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EC number: 616-017-7 | CAS number: 7377-08-4
- 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 in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- A single oral dose of radiolabelled ABA was given to rats. Blood samples were collected at 15 min and 2 and 6 hours after dosing. Urine and faeces samples were collected from 0-6, 6-12 and 12-24 hrs after dosing. Plasma and urine levels of ABA and its metabolite NABA were determined using HPLC. The radioactivity was determined using liquiid scintillation counting.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3-[(4-aminobenzoyl)amino]propanoic acid
- EC Number:
- 616-017-7
- Cas Number:
- 7377-08-4
- Molecular formula:
- C10 H12 N2 O3
- IUPAC Name:
- 3-[(4-aminobenzoyl)amino]propanoic acid
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- Single dose
Doses / concentrations
- Dose / conc.:
- 64 mg/kg bw (total dose)
- No. of animals per sex per dose / concentration:
- Not specified
- Control animals:
- not specified
- Details on dosing and sampling:
- A single oral dose of 64 mg/kg was given. Blood samples were taken at 15 minutes, 2 and 6 hrs after dosing. Urine and faecal samples were collected from 0-6, 6-12 and 12-24 hrs after dosing.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- 14% as calculated using the radioactivity found in the urine following oral and i.v. administrations (see seperate summary for iv)
- Type:
- distribution
- Results:
- Maximum plasma levels of ABA, NABA and radioactivity were reached 15 minutes after dosing. Values were 0.0034, 0.0116 and 0.0163 micromol/ml respectively.
- Type:
- metabolism
- Results:
- The ratio of the maximum plasma levels of ABA to NABA after only 15 minutes from dosing, was already 0.0034:0.0116, which indicates 77% metabolism of the dosed ABA to its N-acetylated metabolite NABA.
- Type:
- excretion
- Results:
- Plasma radioactivity declined quickly and was below the limit of detection 24 hrs after dosing.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The 14% oral absorption stated in the review of the study is assumed to refer to bioavailability rather than GI tract absorption, which is different. Bioavailability in pharmacology (which is the context of the review) relates to a comparison of the amount of a substance in the plasma when administered via i.v. against the plasma concentration for the same dose but given orally. In this case, the comparison has used levels in urine instead of plasma, after 24 hrs. In this case therefore, 14% bioavailability would indicate a > 14% GI tract absorption, with the balance potentially excreted from the liver back to the lower GI tract via bile and/or passing unabsorbed to ultimately be excreted in faeces.
- Details on distribution in tissues:
- Insufficient information available
- Details on excretion:
- Most of the radioactivity that was excreted in urine, was associated with the metabolite NABA (11.5% of the dose). Given that the oral absorption was assigned as 14% of the dose in the review, this NABA would equate to metabolism of at least 80% of the ABA reaching the systemic circulation . The rapid drop in radioactivity in the plasma and its detection in urine, indicates that clearance of the ABA is via its metabolite NABA and is rapid and extensive.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- The metabolite is N-acetyl-4-aminobenzoyl-5-alanine (NABA).
Applicant's summary and conclusion
- Conclusions:
- Orally dosed ABA was rapidly absorbed (most likely) from the upper GI tract, as indicated by the plasma Tmax of only 15 minutes. The extent of oral absorption was at least 14% based on comparison of urine for oral and i.v. tests. The majority (approx 80%) of the absorbed ABA was rapidly metabolised to N-acetyl-4-aminobenzoyl-5-alanine (NABA) as indicated by the relative Tmax plasma concentrations after 15 minutes. The rapid drop in radioactivity in the plasma and its detection in urine, indicates that ABA is unlikely to be distributed to body tissues and that clearance of the ABA via its metabolite NABA is rapid and extensive.
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