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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4-04-2002 to 18-04-2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is with registered substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml
- Concentration (if solution): undiluted
VEHICLE
- No vehicle
NEGATIVE CONTROL
- Not applicable
POSITIVE CONTROL
- Not applicable - Duration of treatment / exposure:
- The cotton gauze patch was removed after 4 hours.
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: the back of each rabbit
- % coverage: the patch is 2.5 by 2.5 cm in size
- Type of wrap if used: cotton gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with cotton wool soaked in 74% Industrial Methylated Spirits
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
one hour, 24, 48 and 72 hours after removal of the patches
SCORING SYSTEM:
- Method of calculation:The scores for erythema and oedema at the 24- and 72- hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the study material.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days After 7 days crust formation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days After 7 days there was crust formation observed
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 3
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Erythema: Well defined erythema was noted for all animals within the first 72 hours following removal of the patch. Crust formation was observed after 7 days. The effects were fully reversible after 14 days.
Oedema: Slight oedema was noted for all animals within the first 72 hours following removal of the patch. Adverse reactions prevented the evaluation after 7 days for test animal #93, but the effects for testanimal #91 and #94 were fully reversible after 14 days.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 irritant Annex I of the CLP Regulation (1272/2008/EC)
- Conclusions:
- Based on the results in this study the compound needs to be classified as a category 2 irritant in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
An acute dermal irritation study was conducted, according to OECD GL 404, on 3 male New Zealand White rabbits using the test material Methyl Nonyl Ketone. 0.5 ml of the test material was applied under semi-occlusion to the clipped backs of the 3 rabbits. The patch was removed after 4 hours. Observations for dermal irritation or defects were made at 1, 24, 48 and 72 hours after patch removal, and after 7 and 14 days. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced well-defined erythema and slight to moderate oedema. Crust formation was noted at all treated skin sites at the 7-day observation. All treated skin sites appeared normal at the 14-day observation. The test material produced a primary irritation index of 4.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. Based on these results Methyl Nonyl Ketone needs to be classified as a category 2 irritant in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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