Hexane-1,2,6-triol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

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: 10 animals (5 males and 5 females)
- Body weigth: Males 227 - 241 g, Females 212 - 233 g
- Age: 10 - 14 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: individually in polypropylene cages during exposure period, afterwards in groups of five by sex
- Temperature: 20-23°C
- Rel. Humidity: 50 - 62%
- Light/dark period: 12/12h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The calculated volume of the undiluted test material, as received, was applied uniformly to an area of shorn skin (approximating to 10% of the total body surface area) using a graduated syringe. A piece of surgical gauze measuring 7 cm x 4 cm was placed over the treatment area and semioccluded with a piece of self-adhesive bandage (HYPERTIE). The bandage was further secured with a piece of BLENDERM wrapped around each end. The animals were caged individually for the 24-hour exposure period.

Duration of exposure:

24 h

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male / 5 female

Control animals:

no

Details on study design:

The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. The animals were also observed for any dermal reactions after removal of the dressings and subsequently once daily for the remainder of the
study. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14. At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed during the study.

Clinical signs:

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

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

No signs of skin irritation were noted during the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal 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 2000 mg/kg bodyweight. Thus, according to Regulation (EC) 1272/2008, the data are conclusive but not sufficient for classification.