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EC number: 204-841-6 | CAS number: 127-41-3
- 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: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication .
Data source
Reference
- Reference Type:
- publication
- Title:
- Repeated oral toxicity study of the test chemical
- Author:
- Oser et al
- Year:
- 1 965
- Bibliographic source:
- Food and Cosmetic Toxicology
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- A repeated dose study was conducted to investigate the effects of test substance in rats for 90 days when administered orally.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
- EC Number:
- 204-841-6
- EC Name:
- 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
- Cas Number:
- 127-41-3
- Molecular formula:
- C13H20O
- IUPAC Name:
- 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one
- Details on test material:
- - Name of test material: alpha -Ionone
- Molecular formula: C13H20O
- Molecular weight: 192.3 g/mol
- Substance type:organic
- Physical state:liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: FDRL
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source:Not available
- Age at study initiation: Not available
- Weight at study initiation: 59.5±1.5 g(males) and 58.0±1.6 g (females)
- Fasting period before study: Not available
- Housing: Animals were housed individually in wiremesh cages.
- Diet (e.g. ad libitum): Purina Laboratory Chow, ad libitum
- Water (e.g. ad libitum): Fresh water, ad libitum
- Acclimatization period: No data available
ENVIRONMENTAL CONDITIONS
Not available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Purina Laboratory Chow
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Test substance was diluted in cotton-seed oil in a concentration sufficient to provide the predetermined dosage in 2% of the diet. The oil solutions were incorporated into basal ration.
DIET PREPARATION
- Rate of preparation of diet (frequency): biweekly
- Mixing appropriate amounts with (Type of food): nutritional adequate basal ration (Purina Laboratory Chow)
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Purina Laboratory Chow
- Concentration in vehicle: 0 or 10.6 mg/kg body weight/day (expected dose) (0 or 11.8 (males) and 11.1 (females) mg/Kg bw/day)
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not available
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 or 10.6 mg/kg body weight/day (expected dose) (0 or 11.8 (males) and 11.1 (females) mg/Kg bw/day)
Basis:
nominal in diet
- No. of animals per sex per dose:
- Control: 15 males, 15 females
10.6 mg/kg/day: 15 males, 15 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Single dosage levels for each substance were derived from total estimated daily intake, calculated on a mg/kg body weight basis assuming 50kg as the average body weight, and multiplying by 100.
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data available
BODY WEIGHT: Yes
- Time schedule for examinations: No data available
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
- Time schedule for examinations: No data available
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 6 and 12 week period
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: 8 rats of each sex at a 6-week period and all rats at 12 weeks.
- Parameters checked:Haematocrit,haemoglobin, red blood cells, white blood cells, neutrophils, lymphocytes and blood urea nitrogen.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 6 and 12 week period
- Animals fasted: No data available
- How many animals: 8 rats of each sex at a 6-week period andall rats at 12 weeks.
- Parameters checked:Endpoints not specified.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER:No other observations described. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
At autopsy, liver and kidney weights were recorded.
HISTOPATHOLOGY: Yes
Organs from half of the animals in each group were taken for histological examination. The following organs and tissues were investigated: liver, kidneys, stomach, small and large intestines, spleen, pancreas, heart, lungs, bonemarrow, muscle, brain, spinal cord, bladder, adrenals, thyroid, pituitary, gonads, salivaryglands and lymph nodes. - Other examinations:
- No other examinations.
- Statistics:
- Not available
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on body weight and weight gain were observed.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effect in food consumption and compound intake were observed.
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- No effect in food efficiency was observed.
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No effect in any the examined heamotological parameters was noted.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No effect in clinical chemistry was observed.
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Liver and kidney weights were normal.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No significant gross pathological changes were observed, with the exception of occasional pulmonary alterations associated with a respiratory infection.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No dose related effect was observed.
- Histopathological findings: neoplastic:
- not specified
- Description (incidence and severity):
- It was also noted that a few of the animals in the treated group and their corresponding controls showed a slight degree of reactive lymphatic hyperplasia; in the case of one male in the treated group this was associated with foci of myeloid metaplasia. However these effects were considered to be dose independent effects.
- Details on results:
- Body weight and weight gain: No effects observed on rat weight or weight gain.
FOOD CONSUMPTION AND COMPOUND INTAKE:No effects observed at intake of 11.8 mg/kg/day(males) and 11.1 mg/kg/day(females).
FOOD EFFICIENCY: No effects observed.
HAEMATOLOGY: No other effects observed in any of the parameters examined.
CLINICAL CHEMISTRY: No effects observed in the blood parameters examined.
GROSS PATHOLOGY: No significant gross pathological change was observed at autopsy in any of the rats in
this study.
Histopathology: slight lymphatic hyperplasia.No other effects observed.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 11.1 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No effects were observed based on evaluations of body weight, food and water intake, hematology, bloodchemistry,liver and kidney weights and histopathology.
- Remarks on result:
- other: No toxic effect were observed
- Dose descriptor:
- NOAEL
- Effect level:
- 11.8 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No effects were observed based on evaluations of body weight, food and water intake, hematology, bloodchemistry,liver and kidney weights and histopathology.
- Remarks on result:
- other: No toxic effect were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No Obserevd adverse effect level (NOAEL) was considered to be the measured dose of 11.8 mg/kg/day in male and 11.1 mg/kg/day in female FDRL rats. The expected dose of test chemical was 10.6 mg/kg/day.
- Executive summary:
Repeated dose oral 90 days study was performed to determine the toxic nature of the test chemical. Male and female FDRL rats were fed diet containing 0 or 10.6 mg/kg/day test chemical, a concentration that was reported by conducted measurement to provide an average intake of 11.8 mg/kg/day for males and 11.1 mg/kg/day for females for 90 days. In addition to the usual observations (i.e. body weight and food consumption), haematologieal and blood chemical determinations were made on 8 rats of each sex at a 6-wk period, and in all rats at 12 wk. The tests were terminated at 0 days and at autopsy, liver and kidney weights were recorded and the following organs from half the animals in each group were taken for histological examination: liver, kidneys, stomach, small and large intestines, spleen, pancreas, heart, lungs, bone marrow, muscle, brain, spinal cord, bladder, adrenals, thyroid, pituitary, gonads, salivary glands, and lymph nodes. No exposure-related effects were observed based on evaluations of body weight, food intake, hematology, blood chemistry (endpoints not specified), liver and kidney weights and histopathology. Therefore, the No Observed Adverse Effect Level (NOAEL) for male FDRL rats was considered to be 11.8 mg/kg/day while NOAEL for female FDRL rats was considered to be 11.1 mg/kg/day when exposed to test chemical
.
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