Oxydipropanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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 81-2 (Acute Dermal 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%
- Lot/batch No.: TB41213-04-2
- Storage condition of test material: in the original container (blue metal can), at room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

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 approximately 17 weeks of age, females approximately 16 weeks of age.
- Weight at study initiation: males 2.70 to 2.95 kilograms, females 2.50 to 2.60 kg.
- Housing: the animals were housed singly in wire cages in the study room
- Diet (e.g. ad libitum): Blue Seal Rabbit Feed, ID #1679 JJA, supplemented with oats if necessary
- Water (e.g. ad libitum): potable municpal water (ad libitum)
- Acclimation period: acclimated to the study room for 5 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68-74ºF
- Humidity (%): 35-65
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours on/12 hours off cycle

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The test substance was applied uniformly at the required dose to the shaved intact skin in an area forming a band on the dorsal and lateral trunk that approximated 10% of the body surface of the rabbit as nearly as the dose allowed. The test substance was held in contact with the skin by a gauze pad held in place with hypo-allergenic tape. The entire trunk of the rabbit was then wrapped with no-irritating perforated plastic sheeting secured at each end with masking tape in order to prevent displacement or ingestion of the test substance.

Duration of exposure:

24 hours

Doses:

5.01 g/kg body weight

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Observation and scoring: 30 to 60 minutes after cleaning the skin at approximately 24 hours, the local reaction was recorded; erythema and edema were scored using the variation of the method of Draize. Readings were also made on days 3, 7, 14 and at other times if major changes were observed. The animals were observed for mortality and pharmacotoxic signs frequently on the day of dosing and once daily for the remainder of the 14 day observation period. This included time of death, or nature, onset, severity and duration of all gross visible toxic or pharmacologic effects, e.g. changes in skin and fur, eye and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somato-motor activity and behavioral pattern. In addition, animals were checked for mortality each afternoon (except weekends and holidays).
- Body weights: were detemined on the day of dosing, weekly thereafter and at sacrifice.
- Necropsy of survivors performed: yes. Animals that survived the 14 day observation period were sacrificed and a gross necropsy was performed. Any animals found dead during the study would have undergon necropsy immediately. Gross necropsy consisted of examination of the carcass (including the test site), the visceral organs in the thorax and abdomen, and examination of the reproductive organs.

Statistics:

None used

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 010 mg/kg bw

Mortality:

The were no deaths

Clinical signs:

other: Cageside observation of the rabbits during the study did not reveal any overt signs of systemic pharmacologic or toxic effects. Approximately three quarters of an hour after removal of the wraps and cleaning the skin there was very slight irritation char

Gross pathology:

At necropsy all organs and tissues examend grossly appeared normal and there were no pathognomonic signes. The shaved skin in the area of application of the test substance appeared normal.