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EC number: 460-490-0 | CAS number: 477218-42-1
- 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:
- 07-05-2004 to 01-06-2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP. All relevant validity criteria were met.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected: November 2002 ; signature: March 2003
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 460-490-0
- EC Name:
- -
- Cas Number:
- 477218-42-1
- Molecular formula:
- C18H32O3
- IUPAC Name:
- 2-[(1S)-1-[(1R)-3,3-dimethylcyclohexyl]ethoxy]-2-methylpropyl cyclopropanecarboxylate; 2-[(1S)-1-[(1S)-3,3-dimethylcyclohexyl]ethoxy]-2-methylpropyl cyclopropanecarboxylate
- Test material form:
- liquid
- Details on test material:
- Physical state: Liquid
- Storage condition of test material: at room temperature (range of 20 ± 3 °C), light protected.
- Other: colourless liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HanBrl: WIST (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Recognised supplier
- Age at study initiation: 12 weeks
- Weight at study initiation: 157.1 - 171.5 g
- Fasting period before study: 18-19h (overnight)
- Housing: The animals were housed in 3 per cage suspended solid-floor cages furnished with woodflakes (cage enrichment)
- Water: ad libitum
- Acclimation period: 7 days, under laboratory conditions, after health examination.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 (controlled)
- Humidity (%): 30-70 (controlled) (values above 70% possible during cleaning process)
- Air changes (per hr): 10-15/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark, controlled cycle, music during daylight period.
IN-LIFE DATES: From: 07-05-2004 To: 01-06-2004
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg test item in 10 mL vehicle (200 mg/mL)
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: Choice based on the results of a non-GLP solubility trial (documented in the full study report).
- Lot/batch no. (if required): 448174/1 21203148.
- Purity: Not specified; source documented in the full study report
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION (if unusual): Not applicable.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data suggesting the test item was toxic, 2000 mg/kg was chosen as the starting dose. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to and then 1, 2, 3 and 5 hours after dosing; twice daily. Individual bodyweights prior to and at 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities.
- Clinical signs:
- other: Hunched posture observed from the 1 hour to 5 hours reading in three of six females. Slightly ruffled fur observed in the same three females from 1-hour to test day 6. Slightly-ruffled fur was also noted in two females at the 2 and 3 hours examinations.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test item oral median LD50 was determined to be greater than 2000 mg/kg bw in female HanBrl: WIST (SPF) strain rat.
- Executive summary:
The study was performed according to OECD 423 and EU Method B1 tris Acute Toxicity under GLP to assess the acute oral toxicity of the test item following a single oral administration in the HanBrl: WIST (SPF) strain rat. A group of three fasted females was treated with the test item at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level. The test item was administered orally in a vehicle of 10 mL PEG-300. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. There were no mortalities. Hunched posture was noted in three of six females during the day of dosing and up to 4 hours after dosing. Additionally, these three females were observed to have slightly ruffled fur from the day of dosing to test day 6. Slightly ruffled fur was noted in two of the other females, but only during two examinations on the day of dosing. All females showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test item in the female HanBrl: WIST (SPF) strain rat was estimated to be greater than 2000 mg/kg bw. Applicant assessment indicates: under the conditions of this study the acute toxicity estimate would be considered to be > 5000 mg/kg bw.
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