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EC number: 201-983-0 | CAS number: 90-30-2
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- Objective of study:
- distribution
- excretion
- metabolism
- toxicokinetics
- Principles of method if other than guideline:
- - Kinetic determination of plasma and tissue radioactivity of rats following an oral dose of 14C-PNA.
- Determination of radioactivity in rat tissues 24 hours after administration of an oral dose of 14C-PNA.
- Radiolabeled PNA and metabolites were determined in urine samples pooled over 48 hours.
- Excretion was determined by investigation of total radioactivity in urine and feces of rats after various intervals of time following application of 14C-PNA. - GLP compliance:
- not specified
Test material
- Reference substance name:
- N-1-naphthylaniline
- EC Number:
- 201-983-0
- EC Name:
- N-1-naphthylaniline
- Cas Number:
- 90-30-2
- Molecular formula:
- C16H13N
- IUPAC Name:
- N-phenylnaphthalen-1-amine
- Details on test material:
- - Name of test material (as cited in study report): 14C-labeled PNA (N-phenyl-14C(U) and naphtyl-1-14C)
- Analytical purity: no data
- Radiochemical purity (if radiolabelling): >98 %
- Specific activity (if radiolabelling): 5.68 mCi/mM
- Locations of the label (if radiolabelling): N-phenyl-14C(U) and naphtyl-1-14C, respectively
- Storage condition of test material: refrigerated and protected from light
- Other: Source: New England Nuclear, Boston, Mass.
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Taconic Farms, Germantown, New York
- Weight at study initiation: 225 - 250 g
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Duration and frequency of treatment / exposure:
- single exposure
Doses / concentrations
- Dose / conc.:
- 160 mg/kg bw/day
- No. of animals per sex per dose / concentration:
- - Kinetics and Tissue distribution: 3 males per observation interval
- Metabolism and excretion: not specified - Control animals:
- not specified
- Details on study design:
- no information given
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (Plasma kinetics): blood, plasma
- Tissues and body fluids sampled (Tissue distribution): heart, lung, pancreas, spleen, kidney, testes, liver, fat, stomach, small intestine and contents, caeca, large intestine and contents
- Tissues and body fluids sampled (Excretion): urine, feces
- Time and frequency of sampling (Plasma kinetics): 0.5, 1, 2, 4, 8, 12, 16, 24, 48 and 72 hours
- Time and frequency of sampling (Tissue distribution): 24 hours; for tissue kinetics: 0.5, 1, 2, 4, 8, 12, 16, 24 and 48 hours
- Time and frequency of sampling (Excretion): 2, 4, 8, 12, 24, 32, 48, 72 and 120 hours
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine
- Time and frequency of sampling: pooled over 48 hours
- From how many animals: no data on animal numbers, no data if individual samples were pooled, individual samples were pooled over sampling period
- Method type(s) for identification: HPLC-UV, Liquid scintillation counting
- Limits of detection and quantification: no data - Statistics:
- Percentage of radioactivity in urine extracts.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- Kinetics: the concentration of total radioactivity in the plasma reached a peak of 116 µg PNA equivalents/ml four hours after dosing, thereafter it declined in a biphasic manner. About 3 % of the radioactivity in the plasma could be attributed to the parent compound 4 hours after dosing. The appearance and disappearance of plasma radioactivity shown was fitted to a pharmacokinetic two-compartment open-system model, in which a central blood compartment is in reversible equilibrium with a peripheral tissue compartment, with first-order-absorption. Analysis of the plasma radioactivity according to this relationship gave half-life values of 1.59 hr for the appearance process and 1.68 and 33 hr, respectively, for the two elimination processes. The level of unchanged PNA in the plasma followed a kinetic pattern similar to that of the total 14C but reached its peak level off 1.25 µg PNA/ml plasma at 2 hr after dosing, after which it declined in a biphasic manner. Analysis of the plasma levels of PNA gave half-life values of 0.66 hr for the appearance process and 1.24 and 11.1 hr, respectively, for the two disappearance processes.
Tissue distribution: Appreciable radioactivity was detected in all tissues at 24 hours indicating a rapid absorption and distribution of 14C-PNA and its metabolites. The major sites of distribution of 14C were fat, liver, kidney and lungs with large amounts in the gastro-intestinal tract plus contents. In all four major tissues (liver, fat, kidney, lung), radioactivity reached a maximum about 4 hours after dosing, reflecting a rapid uptake and distribution of the chemical. The levels of radioactivity then appeared to decrease in a biphasic manner. At all times, the highest concentration of 14C was found in the liver followed by fat, kidney, and lung. When radioactivity is expressed in terms of percent of the total dose received, only liver and fat are important tissues which retained most of the unexcreted radioactivity.
- Details on excretion:
- More than 90 % of the administered dose had been excreted into the urine and feces within 48 hours of administration. The primary route of excretion of radioactivity was via the feces, although appreciable amounts of 14C were excreted via the urine. After 72 hours, 60 % of the total dose had been excreted in the feces and about 35 % in the urine. The bulk of the excretion in urine and feces occurred during the first 24 hours after administering the chemical.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Urine contained a high percentage of 14C as materials which remained in the aqueous phase following extraction at pH 12 and 2, suggesting that PNA was extensively metabolized by the rat. HPLC analysis of the ether extract of the urine showed at least five 14C-metabolites (see table), no PNA could be detected in the ether extracts.
Any other information on results incl. tables
Tissue distribution
Distribution of radioactivity in rat tissues 24 hours after oral administration of14C-PNA:
Tissue |
14C-PNA Equivalent µg/g wet tissue |
Percent of administered dose |
Heart |
6.49 |
0.0130 |
Lung |
10.2 |
0.0280 |
Pancreas |
3.62 |
0.00432 |
Spleen |
3.18 |
0.00377 |
Kidney |
28.7 |
0.123 |
Testes |
3.30 |
0.0200 |
Liver |
33.8 |
0.415 |
Fat |
66.0 |
2.35 |
Stomach |
488 |
5.62 |
Small intestine (+ contents) |
235 |
5.34 |
Caeca |
362 |
5.67 |
Large intestine (+ contents) |
435 |
3.10 |
Metabolism
Distribution of radioactivity in 0-48 hr pooled urine samples:
Fraction |
Percent of total radioactivity in the urine |
Ether extract (pH 12) |
16 |
Ether extract (pH 2) |
19 |
Aqueous residue (unextractable) |
65 |
Retention volumes and relative abundance of14C-PNA metabolites in the ether extract (pH 2):
14C-Compound |
HPLC Retention Volume (ml) |
% of14C in the Extract |
Area A 1 |
2.3 |
14 |
2 |
3.4 |
20 |
3 |
4.2 |
11 |
4 |
5.8 |
|
5 |
7.5 |
|
6 |
9.0 |
Σ 18 |
Area B |
12.0 |
23 |
Area C |
14.5 |
14 |
PNA |
28.0 |
0 |
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.
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