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EC number: 203-816-7 | CAS number: 110-93-0
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The results were taken from a review which discusses the Freund's Complete Adjuvant Test and the Open Epicutaneous Test. Data for about 300 fragrance raw materials were presented in tabular form.
Data source
Reference
- Reference Type:
- publication
- Title:
- The Freund's complete adjuvant test and the open epicutaneous test
- Author:
- Klecak G
- Year:
- 1 985
- Bibliographic source:
- Curr. Probl. Derm., vol. 14, 152-171, Karger, Basel
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Open epicutaneous test:
1. Pretest: establishing the primary irritating threshold concentration of the test substance
2. Main study:induction phase: a 3-week period of daily open applications of the test material usually to the same skin site (21 applications)challenge phase: induced and control animals are tested on day 21 and day 35 by topical application of the test substance if sensitisation has occurred - GLP compliance:
- no
- Remarks:
- pre GLP
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- Existing OET of good quality that was generated before 11 October 2016.
Test material
- Reference substance name:
- 6-methylhept-5-en-2-one
- EC Number:
- 203-816-7
- EC Name:
- 6-methylhept-5-en-2-one
- Cas Number:
- 110-93-0
- Molecular formula:
- C8H14O
- IUPAC Name:
- 6-methylhept-5-en-2-one
- Details on test material:
- - Name of test material (as cited in study report): methyl heptenone
- Analytical purity: no data given
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300 - 450g
- Diet: ad libitum
- Water: ad libitum
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: not specified for methyl heptenone
- Concentration / amount:
- Pretest: 1; 3; 10; 30; 100 %; not specified for methyl heptenoneInduction: 0.3; 1; 3; 10; 30; 100%; not specified for methyl heptenone
- Day(s)/duration:
- 20 days
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- other: not specified for methyl heptenone
- Concentration / amount:
- Challenge: min. irritating concentration and three 3-fold serial dilutions (3% for methyl heptenone)
- Day(s)/duration:
- 2 exposures, on days 21 and 35. The reactions are read after 24,48 and/or 72h
- No. of animals per dose:
- Pretest: 6-8 animals; Main study: 6-8 animals per dose in the main study; control: 10 animals
- Details on study design:
- Threshold irritation concentration:
- No. of exposures: 1
- Exposure period: 24 hours
- Control group: vehicle or negative control
- Site: clipped flank
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 21
- Control group: no pretreatment or vehicle (not specified for methyl heptenone)
- Site: clipped flank- Duration: 3 weeks
- Frequency of applications: daily
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 21, 35
- Site: clipped flank
- Evaluation (hr after challenge): 24, 48, 72 - Challenge controls:
- 4 dilutions containing the minimal-irritant and maximal-non irritant concentration in non-pretreated or 21-day vehicle pretreated animals (no further data given)
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: all readings
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 8
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: all readings
- Group:
- negative control
- Dose level:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none specified
- Remarks on result:
- other: control result not specified
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
methyl heptenone was negative in the OET in guinea pigs.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria
- Conclusions:
- Under the conditions of this study, the substance was not found to be sensitising. Based on this result, Methylheptenone does not need to be classified as skin sensitiser in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
Male and female guinea pigs, weighing 300-450g, were used in experimental groups of at least 6 guinea pigs for every concentration group. For controls 10 animals were used. Methylheptenone is applied epicutaneously, uncovered, undiluted and at concentrations of 30, 10, 3 and 1% or lower in a suitable vehicle. Constant volumes of each concentration were applied with a pipette or syringe on standard sites of the clipped flank of each animal. 1 day before starting the induction procedure, the threshold irritating concentration of methylheptenone was estimated on the guinea pigs subsequently used for the experimental group. A single application of 0.025 ml of each test concentration (e.g, 100,30,10 and 3%) was simultaneously performed on one of the sites measuring 2 cm2 of the flank skin previously clipped and marked with a circular stamp. Reactions were read 24 h after the application of the test material.
On day 1application of 0.1 ml of methylheptenone is performed to an site measuring 8 cm2 on the clipped flank skin of the guinea pigs. The applications were repeated daily for 3 weeks or done 5 times weekly during 4 weeks, usually on the same skin sites. The application sites were left uncovered and the reactions, if continuous daily applications were performed, were read 24 h after each application, or at the end of each week.
To determine whether or not contact sensitization was induced, all groups of guinea pigs previously treated for 21 days as described above, as well as 10 untreated, or only pretreated with the vehicle, controls were tested on days 21 and 35 on the contralateral flank with methylheptenone at the minimal irritating and some lower primary nonirritating concentrations. These tests were performed by applying with a pipette 0.025 ml of each concentration to skin sites measuring 2 cm2. The reactions were read after 24,48 and/or 72h. Methyl heptenone was negative in this OET in guinea pigs. Based on this result, Methylheptenone does not need to be classified as skin sensitiser in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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