Registration Dossier

Toxicological information

Acute Toxicity: other routes

Currently viewing:

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific standards with restrictions due to the limited documentation.

Data source

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

Materials and methods

Principles of method if other than guideline:
BASF test
Aqueous preparations of the test substance were injected into the peritoneal cavity of the mice. Group-wise documentation of clinical signs was performed over the 7-day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Aethylpiperidin
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Mean body weight at study initiation: 34 ± 2.8 g (males), 32 ± 2.8 g (females)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
VEHICLE
- Concentration in vehicle: The doses were applied as 0.5 % (50 µL/kg bw), 1 % (100 µL/kg bw), 2 % (125, 160 and 200 µL/kg) , or 20 % (1600 µL/kg bw) v/v preparations of the test substance (aqueous emulsion with Traganth).

MAXIMUM DOSE VOLUME APPLIED: 16 mL/kg

Doses:
50, 100, 125, 160, 200, and 1600 µL/kg bw (corresponding to approx. 41.3, 82.6, 103.25, 132.16, 165.2 and 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: 14 days
- Frequency of observations and weighing: Cageside observations were performed several times on the day of administration and daily on workdays during observation period. Body weights were determined at test start for dose determination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 91 mg/kg bw
Based on:
test mat.
Remarks on result:
other: corresponding to 110 µL/kg bw; calculation was based on a density of 0.826 g/cm³
Mortality:
41.3 mg/kg bw: 0/5 males and 0/5 females died
82.6 mg/kg bw: 3/10 animals died (1/5 males died within 48 hours and 2/5 males within 7 days. 0/5 females died)
103.25 mg/kg bw: 6/10 animals died (1/5 males died within 48 hours and 4/5 males within 7 days. 1/5 females died within 7 days)
132.16 mg/kg bw: 9/10 animals died (2/5 males died within 1 hour after treatment and 2/5 males within 24 hours. 1/5 females died within 1 hour, 3/5 females within 24 hours and 1/5 within 7 days)
165.2 and 1321.6 mg/kg bw: 10/10 animals died (5/5 males and 5/5 females died within 10 min after treatment)

Clinical signs:
165.2 and 1321.6 mg/kg bw: immediately after treatment accelerated respiration, tremor, convulsions, dyspnea, exophthalmos
41.3 and 132.16 mg/kg bw: immediately after treatment accelerated, intermittent respiration, spasmodic convulsions, sunken flanks. 4 hours after application and on the following days suriving animals showed crouched position, irregular and accelerated respiration, scrubby fur. Beginning with day 7 to 10 no abnormalities were detectable.
Gross pathology:
Deceased animals: putrefaction
Sacrificed animals: adhesions in the abdominal cavity

Applicant's summary and conclusion