O,O'-dioctadecylpentaerythritol bis(phosphite)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

13 Decmber 1977 to 15 December 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Federal Register Vol. 41No. 118 (1976) p. 42572

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

only observations for ulceration and necrosis were performed. Observations were performed only up to 48 hours.

Principles of method if other than guideline:

0.5 g of test material was applied to the skin of 6 male rabbits for 4 hours. At the end of the exposure period, the test material was removed and skin reactions recorded over the 48 hour study period.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

O,O'-dioctadecylpentaerythritol bis(phosphite)

EC Number:

223-276-6

EC Name:

O,O'-dioctadecylpentaerythritol bis(phosphite)

Cas Number:

3806-34-6

Molecular formula:

C41H82O6P2

IUPAC Name:

3,9-bis(octadecyloxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

other: albino

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

48 hours

Number of animals:

6 males

Details on study design:

TEST SITE
- Area of exposure: Hair was clipped from the abdomen of the animals.
- Type of wrap: Test material was placed on the skin under a small square of cotton gauze, held in place with a larger square of polyethylene film secured with strips of adhesive tape. A square of flannel cloth was then taped around the trunk of the animal to further protect the patches from being dislodged.

REMOVAL OF TEST SUBSTANCE
After 4 hours the vest and patches were removed and the skin examined for signs of irritation. The test site was washed with an appropriate solvent to prevent further exposure.

SCORING SYSTEM: Corrosion was considered to have resulted if the test material caused destruction or irreversible alteration of the tissue. Tissue destruction was considered to have occurred if, at any of the readings, there was ulceration or necrosis. Tissue destruction did not include sloughing of the epidermis, or erythema, oedema, or fissuring.

Results and discussion

Any other information on results incl. tables

Table 1: Skin Corrosivity - Individual Reactions

Animal number	4 hours		48 hours
	Necrosis	Ulceration	Necrosis	Ulceration
1495	no	no	no	no
1496	no	no	no	no
1497	no	no	no	no
1498	no	no	no	no
1519	no	no	no	no
1520	no	no	no	no

Applicant's summary and conclusion

Interpretation of results:

other: Not possible to classify based on the available information

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Application of the test material to the skin of rabbits produced no necrosis or ulceration up to 48 hours after 4 hours under occlusive exposure.

Executive summary:

The skin corrosivity of the test material was investigated following the method outlined in Federal Register Vol. 41, No. 118 (1976) p 42572. During the study, 0.5 g test material was applied to the skin of 6 rabbits, under an occlusive dressing, for a period of 4 hours. After 4 hours, the test material was removed from the test site and skin reactions recorded. A further evaluation of skin reaction occurred at 48 hours. Under the conditions of the study application of the test material to the skin of rabbits produced no necrosis or ulceration.