1-ethylpiperazine

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

Remarks:

without GLP status

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-ethylpiperazine

EC Number:

226-166-6

EC Name:

1-ethylpiperazine

Cas Number:

5308-25-8

Molecular formula:

C6H14N2

IUPAC Name:

1-ethylpiperazine

Details on test material:

- Name of test material (as cited in study report): Ethylpiperazin, Partie 6, Abl.Nr. 64-6112
- Analytical purity: 98%
- PSN 88/0569

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Thomae, Biberach/Germany
- Weight at study initiation: 181 g (mean weight males), 180 g (mean weight females)
- Fasting period before study: 16 hours before administration, except water
- Housing: groups of 5
- Diet: Kliba Labordiaet, 343; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 1 week

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20, 10, 4.64 mg/ 100 mL
- Amount of vehicle (if gavage): 10 mL/kg

Doses:

464, 1000, 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
- Frequency of weighing: at day 0, 7 and 13 of the study
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 000 - 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 4 male and 4 female animals of the 2000 mg/kg bw dose group died. Observed clinical signs were reversible within 14 days.

Mortality:

4 male and 4 female animals of the 2000 mg/kg bw dose group died during the first two days post treatment. No further mortality observed.

Clinical signs:

other: 2000 mg/kg bw dose group: Dyspnea, apathy, staggering, piloerection and poor general state was observed post treatment (4 hours) and up to 2 days after treatment in all animals. Twitching was observed 4 hours after treatment in the female animals. Afterwa

Gross pathology:

Animals that died (male + female): General congestion.
Stomach: atonic; reddened mucosa; striking liquid contents.
Intestines: atonic; reddened mucosa; liquid contents, in most animal bloody.
No pathological findings noted in surviving animals.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria