Oxydipropanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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 81-5 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: bred in the laboratory colony (Branchville)
- Age at study initiation: approximately 16 weeks
- Weight at study initiation: 2.0 to 2.3 kilograms
- Housing: housed individually under standard laboratory conditions in the study room
- Diet (e.g. ad libitum): Blue Seal Rabbit Feed, ID 1661 JJA, supplemented with oats if necessary
- Water (e.g. ad libitum): potable municipal water ad libitum
- Acclimation period: five 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

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped closely

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

A dose of 0.5 ml of the test substance was applied per application site.

Duration of treatment / exposure:

The exposure was maintained for 4 hours.

Observation period:

Readings were made 30 to 60 min after cleaning the skin at approximately 4 hr, and at the end of 24, 48 and 72 hours after patch removal.

Number of animals:

6 animals; 3 male, 3 female

Details on study design:

On the day before dosing, the dorsal surface around the test site of each rabbit was clipped closely. The skin was gently wiped with clean moistened paper towel. Any animal having a severe reaction two hours after clipping was not used. One site on each animal was selected for testing. Test substance was introduced under a gauze pad approximately 6 cmm secured by hypo-allergenic adhesive tape. The trunk of the rabbit was then wrapped with non-irritating perforated plastic sheeting fastened at each end with masking tape in order to prevent displacement of the test substance. At the end of the 4 hour exposure period, the plastic sheeting and gauze were removed and the skin was wiped with clean moistened paper towel to remove any test substance still remaining. 30 - 60 minutes after cleaning the skin the reactions at each site were scored for erythema and edema using the modification of the method of Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects at 24 hr and thereafter

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects at 24 hr and thereafter

Irritant / corrosive response data:

45 minutes after patch removal there was no irritation except for one site (1/6) which showed very slight erythema. At 24 hours all test areas appeared normal and remained normal throughout the duration of the study. There was no evidence of any corrosive effect.

Other effects:

No evidence of systemic pharmacotoxic effect was obeserved. The rabbits did not show signs of discomfort such as vocalization or excessive struggling upon application of the test substance.