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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
Endpoint summary
Administrative data
Description of key information
Cyclopentadecanone is not irritating to skin and eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- 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
- 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)
- 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. - 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 - 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 - 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. - 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.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 12 February 2001-16 February 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across source chemical cyclohexadecanone and the target chemical cyclopentadecanone are structural homologues of each other, with the only difference between the two being one additional carbon atom in the cyclic aliphatic chain (C16 and C15, respectively). Considering a very long aliphatic chain in both substances, the presence of additional carbon atom (CH2 moiety) in cyclohexadecanone is not expected to influence its toxicological properties in comparison to cyclopentadecanone. Therefore read-across from cyclohexadecanone to cyclopentadecanone is considered to be justified.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Both substances are mono-constituent substances of high purity (details on purity are provided in the confidential sections of the robust study summaries) and do not contain toxicologically relevant impurities which could influence their toxicological behavior.
3. ANALOGUE APPROACH JUSTIFICATION
The read-across source chemical cyclohexadecanone and the target chemical cyclopentadecanone are structural homologues of each other, with the only difference between the two being one additional carbon atom in the cyclic aliphatic chain (C16 and C15, respectively). Considering a very long aliphatic chain in both substances, the presence of additional carbon atom (CH2 moiety) in cyclohexadecanone is not expected to influence its toxicological properties in comparison to cyclopentadecanone. This is confirmed by the data matrix that shows comparable properties for both substances across all endpoints. There are no additional functional groups present in cyclohexadecanone which may influence its skin irritating properties. Both substances have comparable physico-chemical properties, i.e. high log Pow (> 4) and poor water solubility (< 1 mg/L), thus their ability to penetrate the skin is expected to be comparable. Therefore read-across from cyclohexadecanone to cyclopentadecanone is considered to be justified.
4. DATA MATRIX (data on cyclohexadecanone taken from the disseminated REACH file available on the ECHA website)
Substance Cyclopentadecanone Cyclohexadecanone
Molecular formula C15H28O C16H30O
Molecular weight 224.38 238.41
Melting point 61 °C 67.4 °C
Boiling point 246 °C 339-341 °C
Water solubility 0.578 mg/L <1 mg/L
Log Pow 3.3-5.9 6.4
Vapour pressure < 0.63 Pa at 25 °C. 0.008 Pa at 20 °C
Acute oral toxicity LD50 > 5000 mg/kg bw LD50 > 2000 mg/kg bw
Acute dermal toxicity LD50 > 5000 mg/kg bw LD50 > 2000 mg/kg bw
Skin irritation Read-across Not irritating
Eye irritation Not irritating Not irritating
Skin sensitization Read-across Not sensitizing
Repeated dose toxicity LOAEL = 100 mg/kg bw/day NOAEL > 1000 mg/kg bw/day
Reproductive toxicity NOAEL > 1000 mg/kg bw/day No data available
Developmental toxicity NOAEL > 1000 mg/kg bw/day No data available
Toxicity to fish 96-h LC50 0.17 mg/L 96-h NOEC 0.1 mg/L
Toxicity to daphnia 48-h EC50 0.18 mg/L 48-h NOEC 0.19 mg/L
Toxicity to algae 72-h NOEC 0.17 mg/L 72-h NOEC >= 0.18 mg/L - Reason / purpose for cross-reference:
- read-across source
- 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
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the reliable guildeine study with 4 rabbits with a read-across analogue cyclohexadecanone, the test substance was not irritating to rabbit skin. These results can be read across to cyclopentadecanone.
- Executive summary:
In the GLP-compliant study performed according to the EU B.4 method the analogue 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. These results can be read across to cyclopentadecanone.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Deviations:
- yes
- Remarks:
- Observation period 72 hours
- Qualifier:
- according to guideline
- Guideline:
- other: EWG Directive 84/449/EWG, Amtsblatt der Europaeischen Gemeinschaften L 251, Jahrgang 27, 19.9.84 B.5 . Akute Toxizitaet - Augenreizung / 109
- GLP compliance:
- no
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 6002 - Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- KFM (SPF-quality)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf, Switzerland
- Age at study initiation: 15-16 weeks
- Weight at study initiation: 2.4-2.8 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH).
- Diet (e.g. ad libitum): pelleted standard Kliba 341, batch 14/B6 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, 4303 Keiseraugst, Switzerland), ad libitum
- Water (e.g. ad libitum): community tap water from Itingen, ad libitum
- Acclimation period: three days under laboratory conditions after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: April 14, 1986 To: April 17, 1986 - Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Concentration (if solution): 100% (pure substance) or 30% dilution
- Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 1, 24, 48 and 72 hours post-administration
- Number of animals or in vitro replicates:
- 3 (2 males, 1 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed
SCORING SYSTEM: Draize
- Irritation parameter:
- cornea opacity score
- Remarks:
- 100% pure substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no corneal effects observed in any animal at any time point
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 100% pure substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects on iris observed in any animal at any time point
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 100% pure substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Remarks:
- 100% pure substance
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours post-instillation
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- 30% dilution
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no corneal effects noted in any animal at any time point
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- 30% dilution
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no iris effects observed in any animal at any time point
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- 30% dilution
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours post-instillation
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed in any animal at any time point
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 100% pure substance:
After 1 hour, erythema (general, severe in one animal) and ventral edema (slight in one animal) of the conjunctiva was observed in all three rabbits. Severe discharge and erythema of the sclera (slight in one animal) were observed in all animals. Furthermore, test article remains, partly white mass, were observed in one out of three animals.
After 24 hours, conjunctival and scleral erythema were observed in all animals.
After 48 and 72 hours, no abnormal changes were noted in any animal.
30% dilution:
After 1 hour, ventral conjunctival erythema was observed in 2 out of 3 animals. Furthermore, test article remains, ventral erythema of the sclera and slight discharge were observed in 1 out of 3 animals.
After 24 hours, slight, hardly perceptible erythema of conjunctivae and ventral erythema of the sclera, as well as test article remains were noted in one out of three animals.
After 48 and 72 hours, no abnormal changes were noted in any animal. - Other effects:
- - Lesions and clinical observations: in the area of application no discoloration of the cornea and conjunctivae was observed which could be related to the color to the test article.
- Other observations: the body weight gain of all rabbits was similar. Due to the results obtained, no macroscopic organ examination was indicated. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the reliable guideline study with rabbits, cyclopentadecanone administered as a pure substance and at 30% dilution was not irritating to rabbit eyes.
- Executive summary:
In a reliable study performed according to OECD Guideline 405, 0.1 g cyclopentadecanone was instilled into eyes of three rabbits either as a pure substance or at 30% dilution. The average scores over 24, 48 ad 72 hours in case of pure substance were 0 for corneal opacity, 0 for iritis, 0.33 for conjunctival erythema and 0 for chemosis. In case of 30% dilution, the average scores over 24, 48 and 72 hours were 0 for corneal opacity, 0 for iritis, 0.11 for conjunctival erythema and 0 for chemosis. All observed effects were fully reversible within max. 48 hours. Based on these results, classification of cyclopentadecanone for eye irritation is not required.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
For skin irritation, an in vivo study with New Zealand White rabbits, performed according to the EU Method B.4, was available for a structural analogue of cyclopentadecanone, cyclohexadecanone. The read-across source chemical cyclohexadecanone and the target chemical cyclopentadecanone are structural homologues of each other, with the only difference between the two being one additional carbon atom in the cyclic aliphatic chain (C16 and C15, respectively). Considering a very long aliphatic chain in both substances, the presence of additional carbon atom (CH2 moiety) in cyclohexadecanone is not expected to influence its toxicological properties in comparison to cyclopentadecanone. Therefore read-across from cyclohexadecanone to cyclopentadecanone is considered to be justified. 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 this cyclohexadecanone and respectively its structural analogue cyclopentadecanone are considered to be not irritating to skin.
In an in vivo eye irritation study performed with cyclopentadecanone, performed according to OECD guideline 405, erythema and ventral edema of the conjunctiva were observed in all three rabbits one hour post-instillation. Severe discharge and erythema of the sclera (slight in one animal) were observed in all animals. Furthermore, test article remains, partly white mass, were observed in one out of three animals.
After 24 hours, conjunctival and scleral erythema were observed in all animals. After 48 and 72 hours, no abnormal changes were noted in any animal. Based on this, cyclopentadecanone was considered to be not irritating to rabbit eyes.
Justification for classification or non-classification
Based on the results of an in vivo skin irritation study with a structural analogue of cyclopentadecanone, cyclohexadecanone, and an in vivo eye irritation study with cyclopentadecanone, classification for skin and eye irritation is not warranted according to Regulation (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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