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Diss Factsheets
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EC number: 943-554-7 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 28 October - 30 November 1981
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: No guideline specified but procedure listed is similar to OECD Test Guideline 423: Acute toxic class method. Study was conducted according to GLP (certificate not included).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Principles of method if other than guideline:
- Initial dose was set at 5.0 g/kg and only two further doses were tested. Male rats were used (guideline suggests females as they are generally more sensitive).
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Celery ketone
- IUPAC Name:
- Celery ketone
- Reference substance name:
- 3-Methyl-5-propyl-2-cyclohexen-1-one
- IUPAC Name:
- 3-Methyl-5-propyl-2-cyclohexen-1-one
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 3 Methyl 5 propyl 2 cyclohexen 1 one
- Substance type: No data
- Physical state: clear liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: 3 Methyl 5 propyl 2 cyclohexen 1 one (unspecified percentage)
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 81-19
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: ambient room temperature and humidity in a container
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals
- Age at study initiation: No data
- Weight at study initiation: 211-275 g
- Fasting period before study: 16-20 hours
- Housing: suspended wire mesh cages (5/cage)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 28 October 1981 To: 30 November 1981
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Not applicable
- Amount of vehicle (if gavage): Not applicable
- Justification for choice of vehicle: Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
MAXIMUM DOSE VOLUME APPLIED: No data
DOSAGE PREPARATION (if unusual): Not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data - Doses:
- 1.2, 1.9, 5.0 g/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- LD50 (and 95% Confidence Levels) were calculated by the method of Litchfield and Wilcoxon
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 700 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 800 - <= 4 100
- Mortality:
- Nine out ten animals in the the highest dose group died during the observation period. One animal death was reported in each of the two other dose groups.
- Clinical signs:
- Coma, tremors, lethargy, ataxia, prostration, dyspnea, negative righting reflex
- Body weight:
- No data
- Gross pathology:
- Abnormalities of the heart, lungs, gastro-intestinal tract, urinary tract as well as breown staining of the anogenital and nose/mouth areas.
- Other findings:
- Not applicable
Any other information on results incl. tables
Dose level (g/kg) | Group size | Mortality | Day of death | ||
0 | 1 | 2 | |||
5.0 | 10 | 9 | 1 | 5 | 3 |
1.2 | 10 | 1 | 0 | 1 | 0 |
1.9 | 10 | 1 | 0 | 1 | 0 |
Applicant's summary and conclusion
- Conclusions:
- The acute oral toxicity of celery ketone was assessed using gavage dosing of male rats. The LD50 was calculated as 2.7 g/kg (95% CL: 1.8 to 4.1 g/kg).
- Executive summary:
The acute oral toxicity of celery ketone was assessed using groups of ten male rats dosed by gavage in a method similar to OECD TG 423 (no guideline specified). The LD50 was calculated as 2.7 g/kg (95% CL: 1.8 to 4.1 g/kg) by the method of Litchfield and Wilcoxon.
See attached in section 13, a read-across justification document for the use of Celery Ketone in read-across for Azarbre.
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