was a dose-dependent increase in the severity of erythema, and eschar formation. At 50 mg/kg: Dose related increase in liver weight and changes in urinalysis parameters at this dose . At 170 mg/kg: Changes in hematology parameters in both sexes. BUN levels increased with dose in males. Urine albumin levels were significantly increased in male groups at termination. Increases in the absolute and relative weights in the liver and kidneys in both sexes. At 580 and 2000 mg/kg: Reduced body weight gain in females and in males. Food consumption elevations in females, lower efficiency food utilization in both male and females. Serum glucose levels were depressed in males at week 7 and in both sexes at termination. BUN levels increased with dose in males. Urine albumin levels were significantly increased in male groups at termination. Increases in the absolute and relative weights in the liver and kidneys in both sexes Moderate to severe erythema and eschar formation was observed in all test groups and increased with increasing levels of test material. Severe tissue destruction and infection on doses above 50 mg/kg may have combined to elicit increased kidney weight at higher doses. Since erythema and eschar formation occurred in all treatment groups, a NOAEL for this effect could not be established. On the basis of the review of the kidney histopathology data and considering the dermal inflammation and infection in these animals, the results of this study are concluded to show a systemic NOAEL of topical test substance of 50 mg/kg.
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