C18 (branched) fatty acids, esters with mono-, di-, and tri-glycerol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987-04-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented OECD 404 study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

C18 (branched) fatty acids, esters with mono-, di-, and tri-glycerol

EC Number:

701-479-5

Molecular formula:

C42H82O7

IUPAC Name:

C18 (branched) fatty acids, esters with mono-, di-, and tri-glycerol

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Synonyms: Diglycerinisostearat, Polyglycerinisostearat
- Physical state: liquid
- Analytical purity: n.a.
- Composition of test material, percentage of components: 100 % Diglycerinisostearat
- Purity test date: n.a.
- Lot/batch No.: n.a.

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

24, 48 and 72 hours after removal of patch

Number of animals:

3

Details on study design:

Hostacerin DGI was tested for primary skin irritation according to OECD test guideline 404 using three New Zealand albino rabbits. Only animals with intact skin were used. Each animal was treated with 0.5 mL undiluted Hostacerin DGI. The test item was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 hours. After the exposure all remnants of the test material were carefully removed from the skin with warm tap water. Examinations of skin took place after 30-60 minutes, 24, 48 and 72 hours after removal of the patches. Erythema and edema were evaluated numerically according to the score of Draize.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

2

Reversibility:

fully reversible

Remarks:

48 hours

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: no effects seen

Irritant / corrosive response data:

24 hours after removal of the patches one animal exhibited a well defined erythema, whereas the other two animals showed no signs of irritation at all. From 48 hours after removal of the patches all animals were free of skin reactions.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of this study, technical grade of test item is not irritationg to the skin and thus not subject to labeling requirements.

Executive summary:

The test substance was tested for primary skin irritation according to OECD test guideline 404 using three New Zealand albino rabbits. Only animals with intact skin were used. Each animal was treated with 0.5 mL undiluted test substance. The test item was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 hours. After the exposure all remnants of the test material were carefully removed from the skin with warm tap water. Examinations of skin took place after 30-60 minutes, 24, 48 and 72 hours after removal of the patches. Erythema and edema were evaluated numerically according to the score of Draize.

24 hours after removal of the patches one animal exhibited a well defined erythema, whereas the other two animals showed no signs of irritation at all. From 48 hours after removal of the patches all animals were free of skin reactions.