1-(2-hydroxyethyl)pyrrolidin-2-one

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Due to the low vapour pressure, the technically highest attainable concentration is approximately 0.008 mg/L when the test substance is evaporated at 20°C (concentration not determined), which is below cut off values for classification / any limit concentration.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

This test (called inhalation risk test) was performed in principle as described in OECD Guideline 403. It demonstrates the toxicity of an atmosphere saturated with vapors of the volatile components of a test substance at the temperature chosen for vapor generation (20°C). Young adult laboratory rats were purchased from a breeder. In general, the source and strain of the animals were not documented. Several groups of usually 3 rats per sex were exposed sequentially to the vapors, generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for different time periods (e.g. 3 min, 10 min, 1, 3 or 7 or 8 hours). The exposure time not causing lethality was usually tested twice. No analytical determination of the atmosphere concentrations was performed. The nominal concentration usually can be calculated as quotient of the amount of test substance weight loss during the exposure, which is given in the raw data, and the amount of air used during the exposure. Group-wise documentation of clinical signs was performed over the 7- to 14-day study period. Body weight of groups was determined before the start of the study and at the end of the observation period in surviving animals. The clinical signs and findings were reported in summarized form. The study allows for an estimate of the length of time required to cause severe toxic effects resulting from exposure to an atmosphere saturated with volatile components of the test substance. The exposure time causing 50% lethality (LT50) can be estimated from such a study as described for the LD50. Furthermore, using the nominal concentration, vapor pressure and LT50, in many cases a 4-hour LC50 can be estimated using Haber’s law.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-(2-hydroxyethyl)pyrrolidin-2-one

EC Number:

222-359-4

EC Name:

1-(2-hydroxyethyl)pyrrolidin-2-one

Cas Number:

3445-11-2

Molecular formula:

C6H11NO2

IUPAC Name:

1-(2-hydroxyethyl)pyrrolidin-2-one

Details on test material:

Name of the test substance used in the study report: 1-(2-hydroxyethyl)pyrrolidone-2
Test substance number: XIX/367

Test animals

Species:

rat

Strain:

not specified

Sex:

female

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: the atmosphere was saturated with vapors of the volatile components of the test substance (at 20°C). Vapors were generated by bubbling 200 L/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

8 h

Concentrations:

highest attainable concentration when the test substance is evaporated at 20°C: 0.008 mg/L

No. of animals per sex per dose:

12

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LC50

Effect level:

> 0.008 mg/L air

Based on:

test mat.

Exp. duration:

8 h

Mortality:

No mortality was observed.

Clinical signs:

other: No abnormalities detected.

Body weight:

No detials given in study report.

Gross pathology:

No abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Due to the low vapour pressure, the technically highest attainable concentration is approximately 0.008 mg/L when the test substance is evaporated at 20°C (concentration not determined), which is below cut off values for classification / any limit concentration.