Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
No data
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:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Standardised study to determine the acute toxicity of the test item in mice after single i.p. application.
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): Jeffcat DMP
Specific details on test material used for the study:
- Name of test material (as cited in study report): N,N´-Dimethylpiperazin
- Analytical purity: 99 %

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 19-36 g
No further data.

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
No data
Doses:
200, 400, 640, 800 cm³/kg bw (170, 340, 544, 680 mg/kg bw - conversation in mg/kg is based on the density: d= 0.85 g/cm³)
The doses were administered as aqueous solutions of 8% (800 cm³/kg), 4% (400, 640 cm³/kg) and 2% (200 cm³/kg) test substance.
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
- Frequency of weighing: before the start of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 544 - < 680 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Corresponds to 640 and 800 cm³/kg bw; the mg/kg was calculated on the density d= 0.85 g/cm³. 680 mg/kg: all females and 4 males died within 24 hours post application; 544 mg/kg bw: one male and one female animal died within 24 hours post application.
Mortality:
680 mg/kg bw : all female animals and 4 males died within 24 hours post application
544 mg/kg bw : 1 male and 1 female animal died within 24 hours post application
340 mg/kg bw: one female animal died within 7 days post application
No mortalities in the 170 mg/kg bw dose group.
Clinical signs:
Immediately after application, dyspnoea, tremor, indicated morphine tails, shrunken flanks, high stepping gait, struggles in the 680 mg/kg bw dose group were observed. On the next day, the surviving animals showed clotted eyes, scrubby fur, accelerated respiration. 5 to 6 days after exposure, no clinical signs were observed.
Body weight:
no data
Gross pathology:
Animals that died: livers were full of blood, intestine and intraperitoneum were reddened
Animals sacrificed at the end of observation period: connation of liver and stomach in 10 animals

Applicant's summary and conclusion

Conclusions:
After intraperitoneal administration of the substance to mice, the LD50 was observed to be within the range of 544 and 680 mg/kg bw.