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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
LD50 oral (rat): > 2000 mg/kg bw
LD50 dermal (rat): > 2000 mg/kg bw
LC50 inhalation (Male rats) (4h): >= 19.5 mg/L
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 26-NOV-1998 to 03-SEP-1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test substance purity was known. The screening protocol was standard, but not validated for GLP by the quality assurance unit.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (3 animals were used at each dose level)
- Principles of method if other than guideline:
- other: screening protocol similar to OECD guide-line 401 "acute oral toxicity"
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TESTS ANIMALS
- Source: Harlan Nossan S.r.l, Italy
- Age at study initiation: data not available
- Weight at study initiation: 190-203 g (males), 158-169 g (females)
- Fasting period before study: data not available
- Housing, food consumption, water consumption, acclimation period: data not available
ENVIRONMENTAL CONDITIONS (temperature , humidity, air changes, photoperiod): data not available
In-life dates: data not available - Route of administration:
- oral: gavage
- Vehicle:
- other: maize oil
- Details on oral exposure:
- VEHICULE
- Concentration in vehicle: 50 and 200 mg/mL
- Amount of vehicle: 10 mL/kg
- Justification for choice of vehicle: data not available
- Purity: data not available
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION :data not available - Doses:
- 500 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males (500 mg/kg) and 3 females (2000 mg/kg)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 day
- Frequency of observations and weighing: data not available
- Necropsy of survivors performed: yes - Statistics:
- not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: 95% Conf. limits: not applicable
- Mortality:
- no mortality was observed
- Clinical signs:
- other: Toxic effects were observed: - at 500 and 2000 mg/kg bw, reduced activity, piloerection, hunched posture were observed. - at the lower dose, hair loss was noted following dosing. - at the highest dose, lethargy, part-closed eyes and staining of skin/fu
- Gross pathology:
- Necropsy showed no abnormalities at 500 and 2000 mg/kg bw doses.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, no mortality were observed in rats (males and females) at the 2 administred doses
of cyclopentanone (500 and 2000 mg/kg). - Executive summary:
In an acute oral toxicity study (Nunziata A, 1999), groups of male and female Sprague-Dawley rats (3/group) were given a single oral dose of cyclopentanone (99.8% purity) in maize oil at doses of 500 and 2000 mg/kg bw and observed for 14 days.
Oral LD50 Combined > 2000mg/kg bw (no mortality was observed)
Cyclopentanone is not classified for acute oral toxicity based on the LD50 identify in male and female rats.
Reference
Table 2: body weight changes
Dose level |
Animal |
Body weight (g) on Day: |
Change in body weight |
|
(mg/kg) |
Number |
1 |
15 |
Day 1-15 |
182 |
190 |
293 |
103 |
|
500 |
184 |
195 |
316 |
121 |
186 |
203 |
315 |
112 |
|
181 |
159 |
188 |
29 |
|
2000 |
183 |
158 |
201 |
43 |
185 |
169 |
197 |
28 |
Table 1: Clinical signs and mortality
Dose level |
Clinical signs |
Mortality |
(mg/kg) |
||
500 |
Reduced activity, piloerection, hunched posture and hair loss noted following dosing. Recovery within 14 days. Necropsy showed no abnormalities. |
0/3 |
2000 |
Reduced activity/lethargy, piloerection, hunched posture, part-closed eyes and staining of skin/fur noted following dosing. Recovery within 10 days. Necropsy after 14 days showed no abnormalities. |
0/3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Purity of the test substance was not reported even if the cyclopentanone was received from Esso Research and Engineering and was considered to be free from impurities. The study was performed before the GLP standard was established. However, the method and the results were quite well described. The exposure chamber concentrations were nominal dosage concentrations. The LC50 was estimated because mortality data were not suitable for statistical analysis.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- other: no data
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Weight at study initiation: 200 - 225 g
- Housing: Animals were housed in wiremesh cages centred in the
stainless steel exposure chamber.
- Source, age at study initiation, fasting period before study, diet, water, acclimation period: data not available
ENVIRONMENTAL CONDITIONS (temperature, humidity, air changes, photoperiod): data not available.
IN-LIFE DATES: data not available. - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
inhalation exposure to vapours was carried out in a dynamic, 500 litres, stainless steel exposure chamber.
Vaporization of the cyclopentanone was achieved by means of delivering predetermined amounts of the liquid test substance by a metering pump
into a stainless steel spray nozzle tip operating under positive air pressure.
The cyclopentanone metered through the nozzle were then vaporized by the pressurized air flow directly into the exposure chamber.
Nominal dosage concentrations were calculated from the amount of liquid being metered and the total airflow through the chamber.
TEST ATMOSPHERE: data not available - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- Concentrations:
- 4.7, 12, 15, 17.8, 19.5 mg/L
- No. of animals per sex per dose:
- 10 male rats per group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and signs of toxicity were observed at half-hour intervals during the actual exposure and daily during a 14-day post-exposure observation period.
- Necropsy of survivors performed: yes - Statistics:
- no data available
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- >= 19.5 mg/L air
- Exp. duration:
- 4 h
- Remarks on result:
- other: 95% CL: results not suitable for statistical analysis
- Mortality:
- Groups of animals were exposed to test concentrations of 4.7, 12, 15, 17.8 or 19.5mg/L, resulting in the following cumulative mortality data
(no. animals dead/no. animals tested): 0/10, 1/10, 3/10, 3/10 and 4/10, respectively.
All animals survived the exposure period, with deaths occurring during the 14 day observation period. - Clinical signs:
- other: During exposure, dyspnea, depression and decreased activity were observed. Moreover, ataxia and prostration were also noted at the two highest levels. These signs disappeared within 48 hours.
- Body weight:
- no data available
- Gross pathology:
- Autopsy of dead animals showed moderate congestion of the lungs, liver and kidneys. No gross findings were noted from autopsies at the end of the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study, no mortality were observed in male rats at 4.7, 12, 15 mg/L of cyclopentanone.
Three and 4 rats died respectivelly after 17.8 and 19.5 mg/L. - Executive summary:
In an acute inhalation toxicity study (Anon., 1965), groups of Wistar rats (10 males/group) were exposed by inhalation (whole body) to cyclopentanone (purity unknown) for 4 hours at concentrations of 4.7, 12, 15,n 17.8, 19.5 mg/L.
Animals then were observed for 14 days.
No mortality were observed in male rats at 4.7, 12, 15 mg/L of cyclopentanone. Three and 4 rats died respectivelly after 17.8 and 19.5 mg/L.
Based on these results a LC50 for male rats was identified. LC50 (male rats) >= 19.5 mg/L
Cyclopentanone is classified as being of LOW Toxicity based on male results.
Reference
Copy of Exxon's submission to EPA of test data on Isophorone & cyclopentanone. LC50 studies in rats were reported.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 19 500 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 26-NOV-1998 to 03-SEP-1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test substance purity was known. The screening protocol was standard, but not validated for GLP by the quality assurrance unit.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- (only 3 animals were used per dose level)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Species: COMMON SPECIES: rat
- Strain: RAT STRAINS: Sprague-Dawley
- Sex: male/female
- Source: Harlan Nossan S.r.l., Italy
- Age at study initiation: data not available
- Weight at study initiation: 251 to 274 g (males), 208 to 212 g (females)
- Fasting period before study, 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:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE: (area of exposure, % coverage, type of wrap if used): data not available
REMOVAL OF TEST SUBSTANCE: data not available
TEST MATERIAL: data not available - Duration of exposure:
- no data available
- Doses:
- 400 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females (400 mg/kg) and 3 males (2000 mg/kg)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: data not available
- Necropsy of survivors performed: yes - Statistics:
- not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: 95% CL not applicable
- Mortality:
- At the 400 and 2000 mg/kg bw doses, no mortality occurred
- Clinical signs:
- other: At the lower dose (400 mg/kg), no clinical signs were observed. At the highest dose (2000 mg/kg), piloerection and staining of skin/fur were observed during period of exposure and disappeared within 24 hours (See table 1 in the attached document).
- Gross pathology:
- necropsy after 14 days revealed no abnormalities at the 2 doses.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- At the 2 tested doses (400 and 2000 mg/kg) no mortality were observed in male and female rats after dermal exposure.
- Executive summary:
In an acute dermal toxicity study (Nunziata A, 1999), groups of Sprague-Dawley male and female rats (3/group) were dermally exposed to cyclopentanone (99.8% purity) undiluted at doses of 400 and 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 for male and female rats was greater than 2000 mg/kg bw. Based on this result, cyclopentanone is not classified for dermal acute toxicity.
Reference
CYCLOPENTANONE: dermal LD50 (Nunziata A, 1999)
Table 1: Clinical signs and mortality
Dose level |
Clinical signs |
Mortality |
(mg/kg) |
||
2000 |
Piloerection and staining of skin/fur during period of exposure. Recovery within 24 hours. Necropsy after 14 days revealed no abnormalities. |
0/3 |
400 |
No clinical signs observed. Necropsy after 14 days revealed no abnormalities. |
0/3 |
Table 2: body weight changes
Dose level |
Animal |
Body weight (g) on Day: |
Change in body weight |
|
(mg/kg) |
Number |
1 |
15 |
Day 1-15 |
112 |
274 |
339 |
65 |
|
2000 |
114 |
269 |
343 |
74 |
116 |
251 |
320 |
69 |
|
111 |
209 |
221 |
12 |
|
400 |
113 |
208 |
227 |
19 |
115 |
212 |
255 |
43 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Value:
- 2 000 mg/kg bw
Additional information
Oral:
Four studies were available with reliability from 2 (2 studies) to 3 (2 studies) according to Klimisch rating. One of them (internal report from RTC, 1999 - Nunziata A, 1999) with reliability 2 was selected as key study and gave a LD50 by oral route in rats (males and females) above 2000 mg/kg.
In this study, groups of male and female Sprague-Dawley rats (3/group) were given a single oral dose of cyclopentanone (99.8% purity) in maize oil at doses of 500 and 2000 mg/kg bw and observed for 14 days.
Oral LD50 Combined > 2000 mg/kg bw (no mortality was observed)
Cyclopentanone is not classified for acute oral toxicity based on the LD50 identify in male and female rats.
Inhalation:
Two studies
were available with reliability 2 and 3 according to Klimisch scale. The
study with reliability 2 during 4 hours was retained. The summary of
this study is the following: In
an acute inhalation toxicity study (Anonymous, 1965 - Esso, 1965),
groups of male Wistar rats (10 males/group) were exposed by inhalation
route to cyclopentanone (purity unknown) for 4 hours to (whole body) at
concentrations of 4.7, 12, 15,n 17.8, 19.5 mg/L. Animals then were
observed for 14 days.
LC50 Male rats (4h) >= 19.5 mg/L
Cyclopentanone is classified as being of LOW Toxicity based on male
rat results.
Dermal:
Two studies with reliability 2 according to Klimisch rating were available, and one of them (internal report from RTC, 1999) was selected as key study.
In this study, groups of Sprague-Dawley male and female rats (3/group) were dermally exposed to cyclopentanone (99.8% purity) undiluted at doses of 400 and 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 for male and female rats was greater than 2000 mg/kg bw.
Based on this result, cyclopentanone is not classified for dermal acute toxicity.
Justification for classification or non-classification
Oral: Based on the oral LD50 greater than 2000 mg/kg bw, cyclopentanone is not classified for oral acute toxicity according to 67/548/EEC Directive (Annex VI) and to CLP Annex I of the Regulation 1272/2008.
Inhalation: According to the LC50 Male rats (4h) >= 19.5 mg/L, acute inhalation toxicity of cyclopentanone is low. Therefore, no classification for this endpoint is required.
Dermal: Based on the dermal DL50 in male and female rats greater than 2000 mg/kg bw, cyclopentanone is not classified for dermal acute toxicity according to 67/548/EEC Directive (annex VI) and to CLP Annex I of the Regulation 1272/2008.
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