Registration Dossier
Registration Dossier
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EC number: 202-870-9 | CAS number: 100-61-8
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- publication
- Title:
- 3,Q-Benzpyrene and N-Methylaniline Metabolizing Enzymes in the Immature Human Foetus and Placenta
- Author:
- Pelkonen O., Arvela P. and Karki N.T.
- Year:
- 1 971
- Bibliographic source:
- Acta pharmacol. et toxicol. 1971, 30, 385-395.
Materials and methods
- Objective of study:
- metabolism
Test guideline
- Qualifier:
- no guideline required
- GLP compliance:
- no
Test material
- Reference substance name:
- N-methylaniline
- EC Number:
- 202-870-9
- EC Name:
- N-methylaniline
- Cas Number:
- 100-61-8
- Molecular formula:
- C7H9N
- IUPAC Name:
- N-methylaniline
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- human
Administration / exposure
- Route of administration:
- other: Not applicable: in vitro study
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- Not applicable: in vitro study
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Not relevant.
- No. of animals per sex per dose / concentration:
- Not applicable: in vitro study
- Control animals:
- other: Not applicable: in vitro study
Results and discussion
Main ADME resultsopen allclose all
- Type:
- metabolism
- Results:
- Metabolizing enzymes were present in liver tissues of all foetuses. The activity was not proportional to foetal age. The requirements for full activity in the foetal liver depended on NADP, glucose-6-phosphate and Mg++ ions.
- Type:
- metabolism
- Results:
- Human foetal liver: 0.7 pmol the test substance per gram tissue per hour
- Type:
- metabolism
- Results:
- No significant activity in foetal gastrointestinal tract, brain, kidneys, and lungs.
- Type:
- metabolism
- Results:
- No significant activity in in placenta tissue except for one (out of five), which showed activity comparable to liver tissue.
Toxicokinetic / pharmacokinetic studies
Toxicokinetic parameters
- Test no.:
- #1
- Toxicokinetic parameters:
- other: Michaelis constant Km for N-methylaniline demethylase: 1.2 X 10-4 M.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Demethylation of the test substance to aniline.
Any other information on results incl. tables
Metabolism of the test substance by human fetal liver tissue in (mmol/g/h).
Tissue | Mean | range |
Liver | ||
-homogenate | 0.61 | 0.34-0.90 |
-supernatant | 0.50 | 0.27-0.82 |
-microsomal fraction | 0.46 | 0.37-069 |
-soluble fraction | 0.02 | |
Stomach | 0.01 | |
Small intestine | 0.15 | |
Large intestine | 0.06 | |
Kidneys | 0.16 | |
Lungs | 0.01 | |
Brain | 0.00 | |
Adrenal gland | 0.26 | 0.07-0.35 |
Testes | 0.00 | |
Placenta | 0.08 | 0.00-0.26 |
Adult rat liver | 3.74 | 2.77-5.02 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: bioaccumulation potential cannot be judged based on study results
This study examined demethylation of the test substance in human foetuses and compared to rat livers, activity in liver tissue of the foetuses ranged from 5 to 15 % of the value observed in the rat liver. The Km value obtained, 1.2 X 10-4 M, was of the same order of magnitude as those reported for animal and human liver demethylases.
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