Hexane-1,2,6-triol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02.06.1993 to 23.06.1993

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 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute 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: 12 animals (6 males and 6 females)
- Body weigth: Males 149 - 175 g, Females 141 - 155 g
- Age: 5 - 8 weeks
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS:
- Diet: Rat and Mouse Expanded Diet No. I (Special Diet Services Limited, Witham, Essex, U.K.)
- Water: tab water ad libitum
- Housing in groups of 5 animals in polypropylene cages
- Temperature: 20-23°C
- Rel. Humidity: 55 - 60%
- Light/dark period: 12/12h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

5000 mg/Kg

No. of animals per sex per dose:

5 male / 5 female

Control animals:

no

Details on study design:

A range-finding study was performed to establish a dosing regime using a single dose of 5000 mg/kg (10 mL/kg dose volume) in one male and one female animal. Based on the results of the range-finding study a further group of 5 male and 5 female animals was treated with a single oral dose of 5000 mg/kg.

Results and discussion

Preliminary study:

There were no deaths recorded in the range-finding study. Common signs of systemic toxicity noted were hunched posture, lethargy and pilo-erection. Based on this information, a dose level of 5000 mg/kg bodyweight was selected for the main study.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were recorded during the observation period.

Clinical signs:

other: No signs of systemic toxicity were noted during the study .

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test material, 1,2,6-HEXANETRIOL, in the Sprague-Dawley rat was found to be greater than the highest tested dose of 5000 mg/kg. Thus, according to Regulation (EC) 1272/2008, the data are conclusive but not sufficient for classification.