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Diss Factsheets
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EC number: 246-014-2 | CAS number: 24085-08-3
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: predictions from Basic Data set
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A qualitative assessment of the toxicokinetics of the substance has been performed, based upon its physical properties and the results of toxicological studies.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7c: Endpoint specific guidance Version 2.0 November 2014
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride
- EC Number:
- 246-014-2
- EC Name:
- 2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride
- Cas Number:
- 24085-08-3
- Molecular formula:
- C20H25NO3.HCl
- IUPAC Name:
- 2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride
Constituent 1
- Radiolabelling:
- no
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- not specified
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- key physical properties:
Molecular weight: 363.87
Water solubility: 16.3 g/L
Partition co-efficient log Pow: -0.77
Particle size distribution: 90% (<182 µm), 50% (<96.87 µm), 10% (<47 µm)
Dissociation constant: not determined
pH (10% suspension ): 2.8
Hydrolysis: t1/2 >1 year
Structural alerts- tertiary amine group.
Any other information on results incl. tables
acute oral toxicity: discriminating dose 2000 mg/kg; lethargy noted in males 2 hours post dosing.
Reproductive Toxicity Screen (OECD422): No toxicologically significant effects on fertility, reproductive performance or pup development were noted up to the maximum dose tested (500 mg/kg bw/day), however at the highest dose tested day there was a higher incidence of offspring showing clinical signs concentrated in only a few isolated litters.
28 day repeat dose oral toxicity (OECD422) : Significant systemic effects (clonic convulsions leading to termination) were noted when animals were treated with 750 or 1000 mg/kg bw /day in the initial stages of the study. The following clinical signs were noted in animals treated with 300 mg/kg bw/day: piloerection, hunched posture, lethargy, decreased respiratory rate, pallor of the extremities and diarrhoea.
skin exposure: no irritant effects were noted in in vivo studies with guinea pigs and also the acute dermal toxicity study in rats. these results are equivocal for the potential for the substance to penetrate the stratum corneum.
eye exposure: when tested in the BCOP test system the substance did not induce severe eye damage, and does not significantly increase corneal permeability.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
oral: clinical signs witnessed in the repeat dose oral toxicity study indicates that the substance is absorbed following administration in polyethylene glycol with systemic effects noted: clinical chemistry,thyroid, liver and kidney following exposure to all dose levels. NO toxicologically significant effects were observed on reproductive or developmental parameters in the exposed animals.
The water solubility, partition coefficient and molecular mass all indicate that this substance will be bioavailable via the oral route.
Inhalation: The particle size distribution indicates that there is limited potential for exposure by this route.
Dermal absorption: the physical parameters of the substance: molecular weight and log Pow, indicate that the substance may penetrate the stratum corneum and be systemically available from dermal exposure.
Metabolism: There is significant evidence from the 28 day study to indicate that the substance is undergoing extensive hepatic metabolism (adaptive hepatic hypertrophy at all dose levels with diffuse midzonal/centilobular hypertrophy; increases in serum cholesterol and ALAT).
Excretion: There is limited evidence from the oral toxicity studies conducted ( significant increases in calcium and inorganic phosphorus, presence of hylaine droplets and increases in absolute and relative kidney weights in both sexes in repeat dose studies) that the substance may interact with the kidneys.
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