Reaction mass of 2-Piperazin-1-ylethanol and Piperazine-1,4-diethanol and Piperazine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable report which meets basic scientific principles. Hydroxyethylpiperazine is the major constituent (ca. 40%) of the test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

(weight variations in animals exceed 20% of the mean weight, observation period of 7 days, no details on animal husbandry)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-piperazin-1-ylethanol

EC Number:

203-142-3

EC Name:

2-piperazin-1-ylethanol

Cas Number:

103-76-4

Molecular formula:

C6H14N2O

IUPAC Name:

2-piperazin-1-ylethanol

Details on test material:

- Name of test material (as cited in study report): Hydroxyaethylpiperazin
- Analytical purity: 99 %

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: young adult laboratory rats
- Weight at study initiation: 100 - 224 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

(doubly distilled)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10-20 mL/kg bw
The doses were administered as aqueous solutions of 8% (800 cm³/kg), 20% (1600 cm³/kg) and 30% (3200, 4000 and 5000 cm³/kg) test substance.

Doses:

800, 1600, 3200, 4000 and 5000 cm³/kg (849, 1698, 3396, 4244, 5305 mg/kg bw - conversion in mg/kg is based on the density: d= 1.06 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
- Frequency of weighing: before the start of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 4 244 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Corresponds to 4000 cm³/kg; the mg/kg was calculated on the density d: d= 1.061 g/cm³. 1 male/3 females died within the first 24 h post exposure in this dose group.

Mortality:

5305 mg/kg bw: All females died within the first 24 h and 3 males died within 48 h.
4244 mg/kg bw: 1 male and 3 females died within the first 24 h.
3396 mg/kg bw: 1 male and 2 females died within the first 24 h.
1698 mg/kg bw: 1 animal died within 7 days.

Clinical signs:

5305 and 4244 mg/kg bw: high stepping gait, motor excitation, intermittent respiration, abdominal position and paresis (hindlimb), immediately after application; piloerrection, nose and eyes with reddish crusts, intermittent respiration, apathy and squatting posture until including day 3. No clinical signs and findings in the surviving animals from the fifth post observation day onward.

3396 and 1698 mg/kg bw: irregular respiration and squatting posture from hour 2 until hour 4 after application. Irregular respiration and piloerection until day 4. No clinical signs and findings in the surviving animals from the fifth post observation day onward.

Body weight:

no data

Gross pathology:

Animals that died:
5305 mg/kg bw: smeared fur (snout and anogenital region), dilatation of the stomach and intestine (partly filled with blood and liquid content).
4244 mg/kg bw: smeared fur (snout); dilatation of the stomach and intestine (partly filled with blood and liquid content).
3396 mg/kg bw: smeared fur (snout and anogenital region), diarrhea.
Animals examined at termination of the study: Organs without particular findings.

Any other information on results incl. tables

Mortality:

Dose (mg/kg)	Conc.(%)	dead within 1h	dead within 1 day	dead within 2 days	dead within 7 days
5305	30	0/10	6/10	8/10	8/10
4244	30	1/10	4/10	4/10	4/10
3396	30	0/10	3/10	3/10	3/10
1698	20	0/10	0/10	0/10	1/10
849	8	0/10	0/10	0/10	0/10