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EC number: 428-290-8 | CAS number: 120606-08-8
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Benzyl-N-(2-(2-methoxy-phenoxy)-ethyl)amine hydrochloride
- EC Number:
- 428-290-8
- EC Name:
- Benzyl-N-(2-(2-methoxy-phenoxy)-ethyl)amine hydrochloride
- Cas Number:
- 120606-08-8
- Molecular formula:
- C16H20ClNO2
- IUPAC Name:
- benzyl[2-(2-methoxyphenoxy)ethyl]amine hydrochloride
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Meosixtetroxy (Tetrome I. intermediate)
- Physical state: white crystalline powder
- Purity test date: 07. 10. 1998
- Lot/batch No.: 9801
- Expiration date of the lot/batch: : 10. 1999
- Storage condition of test material: at 2-5 °C temperature (cooled)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CHARLES RIVER HUNGARY Ltd. Budapest
- Age at study initiation: 7 weeks
- Fasting period before study: overnight (after the test item administration food was withheld for 3 hours)
- Housing: 5 animals / box, in OMKER II type plastic boxes. (40x28x10cm)
- Diet (e.g. ad libitum): ad libitum, CRLT / N standard diet for rodent (produced by Farmer Prompt Ltd. Hungary)
- Water (e.g. ad libitum): potable water, ad libitum, offered daily in 500-ml MAKROLON type drinking bottles
(sterilized before use (121 °C, 20 minutes)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9-24.3 °C
- Humidity (%): 31.9-38.7 %
- Air changes (per hr): 10-15 / h
- Photoperiod (hrs dark / hrs light): 12 h dark / 12 h artificial light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Oleum Helianthi PH.HG. VII.
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2000 mg / kg bodyweight = 20 ml / kg test item in vehicle suspension
- Doses:
- 2000 mg / kg
740 mg / kg
270 mg / kg
100 mg / kg
control - No. of animals per sex per dose:
- 5 (total 50)
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: for 6 hours after treatment and then at least twice a day
- Necropsy of survivors performed: yes ( macroscopic)
- Other examinations performed: clinical signs of toxicity, status of skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 936 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 838 mg/kg bw
- Mortality:
- Three males and one female died after 740 mg/kg doses, four males and all of the females died after single oral administration of the test article in the 2000 mg/kg dose group. No lethalities occured in other dose group.
- Clinical signs:
- Test article absorbed rapidly and animals showed clinical symptoms in all treated groups. Serious CNS disturbances and respiratory failure (decreased body tone, dyspnea, moderate somnolence) were observed in the 100 and 270 mg/kg dose groups. The animals besame symptom-free on the 2nd day.
In addition, clonic convulsion and hypersalivation in the 740 mg/kg dose group also clonic convulsion in the 2000 mg/kg dose group observed. The survivors became symptom-free not earlier than the 3rd day after treatment.
The death of he animals in the 740 and 2000 mg/kg happened rapidly after treatment. The death of animals was preceded by the mentioned several toxic symptoms, mainly dyspnea and clonic convulsion. - Body weight:
- The mean body weight of females in 740 mg/kg dose group was significantly below the control (-11%, p<0.05), but not dose-dependently above the control, in all dose groups during the study (from 1-14 days). This alteration is due to the lower body weight gain of three control animals, whitout test article.related toxicological meaning.
- Gross pathology:
- In the animals died on study, mottled and congested lungs with haemorrhages, congested brain wih haemorrhages, foamy or bloody-foamy oral discharge, point-like haemorrhages in the thymus, bleedings or point-like haemorrhages on the mucous membrane of the stomaxh and mucosal haemorrhages of small intestines was found. The latters suggested the local irritative effect of the test article.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions the LD50 values of the test materila administered by oral route to Wistar rats was 936 mg/kg at males and 838 mg/kg at females, so according to the requirements of the 4/1997. (II.21.) NM regulation the article was classified to the Xn Harmful cathegory. According to the IATA specifications the test article is not classified.
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