sec-butylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: public study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

publication

Title:

The Acute Oral Toxicity of lsomeric Monobutylamines i

Author:

Chever K

Year:

1982

Bibliographic source:

Toxicology and applied pharmacology 63, (150-152)

Materials and methods

Principles of method if other than guideline:

Male and female weanling Sprague-Dawley CD rats
of the same age were obtained from the Charles River
Breeding Laboratories, Wilmington, Massachusetts.
These animais were housed two per cage and were acclimated
to laboratory conditions for 2 weeks prior to
initiation of the experiment. Laboratory temperatures
ranged from 22 to 26°C, and the relative humidity
ranged from 22 to 49%. A 12-hr light-dark schedulewas maintained with the light cycle beginning at 7:00
AM. Except for an 18-hr period immediately prior to
treatment, the animais were provided with Rodent Laboratory
Chow (Ralston Purina Co., St. Louis, Mo.). Tap
water was available ad libitum.
In a range-finding study, rats were treated in groups
of two males and two females with various amounts of
the test compound. From the resulting mortality data,
a range of doses was
established. Solutions of the monobutylamines were
then prepared in corn oil such that doses of 1 OO, 200,
300, 400, 500, and 600 mg/kg body wt for sec.-butylamine,
could be administered in a constant 4-ml volume.
Upon initiation of the toxicity experiment, the rats
were starved overnight, weighed (males, 194. 7 ± 20. 5
g; females, 156 ± 16.8 g), and randomly assigned to 24
dosage groups, each group consisting of 10 male and 10
female rats. The specified doses of each monobutylamine
were administered, by gavage, to ail rats within the corresponding
dosage groups. These animais were observed
for signs of toxicity or mortality during the subsequent
14-day period, and those that died during this period
were subjected to gross pathological examination. LD,0
values for each monobutylamine were calculated for
both niales and females from the mortality in the several
groups by the probit method of Finney ( 1971 ).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

sec-butylamine

EC Number:

237-732-7

EC Name:

sec-butylamine

Cas Number:

13952-84-6

Molecular formula:

C4H11N

IUPAC Name:

butan-2-amine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

These animais were observed
for signs of toxicity or mortality during the subsequent
14-day period, and those that died during this period
were subjected to gross pathological examination. LD,0
values for each monobutylamine were calculated for
both niales and females from the mortality in the several
groups by the probit method of Finney ( 1971 ).

Doses:

1 OO, 200,300, 400, 500, and 600 mg/kg body wt for sec.-butylamine

No. of animals per sex per dose:

2 males and 2 females

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

157.5 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

146.8 mg/kg bw

Based on:

test mat.

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

152.4 mg/kg bw

Based on:

test mat.

Mortality:

sedation, ataxia, nasal
discharge, gasping, salivation, and, at higher
doses, convulsions and death. At the dose
levels tested, death generally occurred within
1 to 3 hr after administration of the amine.
Animais which survived the 14-day period
appeared normal and were not further examined.
Gross pathological examination of
animais that died following treatment showed pulmonary edema

Clinical signs:

other: sedation, ataxia, nasal discharge, gasping, salivation, and, at higher doses, convulsions and death. At the dose levels tested, death generally occurred within 1 to 3 hr after administration of the amine. Animais which survived the 14-day period appeared

Any other information on results incl. tables

sec.-Butylamine              LD (50)                                          slope (+/_ SD)

M                               157.5 ( 35.1 -242.8)                            1.89 (±0.67)

F                              146.8 (12.4-239.3)                           1.67 (±0.66)

M and F                        152.4 (69.3-214.8)                          1.78 (±0.47)

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Sec butylamine is toxic after oral ingestion in rats.

Executive summary:

The LD50 values for the substance was calculated by the probit method.

No significant sex-related differences were noted. The 14-day, po single-dose

LD50 values (mg/kg body wt) were: for male, 157.5 mg/kg, and for female, 146.8 mg/kg.