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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
only 1 test person

Data source

Reference
Reference Type:
publication
Title:
Ueber die fluechtigen Alkylamine im menschlichen Stoffwechsel
Author:
Rechenberger J.
Year:
1940
Bibliographic source:
Hoppe-Seylers Z. Physiol. Chemie 265, 275-284

Materials and methods

Objective of study:
excretion
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- application of the test substance: oral
- determination of the amount of the test substance in the urine
- isolation and identification of the test substance (amount of N and melting temperature)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylamine
EC Number:
200-834-7
EC Name:
Ethylamine
Cas Number:
75-04-7
Molecular formula:
C2H5NH2
IUPAC Name:
ethanamine
Details on test material:
- Name of test material (as cited in study report): Ethylamine
- Analytical purity: no data
Radiolabelling:
no

Test animals

Species:
human
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Duration and frequency of treatment / exposure:
no data
Doses / concentrations
Dose / conc.:
2 other: g
Remarks:
=0,639g N
No. of animals per sex per dose / concentration:
only one test person
Control animals:
no

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on excretion:
31.1 % of the ingested test substance was found unchanged in the urine (total urine amount: 1500ccm).

Any other information on results incl. tables

31.1 % of the ingested test substance was found unchanged in the urine (total urine amount: 1500ccm).

Applicant's summary and conclusion

Conclusions:
2g of the test substance war applied orally to the test person. The total urine amount was 1500ccm. 31.1 % of the ingested test substance was found unchanged in the urine.
Executive summary:

In a study conducted in 1940, not according to current guidelines, a subject who received an oral dose of 2 g of the hydrochlorid form of the test substance (the dose was well tolerated by the person) excreted 32 % (after correction for the normal concentration of N) unchanged test substance in the day urine. The remaining 68% are excreted as urea in the urine and C02 in the expiration air.

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