Piperazine

Acute Toxicity: oral

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

Test material information

Constituent 1

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:

other: dyspnoea, apathy, abnormal position, staggering, tremor, scrubby coat, lacrimation, yellow coloured urine, bad general condition surviving animals without findings

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.