Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 275-156-8 | CAS number: 71048-82-3
- 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:
- other information
- Study period:
- 1980
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, non-guideline, published in peer reviewed literature, limitations in design and/or reporting, not adequate for assessment due to endogenous disease of the test animals.
Data source
Reference
- Reference Type:
- publication
- Title:
- A toxicologic and dermatologic assessment of ionones when used as fragrance ingredients
- Author:
- Belsito D. et al.
- Year:
- 2 007
- Bibliographic source:
- Food and Chemical Toxicology 45 (2007) S130-SI67
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- no data
- 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
- IUPAC Name:
- 3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one
- Reference substance name:
- Aplha-Iso-Methylionone
- IUPAC Name:
- Aplha-Iso-Methylionone
- Details on test material:
- no data
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Via clipped skin
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- no data
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
50
Basis:
analytical per unit body weight
- Remarks:
- Doses / Concentrations:
170
Basis:
analytical per unit body weight
- Remarks:
- Doses / Concentrations:
580
Basis:
analytical per unit body weight
- Remarks:
- Doses / Concentrations:
2000
Basis:
analytical per unit body weight
- No. of animals per sex per dose:
- 15/sex/dose
- Control animals:
- not specified
- Details on study design:
- no data
- Positive control:
- yes
Examinations
- Observations and examinations performed and frequency:
- Clinical, laboratory evaluations were conducted
- Sacrifice and pathology:
- Gross and histopathological evaluations were conducted.
- Other examinations:
- no data
- Statistics:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Body weight gains were significantly reduced in females in the highest dose group and in males treated at 580 and 2000 mg/kg body weight/day. Total food consumption throughout the study was significantly increased in females treated at the 2 highest dose levels and there was a significant decrease in food efficiency and food intake in both sexes in the 2 highest dose groups. The body weight changes may not represent a direct, test-material-related effect many of these animals manifested severe skin lesions. There were hematological changes in the 2 highest dose groups and reduced serum glucose in the high-dose animals, all largely attributable to the inflammation and infection at the site of application.
A significant increase in serum BUN was reported in males in the top 2 dose groups. Urinalysis showed a significant increase in the incidence of albuminuria in males in the 3 highest dose groups. In the high-dose males, abundant eosinophilic globules were observed in the kidney epithelium at necropsy. At necropsy there was a significant increase in the absolute and relative liver weights in both sexes at all dose levels. Increases, most of which attained statistical significance, in the absolute and relative weights of the kidneys were reported in all but the lowest dose groups of each sex. The absolute adrenal weights were significantly increased in the 2 highest dose groups of both sexes.
The interpretation of the data is complicated by the severe skin damage at the application site, especially in the 2 highest dose groups. Depressed body weight gains and increased neutrophil count are probably attributable to infection and inflammation. Azotemia and proteinuria likely are a result of chronic severe tissue damage and infection. The liver weight increase probably resulted from induction of microsomal mixed-function oxidases. Increased adrenal weights probably reflect the response to stress caused by tissue damage and infection. 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 kidneys 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. Body weight gains were significantly reduced in females in the highest dose group and in males treated at 580 and 2000 mg/kg body weight/day. Total food consumption throughout the study was significantly increased in females treated at the 2 highest dose levels and there was a significant decrease in food efficiency and food intake in both sexes in the 2 highest dose groups. The body weight changes may not represent a direct, test-material-related effect many of these animals manifested severe skin lesions. There were hematological changes in the 2 highest dose groups and reduced serum glucose in the high-dose animals, all largely attributable to the inflammation and infection at the site of application. A significant increase in serum BUN was reported in males in the top 2 dose groups. Urinalysis showed a significant increase in the incidence of albuminuria in males in the 3 highest dose groups. In the high-dose males, abundant eosinophilic globules were observed in the kidney epithelium at necropsy. At necropsy there was a significant increase in the absolute and relative liver weights in both sexes at all dose levels. Increases, most of which attained statistical significance, in the absolute and relative weights of the kidneys were reported in all but the lowest dose groups of each sex. The absolute adrenal weights were significantly increased in the 2 highest dose groups of both sexes.
The interpretation of the data is complicated by the severe skin damage at the application site, especially in the 2 highest dose groups. Depressed body weight gains and increased neutrophil count are probably attributable to infection and inflammation. Azotemia and proteinuria likely are a result of chronic severe tissue damage and infection. The liver weight increase probably resulted from induction of microsomal mixed-function oxidases. Increased adrenal weights probably reflect the response to stress caused by tissue damage and infection. 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 kidneys 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.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- <= 50 mg/kg bw/day
- Sex:
- not specified
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Route: .live2