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EC number: 408-090-7 | CAS number: 100418-33-5 METHYLGELB
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
- Objective of study:
- absorption
- other: bioavailability
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The bioavailability of Hydroxyethyl-2-nitro-p-toluidine across the intestinal barrier was investigated in a human intestinal epithelial (TC-7) cell model in vitro. The permeability from the apical (A, pH 6.5) to the basolateral (B, pH 7.4) side was investigated at 37°C in 96-well transwell plates with shaking for a 60 min contact time. Analysis of the donor (apical) and receiver (basolateral) samples was done by means of HLPC-MS/MS and the apparent permeability coefficient (Papp) was calculated for two independent experiments. 14C-mannitol (about 4µM) was used to demonstrate the integrity of the cell monolayers. Only monolayer revealing a permeability of < 2.5x10-6 cm/sec were used. Propranolol, vinplastine and ranitidine were analysed concurrently to demonstrate the validity of the test system.
- GLP compliance:
- no
- Remarks:
- The study was not performed under GLP conditions, but a statement of the quality assurance unit of the test facility is included. However, the study was performed according to recommendations by ECVAM and is generally recognised as scientifically sound.
Test material
- Reference substance name:
- 2-((4-methyl-2-nitrophenyl)amino)ethanol
- EC Number:
- 408-090-7
- EC Name:
- 2-((4-methyl-2-nitrophenyl)amino)ethanol
- Cas Number:
- 100418-33-5
- Molecular formula:
- C9H12N2O3
- IUPAC Name:
- 2-[(4-methyl-2-nitrophenyl)amino]ethan-1-ol
- Test material form:
- solid: crystalline
- Details on test material:
- red powder
Batch # : 6718 Fass 10/20
Constituent 1
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- The total recovery for the reference substances and Hydroxyethyl-2-nitro-p-toluidine ranged from 83 to 100 %. The figures obtained for the reference substances propranolol (Papp = 29.6 x 10-6 cm/sec), a high permeability reference compound with about 90 % absorption in humans, and ranitidine (Papp= 0.4 x 10-6 cm/sec; revealing a absorption of about 50 % in humans) were well within the acceptance range of 20 –45 x 10-6 cm/sec and 0.2 – 2 x 10-6 cm/sec, respectively, and demonstrated the validity of the assay. Hydroxyethyl-2-nitro-p-toluidine revealed a Papp of 93.6 x 10-6 cm/sec and was classified to be of high permeability accordingly. The observed value indicates very good absorption from the gastro-intestinal tract.
Metabolite characterisation studies
- Metabolites identified:
- no
Applicant's summary and conclusion
- Conclusions:
- With Hydroxyethyl-2-nitro-p-toluidine a mean permeability in human intestinal epithelial (TC-7) cells of 93.6 x 10-6 cm/sec was obtained, which classifies the test item to be of high permeability. As the absorption across the intestinal epithelial is considered to be the limiting factor of the uptake through the gastro-intestinal tract, the high permeability observed in this assay indicates a good absorption Hydroxyethyl-2-nitro-p-toluidine after oral administration.
- Executive summary:
The bioavailability of Hydroxyethyl-2-nitro-p-toluidine across the intestinal barrier was investigated in a human intestinal epithelial (TC-7) cell model in vitro. The permeability from the apical (A, pH 6.5) to the basolateral (B, pH 7.4) side was investigated at 37°C in 96-well transwell plates with shaking for a 60 min contact time. Analysis of the donor (apical) and receiver (basolateral) samples was done by means of HLPC-MS/MS and the apparent permeability coefficient (Papp) was calculated for two independent experiments. 14C-mannitol (about 4µM) was used to demonstrate the integrity of the cell monolayers. Only monolayer revealing a permeability of < 2.5x10-6 cm/sec were used. Propranolol, vinplastine and ranitidine were analysed concurrently to demonstrate the validity of the test system.
According to the laboratory’s classification system, a low permeability is considered for test items revealing a Papp < 2 x 10-6 cm/sec. A Papp of 2 - 20 x 10-6 cm/sec and a Papp 20 x 10-6 cm/sec classify a substance to have a moderate and a high permeability, respectively. Ranitidine, which has a 50 % absorption in humans was used as low permeability reference compound, as recommended by FDA. The total recovery for the reference substances and Hydroxyethyl-2-nitro-p-toluidine ranged from 83 to 100 %. The figures obtained for the reference substances propranolol (Papp = 29.6 x 10-6 cm/sec), a high permeability reference compound with about 90 % absorption in humans, and ranitidine (Papp= 0.4 x 10-6 cm/sec; revealing a absorption of about 50 % in humans) were well within the acceptance range of 20 – 45 x 10-6 cm/sec and 0.2 – 2 x 10-6 cm/sec, respectively, and demonstrated the validity of the assay. Hydroxyethyl-2-nitro-p-toluidine revealed a Papp of 93.6 x 10-6 cm/sec and was classified to be of high permeability accordingly. The observed value indicates very good absorption from the gastro-intestinal tract.
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