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EC number: 700-232-9 | CAS number: 68489-09-8
- 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:
- 2008-06-10 to 2008-07-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline 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 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- , adopted 2001-12-17
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- , 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2007-10-15
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- (1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide
- EC Number:
- 700-232-9
- Cas Number:
- 68489-09-8
- Molecular formula:
- C18H27NO2
- IUPAC Name:
- (1R,2S,5R)-N-(4-methoxyphenyl)-5-methyl-2-(propan-2-yl)cyclohexane-1-carboxamide
- Test material form:
- solid: crystalline
- Details on test material:
- - Physical state: solid, whitish to white crystals
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley CD
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: eight to twelve weeks of age
- Weight at study initiation: 151 g - 190 g
- Fasting period before study: overnight fast immediately before dosing and for approximately three to four hours after dosing
- Housing: housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (ad libitum; exception: see "Fasting period before study" above): Certified Rat and Mouse Diet
- Water (ad libitum): mains drinking water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature : 19 to 25 °C
- Relative humidity: 30 to 70 %
- Air changes: at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Remarks:
- BP
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: arachis oil BP was used because the test material did not dissolve/suspend in distilled water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg; the volume administered to each animal was calculated according the the fasted bodyweight at the time of dosing. - Doses:
- 300 mg/kg (sighting study)
2000 mg/kg (sighting study / main study) - No. of animals per sex per dose:
- 300 mg/kg: one female (sighting study)
2000 mg/kg: five females (sighting study/main study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
clinical observations: 0.5, 1, 2 and 4 hours after dosing and then daily for fourteen days.
morbidity and mortality checks: twice daily
individual bodyweights: Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were killed and all animals were subjected to gross necropsy consisting of external examination and opening of the abdominal and thoracic cavities. - Statistics:
- Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) was made.
Results and discussion
- Preliminary study:
- First, a single animal was treated with 300 mg/kg. There was no mortality. No signs of systemic toxicity were noted and the animal showed expected gains in body weight during the observation period. No abnormalities were noted at necropsy.
In the absence of toxicity, an additional animal was treated with 2000 mg/kg. In the absence of toxicity, an additional group of four animals was treated with 2000 mg/kg.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 2000 mg/kg: 100 % survival.
- Clinical signs:
- other: 2000 mg/kg: no signs of systemic toxicity during observation period.
- Gross pathology:
- 2000 mg/kg: no abnormalities were observed at the necropsy
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 (female rats) > 2000 mg/kg bw
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the test item is not acutely toxic via the oral route. - Executive summary:
The acute oral toxicity of the test substance was investigated according to the OECD guideline 420 (2001). Four female Sprague-Dawley CD rats received a single dose of 2000 mg/kg bw in peanut oil by gavage. All animals were subjected to gross necropsy. Mortality, clinical signs or abnormalities at necropsy were not observed during the study. Furthermore, all animals gained the expected weight during the observation period. Thus, the LD50 is estimated with > 2000 mg/kg bw for female rats. According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the test item is not acutely toxic via the oral route.
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