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Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Published: 1976
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment.

Data source

Reference
Reference Type:
publication
Title:
Metabolism of N-Nitrosohexamethyleneimine
Author:
Grandjean, Carter J.
Year:
1976
Bibliographic source:
J. Natl. Cancer Inst., Vol 57, No 1, 181-185

Materials and methods

Objective of study:
metabolism
Principles of method if other than guideline:
Analysis of metabolism of Hexamethyleneiminie in rats.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Perhydroazepine
EC Number:
203-875-9
EC Name:
Perhydroazepine
Cas Number:
111-49-9
Molecular formula:
C6H13N
IUPAC Name:
azepane
Details on test material:
- Name of test material (as cited in study report): Hexamethyleneiminie, radioactively labelled: (14C)
- purity: not stated (but standard chemical was purchased and purified before use)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Duration and frequency of treatment / exposure:
Not clearly stated which of the below mentioned study designs was chosen for Hexamethyleneimine study.
Exp I: single treatment
Exp. II: daily treatment for 10 weeks
Doses / concentrations
Remarks:
Doses / Concentrations:
Not clearly stated which of the below mentioned study designs was chosen for Hexamethyleneimine study.
Exp. I: 12 mg/kg bw/day, 10-21 /µCi
Exp. II: 12 mg/kg bw/day, then once radioactive labelled test substance
No. of animals per sex per dose / concentration:
Not clearly stated which of the below mentioned study designs was chosen for Hexamethyleneimine study.
Exp I: not indicated, but at 9 time points within 10 days groups of 3 animals were killed (makes a total of 27 animals)
Exp II: 6 male animals
Control animals:
not specified

Results and discussion

Main ADME results
Type:
metabolism
Results:
at least two non-volatile organic compounds in urine were detected which resulted from the test substance.

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
no further characterisation

Applicant's summary and conclusion

Conclusions:
A study was performed administrating C14 -labelled Hexamethyleneimine to male rats and analysis of the urine for nonvolatile radioactive compounds was performed (details on administration and sampling of urine not clearly stated). Analysis revealed that there were at least two radioactive compounds detectable (which were not further characterised).