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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

Constituent 1
Chemical structure
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.