Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
BASF-test following internal SOP.
In principle, the methods described in OECD Guideline 401 were used.
Young adult laboratory rats were purchased from a breeder. Usually the source and strain of the animals were not documented. Several groups of 5 to 10 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in a suitable vehicle. The concentrations of these preparations were usually adjusted to achieve comparable volumes (e.g. 10 ml) per kg body weight. Group-wise documentation of clinical signs was performed over the 7- to 14- day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form. More details e.g. on substance preparation, or dose and time dependence of symptoms, can be inferred from the German hand written raw data.
On the basis of the observed lethality, the LD50 value was estimated or determined using a graphical evaluation of the dose response curve on probability paper.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Piperazine
EC Number:
203-808-3
EC Name:
Piperazine
Cas Number:
110-85-0
Molecular formula:
C4H10N2
IUPAC Name:
piperazine
Specific details on test material used for the study:
- Name of test material (as cited in study report): Piperazine
- Substance ID: 79/562
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Wiga
- Weight at study initiation: mean weights 150-220 g
- Fasting period before study: no data
- Housing: in groups of 5 animals, separated by sex
- Diet: Herilan MRH, Eggersmann KG ad libitum
- Water ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5 % CMC in water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5 %
- Justification for choice of vehicle: standard vehicle used for gavage studies
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
Doses:
3830, 2610, 1780, 1210, 1000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females per dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of application, at least once in the days thereafter
- 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. 2 600 mg/kg bw
Mortality:
3830 mg/kg bw dosing group: 5/5 males, 5/5 females
2610 mg/kg bw dosing group: 2/5 males, 3/5 females
1780 mg/kg bw dosing group: 0/5 males, 0/5 females
1210 mg/kg bw dosing group: 0/5 males, 0/5 females
1000 mg/kg bw dosing group: 0/5 males, 0/5 females
Clinical signs:
dyspnoea, apathy, abnormal position, staggering, tremor, scrubby coat, lacrimation, yellow coloured urine, bad general condition
surviving animals without findings
Body weight:
one male animal of the 2610 mg/kg bw dosing group showed strongly reduced body weight; in general reduced body weight gain was observed at this dose level
Gross pathology:
deceased animals: acute right heart dilatation acute congestion stomach atonic with liquid content; glandular stomach diffuse reddened; gut atonic with bloody liquid content diffuse reddened;

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 for acute oral toxicity in rat is 2600 mg/kg bw.
Executive summary:

In an acute oral toxicity study Sprague Dawley rats were dosed with piperazine by gavage. Groups with 5 males and 5 females in each group received doses of 1000, 1210, 1780, 2860 or 3830 mg/kg bw. The LD50 value was 2600 mg/kg.