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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
Study period:
1982-01-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Principles of method if other than guideline:
Method: other: in analogy to OECD Guide-line 401
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyl(ethyl)amine
EC Number:
236-415-0
EC Name:
Butyl(ethyl)amine
Cas Number:
13360-63-9
Molecular formula:
C6H15N
IUPAC Name:
butyl(ethyl)amine
Details on test material:
- Name of test material (as cited in study report): N-Ethyl-N-Butylamine [CAS No. 13360-63-9], not further specified

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: A. Tucks and Sons Ltd., Battlesbridge, Essex
- Age at study initiation: 4 to 6 weeks
- Weight at study initiation: 86-182 g
- Fasting period before study: overnight and 2 hours after dosing
- Housing: in groups of 5 in polypropylene cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimu of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 65-75
- Air changes (per hr): 15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): up to 0.7 mL/kg bw
- Justification for choice of vehicle: none provided
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 1.36 mL/kg bw

DOSAGE PREPARATION (if unusual): suspension
Doses:
200; 271; 368; 500; 679 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation at least daily
- Necropsy of survivors performed: yes (one surviving male and female from the top dose. If effects are seen, further animals from lower doses were planned to be examined).
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
467 mg/kg bw
95% CL:
397 - 549
Mortality:
Deaths occurred in groups at 368 mg/kg bw and above, on the day of dosing or one day thereafter
Clinical signs:
Hunched posture, lethargy, piloerection, ptosis, decreased respiration  rate. At the higher doses, additionally convulsions, ataxia, gasping  respiration, tremor, pallor of extremities. Survivors showed apparently normal appearance after day 11.
Body weight:
no data
Gross pathology:
No abnormal findings (only survivors examined, very few animals)

Any other information on results incl. tables

Mortality (day 14)

Dose (mg/kg bw)

Males

Females

200

0/5

0/5

271

0/5

0/5

368

2/5

1/5

500

2/5

3/5

679

5/5

4/5

 

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity of Ethylbutylamine was examined in rats (5/sex and dose; dose levels 200, 271, 368, 500, and 679 mg/kg bw. Test material was administered as an emulsion (50% in arachis oil) by oral gavage. The study was conducted similar to OECD TG 401 and under GLP conditions. The purity of the test material was not reported.

Mortalities occurred within one day after dosing in groups at 368 mg/kg bw and above. The LD50was 467 mg/kg bw in this study (Safepharm, 1982).