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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 November 1994 - 13 December 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- The study was extended to investigate 5 different concentrations of the test article and a vehicle control on each animal
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 29 December 1992
- Deviations:
- yes
- Remarks:
- The study was extended to investigate 5 different concentrations of the test article and a vehicle control on each animal
- GLP compliance:
- yes
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: at room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: soluble in ethanol/diethyl phthalate 1:1 (w/w)
Test animals
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved
- Weight at study initiation: 2.0-2.3 kg
- Housing: single 62 x 52 cm PPO cages with perforated floor
- Diet (e.g. ad libitum): a pelleted complete rabbit diet "Altromin 2123" from Chr. Petersen, DK-4100 Ringsted, ad libitum.
- Water (e.g. ad libitum): bottles with domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10/hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 28-11-1994 To: 13-12-1994
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: ethanol/diethylphthalate 1:1 (w/w)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100% (undiluted test substance), 20%, 10%, 5%, 1% in ethanol/diethylphthalate
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 0.5 mL ethanol/diethylphthalate 1:1 (w/w) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours, 7 and 14 days
- Number of animals:
- 4 females
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm on a total of 6 test sites: 2 anterior located, 2 centrally located and 2 posterior located. In total 5 different concentrations and a vehicle control were tested on each animal.
- % coverage: 100
- Type of wrap if used: 1 cm wide adhesive tap, fixed with Scanpor tape, 4.5 cm width, loosely wound round the truml
REMOVAL OF TEST SUBSTANCE
- Washing (if done): soap and lukewarm water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 hours, 7 and 14 days after the end of the exposure
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 100% test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.58
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- 100% test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.08
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Remarks:
- 20% test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- 20% test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.08
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Remarks:
- 10% test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.92
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- 10% test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed in any animal at all time points
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 5% test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.415
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- 5% test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed in any animal at any time point
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- 1% test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.92
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Remarks:
- 1% test substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema observed in any animal at any time point
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- vehicle control
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours (weak erythema in 1 animal 1 hour post-exposure)
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no edema in any animal at any time point
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- In general slight to well defined erythema was observed 1 to 72 hours after termination of exposure of 100% and 20% concentration of test article. Similarily in general slight erythema was observed 1 to 72 hours alter termination of exposure of 10%, 5% and 1% concentration of test article. Slight oedema was only observed in 1 rabbit 48 hours after termination of exposure of 100% and 20% concentration of test article. Thereafter no oedema was observed.
On day 7 and 14 dose related accumulations of scales were observed in all rabbits. On day 14 the skin of all rabbits was intact.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the GLP-compliant guideline study, the test substance oxacyclohexadecan-2-one was not irritating to rabbit skin.
- Executive summary:
In a GLP-compliant OECD 404 guideline study, the test substance oxacyclohexadecan-2 -one was tested for skin irritation in 4 rabbits, as a neat substance, 20%, 10%, 5% and 1% solution. Each animal received in total 6 applications (5 tested concentrations and a vehicle control). The exposure was 4 hours under semi-occlusive conditions. In general slight to well defined erythema was observed 1 to 72 hours after termination of exposure of 100% and 20% concentration of test article. Similarily in general slight erythema was observed 1 to 72 hours alter termination of exposure of 10%, 5% and 1% concentration of test article. Slight oedema was only observed in 1 rabbit 48 hours after termination of exposure of 100% and 20% concentration of test article. Thereafter no oedema was observed. Based on the calculated scores (mean for erythema and oedema at 24/48/72 hours of 1.58 and 0.08, respectively) for the neat substance no classification of oxacyclohexadecan-2-one for skin irritation is warranted according to Regulation 1272/2008/EC.
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