Registration Dossier

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
other: Kisslegg-mice
Sex:
male/female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Doses:
50, 100, 160, 200, 250, 320, 400, 1600 µl/kg
(48, 97, 155, 194, 243, 310, 388, 1552 mg/kg)
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Animals were observed over a 14 day period after administration of the test article

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 184 mg/kg bw
Remarks on result:
other: after 14 days of observation
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 194 mg/kg bw
Remarks on result:
other: after 14 days of observation
Mortality:
1600 µl/kg: all animals died within 1h.
400 µl/kg: 4 males and 5 females died within 24 h and 1 male within 48h.
320 µl/kg: 1 male and 3 females died within 24 h, 1 male and 1 female within 48 h and 3 males and 1 female within 7 days.
250 µl/kg: 1 male and 1 female died within 48 h, 2 males and 2 females within 7 days and 1 female between 7 and 14 days.
200 µl/kg: 4 males and 2 females died between 48 h and 7 days.
160 µl/kg: 1 female died within 48 h and 1 female within 7 days.
50 and 100 µl/kg: no mortality occured.
Clinical signs:
1600 µl/kg:
Immediately post application slight spasms and after 2 min tonic convulsions, gaunted sides, irregular decelerated and intermittent respiration, hobbled gait, cry of pain, stretching and bending in convulsions.

400 and 200 µl/kg:
Immediately post application hobbled gait, gaunted sides, irregular accelerated and intermittent respiration, flattened ears, in short intervals spasmic convulsions, squatting posture, tremor, stagger.
3 h after application: very calm attitude, abdominal position, gaunted sides, apathy, hypothermia.
3 days after application: very calm attitude, irregular accelerated intermittent respiration, ruffled fur, squatted posture, crusted eyelid.
4 days after application: irregular respiration, ruffled fur.
5 days after application: very calm attitude, squatted posture, ruffled fur.
day 6 - sacrifice: ruffled fur.

160, 250 and 320 µl/kg:
Immediately post application slight spasms and after 2 min tonic convulsions, high stepping gait, stagger, gaunted sides, bending in convulsions, irregular accelerated respiration, flattened ears.
1.5 h after application: very calm attitude, gaunted sides, ruffled fur, stretching.
48 h after application: very calm attitude, ruffled fur, squatting posture, irregular respiration, crusted eyelids.
3 days after application: calm attitude, ruffled fur.
6 days after application: squatting posture, ruffled fur, irregular respiration, crusted eyelids,
7 days after application: ruffled fur, squatting posture, hypothermia, irregular respiration, gaunted sides, eyes closed.
9 days after application: calm attitude, gaunted sides.

100 µl/kg:
Squatting posture, hobbled gait, accelerated intermittent respiration, gaunted sides, calm attitude, stagger, eyes closed.
24 h after application: calm attitude, slight stagger, stretching, ruffled fur, irregular slightly accelerated respiration.
48 h - sacrifice: ruffled fur.

50 µl/kg:
Immediately post application accelerated respiration.
Gross pathology:
Histopathology data only for some animals available.
Dying animals: 3 animals showed agglutination of the abdominal cavity.
Sacrificed animals: 7 animals showed agglutination of the abdominal cavity and 5 animals swelling of the liver.

Any other information on results incl. tables

Table 1: Results of the i.p. experiment

 Dose (µl/kg)  Conc.(%)  dead within 1h  dead within 1 day  dead within 2 days  dead within 7 days  dead within 14 days  
 1600  20  10/10  10/10  10/10  10/10  10/10  
  400  2  0/10  9/10  10/10  10/10  10/10  
  320  2  0/10  4/10  6/10  10/10  10/10  
 250  2  0/10  0/10  2/10 6/10  7/10  
  200  2  0/10  0/10  0/10  6/10  6/10  
160  2  0/10  0/10  1/10  2/10  2/10  
  100  2  0/10 0/10  0/10  0/10  0/10   
  50  0.5  0/10 0/10  0/10  0/10  0/10   

Applicant's summary and conclusion