2,5-dimethylhexane-2,5-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well-documentend, guideline-conform, but non-GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,5-dimethylhexane-2,5-diol

EC Number:

203-731-5

EC Name:

2,5-dimethylhexane-2,5-diol

Cas Number:

110-03-2

Molecular formula:

C8H18O2

IUPAC Name:

2,5-dimethylhexane-2,5-diol

Details on test material:

- Name of test material used in the study report: 2,5-Dimethylhexandiol-2,5
- Analytical purity: 99.5%
- Lot/batch No.: 21922-108
- Expiration date of the lot/batch: not reported
- Stability under test conditions: yes

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Five rats per cage (stainless steel wire mesh cages, type DK-III; no bedding). They were housed in fully air-conditioned rooms with a room temperature between 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h dark and 12 h light.
The animals were offered a standardized animal laboratory diet as well as tap water ad libitum.
The rats were identified using cage cards.
Young adult rats of a comparable weight were used.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Vehicle: Aqueous formulation corresponds to the physiological medium.
Concentration: 20,000 g/100 ml; administration volume: 10,00 ml/kg.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days
Recording of clinical signs and symptoms several times on the day of administration. At least once each workday.
A check for moribund and dead animals were made twice each workday and once on holidays.
Withdrawal of food about 16 h before sacrifice with CO2, then necropsy with gross-pathological examination (necropsy of all animals that die as soon as possible).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

none

Clinical signs:

other: Male and female animals: poor general state, dyspnoea, apathy, staggering, ataxia, piloerection

Gross pathology:

nothing abnormal detected

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based on the available data, the acute oral LD50 was determined to be greater than 2000 mg/kg bw.

Executive summary:

After a single oral dose of 2,5-dimethylhexane-2,5-diol administered to male and female rats via gavage the observed LD50 value was greater than 2000 mg/kg bw.