Pyrrolidine

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1959

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study meets generally accepted scientific standards with restrictions due to the limited documentation.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1959

Report date:

1959

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

1959

Reference 3

Reference Type:

review article or handbook

Title:

Gesundheitsschaedliche Arbeitsstoffe, Toxikologisch-arbeitsmedizinische Begruendung von MAK-Werten (Maximale Arbeitsplatz-Konzentrationen), Pyrrolidin

Author:

MAK-Kommission

Year:

1977

Bibliographic source:

published in: VCH Weinheim, Germany, 20. Lieferung 1994

Materials and methods

Principles of method if other than guideline:

BASF test
Aqueous preparations of the test substance were injected into the peritoneal cavity of the mice. Group-wise documentation of clinical signs was performed over the 7-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.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Pyrrolidine

EC Number:

204-648-7

EC Name:

Pyrrolidine

Cas Number:

123-75-1

Molecular formula:

C4H9N

IUPAC Name:

pyrrolidine

Details on test material:

- Name of test material (as cited in study report): Pyrrolidin
- Physical state: fluid
- Analytical purity: 95 - 97 %

Test animals

Species:

mouse

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Mean body weight at study initiation: 25.3 g (males), 20.2 g (females)

ENVIRONMENTAL CONDITIONS
no details given

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

water

Details on exposure:

VEHICLE
- Concentration in vehicle: The doses were applied as 1 % or 10 % preparations of the test substance in aqua dest.
- Justification for choice of vehicle: soluble in water

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:

1600, 200, 100, 80, 50, 40, 32, and 25 µL/kg bw (corresponding to approx. 1374, 172, 86, 69, 43, 34, 27, and 21 mg/kg bw)
Calculation based on density of 0.859 g/mL

No. of animals per sex per dose:

1600 µL/kg bw: 3 females, 200 µL/kg bw: 3 females, 100 µL/kg bw: 5 males, 80 µL/kg bw: 3 females, 7 males, 50 µL/kg bw: 10 males, 40 µL/kg bw: 10 animals, 32 µL/kg bw: 5 animals, and 25 µL/kg bw: 10 males.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Cageside observations were performed several times on the day of administration and daily on workdays during observation period. Body weights were determined at test start for dose determination.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, gross-pathological investigation

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

30 mg/kg bw

Based on:

test mat.

Remarks on result:

other: corresponding to 35 µL/kg bw; calculation was based on a density of 0.859 g/cm³

Mortality:

1374 mg/kg bw: 3/3 animals died within 1 hr after administration
172 mg/kg bw: 3/3 animals died within 24 hours
86 mg/kg bw: 2/5 animals died within 24 hours; 3/5 within 48 hours
69 mg/kg bw: 2/10 animals died within 24 hours; 4 within 48 hours and 4 within 7 days
43 mg/kg bw: 5/10 animals died within 48 hours; 5 within 7 days
34 mg/kg bw: 4/10 animals died within 48 hours; 4 within 7 days
27 mg/kg bw: 1/5 animals died within 48 hours
21 mg/kg bw: 1/10 animals died within 48 hours; 1 within 7 days

Clinical signs:

1374 mg/kg bw: after treatment accelerated, intermittent respiration and abdominal position.
172 to 34 mg/kg bw: after treatment intermittent respiration, abdominal position and apathy. On day 2 moderate food intake and scrubby fur. On day 2 adhering eye lids and poor general state until death.
27 to 21 mg/kg bw: after treatment slightly accelerated respiration, moderate food intake. On day no abnormalities detectable.

Gross pathology:

1374 mg/kg bw: strong gastro-intestinal redness
172 and 86 mg/kg bw: intestinal redness
86 to 21 mg/kg bw: putrescence

Other findings:

No other findings.

Applicant's summary and conclusion

Conclusions:

The LD50 was determined to be 30 mg/kg bw.

Executive summary:

In this study, the test substance was injected into the peritoneal cavity of young adult laboratory mice. Several groups of male and female mice were treated simultaneously with preparations of the test substance in water in a dose range of 23 – 1374 mg/kg bw. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The LD50 was determined to be 30 mg/kg bw.