Registration Dossier
Registration Dossier
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: 438-340-0 | CAS number: 119344-86-4
- 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:
- 18.10.2001 - 23.11.2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 438-340-0
- EC Name:
- -
- Cas Number:
- 119344-86-4
- Molecular formula:
- C24 H32 N2 O2
- IUPAC Name:
- 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one
- Details on test material:
- - Physical state: solid
- Analytical purity: commercial grade
- Lot/batch No.: 766/130
- Expiration date of the lot/batch: 31-AUG-2003
- Stability under test conditions: 4 hours
- Storage condition of test material: at room temperature (range of 17-23°C). In a closed container in the dark.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanBrl: Wist
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division, Fullinsdorf / Switzerland
- Age at study initiation: Males: 8 weeks, Females: 10 weeks
- Mean weight at study initiation: Females: 174.27 g; Males: 203.6 g
- Fasting period before study: 16 to 20 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing.
- Housing: three per sex in Makrolon type-4 cages
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 73/01 (Provimi Kliba AG, Kaiseraugst/ Switzerland), ad libitum.
- Water (e.g. ad libitum): Community tap-water, from Itingen ad libitum.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial performed before experimental starting date.
- Lot/batch no. (if required): 424718/142701
DOSAGE PREPARATION (if unusual): The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added (weight:volume). The mixtures were prepared using a glass stick first then a magnetic stirrer.
Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 3
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Mortality / Viability: Daily during acclimatization and twice daily during days 1-15.
Body weights: On test days 1 (pre-administration), 8 and 15.
Clinical signs: Daily during acclimatization and at least four times on test day 1 after the test item administration. Once daily during days 2-15. All abnormalities were recorded.
- Necropsy: All surviving animals were killed at the end of the observation period and discarded after macroscopic examinations were performed. No organs or tissues were retained. - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality and no clinical signs were observed.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: Slight emaciation was evident in one female on the test days 5 and 6. All other animals were without clinical signs.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was determined to have an acute oral LD50 >2000 mg/kg bw (in the rat) under the conditions of the test. The substance is not orally toxic.
- Executive summary:
In this guideline (OECD 423) study conducted with GLP, the acute oral LD50 of the test material (EC 438-340-0) to rats was determined to be >2000 mg/kg bw (both sexes). The test material was administered via gavage at a dose of 2000 mg/kg bw. The result of the test was not sufficient to trigger classification and labelling of the test material for acute toxicity under the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).
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.
