Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Study period:
06. Jan 1965 - 19. Jan 1965
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:
other: BASF-Test
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diisopropanolamin

Test animals

Species:
mouse
Strain:
other: Tuebinger-Mice
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 36 g (mean), female: 28 g (mean)

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Doses:
200, 250, 320, 400, 800, 1600 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 350 mg/kg bw
Mortality:
1600 mg/kg: all animals died within the first 24 h.
800 mg/kg: all animals died within the first 24 h.
400 mg/kg (8%): 3 males died n the first day, 1 on the second and 1 on the fourth day. 1 female died on the first day, 2 on the second and 1 each on days 5 and 6.
400 mg/kg (4%): 1 male died on day 2 and 1 on day 7. 1 female died within 24 h and one on day 6.
320 mg/kg (4%): 1 male each died on day 3 and 4.
320 mg/kg (2%): 1 male died on day 2.
250 mg/kg (4%): 1 male died on day 6.
250 mg/kg (2%): 1 male died on day 4.
Clinical signs:
1600 mg/kg: Immediatelyy post application high stepping gait, staggering, in intervals clonic convulsions.

800 mg/kg: high stepping gait, intermittent respiration.

400 mg/kg (8%): high stepping gait, intermittent respiration. 4 days after application: very calm attitude, gaunted sides, irregular respiration, agglutinated eyes, aquatting posture, bad general condition.

400 and 320 mg/kg (4%): immediately post application convulsions, intermittent respiration, animals are agressive. One day after application: intermittent respiration, fluffy fur, partly abdominal position. 2 days after application: calm attitude, fluffy fur, accelerated respiration.

320 and 250 mg/kg (2%): 10 min post application abdominal position, flattened ears, accelerated repiration, waddling gait. One day after application: ruffled and partly fluffy fur, accelerated respiration. 2 daysafter application: squatting posture
Gross pathology:
1600 mg/kg: peritoneal and gastrointestinal irritation. Liquid in abdomial cavity.
800 and 400 mg/kg (8%): Liquid in abdominal cavity, gastointestinal irritation, clouded adiposal tissue.
400 mg/kg (4%): Residual substance and agglutination.
250 mg/kg: clouded adiposal tissue.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg)  Conc. (%)  1 h  24 h  48 h  7 days  14 days          
 1600  16  0/10  10/10  10/10  10/10  10/10          
 800  8  0/10  10/10  10/10  10/10  10/10          
 400  8 0/10  4/10  7/10  10/10  10/10          
 400  4  0/10  1/10  2/10  4/10  4/10          
 320  4  0/10  0/10  0/10  2/10  2/10          
 320  2  0/10  0/10  1/10  1/10  1/10          
 250  4  0/10  0/10  0/10  1/10  1/10          
 250  2  0/10  0/10  1/10  1/10  1/10          
 200  2  0/10  0/10  0/10  0/10  0/10          

Applicant's summary and conclusion