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Toxicological information

Basic toxicokinetics

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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:
1972

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

Constituent 1
Chemical structure
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
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