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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: 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from a peer-reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicological Tests on Flavouring Matters
- Author:
- B. L. Oser
- Year:
- 1 965
- Bibliographic source:
- Food and cosmetics toxicology
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: see Principles below
- Principles of method if other than guideline:
- A repeated dose study investigating the effect of test substance in rats..
- GLP compliance:
- not specified
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:
- other: FDRL
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: Males: 59.5 ±1.5 g; Females: 58.0 ± 1.6 g
- Fasting period before study: No data available
- Housing: Animals were housed individually in wire mesh 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
- Temperature (°C):No data available
- Humidity (%):No data available
- Air changes (per hr):No data available
- Photoperiod (hrs dark / hrs light):No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The 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 a nutritionally adequate basal ration (Purina Laboratory Chow).
DIET PREPARATION
- Rate of preparation of diet (frequency): Biweekly
- Mixing appropriate amounts with (Type of food): Purina Laboratory Chow
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Cotton-seed oil
- Concentration in vehicle: 2% of the diet.
- 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:
- No data available
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations: 3.66 mk/kg (measured conc. 3.55 mg/kg (males) and 4.10 mg/kg (females))
- No. of animals per sex per dose:
- Total: 60 rats
Control: 15 males, 15 females
3.66 mg/kg: 15 males, 15 females - Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Single dosage levels for each substance were derived from the total estimated daily intake, calculated on a mg/kg body weight basis assuming 50 kg as the average body weight, and multiplying by 100.
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data available
DETAILED CLINICAL OBSERVATIONS: No data available
BODY WEIGHT: Yes
- Time schedule for examinations: Not specified
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- 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: No data available
FOOD EFFICIENCY: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 6 week and 12 week
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: 8 rats of each sex at 6 week period and all rats at 12 week period
- Parameters examined: Hematocrit, hemoglobin, red blood cells white blood cells, neutrophils and lymphocytes.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 6 week and 12 week
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: 8 rats of each sex at 6 week period and all rats at 12 week period
- Parameters examined: Blood urea nitrogen
URINALYSIS: No data available
NEUROBEHAVIOURAL EXAMINATION: No data available - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
At autopsy, liver and kidney weights were recorded.
HISTOPATHOLOGY: Yes
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. - Other examinations:
- No data available
- Statistics:
- Statistical limits (P=0.05) for the controls.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- 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):
- The males showed a slightly reduced haemoglobin level but the haematocrit and erythrocyte counts were within the control ranges.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The males also had a mean blood urea nitrogen level somewhat below that of the composite controls.. However, the male control rats showed a mean blood urea nitrogen at 12 wk of 9.2 mg/100 ml; the value at 6 wk was 10.8 compared with 9.9 mg/100 ml for the controls.
- 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 throughout the study.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No significant gross pathological change was observed at autopsy in any of the rats in this study.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 3.55 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- clinical biochemistry
- gross pathology
- haematology
- Remarks on result:
- other: No toxiceffect were observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 4.1 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical biochemistry
- gross pathology
- haematology
- 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 test substance was considered to have a NOAEL of 3.55 mg/kg/day in male rats and 4.10 mg/kg/day in female rats after 90-Days of feeding.
- Executive summary:
The activity of test substance was studied in a 90-day feeding studies in rats. The test material was given orally in diet to male and female FDRL rats at a dose concentration of 3.66 mg/kg (actual dose received: 3.55 mg/Kg bw/day for males and 4.10 mg/Kg bw/day for females). No significant gross pathological change was observed at autopsy in any of the rats, and only mino effects were seen on hemoglobin and blood urea nitrogen in male rats. The 90-day feeding study corresponded to at least 100 times the maximum estimated human dietary levels, and revealed no evidence of adverse toxic effects. Therefore, NOAEL was considered to be 3.55 mg/bg bw/day in male rats and 4.10 mg/kg bw/day in female rats.
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