Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: oral
Administrative data
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Cyclopentanone
- EC Number:
- 204-435-9
- EC Name:
- Cyclopentanone
- Cas Number:
- 120-92-3
- Molecular formula:
- C5H8O
- IUPAC Name:
- cyclopentanone
Constituent 1
Test animals
- 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
Administration / exposure
- 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
Results and discussion
Effect levels
- 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.
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.