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EC number: 907-706-6 | CAS number: -
- 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:
- 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 peer-reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- Repeated dose oral toxicity study of the test chemical
- Author:
- Hagan et al
- Year:
- 1 967
- Bibliographic source:
- Fd Cosmet. Toxicol
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The chronic repeated dose toxicity study of the test chemical in rat was conducted to evaluate adverse effects by oral route.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one and 4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one
- EC Number:
- 907-706-6
- Molecular formula:
- C13H20O
- IUPAC Name:
- Reaction mass of 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one and 4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one
- Details on test material:
- - Name of test material: Reaction mass of 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one and 4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one
- IUPAC name: Reaction mass of 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one and 4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one
- Molecular formula: C13H20O
- Molecular weight: 192.3 g/mole
- Smiles : C1([C@@H](C(=CCC1)C)\C=C\C(C)=O)(C)C
- Inchl: 1S/C13H20O/c1-10-6-5-9-13(3,4)12(10)8-7-11(2)14/h6-8,12H,5,9H2,1-4H3/b8-7+
- Substance type: Organic
- Physical state: Solid (yellow)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Substance tested: Reaction mass of 4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one and -(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one Standard (60% alpha-ionone and 40% ß-ionone)
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Females (if applicable) nulliparous and non-pregnant: No data available
- Age at study initiation: Weanling rats used in the study.
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: The animals were housed individually in wire cages.
- Diet (e.g. ad libitum): Food, ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period: No data available
DETAILS OF FOOD AND WATER QUALITY: 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
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Diet
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: No data available
DIET PREPARATION
- Rate of preparation of diet (frequency): Fresh diets were made and distributed weekly.
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Diet
- Concentration in vehicle: 0, 50, 125, 500 mg/kg bw
- 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
- Duration of treatment / exposure:
- 17 weeks
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Remarks:
- (approximately equivalent to 0 mg/kg body weight)
- Dose / conc.:
- 1 000 ppm
- Remarks:
- (approximately equivalent to 50 mg/kg body weight)
- Dose / conc.:
- 2 500 ppm
- Remarks:
- (approximately equivalent to 125 mg/kg body weight)
- Dose / conc.:
- 10 000 ppm
- Remarks:
- (approximately equivalent to 500 mg/kg body weight)
- No. of animals per sex per dose:
- 0 ppm (approximately equivalent to 0 mg/kg body weight) : 10 male and 10 female
1000 ppm (approximately equivalent to 50 mg/kg body weight) : 10 male and 10 female
2500 ppm (approximately equivalent to 125 mg/kg body weight) : 10 male and 10 female
10,000 ppm (approximately equivalent to 500 mg/kg body weight) : 10 male and 10 female - Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Not specified
- Time schedule: Not specified
- Cage side observations checked in table [No.?] were included. Not specified
DETAILED CLINICAL OBSERVATIONS: Not specified
- Time schedule: Not specified
BODY WEIGHT: Yes
- Time schedule for examinations: Recorded every week.
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: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
- The rat's food intake were recorded every week.
FOOD EFFICIENCY:Not specified
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
- Time schedule for examinations: Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Not specified
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: Not specified
- Parameters checked in table [No.?] were examined: These examinations included white cell counts, red cell counts, haemoglobins and haematocrits.
CLINICAL CHEMISTRY: Not specified
- Time schedule for collection of blood: Not specified
- Animals fasted: Not specified
- How many animals:Not specified
- Parameters checked in table [No.?] were examined. Not specified
URINALYSIS: Not specified
- Time schedule for collection of urine:Not specified
- Metabolism cages used for collection of urine: Not specified
- Animals fasted: Not specified
- Parameters checked in table [No.?] were examined. Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified
- Time schedule for examinations: Not specified
- Dose groups that were examined: Not specified
- Battery of functions tested: sensory activity / grip strength / motor activity / other: Not specified
IMMUNOLOGY: Not specified
- Time schedule for examinations: Not specified
- How many animals: Not specified
- Dose groups that were examined: Not specified
- Parameters checked in table [No.?] were examined: Not specified
OTHER: General condition of rats were recorded every week. - Sacrifice and pathology:
- At the termination of the experiment the rats were sacrificed and exsanguinated.
GROSS PATHOLOGY: Yes
The tissues of all the rats were examined macroscopically at the time of sacrifice. The viscera were removed and the liver, kidneys, spleen, heart, and testes were weighed.
HISTOPATHOLOGY: Yes
These organs, the remaining abdominal and thoracic viscera, and one hind leg, for bone, bone marrow, and muscle, were preserved in 10 % buffered formalin-saline solution for histopathological examination. - Other examinations:
- No data available
- Statistics:
- No data 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 adverse effects were observed on final body weight of rats on all levels of the test chemical in the diet.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No adverse effects were observed on food intake of rats on all levels ofthe test chemical in the diet.
- Food efficiency:
- not specified
- 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 adverse effects were observed on haematology of rats on all levels of the test chemical in the diet.
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- No adverse effects were observed on growth and appearance of rats on all levels of the test chemical in the diet.
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No adverse effects were observed on organ weights of rats on all levels of the test chemical in the diet.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No adverse effects were observed on macroscopic appearance of organs of rats on all levels of the test chemical in the diet.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- A dose-dependent slight to moderate swelling of liver parenchyma was noted which occurred to a very slight degree at the lowest level.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
- other: No adverse effects were seen.
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- It was concluded that the no-observed adverse effect level (NOAEL) of the test chemical in this chronic study was considered to be 125.0 mg/kg bw.
- Executive summary:
The chronic repeated dose toxicity study of the test chemical in rat was conducted to evaluate adverse effects by oral route. Groups of 10 male and 10 female rats were maintained for 17 weeks on diets containing the test chemical at levels of 0, 1000, 2500, and 10.000 ppm (approximately equivalent to 50, 125, and 500 mg/kg body weight). No adverse effects were observed on growth, appearance, food intake, haematology, final body weight, organ weights or macroscopic appearance of organs of rats on all levels of the test chemical in the diet. However, microscopic examination revealed swelling of the hepatic parenchymal cells at all dietary levels. This "swelling of parenchymal cells" was dose-dependent, being "slight to moderate" at the highest dietary level (500 mg/kg bw/day), "slight" at the intermediate level (125 mg/kg bw/day), and "very slight" at the lowest level (50 mg/kg bw/day). Thus, it was concluded that the no-observed adverse effect level (NOAEL) of the test chemical in this chronic study was considered to be 125.0 mg/kg bw.
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