N-vinylformamide

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Aug. 21, 1981 to Sept. 7, 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 with acceptable restrictions (non-GLP, low number of rats).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

Annex: Inhalation Hazard Test

Deviations:

yes

Remarks:

only 6 animals instead of 10

GLP compliance:

no

Test type:

other: Inhalation Hazard Test

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-vinylformamide

EC Number:

236-102-9

EC Name:

N-vinylformamide

Cas Number:

13162-05-5

Molecular formula:

C3H5NO

IUPAC Name:

N-vinylformamide

Details on test material:

- Analytical purity: 97.5%
- Impurities (identity): Formamide
- Physical state: liquid
- Storage condition of test material: refrigerator

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, Germany
- Age at study initiation: 7-10 weeks
- Weight at study initiation: 180-250 g
- Housing: Wire mesh cage (Becker, D III), 3 animals/cage
- Diet: Herilan MRH of EGGERSMANN KG, Rinteln, Germany, in the form of pellets ad libitum
- Water: About 250 ml/cage tap water daily
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 5%
- Photoperiod (hrs dark / hrs light): 12 / 12 (6 .00 - 18 .00 h light, 18 .00 - 6 .00 h dark)

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other:

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The test substance was filled to a height of 5 cm in a glass bottle (fritted glass flask, pore-size 90 - 150 µm, diameter 30 mm), and the net weight was determined. A stream of 200 l/h compressed air was supplied to the fritted glass flask containing the product, which had been placed in a water bath maintained at 20 +/- 1°C by a thermostat. 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. After 30 min, the fritted glass flask was replaced by a new one filled with fresh test substance as described above. This generator was then used for the whole remaining time of the test.

TEST ATMOSPHERE
- Samples taken from breathing zone: no

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

7 h

Concentrations:

Saturated vapour (The test substance consumed was determined by reweighing the fritted glass flasks).

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Clinical signs of the animals were recorded daily.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

other: Inhalation Hazard Test

Effect level:

other: saturated vapor

Exp. duration:

7 h

Remarks on result:

other: no mortality observed

Effect levels 2

Sex:

male/female

Dose descriptor:

LC0

Effect level:

ca. 380 mg/m³ air

Exp. duration:

7 h

Remarks on result:

other: calculated using MW 71.08 and vapour pressure 0.13 hPa

Mortality:

No mortality observed

Clinical signs:

other: During exposure: attempts to escape, wiping of snouts After exposure: normal

Body weight:

Not determined

Gross pathology:

Nothing abnormal detected in the organs

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

No mortality occurred in rats exposed for 7 h to a saturated vapour of the test substance.

Executive summary:

The study is comparable to the inhalation hazard test described in the Annex of OECD Guideline 403 with acceptable restrictions (non-GLP, low number of rats).

Three male and 3 female rats were exposed for 7 h to a saturated vapour of the test substance. Clinical signs during exposure were attempts to escape and wiping of snouts. After exposure no clinical signs were observed. No mortalities occurred during the 14 days of post-exposure observation period. Nothing abnormal was detected in the organs at necropsy.

Conclusion: No mortality occurred in rats exposed for 7 h to a saturated vapour of the test substance.