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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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 levelsopen allclose all
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
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
365.7 mg/kg bw
95% CL:
283.6 - 475.8
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:
Sedation, ataxia, salivation, nasal discharge, gasping, and at higher  doses, also convulsions 
Body weight:
no data
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).