Butylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions, only short communication, sufficiently documented

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

vehicle: corn oil instead of aqueous solution; survivors not examined at the end of the 14-d observation period

Principles of method if other than guideline:

Comparative study including tert. butylamine, sec-butylamine,  isobutylamine and n-butylamine.

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butylamine

EC Number:

203-699-2

EC Name:

Butylamine

Cas Number:

109-73-9

Molecular formula:

C4H11N

IUPAC Name:

butan-1-amine

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): n-butylamine
- Analytical purity: >99%)
- Source: obtained from Tridom Chemical Inc., Hauppage, New York.

- other test materials also included: isobutylamine; sec. butylamine; tert. butylamine

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, MA
- Age at study initiation: not stated
- Weight at study initiation: males: 195 +/- 20.5 g; females: : 156 +/- 16.8 g
- Fasting period before study: yes, overnight
- Housing: two animals per cage
- Diet: Rodent Laboratory Chow from Ralston Puirna Co. , St. Louis, MO; ad libitum
- Water: tap water ad libitum
- Acclimation period: 2 weeks


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-26
- Humidity (%): 22-49
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: treatement To: end of 14-day observation period

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: variable dose
- Amount of vehicle (if gavage):
- Justification for choice of vehicle: no data


MAXIMUM DOSE VOLUME APPLIED: 4 mL/kg bw

Doses:

100, 200, 300, 400, 500, 600 mg/kg bw (in 4 ml corn oil)

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not reported, probably daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight (bw not documented), necropsy of animals that died

Statistics:

Statistical data evaluation: LD50-values were calculated using the probit  method of Finney (1971). Data for male and female animals were compared statistically for each compound by the chi-square contingency table analysis (Snedecor and Cochran, 1967).

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

371.8 mg/kg bw

95% CL:

307.8 - 458.4

Remarks on result:

other: in corn oil

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

365.7 mg/kg bw

95% CL:

283.6 - 475.8

Effect levels 3

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

382.4 mg/kg bw

95% CL:

278.1 - 490.5

Mortality:

Number of deaths: not reported
Time to death: generally 1 - 3 h post-administration

Clinical signs:

other: Sedation, ataxia, salivation, nasal discharge, gasping, and at higher  doses, also convulsions 

Gross pathology:

Deceased animals mainly exhibited pulmonary edema. 
Surving animals appeared normal after 14 d and were not further examined.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Under the experimental conditions an oral LD50 of 371.8 mg/kg bw was determined in male/female rats.

Executive summary:

The acute oral LD₅₀value of n-butylamine was determined in male and female Sprague-Dawley CD rats in a dose range of 100 -600 mg/kg bw. Signs of toxicity observed after single oral doses of the monobutylamines included sedation, ataxia, nasal discharge, gasping, and salivation followed by convulsions and death at the higher dose levels. Gross pathological examination of animals that died after the monobutylamine treatment revealed pulmonary edema. The LD50 values were calculated by the probit method of D. J. Finney. The LD50 for n-butylamine after an observation period of 14 days was 365.4 mg/kg bw in male rats and 382.7 mg/kg bw for female rats (mean 371.8 mg/kg bw).