Registration Dossier

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 (no data on test substance purity, reduced observation period, limited documentation).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1981
Deviations:
yes
Remarks:
(observation period 7 days instead of 14 days, 10 animals per sex instead of 5, no data on test substance purity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: Aethylpiperidin
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: breeder, Gassner
- Weight at study initiation: males: 225 ± 22 g; females: 187 ± 13 g

ENVIRONMENTAL CONDITIONS
- No data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: The test substance was applied as 2, 4, 8 or 20% (v/v) aqueous emulsion with Traganth.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
200, 250, 320, 400, 800, 1600 µL/kg bw (corresponding to approx. 165.2, 206.5, 264.3, 330.4, 660.8, 1321.6 mg/kg bw; calculation based on density of 0.826 g/cm³)
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. Observation of clinical signs was determined several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 280 mg/kg bw
Based on:
test mat.
Remarks on result:
other: The original value ca. 340 µL/kg was converted to mg/kg body weight using the density of 0.826 g/cm³
Mortality:
Results are given as dead animals/total number of animals:
165.2 and 206.5 mg/kg bw: 0/10 males and 0/10 females
264.3 mg/kg bw: 2/10 males and 5/10 females within 3 hours (6 animals) and 24 hours (one animal)
330.4 mg/kg bw: 8/10 males and 10/10 females within 1.5 (17 animals) to 3 (1 animal) hours
660.8 mg/kg bw: 10/10 males and 10/10 females within 1.5 hours
1321.6 mg/kg bw: 10/10 males and 10/10 females within 0.5 hour
Clinical signs:
264.3 - 1321.6 mg/kg bw: immediately after gavage sedate behaviour; 3 to 10 min after application convulsions; opisthotonus; flexor spasms; tremor; pain; dyspnea; lacrimation; salivation; exophthalmus; abdominal position; chromodakryorrhoe in the highest dose group.
264.3 - 660.8 mg/kg bw: surviving animals showed 4 to 6 hours after treatment crouching position; movement dislike; accelerated, irregular respiration; scrubby fur; sedate behaviour. Beginning on day 5 up to day 7 no abnormalities detectable.
165.2 and 206.5 mg/kg bw: immediately after gavage sedate behaviour; accelerated respiration; dyspnea; spasmodic convulsions; lacrimation; salivation. During the following observation period up to day 5: sedate behaviour; accelerated respiration; scrubby fur. Beginning with day 5 no abnormalities were detectable.
Body weight:
No data on body weight gain.
Gross pathology:
Deceased animals:
no abnormalities detected.

Sacrificed animals:
no abnormalities detected.

Any other information on results incl. tables

Table 1 Acute oral toxicity.

 

Dose

[mg/kg bw]

Mortality

Clinical signs

 

N*

%

Time of death

N*

Duration

Males

 

 

 

 

 

165.2

0/10

0

-

10/10

day 5

206.5

0/10

0

-

10/10

day 5

264.3

2/10

20

1.5 hours

10/10

until death, day 5

330.4

8/10

80

1.5 hours

10/10

until death, day 5

660.8

10/10

100

1.5 hours

10/10

until death

1321.6

10/10

100

0.5 hours

10/10

until death

Females

 

 

 

 

 

165.2

0/10

0

-

10/10

day 5

206.5

0/10

0

-

10/10

day 5

264.3

5/10

50

1.5 hours

10/10

until death, day 5

330.4

10/10

100

1.5 hours

10/10

until death

660.8

10/10

100

1.5 hours

10/10

until death

1321.6

10/10

100

0.5 hours

10/10

until death

*N= Number of animals / number of animals used

 

Applicant's summary and conclusion