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Diss Factsheets

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: Scientifically acceptable study report, comparable to guideline with acceptable restrictions (due to reduced reporting in times before GLP).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
only 7 days observation period
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexylamine
EC Number:
203-851-8
EC Name:
Hexylamine
Cas Number:
111-26-2
Molecular formula:
C6H15N
IUPAC Name:
hexan-1-amine

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Willi Gassner, Sulzfeld, Germany
- Age at study initiation: young adults
- Mean weight at study initiation (± SD): males: 168.4 ± 29 g, females: 139.8 ± 18 g


Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous emulsion containing Traganth
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2; 4; 8 and 20 % (v/v)
- Amount of vehicle: 8; 10; 12.5; 16 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 16 mL/kg bw
Doses:
200; 250; 320; 400; 800; 1600 µL/kg bw (corresponding to 152.84, 191.05, 244.54, 305.68, 611.36, 1222.72 mg/kg bw; calculated using the density of 0.7642)
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Body weight was determined before the beginning of the study for dose calculation.
- Other examinations performed: Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes
Statistics:
On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
ca. 244 mg/kg bw
Based on:
test mat.
Remarks on result:
other: corresponding to the original value of ca. 320 mm3, calculated with density of 0.7642
Mortality:
Results are given as dead animals/total number of animals at this dose at 1 h / 24 h / 48 h / 7 days after dosing:
Males
153 mg/kg bw: 0/10, 0/10, 0/10, 0/10
192 mg/kg bw: 0/10, 0/10, 0/10, 0/10
245 mg/kg bw: 0/10, 1/10, 0/10, 0/10
306 mg/kg bw: 0/10, 7/10, 7/10, 7/10
613 mg/kg bw: 10/10, 10/10, 10/10, 10/10
1226 mg/kg bw: 10/10, 10/10, 10/10, 10/10

Females
153 mg/kg bw: 0/10, 0/10, 0/10, 0/10
192 mg/kg bw: 0/10, 2/10, 2/10, 2/10
245 mg/kg bw: 1/10, 4/10, 4/10, 4/10
306 mg/kg bw: 0/10, 10/10, 10/10, 10/10
613 mg/kg bw: 10/10, 10/10, 10/10, 10/10
1226 mg/kg bw: 10/10, 10/10, 10/10, 10/10

Clinical signs:
other: 153 mg/kg bw: Approximately 5 min after gavage crouched position, apathy and shallow respiration were observed. On the following days no abnormalites were detected. 192 - 245 mg/kg bw: Immediately after gavage increased disposition to develop convulsions,
Gross pathology:
Sacrificed animals: no abnormality detected.
Other findings:
No other fndings

Any other information on results incl. tables

Table 1 Acute oral toxicity

 

Dose*

[mg/kg bw]

Mortality

 

N

%

Time of death

Males

 

 

 

152.84

0/10

0

-

191.05

0/10

0

-

244.54

1/10

10

Within 24 hours

305.68

7/10

70

Within 24 hours

611.36

10/10

100

Within 24 hours

1222.72

10/10

100

Within 1 hour

Females

 

 

 

152.84

0/10

0

-

191.05

2/10

20

Within 24 hours

244.54

4/10

40

Within 1 to 24 hours

305.68

10/10

100

Within 24 hours

611.36

10/10

100

Within 24 hours

1222.72

10/10

100

Within 1 hour

* original doses (200, 250, 320, 400, 800 and 1600 mm3) converted using the densitiy of 0.7642

N= number of dead animals / number of animals used

Applicant's summary and conclusion