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EC number: 812-739-3 | CAS number: 157357-30-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 11 to April 03, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted according to OECD test Guideline No. 423 without any deviation.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (inspected on April 22, 25-29, 2005; May 09-13, 2005 / signed on November 2005)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- cis-2- Pentylcyclopentanol
- Cas Number:
- 157357-30-7
- Molecular formula:
- C10H20O
- IUPAC Name:
- cis-2- Pentylcyclopentanol
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: colourless liquid
- Stability: stable under storage conditions. Stability is unknown in PEG 300.
- Storage conditions: in the refrigerator (range of 5±3°C), light protected and under nitrogen gas.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanRcc:WIST (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Wölferstrasse 4, 4414 Füllinsdorf, Switzerland.
- Age at study initiation: 11 weeks
- Weight at study initiation: 185-207 g
- Housing: in groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding.
- Fasting period before study: 16.5 to 18 hours (access to water was permitted). Food was provided again approximately 4 hours after dosing.
- Diet: pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no 77/07 (Provini Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad libitum. Not contaminated.
- Water: community tap water from Füllinsdorf ad libitum. Not contaminated.
- Acclimation: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From 2008-03-11 to 2008-04-03
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE: PEG 300
- Concentration in vehicle: : 0.2 g/mL
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation.
- Lot/batch no. (if required): 1310049
- Source: FLUKA Chemie GmbH, CH-9471 Buchs.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2 groups, each of 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 day
- Clinical signs: 30 minutes, 1, 2, 3 and 5 hours after treatment on Day 1 and once daily during test days 2-15.
- Mortality/viability: 30 minutes, 1, 2, 3 and 5 hours after treatment on Day 1 and twice daily during test days 2-15.
- Frequency of weighing: recorded on Day 1(just prior to administration) and on day 8 and 15.
- Necropsy of survivors performed: yes, macroscopic examination. No organ or tissues were retained. - Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: Shortly after dosing or at the 1-hour observation, a slight sedation was recorded in the 6 females which persisted up to the 5-hour observation. In 2 females, the sedation progressed into moderate at the 5-hour reading. Additionally, 5 females were found
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Oral LD50 (Female rat) > 2000 mg/kg bw
- Executive summary:
In a limit acute oral toxicity study performed according to the OECD test guideline No. 423 and in compliance with GLP, two groups, each of three fasted female HanRcc:WIST (SPF) rats were treated with a single oral gavage administration of 2000 mg/kg bw. The test material was diluted in PEG 300 at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.
No deaths occurred during the study.
Shortly after dosing or at the 1-hour observation, a slight sedation was recorded in the 6 females which persisted up to the 5-hour observation. In 2 females, the sedation progressed into moderate at the 5-hour reading. Additionally, 5 females were found to express a slightly poor coordination 20 minutes post-dose, or at the 1- or 5 hour reading. This symptom persisted up to the 1-, 2-, 3- or 5-hour reading. Furthermore, 5 females were found with a slightly ruffled fur shortly after treatment or at the 1-hour evaluation which persisted up to the 5-hour evaluation. Otherwise, no clinical signs were observed in any animal at any observation.
The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were recorded at necropsy.
Oral LD50 (Female rat) > 2000 mg/kg bw
Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.
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