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EC number: 266-719-9 | CAS number: 67564-91-4
- 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:
- 09. - 12.2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 17, 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Umweltministerium Baden-Württemberg
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- cis-4-[3-(p-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine
- EC Number:
- 266-719-9
- EC Name:
- cis-4-[3-(p-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine
- Cas Number:
- 67564-91-4
- Molecular formula:
- C20H33NO
- IUPAC Name:
- (2R,6S)-4-[3-(4-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young adult animals (approx. 10 weeks)
- Weight at study initiation: 168.0 g mean bw of test group 2000 mg/kg; 188.3 g mean bw of test group 500 mg/kg (1); 182.7 g mean bw of test group 500 mg/kg (2)
- Fasting period before study: at least 16 hours
- Housing: Animals were single housed
- Diet: VRF1 (P), ad libitum except for the day of administration
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days
- Method of randomisation in assigning animals to test and control groups : not applicable
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): not specified
- Photoperiod (12h dark /12h light): 6.00 a.m. - 6.00 p.m. / 6.00 p.m. - 6.00 a.m.
IN-LIFE DATES
- From: 2010-09-22
- To: 2010-10-19
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 g /100 mL
- Amount of vehicle (if gavage): 500 mg/kg bw (0.5% solution of CMC in deionized water)
- Justification for choice of vehicle: good homgeneity in water could not be guaranteed
- Purity: not specified
MAXIMUM DOSE VOLUME APPLIED: 2.12 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: By the request of the sponsor a starting dose of 500 mg/kg bw was chosen in the first step with 3 female animals. - Doses:
- 2000 mg/kg bw (undiluted); 500 mg/kg bw (emulsion)
- No. of animals per sex per dose:
- 3 female animals per 2000 mg/kg; 6 female animals per 500 mg/kg
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of clinical observations: Recording of clinical signs several times on the day of administration and at least once daily thereafter each workday.
- Frequency of weighing: On day 0 shortly before administration, thereafter weekly and on the last day of observation. Additionally, at day of death in animals that diet starting with study day 6.
- Necropsy of survivors performed: yes
- Clinical signs including body weight : yes
- Other examinations performed: check for mortality once each workday - Statistics:
- No statistical analysis was conducted.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 500 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - 500 mg/kg bw test group: No mortality occured in the six females
- 2000 mg/kg bw test group: A delayed mortality was observed in two out of three animals at study day 6 after the administration - Clinical signs:
- other: - 500 mg/kg bw test group: Impaired general state, dyspnoea and piloerection from hour 3 to hour 5 after administration in four out of six animals. Two out of six animals did not show any clinical signs. - 2000 mg/kg bw test group: Impaired general state,
- Gross pathology:
- There were no macroscopic pathological findings in the animals which died or were sacrified at the end of the observation period.
Applicant's summary and conclusion
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.
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