Registration Dossier

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:
1986

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

Constituent 1
Chemical structure
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:
N-(1,3-dimethylbutyl)-N'-phenylbenzene-1,4-diamine
Details on test material:
Santoflex 13

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