Registration Dossier
Registration Dossier
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EC number: 200-834-7 | CAS number: 75-04-7
Basic toxicokinetics
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:
- 1 940
- 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
- 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
Constituent 1
- 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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