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EC number: 203-937-5 | CAS number: 112-12-9
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09-March-2002 to 11-July-2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted
17 July 1992
- GLP compliance:
- yes
- Remarks:
- (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing GPMT study of good quality that was generated before 11 October 2016.
Test material
- Reference substance name:
- Undecan-2-one
- EC Number:
- 203-937-5
- EC Name:
- Undecan-2-one
- Cas Number:
- 112-12-9
- Molecular formula:
- C11H22O
- IUPAC Name:
- undecan-2-one
- Test material form:
- liquid
- Details on test material:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 05500109421007
- 07 November 2001
- Storage conditions room temperature in the dark
- clear colourless liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 05500109421007
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperatt,rre in the dark
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test material was used as supplied
OTHER SPECIFICS: clear colourless liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK and Harlan UK Limited, Bicester, Oxon, UK. (The animals used in the topical induction sighting study were obtained from Harlan UK Limited and those for the remainder of the study were from David Hall Limited)
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 300 to 450g,
- Housing: oused singly or in pairs in solid-floor polypropylene cages furnished with woodflakes. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Diet: ad libitum, Certified Guinea Pig Diet (Code 5026) supplied by PMI Nutrition International, Nottingham, UK
- Water: ad libitum
- Acclimation period: acclimatisation period of at least five days
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- 1% (v/v)
- Day(s)/duration:
- 1 injection, with evaluation after 24 and 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adjuvant 1:1 Distilled water
- Concentration / amount:
- 1% (v/v)
- Day(s)/duration:
- 1 injection, with evaluation after 24 and 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adjuvant 1:1 diluted with Distilled water
- Concentration / amount:
- 0%
- Day(s)/duration:
- 1 injection, with evaluation after 24 and 48 hours
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Undiluted
Loaded WHATMAN No. 4 dressing, 40 mm x 20 mm - Day(s)/duration:
- Exposure for 48 h (7 days after intradermal induction)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- 100% and 75% (v/v)
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 (Each animal was exposed to the substance 100% on one flank and 75% (v/v) on the other)
- Details on study design:
- RANGE FINDING TESTS:
Range for Intradermal induction:
- Exposure period: 1 Injection
- Number of animals: 2
- Site: Shoulder (clipped)
- Observation period: 24/48/72 h and 7 Days
- Concentrations: 1% and 5% (v/v) in Arachis Oil
Range for Topical induction:
- Exposure period: 48 h (occusive)
- Number of animals: 2
- Site: flank (clipped)
- Observation period: 1/24/48 h after dressing removal
- Concentrations: 75%, 50% arid 25% v/v in arachis oil BP
Range for Topical challenge:
- Exposure period: 24 h (occusive)
- Number of animals: 2 (Animals were treated identically to the control animals of the main study)
- Site: flank (clipped)
- Observation period: 1/24/48 h after dressing removal
- Concentrations: 75%, 50% arid 25% v/v in arachis oil BP
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal, 1 epicutaneous
Intradermal
- Exposure period: 1 injection
- Test group: 1
- Control group: 1
- Site: shoulder
- Frequency of applications: once
- Observation period: 24/48 h
- Concentrations:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1: 1
b) a 1 % v/v formulation of the test material in arachis oil BP
c) a 1 % v/v formulation of the test material in a 1: 1 preparation of Freund's Complete Adjuvant plus distilled water epicutaneous
- Exposure period: 48 hours (7 days after intradermal induction)
- Test groups: 1
- Control group: 1
- Site: shoulder
- Observation period: 24 h after removal of the patch
- Frequency of applications: once
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Site: flank (Shorn)
- Observation period: 24/48 h after removal of the patch
- Concentrations: 100% and 75%
- Evaluation (hr after challenge):
OTHER: The challenge sites were swabbed with cotton wool soaked in diethyl ether to remove residual material. The position of the treatment sites was identified by using a black indelible marker-pen. - Challenge controls:
- The procedure was identical to that used for the test animals except that the test material was omitted.
- Positive control substance(s):
- yes
- Remarks:
- Historical control data: 2-Mercaptobenzothiazole and alpha-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Historical data:
- 2-Mercaptobenzothiazole: 100% sensitisation
- alpha-Hexylcinnamaldehyde: 20-50% sensitisation
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Neg.Control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Neg. Control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified Annex I of the CLP Regulation (1272/2008/EC)
- Conclusions:
- Based on the results in this study the compound does not need to be classified as a skin sensitizer in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
The study was performed to assess the contact sensitisation potential of Methyl Nonyl Ketone in the albino guinea pig. The method was designed to meet the requirements of OECD guideline No. 406, and was performed under GLP. Ten test and five control animals were used for the study. Two phases were involved in the main study; an induction of a response by intradermal injection and topical application and a topical challenge of that response. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as: 1 % v/v in arachis oil BP for intradermal induction, undiluted for topical induction, undiluted as supplied and 75% v/v in arachis oil BP for topical challenge. Under the conditions of the test, the test material produced a 0% sensitisation rate.The test material therefore does not need to be classified as a skin sensitizer in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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