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EC number: 203-662-0 | CAS number: 109-29-5
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 August 2009 - 08 September 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 24 April 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Commission Regulation No. 440/2008
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Pentadecan-15-olide
- EC Number:
- 203-354-6
- EC Name:
- Pentadecan-15-olide
- Cas Number:
- 106-02-5
- Molecular formula:
- C15H28O2
- IUPAC Name:
- oxacyclohexadecan-2-one
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: soluble in acetone/olive oil 4:1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- (CBA/CaOlaHsd)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: individuall in suspended solid-floor polypropylene cages furnished with softwood woodflakes
- Diet (e.g. ad libitum): 2014 Teklad Global Rodent diet, Harlan Teklad, Blackthorn, Bicester, Oxon, UK, ad libitum
- Water (e.g. ad libitum): mains tap water, ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: none
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 (target)
- Humidity (%): 30-70 (target)
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 26 August 2009 To: 8 September 2009
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 50% w/w in the prelimianry study
50%, 25% and 10% w/w in the main study - No. of animals per dose:
- Preminary study: 1
Main study: 4 females/dose - Details on study design:
- PRE-SCREEN TESTS:
- Irritation: no excessive local irritation
- Systemic toxicity: there were no signs of systemic toxicity during 6 days post-administration
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
The test material is regarded as a sensitizer if at least one concentration of the test material results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test material feiling to produce a threefold or greater increase in 3HTdR incorporation will be classified as a non-sensitizer.
TREATMENT PREPARATION AND ADMINISTRATION: The test mateial was freshly prepared as a solution in acetone/olive oil 4:1. The mice were treated by daily application of 25 µL of the test material at a concentration of 50%, 25% and 10% of the test material to the dorsal surface of each ear for three consecutive days. The test material forulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not applied.
Results and discussion
- Positive control results:
- Hexyl cinamic aldehyde produced SI of 8.34 at 15% (v/v) in acetone/olive oil (project number 0039/1080, study dates 24 April 2009-30 April 2009).
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.34
- Test group / Remarks:
- 10% cyclohexadecanone
- Key result
- Parameter:
- SI
- Value:
- 1.92
- Test group / Remarks:
- 25% cyclohexadecanone
- Key result
- Parameter:
- SI
- Value:
- 2.56
- Test group / Remarks:
- 50%
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA:
DPM:
Vehicle 15727.81
10% cyclohexadecanone: 20996.87
25% cyclohexadecanone: 30196.62
50% cyclohexadecanone: 40312.02
DETAILS ON STIMULATION INDEX CALCULATION
DPM/Node:
Vehicle: 1965.98
10% cyclohexadecanone: 2624.61
25% cyclohexadecanone: 3774.58
50% cyclohexadecanone: 5039.00
CLINICAL OBSERVATIONS:
There were no clinical signs noted.
BODY WEIGHTS
There were no mortalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the reliable OECD 429 guideline study performed with 50%, 25% and 10% test substance in acetone/olive oil (4:1 v/v), oxacyclohexadecan-2-one is not sensitizing to skin.
- Executive summary:
In the GLP-compliant OECD 429 guideline study, oxacyclohexadecan-2 -one at concentrations 10%, 25% and 50% was found to be not sensitizing to skin . The Stimulation Indices were 1.34, 1.92 and 2.56 for 10%, 25% and 50% solutions, respectively. No mortalities occurred and no clinical signs were noted. The potisive control hexyl cinnamic aldehyde produced a Stimulation Index 8.34 at 15% in acetone/olive oil (4:1 v/v). Based on these results, classification of oxacyclohexadecan-2-one for skin sensitization is not warranted.
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