Registration Dossier
Registration Dossier
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EC number: 212-344-0 | CAS number: 793-24-8
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable-well documented publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
- Objective of study:
- other: hydrolysis rate of test substance in simulated gastric juice
- Principles of method if other than guideline:
- other: determination of hydrolysis rate in simulated gastric juice
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
- EC Number:
- 212-344-0
- EC Name:
- N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine
- Cas Number:
- 793-24-8
- Molecular formula:
- C18H24N2
- IUPAC Name:
- N1-(4-methylpentan-2-yl)-N4-phenylbenzene-1,4-diamine
- Details on test material:
- Santoflex 13
Constituent 1
Test animals
- Species:
- other: in vitro
Results and discussion
Main ADME resultsopen allclose all
- Type:
- other: hydrolysis rate in gatric juice
- Results:
- hydrolysis rate -0.0188, half-life 36.9 hours
- Type:
- other: hydrolysis products
- Results:
- major hydrolysis product: aniline, minor intermediate hydrolyse products: benzoquinoneimine-N-phenyl, N-1,3 dimethyl-butylamine p-phenol
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- within 48 hours 60 % of 6PPD was hydrolyzed in gastric juice; hydrolysis rate -0.0188, half-life 36.9 hours
major hydrolysis product: aniline, minor intermediate hydrolyse products: benzoquinoneimine-N-phenyl, N-1,3 dimethyl-butylamine p-phenol
Any other information on results incl. tables
During the 48 -hour period approximately 60% of the test compound hydrolyzed. A hydrolysis rate constant of -0.0188 and a half-life of 36.9 hours were observed. The approximate solubility of the test compound in gatric juice was determined to be 173 mg/l.
The major observed hydrolysis product was aniline. A trace of two intermediate hydrolysis product, benzoquinoneimine-N-phenyl, and N-1,3 dimethyl-butylamine p-phenol were observed in the reaction sample. The authors suggested that quinone as well as 2 amino-4methyl pentane are also hydrolysis products.
Applicant's summary and conclusion
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