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EC number: 700-655-9 | CAS number: 857288-56-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and EU method. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- [3-(2-methoxy-5-methylphenyl)-3-phenylpropyl]bis(propan-2-yl)azanium bromide
- EC Number:
- 700-655-9
- Cas Number:
- 857288-56-3
- Molecular formula:
- C23H34BrNO
- IUPAC Name:
- [3-(2-methoxy-5-methylphenyl)-3-phenylpropyl]bis(propan-2-yl)azanium bromide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: White powder
- Analytical purity: 100%
- Lot/batch No.: I10110E
- Storage condition of test material: Room temperature, in the dark.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd., Oxon, UK
- Age at study initiation: Approximately 8 to 12 weeks at stari of treatment
- Weight at study initiation: 154-177 g
- Fasting period before study: Food will be removed overnight prior to dosing and returned approximately three to four hours after dosing.
- Housing: The animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Rodent 2014C Teklad Global Certified Diet, ad libitum.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 ºC
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours of continuous artificial light in each twenty-four hour period
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- Five animals at 300 mg/kg bw
One animal at 2000 mg/kg bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: Morbidity and mortality checks were made twice daily.
Clinical Observations: At ½, 1, 2, and 4 hours after dosing and then daily for up to fourteen days.
Bodyweights: Recorded on Day 0 (prior to dosing), Day 7 and 14, or at death.
- Necropsy of survivors performed: yes
- Other examinations performed:
All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 - 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose Level - 2000 mg/kg: The animal was killed for humane reasons, four hours after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit.
Dose Level - 300 mg/kg: There were no deaths. - Clinical signs:
- other: Dose Level - 2000 mg/kg: Signs of systemic toxicity noted were body tremors, ataxia, increased lachrymation, pallor of the extremities and hypothermia. Dose Level - 300 mg/kg: No signs of systemic toxicity were noted during the observation period.
- Gross pathology:
- Dose Level - 2000 mg/kg: Abnormalities noted at necropsy were abnormally red lungs, off white solid substance present in the stomach and epithelial sloughing of the gastric mucosa.
Dose Level - 300 mg/kg: No abnormalities were noted at necropsy.
Any other information on results incl. tables
Table 1: Mortality
Dose (mg/kg bw) |
Mortality |
300 |
0/5 |
2000 |
1/1 |
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg bodyweight.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat. The method was designed to be compatible with the following:
-OECD Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed Dose Method” (2001)
- Method B1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008
Following a sighting test at dose levels of 2000 mg/kg and 300 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 300 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. The animal treated at a dose level of 2000 mg/kg was killed for humane reasons, four hours after dosing, due to the occurrence of clinical signs of toxicity that exceeded the severity limit. There were no deaths at a dose level of 300 mg/kg. Signs of systemic toxicity noted in the animal treated at a dose
level of 2000 mg/kg were body tremors, ataxia, increased lachrymation, pallor of the extremities and hypothermia. There were no signs of systemic toxicity noted at a dose level of 300 mg/kg. Surviving animals showed expected gains in bodyweight except for one
animal treated at a dose level of 300 mg/kg which showed expected gain in bodyweight during the first week but no gain in bodyweight during the second week. Abnormalities noted at necropsy of the animal treated at a dose level of 2000 mg/kg were abnormally red lungs, off white solid substance present in the stomach and epithelial sloughing of the gastric mucosa. No abnormalities were noted at necropsy animals treated at a dose level of 300 mg/kg. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg bodyweight (Globally Harmonised Classification System - Category 4).
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