Oxydipropanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oxydipropanol

EC Number:

246-770-3

EC Name:

Oxydipropanol

Cas Number:

25265-71-8

Molecular formula:

C6H14O3

IUPAC Name:

1,1-Oxydi-2-Propanol

Details on test material:

- Name of test material (as cited in study report): dipropylene glycol
- Physical state: clear viscous liquid
- Analytical purity: 100%
- Storage condition of test material: in the original container (blue metal can) at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: bred in the laboratory colony (Branchville)
- Age at study initiation: males, 8 weeks of age; females, 10 weeks of age
- Weight at study initiation: males, 254 to 259 grams; females, 201 to 216 grams
- Fasting period before study: 18 hours, water was available at all times
- Housing: individually housed in wire cages under laboratory conditions.
- Diet (e.g. ad libitum): Agway NIH-31M Rodent Diet or equivalent
- Water (e.g. ad libitum): potable municipal water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68-74ºF
- Humidity (%): 35-65%
- Photoperiod (hrs dark / hrs light): 12 hours /12 hours

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5.01 g/kg body weight

No. of animals per sex per dose:

group of 5 male and 5 female rats.

Control animals:

no

Details on study design:

- Duration of observation period following administration: Animals were observed for mortality and pharmacotoxic signs frequently during the first 5 hours and then at approximately 24 hours following dosing and twice daily for the remainder of the 14 day observation period, (once daily Saturday and Sunday)
- Frequency of weighing: each animal were determined pre-fasted, on the day of dosing, weekly thereafter and at sacrifice.
- Necropsy of survivors performed: yes. Animals that survived through the 14 day observation period were sacrified and a gross necropsy was performed. Any animal found dead during the study would have undergone necropsy immediately. The gross necropsy included by was not limited to the following organs: heart, lungs, spleen, liver, adrenals, kidneys, urinary bladder, stomach, small intestine, large intestine and reproductive organs.

Statistics:

None used

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 other: g/kg bw

Mortality:

There were no deaths

Clinical signs:

other: At one hour after dosing two males showed decreased locomotor activity and the remaninder of the group (3 male, 5 female) were ataxic. Similar signs persisted at three hours. At five hours following dosing several rats (4 male, 1 female) also showed yello

Gross pathology:

At necropsy all organs and tissues examined grossly appeared normal and there were no pathognomonic signes.

Any other information on results incl. tables

There were no deaths among rats dosed at 5.01 g/kg body weight, therefore the LD50 is greater than 5.0 g/kg. The EPA oral toxicity indicator for test substance dipropylene glycol is best described ar Category IV.