Pentaerythritol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 September 1982 to 23 September 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP but guideline-comparable proprietray study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECO Guideline for Testing of Chemicals. OECO, ISBN-92-64-12221-4 (1981)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize, J.H. In appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 46-59, Association of Food and Drug Officials of the United States, Topeka, Kansas 1995

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize, J.H., Woodward, G. and H.O. Calvery, J. Pharmacol. Exp. Therap., 82, 377-390 (1944)

Principles of method if other than guideline:

The test was carried out on the instructions of the Specialist Department of Industrial
Toxicology of Degussa, Frankfurt/Main. It was carried out after a single application of the test product to the intact and scarified skin on the back of a rabbit.

GLP compliance:

no

Remarks:

: older study, pre-dating mandatory GLP

Test material

Test material information

Constituent 1

Reference substance name:

Pentaerythrite D

IUPAC Name:

Pentaerythrite D

Details on test material:

Pentaerythrite D (very finely ground), was available as a white powder. Charge no. 17.08.1982

Specific details on test material used for the study:

Pentaerythrite D (very finely ground), was available as a white powder. Charge no. 17.08.1982

Test animals

Species:

rabbit

Strain:

other: white russian (albino)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Asta-Werke AG
- Age at study initiation: 10 months
- Weight at study initiation: 2.2-3.2kg
- Housing:stainless steel cage, Asta model
- Diet (e.g. ad libitum): standardised experimental animal feed Altromin
- Water (e.g. ad libitum):ad lib
- Acclimation period:1 day


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-1°C
- Humidity (%): 50-60%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):12


IN-LIFE DATES: From: To:

Test system

Type of coverage:

occlusive

Preparation of test site:

other: both abraded and intact skin were assessed

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.5 g of the test material was dampened with 0.3 ml demineralised water.

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours

Number of animals:

3 females

Details on study design:

The back skin of the rabbits was shaved between the shoulder and crucial ligament region. The skin on the back of each rabbit was divided on both sides of the vertebral colum into 2 (a total of 4) areas. The contralateral areas were distinguished in that they consisted on the left side of intact skin, and on the right of scarified skin. The scarification was carried out superficially, avoiding more deep-seated defects and bleeding. Each of the 4 areas was covered with a piece of linen cloth approximately 6.25 cm² in size; 2 pieces of cloth were used to cover the applied test substance (one in the intact and one in the scarified region), sealed at suitable points in the untreated areas of skin. The linen cloth was adhered to a synthetic adhesive film. An occlusive bandage (Acrylastic, P. Beiersdorf and C.o. AG, Hamburg, no. 2408, width 8cm) was applied circularly around the body of the animal.

The patches were left in place for 4 hours. After removal of the bandage, skin reactions were scored at 1, 24, 48 and 72 hours later according to the Draize and OECD guidelines.

SCORING SYSTEM:
Erythema and scab formation
no erythema: 0; quite mild erythema (hardly perceptible): 1; clearly definable erythema: 2; moderate to severe erythema: 3; severe erythema (intense reddening) to mild scabbing (with deep-seated injury): 4

Oedema formation
no oedema: 0; quite mild oedema (hardly perceptible): 1; mild oedema (edges of the areas
well demarcated, marked swelling) :2; moderate oedema (swelling approx. 1 mm): 3;
intense oedema (swelling> 1 mm, extending beyond the point of application): 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: No reaction at any time point (intact skin)

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Remarks on result:

other: A theoretical assessment of the toxicokinetics of pentaerythritol indicates rapid and extensive absorption and distribution; rapid metabolism and excretipn are likley to limit systemic exposure and toxicity. No bioaccumulation is predicted.

Irritant / corrosive response data:

Erythema occurred neither on the intact nor on the scarified skin areas. The oedemas were of varying intensity. One hour after substance application both quite mild (evaluation stage 1) and intense oedema (evaluation stage 4) were observed on scarified skin only. These findings had already disappeared completely after 24 and 48 hours respectively.

No reactions were seen on intact skin at any time point.

Other effects:

Systemic-toxic effects did not occur after dermal application of the test product. The general health of the experimental animals was not affected.

Any other information on results incl. tables

No evidence of skin irritation was seen (inact skin).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No evidence of irritation was seen on the intact skin sites; the substance is not classified as a skin irritant.

Executive summary:

The skin irritation properties of Pentaerythrite D (very finely ground) were evaluated in 3 female White Russian albino rabbits. 0.5 g of the moistened test substance was applied to the intact or scarified skin under an occlusive dressing. The dressing remained in place for 4 hours. After removal of the bandage, skin reactions were scored at 1, 24, 48 and 72 hours later according to the Draize and OECD guidelines. Systemic-toxic effects did not occur after dermal application of the test product. The general health of the experimental animals was not affected. No evidence of irritation was seen on the intact skin sites; the substance is not classified as a skin irritant.