Registration Dossier
Registration Dossier
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EC number: 203-699-2 | CAS number: 109-73-9
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, limited documentation, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 972
Materials and methods
- Objective of study:
- excretion
- Principles of method if other than guideline:
- Biochemical/physiological model study on the mechanism of ammonia and amine excretion in acidosis and alkalosis:
Excretion into urine of rats after i.p. injection of the HCl salts of various amines under artificially alkalotic or acidotic metabolic conditions.
Identification and quantification of the urinary amines after derivatisation with dinitrophenol by reverse-phase HPLC. - GLP compliance:
- no
Test material
- Reference substance name:
- Butylammonium chloride
- EC Number:
- 223-369-1
- EC Name:
- Butylammonium chloride
- Cas Number:
- 3858-78-4
- Molecular formula:
- C4H11N.ClH
- IUPAC Name:
- butan-1-aminium chloride
- Details on test material:
- n-Butylamine hydrochlorid, not further specified
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- ca. 250 g body weight
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- physiological saline
- Duration and frequency of treatment / exposure:
- 12 hour(s)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100 mg/kg bw (related to free base) in 5 mL saline
- No. of animals per sex per dose / concentration:
- 6
- Control animals:
- not specified
Results and discussion
Metabolite characterisation studies
- Metabolites identified:
- no
Any other information on results incl. tables
n-Butylamine was easily excreted into the urine within 8 h, 4.2 times
higher under acidotic conditions (urinary pH 5.4 - 6.0) than under
alkalotic conditions (urinary pH 7.7 - 8.7).
No mass balance or quantitative data are documented.
It can concluded that the un-ionised, more lipohilic n-butylamine partitions rapidly across membranes by diffusion, and excretion into urine is favoured by ionisation under acidotic conditions, thus the amine (like ammonia) serving as vehicle to get rid of excess H+ (compensation of acidosis).
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Applicant's summary and conclusion
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