1-ethylpiperazine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

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:

Inhalation hazard test; Annex of OECD 403 as adopted (1981)); 3 animals per sex, no definition of chamber volume, no data on body weight gain, no determination of test atmosphere concentration

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

(IHT, adopted on 1981, 12th of may)

Deviations:

yes

Remarks:

(only 3 animals per sex were used, no definition of chamber volume, no data on body weight gain, no determination of test atmosphere concentration)

GLP compliance:

no

Test type:

other: IHT

Limit test:

yes

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): 1-Ethylpiperazin
- PSN 88/0950
- Physical state: liquid/colorless
- Analytical purity: > 98%
- Batch No.: 58-8751
- Storage condition of test material: Room temperature

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
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 279 g (mean male weight), 208 g (mean female weight)
- Housing: groups of 3 (singly during exposure)
- Diet (ad libitum in the period without exposure): KLIBA 24-343-4 rat/mouse laboratory diet
- Water (ad libitum in the period without exposure): tap water
- Acclimation period: at least 5 days

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

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The product was introduced to a height of 5 cm into a glass bottle (generator) with a sintered glass disc (pore-size 90 - 150 µm, diameter 30 mm), and the weight was determined. The generator containing the product was placed in a waterbath maintained at 20°C by a thermostat, and a stream of 200 L/h compressed air was supplied to a downstream mixing chamber. The mixture of air and test substance generated in this way was passed through a glass distributor to 6 glass tubes in which 3 male and 3 female animals had been placed. The emerging mixtures of test substance and air were exhausted.
Suitable measures were applied to ensure that the air supply had the same temperature as in the laboratories, so that the temperature in the exposure apparatus was between 19 and 25°C. There were no deviations from these set conditions which might have adversely affected the results of the study.
After 30 minutes, the generator was replaced by a new one containing fresh test substance as described above. This generator was then used for the remainder of the test.

TEST ATMOSPHERE
The amount of test substance used was determined by reweighing the generators. The nominal concentration was calculated from the amount of test substance consumed and the air volume.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

7 h

Concentrations:

The mean nominal concentration of the test substance, calculated for a test lasting 7 h was 10.43 mg/L.

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical examinations took place each work day. Lethality was checked each day.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

other: IHT

Effect level:

10.43 mg/L air (nominal)

Based on:

test mat.

Exp. duration:

7 h

Remarks on result:

other: No animals died after exposure to the saturated vapour of the test substance at 20°C.

Mortality:

No animals died.

Clinical signs:

other: Immediately after exposure, accelarated respiration, reddish nasal/eye discharge, squatting posture, piloerection, urine-contaminated fur and high-stepping gait were observed in male and female animals. On the first day post exposure piloerection was obes

Body weight:

No data on body weight changes.

Gross pathology:

No pathologic findings were observed.

Other findings:

During the exposure, irritating effects to the eyes and the respiratory tract (accelerated/intermittent respiration, eyelid closure, wiping of snouts, salivation, nasal discharge, reddish nasal/eye discharge) were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met