Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12. Jan 1978 - 23. Mar 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF-Test, see details in remarks on material and methods.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 218 g (mean); female: 172 g (mean)
- Diet: Alleinfutter fuer die Haltung von Maeusen, Ratten und Hamstern, Heinrich Eggersmann, Rinteln, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
147, 215, 316, 464, 1000 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations daily; weighing on days 3, 7, and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 370 mg/kg bw
Mortality:
see details in table in remarks on results.
Clinical signs:
1000 mg/kg bw:
15 min past application: dyspnoea, irregular respiration.
30 min past application: spastic gait, ruffled fur.
1 h past application: staggering, apathy.
2 h past application: lateral-abdominal position, exophthalmia

464 mg/kg bw:
15 min past application: dyspnoea, apathy, staggering, spastic gait.
2 h past application: ruffled fur.

316 mg/kg bw:
2 h past application: ruffled fur.
Body weight:
Initially the animals lost weight.
Gross pathology:
Animals that died during the study (316, 464 and 1000 mg/kg bw):
Heart: acute dilatation of the right ventricle; acute congestion;
Lung: some animals with slight acute distensions;
Stomach: strong diffuse erythema in the glandular stomach;
Intestine: atonic, strong erythema of the mucosa; bloody diarrhetic content.

Sacrificed animals: stomach: boutons in the forestomach, agglutination of the forestomach with the peritoneum.

Sacrificed animals (316, 215, 147 mg/kg bw):
No abnormalities were observed.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg bw)  Gender  1 h  24 h  48 h  7 days  14 days  
 1000 male   0/5  5/5  5/5  5/5  5/5  
   female  1/5  5/5  5/5  5/5  5/5  
 464  male  0/5  3/5  3/5  4/5  4/5  
   female  0/5  2/5  2/5  5/5  5/5  
 316  male  0/5  0/5  1/5  2/5  2/5  
   female  0/5  0/5  0/5  0/5  0/5  
 215  male  0/5  0/5  0/5  0/5  0/5  
  female   0/5 0/5   0/5  0/5  0/5  
 147  male  0/5  0/5  0/5  0/5  0/5  
   female  0/5  0/5  0/5  0/5  0/5  

Weight:

Dose (mg/kg) Gender  0 h 3 days  7 days 14 days  
 1000 male 180  - - -    
  female 160 - -  
 464 male 210   187 200   245  
  female 160  -  
 316 male 230 220 252 277  
  female  190  185  213 224   
 215 male 240  239  264 291   
  female  160  158 178  186    
 147 male   230 228 266   263  
  female  190  197 219 230 

The test substance caused systemic toxicity (including mortality) and local irritation in a dose dependent manner.

Applicant's summary and conclusion