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Diss Factsheets
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EC number: 223-069-0 | CAS number: 3720-16-9
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 June 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-methyl-5-propylcyclohex-2-enone
- EC Number:
- 223-069-0
- EC Name:
- 3-methyl-5-propylcyclohex-2-enone
- Cas Number:
- 3720-16-9
- Molecular formula:
- C10H16O
- IUPAC Name:
- 3-methyl-5-propylcyclohex-2-en-1-one
- Reference substance name:
- 3-methyl-5-propylcyclohexen-2-one
- IUPAC Name:
- 3-methyl-5-propylcyclohexen-2-one
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): 3-Methyl-5-propylcyclohexen-2-one
- Substance type: No data
- Physical state: colourless to slightly yellow liquid
- Analytical purity: 99.9%
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: 3-Methyl-5-propylcyclohexen-2-one (99.9%)
- Isomers composition: No data
- Purity test date: 6 March 2014
- Lot/batch No.: SC00005427
- Expiration date of the lot/batch: 16 December 2014
- Stability under test conditions: No data
- Storage condition of test material: room temperature in the dark
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- other: chicken eye
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Etablissement Brun, 33820 Etauliers, France
- Age at study initiation: 7 weeks
- Weight at study initiation: 1.5-2.5 kg
- Housing: Not applicable
- Diet (e.g. ad libitum): Not applicable
- Water (e.g. ad libitum): Not applicable
- Acclimation period: Eyes were incubated between 54 and 67 minutes to equilibrate them to the test system prior to dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 31.9-33
- Humidity (%): Not applicable
- Air changes (per hr): Not applicable
- Photoperiod (hrs dark / hrs light): Not applicable
IN-LIFE DATES: From: 4 June 2014 To: 4 June 2014
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: one negative and three postive controls
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 μL
- Concentration (if solution): Not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- 4 hours
- Number of animals or in vitro replicates:
- 3 enucleated chicken eyes
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with 20 mL of physiological saline
- Time after start of exposure: 10 seconds
SCORING SYSTEM: ICE classes were assigned based on a pre-determined range (see table) as specified in the guideline
TOOL USED TO ASSESS SCORE: corneal swelling was assessed using a slit-lamp microscope
OTHER:
Negative control: physiological saline
Positive control: 5% Benzalkonium chloride (0.5 g in 10 mL physiological saline)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: maximal mean corneal opacity score
- Basis:
- mean
- Time point:
- other: 120-240 minutes
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- other: fluorescein retention
- Basis:
- mean
- Time point:
- other: 30 minutes
- Score:
- 0.5
- Max. score:
- 3
- Irritation parameter:
- other: maximal cornea swelling
- Basis:
- mean
- Time point:
- other: 75 minutes
- Score:
- 18
- Max. score:
- 100
- Irritant / corrosive response data:
- No data
- Other effects:
- No data
Any other information on results incl. tables
Endpoint measured | Eye Number | Time/min | |||||
0 | 30 | 75 | 120 | 180 | 240 | ||
Corneal opacity | 9 | 0 | 1 | 2 | 3 | 3 | 3 |
10 | 0 | 1 | 2 | 3 | 3 | 3 | |
11 | 0 | 1 | 2 | 3 | 3 | 3 | |
Mean | 0.0 | 1.0 | 2.0 | 3.0 | 3.0 | 3.0 | |
ICE Class | IV | ||||||
Fluorescein retention | 9 | 0 | 0.5 | ||||
10 | 0.5 | 0.5 | |||||
11 | 0.5 | 0.5 | |||||
Mean | 0.3 | 0.5 | |||||
ICE Class | I | ||||||
Corneal swelling | 9 | - | 11 | 14 | 13 | 11 | 14 |
10 | - | 2 | 16 | 18 | 16 | 16 | |
11 | - | 15 | 25 | 16 | 18 | 16 | |
Mean | - | 9 | 18 | 16 | 15 | 15 | |
ICE Class | III | ||||||
Classification | Non "corrosive/severe irritant" |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a guideline study (OECD TG 438), to GLP, celery ketone was not corrosive/severe irritant to the eye according EU labelling regulations.
- Executive summary:
In an OECD guideline study (TG 438), conducted according to GLP, celery ketone was not a corrosive/severe irritant to the chicken eye. In accordance with EU regulations, the test item does not require the classification Category 1 (irreversible effects on the eyes).
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.
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