Registration Dossier
Registration Dossier
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EC number: 201-642-6 | CAS number: 85-91-6
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Data is available online
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Details of guidelines not mentioned in the publication
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Methyl N-methylanthranilate
- EC Number:
- 201-642-6
- EC Name:
- Methyl N-methylanthranilate
- Cas Number:
- 85-91-6
- Molecular formula:
- C9H11NO2
- IUPAC Name:
- methyl 2-(methylamino)benzoate
- Test material form:
- other: liquid
- Details on test material:
- Methyl N Methylanthranilate (MNMA)
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: Guinea pigs (Liver microsomes & cytosol)
- Strain:
- Hartley
- Sex:
- male
Administration / exposure
- Route of administration:
- other: in-vitro hence not applicable
- Vehicle:
- other: in-vitro hence not applicable
- Details on exposure:
- MNMA was incubated with guinea pigs liver microsomes (5 µg protein) or cytosol (50 µg protein) in sodium-potassium phosphate buffer 38 mM (pH 7.4) in a final volume of 260 µl. The mixture was incubated at 37oC for 10 mins, and the reaction was terminated by the addition of acetonitrile 200 µl containing methyl p-methoxybenzoate (0.20 µg) as an internal standard. After the removal of protein by centrifugation, 50 µl of the supertanant was injected onto a High Performance Liquid Chromatography (HPLC) system.
- Duration and frequency of treatment / exposure:
- 10 mins
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 µM
- No. of animals per sex per dose / concentration:
- Not applicable
- Control animals:
- no
Results and discussion
Main ADME results
- Type:
- metabolism
- Results:
- MNMA was hydrolyzed by guinea pigs liver microsomes to produce N-Methyl Anthranilic acid. MNMA was also N-Demthylated by Guinea pigs liver microsomes & cytosol to form anthranilic acid (AA).
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Not Applicable
- Details on distribution in tissues:
- Not Applicable
- Details on excretion:
- Not Applicable
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- N-Methyl Anthranilic acid &
Anthranilic acid (AA)
Any other information on results incl. tables
MNMA was hydrolyzed byguinea pigs liver microsomes to produceN-Methyl Anthranilic acid.MNMA was also N-Demthylated byGuinea pigs liver microsomes & cytosol to form anthranilic acid (AA).
Kinetic analysis indicated that Vmax/Km values were 7.4 fold higher in microsomes than in cytosolApplicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
In vitro study of hepatic metabolism of Methyl N Methylanthranilate in guinea pigs liver microsomes was conducted wherein the kinetic analysis indicated that Vmax/Km values were 7.4 fold higher in microsomes than in cytosol. Vmax/Km values reflect the intrinsic clearance potential after hydrolysis and thus the bio-accumulation potential of Methyl N Methylanthranilate (MNMA) is expected to be low. - Executive summary:
In vitro study of hepatic metabolism of Methyl N Methylanthranilate in guinea pigs liver microsomes was conducted wherein the kinetic analysis indicated that Vmax/Km values were 7.4 fold higher in microsomes than in cytosol. Vmax/Km values reflect the intrinsic clearance potential after hydrolysis and thus the bio-accumulation potential ofMethyl N Methylanthranilate (MNMA)is expected to be low.
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