1-ethylpyrrolidin-2-one

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-ethylpyrrolidin-2-one

EC Number:

220-250-6

EC Name:

1-ethylpyrrolidin-2-one

Cas Number:

2687-91-4

Molecular formula:

C6H11NO

IUPAC Name:

1-ethylpyrrolidin-2-one

Details on test material:

purity: 99.8%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Only animals free from clinical signs of disease were used for the study. The females were nulliparous and non-pregnant. The animals were subjected to an acclimatization period of at least 1 week in which they were adapted to the surroundings. Age of the animals at the beginning of the study was approx . 8 - 10 weeks for males and approx. 11 - 13 weeks for females. The animals were identified individually numbered consecutively on the tail. The feed used in the study was assayed for chemical as well as for microbiological contaminants. The drinking water is regularly assayed for chemical contaminants by the municipal authorities as well as for the presence of microbes. The animals were kept in fully air-conditioned rooms in which temperatures in the range of 20 - 24°C and relative humidities in the range of 30 - 70% were regulated by means of a central air-conditioning system. The animals were housed singly in cages type DK III without bedding, with a light/dark cycle of 12 hours.

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

nose/head only

Vehicle:

other: The test substance was doses unchanged. A liquid aerosol was generated.

Details on inhalation exposure:

Considering the vapor pressure of the test substance, the test atmosphere was supposed to be a mixture of vapor and liquid aerosols.
After the exposure, the animals were observed for 14 days.
The body weight of the animals was determined just prior to exposure (day 0), weekly thereafter and at the end of the observation period. A check for overt clinical signs of toxicity or mortality as well as a check for the presence of feed and drinking water was made twice a day on workdays and once daily on weekends and public holidays. Detailed clinical observations were recorded for each animal separately several times during exposure and at least once on each workday of the observation period. At the end of the observation period the animals were sacrificed with CO2 and were subjected to gross-pathological examination.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5.1 mg/l

No. of animals per sex per dose:

5

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.1 mg/L air

Exp. duration:

4 h

Remarks on result:

other: aerosol

Mortality:

No mortality occurred at the tested concentration.

Clinical signs:

other: Clinical signs of toxicity comprised visually accelerated respiration, squatting posture, piloerection, smeared and contaminated fur. Findings were observed from hour 0 of exposure until including study day 1.

Body weight:

The mean body weights of the male and female animals did not increase adequately during the first post exposure observation week, but increased during the second week.

Gross pathology:

No gross pathological abnormalities were noted in the animals necropsied at termination of the post exposure observation period.