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Diss Factsheets
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EC number: 929-946-0 | CAS number: -
- 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:
- 2008-08-27 to 2008-09-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- (R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenol
- EC Number:
- 929-946-0
- Cas Number:
- 286930-02-7
- Molecular formula:
- C22 H31 N O2
- IUPAC Name:
- (R)-2-(3-(diisopropylamino)-1-phenylpropyl)-4-(hydroxymethyl)phenol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Sponsor and 902/695838/D/2/1
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: approximately 4°C in the dark
- Solubility and stability of the test substance in the solvent/vehicle: Suspension could be achieved in arachis oil BP tot the desired dosing concentrations
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Suspended in arachis BP oil at a concentration of 300 mg test ingredient/kg bodyweight and 2000 mg test ingredient /kg bodyweight
FORM AS APPLIED IN THE TEST
Suspended in arachis BP oil at a concentration of 300 mg test ingredient/kg bodyweight and 2000 mg test ingredient/kg bodyweight
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: by Harlan UK Limited, Bicester, Oxon, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: +- 20% of 169 g
- Fasting period before study: Overnight fast before dosing and for three to four hours after dosing
- Housing: Groups of three in suspended solid-floor polypropylene cages furnished with woodflake
- Diet (e.g. ad libitum): 2014 Teklad Global Rodent diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Remarks:
- BP
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg test ingredient / ml vehicle and 200 mg test ingredient / ml vehicle
- Amount of vehicle (if gavage): 10 ml dose / kg bodyweight
- 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 dose / kg bodyweight - Doses:
- 1
- No. of animals per sex per dose:
- 3 for the preliminary study
3 for the main test - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observedSigns of systemic toxicity noted in animals treated at a dose level of 300 or 2000 mg/kg were
hunched posture, lethargy, ataxia, pilo-erection and decreased respiratory rate. Additional
observations noted in one animal treated at a dose level of 300 mg/kg were increased
lachrymation, hypothermia and loss of righting reflex. No signs of systemic toxicity were noted
in three animals treated at a dose level of 300 mg/kg. 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for up to fourteen days.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination and clinical signes were observed
Results and discussion
- Preliminary study:
- The preliminary study had no deaths at a dosage level of 300 mg test ingredient / kg bodyweight.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals treated at a dose level of 2000 mg/kg were found dead one day after dosing. One animal treated at a dose level of 300 mg/kg was killed in extremis one day after dosing.
- Clinical signs:
- other: Signs of systemic toxicity noted in animals treated at a dose level of 300 or 2000 mg/kg were hunched posture, lethargy, ataxia, pilo-erection and decreased respiratory rate. Additional observations noted in one animal treated at a dose level of 300 mg/kg
- Gross pathology:
- Abnormalities noted at necropsy of animals that died or were killed in extremis during the study were abnormally red lungs, dark liver or patchy pallor of the liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The test substance was classified as a category 4 oral toxin based on GHS criteria.
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