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Diss Factsheets
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EC number: 207-951-2 | CAS number: 502-72-7
- 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:
- 12 February 2001-16 February 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- Official Journal of the European Union No. L 383 A, p. 124 - 127 of December 29, 1992
- Deviations:
- yes
- Remarks:
- Observation period 72 hours, occlusive dressing
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reference substance 001
- EC Number:
- 607-739-3
- Cas Number:
- 2550-52-9
- Molecular formula:
- C16H30O
- 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
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: unsoluble in water
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was administered as the original substance alter crushing with a pestle and mortar to a fine dust moistened using a mixture of ethanol*/diethylphthalate* 1:1 (v/v) (as ED abbreviated in the following text) or as solutions with fixed concentrations in this mixture.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- Crl:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, D-97320 Sulzfeld, Germany
- Weight at study initiation: 2720, 2465, 2615 and 2626 g (average 2607 g)
- Housing: Cages of stainless steel with bottom grid of oval steel and with tub for faeces, dimensions of the cages: 50 x 55 x 40 cm
- Diet (e.g. ad libitum): ALTROMIN 2123, standard diet for rabbits ad libitum (ALTROMEN, D-32791 Lage/Lippe)
- Water (e.g. ad libitum): tap water, ad libitum (municipal supply), Makrolon® b ottles, changed daily
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5-22.5
- Humidity (%): 30-40
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: February 12, 2001 To: February 16, 2001
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: ethanol / diethylphthalate 1:1 (v/v)
- Controls:
- yes, concurrent no treatment
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g crushed material moistened using a mixture of ethanol/diethylphthalate or 0.5 mL of a 50, 25 and 10% (w/v) solution in a mixture of ethanol/diethylphthalate (1:1 v/v)
- Concentration (if solution): solid material, 50, 25 and 10%
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 minutes, 24, 48 and 72 hours post patch removal
- Number of animals:
- 4 (four different concentrations were applied to the trunk of each of the four animals)
- Details on study design:
- TEST SITE
- Area of exposure: approx. 2 x 3 cm
- % coverage: 100
- Type of wrap if used: occlusive dressing (Lohmann GmbH & Co., Neuwied)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with a mixture of ethanol/diethylphthalate 1:1 (v/v)
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 60 minuts, 24, 48 and 72 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- pure test substance, 50%, 25% and 10% solutions
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no skin effects were observed
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- pure test suibstance, 50%, 25% and 10% solutions
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no skin reactions were noted
- Irritant / corrosive response data:
- All skin areas, treated with the moistened original test item or with solutions of the test item in three concentrations (50, 25 and 10 %) and also the control skin areas (untreated and treated with ethanol/diethylphthalate), did not show any alterations at any observation time.
- Other effects:
- No animal died during the course of investigation and no clinical signs were observed.
Necropsy was not carried out, because no clinical signs were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the reliable guildeine study with 4 rabbits, the test substance cyclohexadecanone was not irritating to rabbit skin.
- Executive summary:
In the GLP-compliant study performed according to the EU B.4 method the test substance cyclohexadecanone was not irritating to rabbit skin, when administered as a pure substance and 10%, 25% and 50% solution in ethanol/diethylphthalate (1:1) v/v for 4 hours to 4 rabbits under occlusive dressing. Animals were observed for 60 minutes, 24, 48 and 72 hours. No skin reactions were noted in any animal at any time point. Based on the results of the study, the test substance cyclohexadecanone is considered to be not irritating to skin.
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