1-vinyl-2-pyrrolidone

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:

other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

Standardized test method (BASF test) to study the acute inhalative toxicity in rats after 4 hours of exposure.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-vinyl-2-pyrrolidone

EC Number:

201-800-4

EC Name:

1-vinyl-2-pyrrolidone

Cas Number:

88-12-0

Molecular formula:

C6H9NO

IUPAC Name:

1-ethenylpyrrolidin-2-one

Test material form:

aerosol dispenser: not specified

Remarks:

migrated information: aerosol

Details on test material:

- Name of test material (as cited in study report): Vinylpyrrolidon
- Physical state: clear, liquid
- Analytical purity: >99%
- Impurities (identity and concentrations): 10 ppm N-N'-Di-2-butyl-p-phenylendiamin (stabilisator)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA, Sulzfeld, D (SPF)
- Mean weight per group at study initiation: males: 182 - 219.5 g; females: 176 - 206 g
- Diet: Herilan MRH, H. Eggersmann KG, Rinteln, D; ad libitum
- Water: tap water ad libitum

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: permanent infusion pump (UNITA I, Braun, Melsungen, D)

TEST ATMOSPHERE
- Brief description of analytical method used: GC HP 5840 A; determination of the test substance in toluol
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

analytical: 0.8, 2.0, 2.8, 5.2 and 5.63 mg/L (mean of 4 measurements)
nominal: 9.4, 18.8, 28.2, 37.6 and 46.4 mg/L

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing was performed on day 0 before treatment, day 7 and day 14; clinical signs were observed daily
- Necropsy of survivors performed: yes

Statistics:

Probit analysis according to Finney, 1971

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

3.07 mg/L air (analytical)

Exp. duration:

4 h

Effect levels 2

Sex:

female

Dose descriptor:

LC50

Effect level:

2.87 mg/L air (analytical)

Exp. duration:

4 h

Effect levels 3

Sex:

male

Dose descriptor:

LC50

Effect level:

3.32 mg/L air (analytical)

Exp. duration:

4 h

Mortality:

0.8 mg/L: 0/10 males and 0/10 females
2.0 mg/L: 2/10 males and 3/10 females
2.8 mg/L: 7/10 males and 5/10 females
5.2 mg/L: 5/10 males and 8/10 females
5.63 mg/L: 8/10 males and 9/10 females
Mortality appeared 2 to 4 days after treatment

Clinical signs:

other: In all treatment groups, accelerated and intermittent respiration, disturbance of equilibrium to narcosis, bloody secretion of the eyes and nose were observed. In the 2.8 mg/L group, bloody urine was observed. Survivors were free from symptoms after 5-8 d

Body weight:

Mean weight at day 0, day 7 and day 14 in g (total bw gain in brackets), based on data of the living animals at any one time

Males
Control: 182.0 - 203.6 - 250.0 (68)
0.8 mg/L: 219.5 - 247.0 - 273.0 (53.5)
2.0 mg/L: 203.8 - 232.0 - 278.0 (74.2)
2.8 mg/L: 208.0 - 223.0 - 225.0 (17.0)
5.2 mg/L: 197.0 - 203.0 - 252.0 (55.0)
5.63 mg/L: 183.0 - 186.0 - 227.0 (44.0)
During the first week, the body weight gain was parallel in all groups. In the second week, the body weight gain of the survivors of the 2.8 and the 5.63 mg/L group were lower than the other groups including control.
Females
Control: 176.0 - 186.2 - 202.0 (26.0)
0.8 mg/L: 193.5 - 201.0 - 217.0 (23.5)
2.0 mg/L: 188.1 - 177.0 - 214.0 (25.9)
2.8 mg/L: 206.0 - 217.0 - 227.0 (19.0)
5.2 mg/L: 206.0 - 218.0 - 232.0 (26.0)
5.63 mg/L: 176.0 - 190.0.0 - 206.0 (30.0)
All treatment groups gained body weight comparably to the control. Females of the 2.0 g/L group lost weight in the first week of observation, but recovered completely in terms of weight gain

Gross pathology:

Animals that died: acute dilatation of the atria; lung with acute congestion hyperemia, partially edematic; liver muddy-grey due to broadened lobe circumference; stomach: bloody ulcerations; intestine: hematinised content; kidneys: slightly lighter coloured

Surviving animals: nothing abnormal found