Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07. Nov 1967 - 15. Nov 1967
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:
1968
Report Date:
1968

Materials and methods

Principles of method if other than guideline:
BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 7 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Monomethylpiperazin
- Analytical purity: 99 %

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 118 - 236 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
800, 1600, 2000, 2500, 3200, 4000 cmm/kg bw (722, 1444, 1806, 2258, 2890, 3612 mg/kg bw - conversation in mg/kg is based on the density: d= 0.903 g/cm3).
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 2 258 mg/kg bw
Remarks on result:
other: conversation in mg/kg is based on the density: d=0.903 g/cm3.
Mortality:
3612 mg/kg: all animals die within 24 h.
2890 mg/kg: 1 male and 5 females died within 24 h.
2258 mg/kg: 1 male and 5 females died within 24 h.
Lower dose levels: no mortalities.
Clinical signs:
3612 mg/kg: 3 h post application abdominal and lateral position, closed eyes, irregular respiration. 24 h post application ruffled fur, apathy, closed eyes, shallow respiration.
2890 mg/kg: After 30 min abdominal position, intermittent respiration, closed eyes. 24 h post application squatting posture, irregular respiration, rufled fur.
1806 mg/kg: After 10 min high stepping gait, accelerated respiration. 24 h post application accelerated respiration, ruffled fur and high stepping gait.
Body weight:
no data
Gross pathology:
Animals that died:
All animals showed stomach ectasia with liquid-mucous, partially bloody content. 10 x blood filled secretion vesicles in the nose.

Any other information on results incl. tables

Mortality:

 Dose (mg/kg)  Gender  Conc.(%)  dead within 1h  dead within 24 h  dead within 48 h  dead within 7 days  
3612  male  30 0/5 5/5 5/5 5/5  
3612  female  30 0/5 5/5 5/5 5/5  
2890  male  30 0/5 1/5 1/5 1/5  
2890  female  30 0/5 5/5 5/5 5/5  
2258  male  20 0/5 1/5 1/5 1/5  
2258  female  20 0/5 5/5 5/5 5/5    
1806  male  20 0/5  0/5 0/5 0/5    
1806   female  20 0/5 0/5  0/5 0/5    
1444  male  20 0/5 0/5  0/5 0/5    
1444  female  20 0/5 0/5  0/5 0/5     
722  male 0/5 0/5  0/5 0/5     
722  female 8 0/5 0/5  0/5 0/5    

Applicant's summary and conclusion