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EC number: 204-435-9 | CAS number: 120-92-3
- 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
Cyclopentanone is officially classified as irritating to eyes and skin in CLP Annex VI tables 3.1 and 3.2 of the regulation 1272/2008.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The used protocol was the method published by the OECD. However, the purity of the test substance was not noted and the GLP were not mentioned.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive application, surface area 4 cm²
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Roucher SA, Couhé
- Weight at study initiation: about 2.5 kg
- Age at study initiation, housing, diet, water, acclimation period: data not available
ENVIRONMENTAL CONDITIONS (temperature, humidity, air changes, photoperiod) data not available
IN-LIFE DATES: data not available - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 hours (up to 7 or 14 days if pronounced irritation)
- Number of animals:
- 6
- Details on study design:
- TEST SITE:
- Area of exposure: 2 x 2 cm
- % coverage: data not available
- Type of wrap if used: gauze + patch
REMOVAL OF TEST SUBSTANCE: data not available
SCORING SYSTEM: according to Draize (1948)
PDII below 0.5, non-irritant; 0.5-3, slightly irritant; 3-5, moderately irritant; 5-8, severely irritant (AFNOR scale) - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 3
- Max. score:
- 8
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Interpretation of results:
- other: Slightly irritating. Classified as irritant in the annex VI 3.2 of the CLP regulation 1272/2008
- Conclusions:
- Slightly irritating.
Classified as irritant in the annex VI 3.2 of the CLP regulation 1272/2008 - Executive summary:
In a primary dermal irritation study (Guillot JP, 1982), New Zealand White rabbits (6/group) were dermally exposed to 0.5 mL of cyclopentanone (purity unknown) undiluted for 4 hours to the flanks. Test sites were covered with an occlusive dressing for 4 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize.
In this study, Cyclopentanone was slightly irritating to the skin in rabbit.
Reference
In the same conditions but with a semi-occlusive protocol, the PDII was 0.31.
No other information are available
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The used protocol was the method published by the OECD. However, the purity of the test substance was not noted and the GLP were not mentioned. The number of scores were not detailed.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS:
- Source: Roucher SA, Couhé
- Weight at study initiation: about 2.5 kg
- Age at study initiation, housing, diet, water, acclimation period data not available
ENVIRONMENTAL CONDITIONS (temperature, humidity, air changes, photoperiod): data not available
IN-LIFE DATES: data not available - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye served as control
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- not rinsed or rinsed after 4 and 30 s
- Observation period (in vivo):
- observation at 1 h, 1, 2, 3, 4 and 7 days after instillation and, in case where lesion persisted, also at later stages
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- - Removal of test system: washing with Dacryoserum after 4 or 30 s (or not rinsed)
- Scoring system: at each observation time, lesions of the conjonctiva, iris and cornea were recorded separately using a numerical system based on that of Kay & Calandra (1962), the sum of these scores being the individual ocular irritation index (IOI) of each animal. Calculation of the mean of the IOI values (over six rabbits) gave the mean ocular irritation index (MOI). The greatest MOI obtained over the range of observation times was identified as the acute ocular irritation index (AOI; corresponding to the OECD approach) which was used for the classification of the substance in one of six categories between "non-irritant" and "extremely irritant" (AFNOR scale). The maximum value of index is 110.
- Tool used to assess score: data not available - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: AOI
- Score:
- 54.33
- Max. score:
- 110
- Reversibility:
- not specified
- Remarks on result:
- other: see results below
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Interpretation of results:
- other: Irritating to the eye. Classified as irritant in the annex VI 3.2 of the CLP regulation 1272/2008
- Conclusions:
- Irritating to the eye.
Classified as irritant in the annex VI 3.2 of the CLP regulation 1272/2008 - Executive summary:
In a primary eye irritation study [Guillot, 1982], 0.1 mL of undiluted cyclopentanone (purity unknown) was instilled into the conjunctival sac of the eye of New Zealand White rabbits (6/group). The eyes were not rinsed, or rinsed after 4 or 30 sec. Animals then were observed for at least 7 days. Irritation was scored by the method of Kay & Calandra, and using the AFNOR scale.
In this study, cyclopentanone was irritating to the eye.
Reference
- Irritation score:
Rinsing AOI (*) MOI IOI
procedure
None 54.33 43.67 [d7] > 30 (d4)
30 sec 49.67 17.50 [d7] > 30 (d1)
4 sec 54.66 20.67 [d7]
*: the AOI was the 24-hr MOI
- Remarks: Cyclopentanone is considered as "severely irritant" according
to the AFNOR quotation since:
- IOI at day 7 was > 30 without rinsing (for 4 rabbits / 6
rabbits) and with rinsing at 30 seconds (1 rabbit / 3 rabbits).
- MOI after 7 days was 43.67 without rinsing, 17.50 after
rinsing at 30 seconds and 20.67 after rinsing at 4 seconds.
- AOI = 54.33 of the OECD approach without rinsing
procedure. After rinsing at 30 or 4 seconds, AOI (at 24
hours) was 49.67 or 54.66 respectively.
Rinsing reduced the severity of the eye lesions and even
affected a significant reversibility by day 14 or 21,
although rinsing at 4 or 30 seconds did not change the classification.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin:
Three studies with reliability 2 and one with reliability 3 were available. One of them with reliability 2 (Guillot JP, 1982), was selected as key study because it followed the recognized guideline:
In a primary dermal irritation study New Zealand White rabbits (6/group) were dermally exposed to 0.5 mL of cyclopentanone (purity unknown) undiluted for 4 hours to the flanks. Test sites were covered with an occlusive dressing for 4 hours. Animals then were observed for 3 days. Irritation was scored by the method of Draize. The mean Primary Dermal Irritation Index (PDII) was 3 (Maximum score: 8).
In this study, Cyclopentanone is slightly irritating to the skin in rabbits.
Eye:
Two studies with reliability 2 according to Klimisch were available. One of them was selected as key study.
In a primary eye irritation study [Guillot, 1982], 0.1 mL of undiluted cyclopentanone (purity unknown) was instilled into the conjunctival sac of the eye of New Zealand White rabbits (6/group). The eyes were not rinsed, or rinsed after 4 or 30 sec. Animals then were observed for at least 7 days. Irritation was scored by the method of Kay & Calandra, and using the AFNOR scale. Score was 54.33/110 (AOI: Acute Ocular Irritation).
Therefore,
based on this study, cyclopentanone is considered as irritating to the
eyes in rabbits.
Justification for classification or non-classification
The official classification of cyclopentanone is the following:
- Eye irrit. Category 2 (H319: Causes serious eye irritation) and Skin irrit. Category 2 (H315: Causes skin irritation) according to CLP Annex VI table3.1 of the Regulation 1272/2008.
Results of key studies are in accordance with the official classification.
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