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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 445-090-6 | CAS number: 5614-37-9
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2002-12-16 to 2003-02-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- traditional method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 445-090-6
- EC Name:
- -
- Cas Number:
- 5614-37-9
- Molecular formula:
- C6 H12 O
- IUPAC Name:
- Cyclopentyl methyl ether
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Lot No.: 020618
Purity: 99.99%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Approximately 8 weeks
- Weight at study initiation: MaIe: 277 - 319 g; Female: 210 - 233 g
- Housing: group housed (2-6/cage) during acclimation, and then individually in suspended stainless steel wire mesh cages during the study.
- Diet: Certified Rodent Diet, No. 5002; (Meal), available without restriction
- Water: available without restriction via an automated watering system
- Acclimation period: approximately 1 week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23°C
- Humidity (%): 13 to 69%
- Photoperiod (hrs dark / hrs light): twelve-hour light/dark cyde controlled via an automatic timer
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: nitrogen
- Mass median aerodynamic diameter (MMAD):
- >= 1.204 - <= 3.775 µm
- Geometric standard deviation (GSD):
- > 1.649 - <= 2.342
- Remark on MMAD/GSD:
- Group 1 - 10.5 mg/L: Mean MMAD: 2.334 µm, mean GSD: 1.891
Group 2 - 21.5 mg/L: Mean MMAD: 2.149 µm, mean GSD: 1.896 - Details on inhalation exposure:
- - Pre-Study Trials: Trials were performed to evaluate the optimal set of conditions and equipment to generate stable atmospheres at the targeted exposure level.
- Chamber Operation:
The flow-past nose-only exposure chamber was operated at a flow rate of 10 Liters per minute. The final airflow was set to provide at least one air change in 5.0 minutes (12 air changes/hour) and a T99 equilibrium time of approximately 3 minutes. The T 99 equilibrium time was added to the 4 hours; i.e., the atmosphere was generated for 4 hours and T 99 minutes. This chamber size and airflow rate is considered adequate to maintain the oxygen level at least 19%. The chamber was exhausted via a 1" tubing through the in-house filtering system, which consisted of a coarse filter, a HEPA filter and an activated charcoal bed. The nose-only exposure chamber was contained within a 10 m3 chamber.
At the end of the exposure, all animals remained in chamber for a minimum of 30 minutes. During this time the chamber was operated at the same flow rate as used during the exposure using clean air only.
Recordings of total chamber flow and static pressure were made every half-hour during the exposure.
- Environmental conditions: Temperature: 20 to 23°C, Relative Humidity 17 to 23% - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Group 1: 10 mg/L (Trarget)
Group 2: 20 mg/L (Trarget) - No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Viability Checks: observed for mortality and general condition twice daily (once in the morning and once in the afternoon).
- Physical Examinations: Day 0 (Day of Exposure): Animals were observed individually prior to exposure, as a group, at fifteen minutes intervals during the first hour of exposure, and hourly for the remainder of the exposure. They were observed individually upon removal from the chamber and hourly for two hours post -exposure. Days 1 – 14: once daily.
- Body Weights: Weighed on Day 0 (prior to exposure), Days 7 and 14 (prior to termination).
- Necropsy: All survivors were euthanized by exsanguination following carbon dioxide inhalation at termination on Test Day 14.
- Macroscopic Examinations: Complete macroscopic postmortem examinations were performed on all animals. - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 21.5 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- All animals survived
- Clinical signs:
- other: There were no signs of toxicity noted during the exposure periods. Clinical signs of toxicity noted immediately following the 10.5 mg/L exposure included lacrimation and red nasal discharge. Clinical signs of toxicity noted immediately following the 21.5
- Body weight:
- AlI animals gained weight during both weeks of observations after both exposures.
- Gross pathology:
- There was no effect of treatment evident from the macroscopic postmortem observations of the test animals from both exposures. All animals were within normallimits.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be relatively non-toxic to rats by nose-only inhalation exposure with a 4-hour LC50 greater than 21.5 mg/L (analytical) for males and females.
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.