Oxybispropanediol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 January - 10 March 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable study report which meets basic scientific principles, performed according to OECD guidelines and GLP. However, no precise info on purity and batchno. of the test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oxybispropanediol

EC Number:

261-605-5

EC Name:

Oxybispropanediol

Cas Number:

59113-36-9

Molecular formula:

C6H14O5

IUPAC Name:

3-(2,3-dihydroxypropoxy)propane-1,2-diol

Details on test material:

- Name of test material (as cited in study report): Diglycerin DSW (highly concentrated)
- Substance type: colourless, severe viscous liquid
- Physical state: liquid
- Analytical purity: not stated
- Lot/batch No.: not stated
- Stability under test conditions: not stated

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Central Institute of Laboratory Animal Breeding, Hannover, Germany
- Age at study initiation: 47 days for males and females
- Weight at study initiation: 174-222 g males, 140-166 g females
- Fasting period before study: 16-20 hours before dosing
- Housing: individually in Makrolon cages (type II)
- Diet (e.g. ad libitum): freely available (R 1324 mixed food, Altromin Co.)
- Water (e.g. ad libitum): tap water freely available
- Acclimation period: 3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 48-55
- Air changes (per hr): hourly air-exchange was about 15-fold.
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% (5000 mg diglycerin in aqua destillata, fixed volume 20 ml/kg b.w.; pH 3.9)

Doses:

5000 mg/kg

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations on food consumption and weighing: day 1, 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: No signs of intoxication.

Gross pathology:

No alterations of internal organs / tissues when compared to control after 14 days.

Any other information on results incl. tables

Dose: 5000 mg/kg b.w. Both sexes combined, no major differences values based in control group means (=100%)

Inhibition of food intake:

Day 1: 4%

Day 7: 0%

Day 14: 0%

Inhibition of body weight gain:

Day1: 13%

Day 7: 4%

Day 14: 0%

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute oral toxicity study, the LD50 of diglycerol was determined to exceed 5000 mg/kg bw.

Executive summary:

In an acute oral toxicity test performed according to OECD 401 and GLP, the LD50 of diglycerin was determined to exceed 5000 mg/kgbw. No signs of intoxication and no abnormal findings at necropsy were observed. No mortality occurred.