Escin

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Justification for type of information:

option an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available"."

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD short-term and long-term Toxicology group. Final report: Acute dermal irritation & corrosion (1981)

Version / remarks:

1981

Deviations:

no

Principles of method if other than guideline:

Skin preparation
Approximately 24 hours before the test fur was removed from an area approximateky 240 cm2 wide by clipping and shaving the dorsal and flank zones of the animals. Two areas of the back, spaced approximately 10 cm aport, was designed for the position of the patches. On area was abraded by making four minor epidermal incision along parallel lines approximately 3 cm long and 0.5 cm apart. The incision were through the statum corneum only and were not sufficiently deep as to produce bleeding.

Administration
Square gauze pads 2.5x2.5 cm fixed to adhesive tape were used 0.5 ml/animal of the assay sample were placed under the pad, which was kept in place by means of thin bands of adhesive hypoallergenic tape. The entire trunk of the animal was then wrapped with rubberized cloth.

Removal of the patches
The patches were removed 24 hours after the application. The exceeding paste was then washed away from skin using a pad soaked in distilled water

Experimental design
Each animal served as its own control, having a treated and a non-treated area, the first on the right side and the latter on the left side of its back.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Escin

EC Number:

229-880-6

EC Name:

Escin

Cas Number:

6805-41-0

Molecular formula:

C110H172O48

IUPAC Name:

(2S,3S,4S,5R,6R)-6-{[(3S,4S,4aR,6aR,6bS,8R,8aR,9R,10R,12aS,14aR,14bR)-9-(acetyloxy)-8-hydroxy-4,8a-bis(hydroxymethyl)-4,6a,6b,11,11,14b-hexamethyl-10-[(2-methylbutanoyl)oxy]-1,2,3,4,4a,5,6,6a,6b,7,8,8a,9,10,11,12,12a,14,14a,14b-icosahydropicen-3-yl]oxy}-4-hydroxy-3,5-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxane-2-carboxylic acid; (2S,3S,4S,5R,6R)-6-{[(3S,4S,4aR,6aR,6bS,8R,8aR,9R,10R,12aS,14aR,14bR)-9-(acetyloxy)-8-hydroxy-4,8a-bis(hydroxymethyl)-4,6a,6b,11,11,14b-hexamethyl-10-{[(2E)-2-methylbut-2-enoyl]oxy}-1,2,3,4,4a,5,6,6a,6b,7,8,8a,9,10,11,12,12a,14,14a,14b-icosahydropicen-3-yl]oxy}-4-hydroxy-3,5-bis({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy})oxane-2-carboxylic acid

Test material form:

solid

Specific details on test material used for the study:

Escin free acid Batch 6033

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Preparation of test site:

other: clipping and shaving

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 ml/animal

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

Skin preparation
Approximately 24 hours before the test fur was removed from an area approximateky 240 cm2 wide by clipping and shaving the dorsal and flank zones of the animals. Two areas of the back, spaced approximately 10 cm aport, was designed for the position of the patches. On area was abraded by making four minor epidermal incision along parallel lines approximately 3 cm long and 0.5 cm apart. The incision were through the statum corneum only and were not sufficiently deep as to produce bleeding.

Administration
Square gauze pads 2.5x2.5 cm fixed to adhesive tape were used 0.5 ml/animal of the assay sample were placed under the pad, which was kept in place by means of thin bands of adhesive hypoallergenic tape. The entire trunk of the animal was then wrapped with rubberized cloth.

Removal of the patches
The patches were removed 24 hours after the application. The exceeding paste was then washed away from skin using a pad soaked in distilled water

Experimental design
Each animal served as its own control, having a treated and a non-treated area, the first on the right side and the latter on the left side of its back.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

other: not irritant

Remarks:

acording to Draze method

Conclusions:

After 24 hours in 2 and 6 treated animals a slight erythema was observed. After 72 hours this erythema was disappared. results referring to the single animals and mean values of erythema and oedema reffering to each observation time are shown in Attachement.
The score of primary skin was: 0165.
According to Classification Draize method: Less than 0.5: NOT IRRITANT