Glycerol trioctanoate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

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:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

only male animals tested; lack of details on test substance

Principles of method if other than guideline:

The study was conducted in 1976, prior to adoption of any OECD guidelines.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, mixed decanoyl and octanoyl

EC Number:

277-452-2

EC Name:

Glycerides, mixed decanoyl and octanoyl

Cas Number:

73398-61-5

Molecular formula:

C27H50O6 to C33H62O6

IUPAC Name:

Glycerides, mixed decanoyl and octanoyl

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Willi Gassner, Sulzfeld, Germany
- Weight at study initiation: approximately 170 g
- Housing: 2 animals per Makrolon Type 3 cage with Vermiculite pad
- Diet: standard pelled diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 60 ± 5

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: unchanged (no vehicle)

Remark on MMAD/GSD:

The inhalable part (aerodynamic diameter < 5 µm) of of test substance in aerosol was 1.97 µL/L air.

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: cylindric inhalation chamber "INBIFO-MAKROLON-Tierrohre Typ 1" with stainless steel head cones, according to KIMMERLE apparatus with 20 animal tubes
- Exposure chamber volume: 40 L
- Method of holding animals in test chamber: cylindric tube
- Source and rate of air: 7.11 L air flow/min
- Method of conditioning air: 0.2 mL of test substance per min was pumped using a dosing pump (BRAUN, Melsungen, Germany)
- System of generating particulates/aerosols: aerosol nozzle, nozzle orifice 0.15 mm (BUNDSCHUH, Griesheim, Germany)
- Calculated test substance concentration in inhalation chamber: 28.1 µL/ L air
- Measured test substance concentration in inhalation chamber with particle size < 5 µm: 1.97 µL/L air

"Zyklon" (BCRIA sampler) was used to sample precipitated particles with a particle size > 5 µm
A cambridge filter was used to sample respirable particles.
Gravimetric analyses were performed to determine the respirable test substance concentration.

TEST ATMOSPHERE
- Brief description of analytical method used: during exposure every hour the aerosol concentration was measured in the inhalation chamber directly in the area of animals noses (head cones)
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1.97 µL test substance / L air was < 5 µm diameter
The test atmosphere was a dense fog.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

Gravimetric analyses were performed to determine the respirable test substance concentration.

Duration of exposure:

6 h

Concentrations:

28.1 µL/L air (calculated concentration)
measured respirable test substance concentration: 1.97 µL/ L air (< 5 and < 10 µm diameter particle size)

No. of animals per sex per dose:

10

Control animals:

other: yes, sham-exposed

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: during exposure, after exposure and thereafter daily
- Frequency of weighing: at beginning, directly after exposure and at the end of 14 days observation period
- Necropsy of survivors performed: yes, 3 test animals and 1 control animal were euthanized 1 h after exposure, all other animals were necropsied 14 days after exposure
- Other examinations performed: Trachea and lungs of all animals were histopathologically analysed.

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LC50

Effect level:

> 1.97 other: µL/L air (analytical)

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: max. attainable concentration

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LC50

Effect level:

> 1.86 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

6 h

Remarks on result:

other: converted from µL/L by using a mean specific gravity value of 0.947

Remarks:

maximum attainable concentration

Mortality:

No mortality occured during the study period.

Clinical signs:

other: No clinical signs toxicity were observed in any of the animals during the 14-day observation period.

Body weight:

No effect on body weight was noted.

Gross pathology:

No abnormal findings.

Other findings:

Histopathology: No abnormal findings in lungs or tracheae.
Microscopically no deposits of oily test substance could be detected in the respiratory tissues.

Any other information on results incl. tables

According to the descriptions in this study report it can be assumed that the maximum attainable concentration of the test substance was used for aerosol inhalation exposure.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.