Hexane-1,2,6-triol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19.07.1993 to 21.07.1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hexane-1,2,6-triol

EC Number:

203-424-6

EC Name:

Hexane-1,2,6-triol

Cas Number:

106-69-4

Molecular formula:

C6H14O3

IUPAC Name:

hexane-1,2,6-triol

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Strain: Rat / Sprague-Dawley
- Number and sex: 10 animals (5 males and 5 females)
- Body weigth: Males 214 - 233 g, Females 207 - 229 g
- Age: young
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS:
- Diet:Rat and Mouse Expanded Diet No. 1 (Special Diet Services Limited, Witham, Essex, U.K.)
- Water: tab water ad libitum
- Housing in groups of 5 animals in polypropylene cages
- Temperature: 19-23°C
- Rel. Humidity: 48-66%
- Light/dark period: 12/12h

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: distilled water (10 %)

Mass median aerodynamic diameter (MMAD):

2 µm

Geometric standard deviation (GSD):

0.38

Remark on MMAD/GSD:

The particle size of the generated atmosphere of the test material inside the exposure chamber was determined at least twice during the exposure period using a Cascade Impactor.
The respirable fraction was 75.6 % (< 4 µm).

Details on inhalation exposure:

Prior to the start of the study the test material was formulated with 10% distilled water to facilitate aerolisation. The test material formulation was then aerosolised using a glass concentric jet nebuliser (Radleys, Saffron Walden, Essex) located at the top of the exposure chamber. The nebuliser was connected to a glass syringe attached to a modified infusion pump, which provided a continuous supply of test material under pressure, and to a metered compressed air supply. Prior to the start of the study test material atmospheres were generated within the exposure chamber. During these periods air flow settings, test material input and the sampling system were varied to achieve the required atmospheric concentrations. The chamber flow rate was maintained at 14 L/min providing 28 air changes per hour.

During the exposure period each rat was individually held in a tapered, polycarbonate res training tube fitted onto a single tier of the exposure chamber and sealed by means of a rubber 'O' ring . Only the noses of the animals were exposed to the test atmosphere.
A single group of ten rats (five males and five females) was exposed to an atmosphere of the test material for a period of four hours. A target concentration of 5 mg/litre was used for the exposure . No deaths occurred and therefore no further levels were required.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

Nominal: 89.9 mg/L
Mean dose achieved: 5.07 mg/L

No. of animals per sex per dose:

5 male / 5 female

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.07 mg/L air (analytical)

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality occurred during the observation period of 14 days.

Clinical signs:

other: During exposure wet fur was common. On removal from the chamber all animals showed hunched posture and pilo-erection and there were incidents of decreased respiratory rate, ptosis and red/brown staining around the head. One hour after completion of exposu

Body weight:

All animals showed expected bodyweight development during the study.

Gross pathology:

No abnormalities were detected at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No deaths occurred in a group of ten rats exposed to a mean achieved concentration of 5.07 mg/L (range 3.93 - 5.46 mg/litre). It was therefore considered that the acute inhalation median lethal concentration (LC50) of the test material in the Sprague-Dawley strain rat was greater than 5.07 mg/litre.Thus, according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.