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Diss Factsheets
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EC number: 220-098-0 | CAS number: 2627-86-3
- 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: Expert statement
- Adequacy of study:
- key study
- Study period:
- 2013-03-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Expert statement in the absence of toxicokinetic studies was performed with the Racemat (DL-alpha-methylbenzylamine). Read across is done to L-alpha-methylbenzylamine, as the substance is expected to behave comparable to the racemat with regard to toxicokinetic properties. For read-across justification please refer to IUCLID section 13.
Data source
Reference
- Reference Type:
- other: Expert statement
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Expert statement
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- DL-α-methylbenzylamine
- EC Number:
- 210-545-8
- EC Name:
- DL-α-methylbenzylamine
- Cas Number:
- 618-36-0
- IUPAC Name:
- 1-phenylethanamine
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- other: Expert statement
- Strain:
- other: Expert statement
- Details on test animals or test system and environmental conditions:
- Not applicable.
Administration / exposure
- Route of administration:
- other: Expert statement
- Vehicle:
- other: Expert statement
- Details on exposure:
- Not applicable.
- Duration and frequency of treatment / exposure:
- Not applicable.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Not applicable.
- No. of animals per sex per dose / concentration:
- Not applicable.
- Positive control reference chemical:
- Not applicable.
- Details on study design:
- Not applicable.
- Details on dosing and sampling:
- Not applicable.
- Statistics:
- Not applicable.
Results and discussion
- Preliminary studies:
- Not applicable.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- After oral administration DL-α-methylbenzylamine is assumed to dissolve in the gastrointestinal fluids and absorption via aqueous pores or carriage across membranes with the bulk passage of water might occur as indicated by the water solubility. In addition, absorption of the substance via passive diffusion might be favoured due to the log Pow value of 1.31. The LD50 evaluated in an oral acute toxicity study indicates that the compound becomes bioavailable after oral administration.
Both, penetration into the stratum corneum and transfer into the epidermis is likely to occur based on the molecular weight, the water solubility and the log Pow value of the test substance. Due to the strong basic properties of DL-α-methylbenzylamine tissue destruction was observed at the sites of first contact in the acute oral toxicity study as well as in the human skin model resulting in an enhanced oral and dermal absorption.
Due to the vapour pressure of 0.56 hPa the test substance might become available for inhalation. As indicated by the molecular weight and the physico-chemical properties the test substance might cross the respiratory tract epithelium by passive diffusion or active transport via aqueous pores.
Taken together, experimental data and physico-chemical properties indicate bioavailability of the test substance via oral, dermal and inhalation route. Regarding absorption no difference between the racemic mixture and the enantiomers is expected due to identical physical properties. - Details on distribution in tissues:
- As D-and L-α-methylbenzylamine are small, water-soluble molecules, a wide distribution of the substances in the organism is expected. Cellular uptake is assumed due to their slight lipophilic properties. This assumption is supported by the adverse effects observed in all lobes of the lung and in the liver after oral administration. Extensive bleedings in the glandular stomach are attributed to the strong basic properties of the substance.
Based on the log Pow value and the water solubility of the test substance no bioaccumulation is expected.
- Details on excretion:
- D- and L-α-methylbenzylamine and its potential oxidised or conjugated metabolites are estimated to be renal excreted due to their low molecular weights and high water solubility.
Metabolite characterisation studies
- Details on metabolites:
- The test substance might be deaminated to ammonia and acetophenone, which in turn might be reduced to 1-phenylethanol. Oxidation or conjugation of the side chain leads to 1-phenyl-1,2-ethanediol, mandelic acid and phenylglyoxylic acid. Ammonia is expected to be cleared by standard physiological pathways.
DL-α-methylbenzylamine and its metabolites are expected not to be genotoxic and metabolic activation is unlikely to occur. Metabolic turnover might be varying between the D- and L-form of the substance.
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- Experimental data and physico-chemical properties indicate bioavailability of the test substance via oral, dermal and inhalation route. Regarding absorption no difference between the racemic mixture and the enantiomers is expected due to identical physical properties.
Applicant's summary and conclusion
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.