Propyloxirane

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: guideline study (OECD 403)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propyloxirane

EC Number:

213-701-3

EC Name:

Propyloxirane

Cas Number:

1003-14-1

Molecular formula:

C5H10O

IUPAC Name:

2-propyloxirane

Details on test material:

- Name of test material (as cited in study report): n-Pentenoxid-1,2
- Physical state: colourless, liquid
- Analytical purity: 90%
- Stability under test conditions: Stability was ensured for at least the study period
- Storage condition of test material: was stored at room temperature excluded from air

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH
- Age at study initiation: 8-9 weeks
- Weight at study initiation: mean(males): 272 +/- 13.8 g, mean(females): 184 +/- 12.0 g
- Housing: 5 animals/cage
- Diet: KLIBA rat/mouse laboratory diet 24-343-4 10 mm pellets (Klingentalmuehle AG) ad libitum (during the post-exposure observation period)
- Water: ad libitum (during the post-exposure obeservation period)



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole-body inhalation system: IKA 02 (glass-steel construction)
- Exposure chamber volume: 200 L
- Source and rate of air: continuous infusion pump INFU 362 (INDIGEN/Switzerland), 3000 L/h
- Method of conditioning air: The blast air was conditioned via a central air-conditioning system
- System of generating particulates/aerosols: glass vaporizer with thermostat (By means of the continuous infusion pump amounts of the test substance per test group were supplied to the heated vaporizer (40°C). The vapors that developed were mixed with supply air and passed into the inhalation system).
- Temperature and pressure: 19-25°C, -10 - -17 Pa


TEST ATMOSPHERE
- Brief description of analytical method used: Sampling: Apparatus: 3 fritted glass flasks, connected in series, filled with sorption solvent (DMF). Two fritted glass flasks were analysed for each sample. The third fritted glass flask was used to control the effectiveness of the sorption for all samples of a test group and was analyzed separately. For the quantitative determination of the vapor concentration a gas chromatographical method was used.
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Remarks:

The nominal concentration was calculated from the amount of substance consumed and the air flow.

Duration of exposure:

4 h

Concentrations:

- means: 5.3, 10.6, 21.3 mg/L (nominal: 5.6, 11.4, 23.1 mg/L)

No. of animals per sex per dose:

5

Control animals:

other: historical control data used for the body weight development

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: - clinical findings: several times during exposure and at least once on each workday in the observation period; -check for dead animals: daily; -weighing: before the beginning of the test, after 7 days and at the end of the observation period;
- Necropsy of survivors performed: yes

Statistics:

The statistical evaluation of the dose-response relationship was carried out using FORTRAN program AKPROZ. Depending on the data of the dose-response relationship obtained by way of experiment, this program is used to estimate the LC50 or to perform a Probit analysis. Estimation of the LC50 will produce types LC50 greater, LC50 about, or LC50 smaller. If the results are Type LC50 greater or LC50 smaller, an additional binominal test will be carried out to verify these statements statistically, if necessary.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 10.6 - < 21.3 mg/L air

Exp. duration:

4 h

Remarks on result:

other: statistical evaluation; 10.6 mg/L: the statistical reliability is 99%; 21.3 mg/L: the statistical reliability is 90%;

Effect levels 2

Sex:

male

Dose descriptor:

LC50

Effect level:

ca. 18 mg/L air

Exp. duration:

4 h

Remarks on result:

other: statistical evaluation

Effect levels 3

Sex:

female

Dose descriptor:

LC50

Effect level:

ca. 18 mg/L air

Exp. duration:

4 h

Remarks on result:

other: statistical evaluation

Mortality:

- test group 1 (5.3 mg/L): 0/10; - test group 2 (10.6 mg/L): 0/10; - test group 3 (21.3 mg/L): 8/10 (4 males, 4 females); the animals died either on the day of exposure or one day after exposure

Clinical signs:

other: - during exposure in all test groups: accelerated respiration (30/30 at the end of the 4 hrs exposure), eyelid closure (30/30 at the end of the 4 hrs exposure), ruffled fur (30/30 at the end of the 4 hrs exposure), wiping of snouts, restlessness; - durin

Body weight:

The body weight gain of male and female rats in the test groups 1 and 2 and female rats in the test group 3, compared with a historical control collective, was not affected by the substance over the total observation period. The body weight gain of male rats in the test group 3, compared with a historical control collective, was retarded in the first week of the observation period and adjusted to normal in the second week of the observation period.

Gross pathology:

- dead animals of test group 3: general congestion; lungs: focal hyperemia with edema and areas with emphysema, thorax: slight hydrothorax; - sacrificed animals: no pathological findings noted

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information