But-3-yn-2-ol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-06-08 to 1988-06-29

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

But-3-yn-2-ol

EC Number:

217-978-1

EC Name:

But-3-yn-2-ol

Cas Number:

2028-63-9

Molecular formula:

C4H6O

IUPAC Name:

but-3-yn-2-ol

Specific details on test material used for the study:

- Color: yellow
- Form: liquid
- Storage: at room temperature

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, 7950 Biberach, Germany
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: males 260 +/- 8.3 g; females 189 +/- 8.0 g
- Housing: 5 animals per cage; wire cages, type DIII (Company Becker); no bedding
- Diet: ad libitum; KLIBA laboratory diet rat/mouse A 343 10-mm pellets (Klingentalmuehle AG, Kaiseraugst, Switzerland)
- Water: ad libitum; tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): AC controlled
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole-body inhalation system
- Exposure chamber volume: V = 200 L
- Method of holding animals in test chamber: single; in wire cages which were located in a glass-steel inhalation chamber
- Source and rate of air: air was supplied by central AC; Volume of air was 3000 L/h
- Method of conditioning air: central air conditioning
- System of generating particulates/aerosols: continuous infusion pump INFU 362 (INDIGEL/Switzerland) and a glass evaporator with thermostat
- Temperature, humidity, pressure in air chamber: temp: 19-25°C in the exposure apparatus; underpressure was adjusted to 100 L/h in the treatment chamber

TEST ATMOSPHERE
- Brief description of analytical method used: once per hour samples were taken (one per treatment group); the vapour was collected into Propanol-2; Analysis was done with a gas chromatograph (GC HP 584ß A, Hewlett Packard)
- Samples taken from breathing zone: yes

VEHICLE
- Composition of vehicle: air
- Concentration of test material in vehicle: Concentration was determined through substance use and air volume used; and in samples via mass determination and sample volume (mg/L)

CLASS METHOD
- Rationale for the selection of the starting concentration: The concentration 3.33 mg/L was selected on the basis of the information available on the toxicity of the test substance. The remaining concentrations were selected in such a way that it was possible to determine an LC50.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

0.53, 2.09, 3.33 mg/L (nominal)

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

After the exposure period, the surviving animals were observed for 14 days.
The body weight of the animals was checked before the beginning of the test, after 7 days and at the end of the observation period. Clinical findings were generally recorded several times during exposure and at least once each workday during the post-exposure observation period. A check for mortalities was made daily.
At the end of the 14-day observation period, the surviving animals were sacrificed with CO2 and were subjected to a gross-pathological examination like all other animals which had died before.

Statistics:

Statistical analysis of concentration-effect ratio was done with FORTRAN-programm AKPROZ.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 0.53 - < 2.09 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

0.53 mg/L: no deaths; 2.09 and 3.33 mg/L: 10/10

Clinical signs:

other: During exposure: irregular, delayed up to lengthy breathing, paleness of ear and extremities, severe apathy, abdominal position, crouch position, ruffled fur, watery nasal secretion, salivation, lachrymation After exposure: lengthy and delayed breathing,

Body weight:

Body weight development was recorded for the surviving animals (0.53 mg/L). Females showed no differences to historical controls. Males had a shlight delay during the 2. week of observation.

Gross pathology:

Animals that died: acute congestive hyperemia; lung: acute emphysema - moderate (9 x)
Sacrificed animals: organs: nothing abnormal detected

Other findings:

No other findings were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 2 based on GHS criteria