Cyclohexapentylose

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: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cyclohexapentylose

EC Number:

233-007-4

EC Name:

Cyclohexapentylose

Cas Number:

10016-20-3

Molecular formula:

C36H60O30

IUPAC Name:

(1S,3R,5R,6S,8R,10R,11S,13R,15R,16S,18R,20R,21S,23R,25R,26S,28R,30R,31R,32R,33R,34R,35R,36R,37R,38R,39R,40R,41R,42R)-5,10,15,20,25,30-Hexakis(hydroxymethyl)-2,4,7,9,12,14,17,19,22,24,27,29-dodecaoxahe ptacyclo[26.2.2.23,6.28,11.213,16.218,21.223,26]dotetracontane-31,32,33,34,35,36,37,38,39,40,41,42-dodecol

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Date of receipt: February 11, 1991
Designation: .alpha.-cyclodextrin
General appearance: white powder
Batch no.: .alpha. W 6, 8708644
CAS. Reg. no.: 10016-20-3
Storage conditions: ambient (circa 20°C)
Just prior to dosing, a smale amount of the test substance was moistened with water in a ration of 1:0.7, by weight.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species: SPF bred New Zealand White albino rabbits.
Supplier: Harlan/CPB, the Netherlands
Sex and age: males, young adult
Date of arrival: November 5, 1991
Body weight range at start of study: 2000-2500g
Identification: earmarking
Acclimatization period: 6/7 days
Caging: individually in suspended galvanized cages, fitted with wire-mesh floor and front
Lighting: 12 hours light/12 hours dark cycle
Temperature: 20 +/- 3 °C
Humidity: 38-72.5% (upper limit higher than 70%, because of meteorological circumstances or because of wet cleaning of the animal room)
Ventilation: ca 10 air changes/hour
Diet: standard laboratory rabbit diet and tap water, ad libitum

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes

Amount / concentration applied:

0.85 g of test mixture (0.5 g of the test substance and 0.35 g of tap water)

Duration of treatment / exposure:

4 hours

Observation period:

skin reading were made at approximately 24, 48, 72 hours after treatment

Number of animals:

3 rabbits

Details on study design:

After the acclimatization period the study was started with one rabbit, which was treated as follows:
A plastic cup with a diameter of ca 2.5 cm was loaded with 0.85 g of the test mixture (0.5 g of the test substance and 0.35 g of tap water). Next, a skin site suitable for application of the test material was selected on the shaven back and flanks of the animal. The cup was placed on the selected, intact skin and fixed to the application site by means of adhesive tape (Leukopor, BDF). The entire trunk of the rabbit was wrapped with a self-adhesive-gauze (Fixomull, art. no. 2112, BDF, W.-Germany) to maintain the cup in position and to retard evaporation of volatile substances. After an exposure period of 4 hours, the cup and the material applied were removed with a paper tissue and tap water, and ca 1 hour later, the resulting skin reactions were evaluated by the method of Draize et al.(J. Pharmacol. Exp. Ther. 82 (1944) 377-390). Since no signs of irritation were observed in this rabbit, it was decided to treat an additional two animals, using the same method as describe above. Further skin readings were made at approximately 24, 48 and72 hours after treatment.

Results and discussion

Any other information on results incl. tables

At all observation time points, no signs of skin irritation were observed in any of the three rabbits.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

At all observation time points, no signs of skin irritation were observed in any of the three rabbits.
On the basis of the results obtained it is concluded that, under the conditions of this study and according to the EEC-standards (mentioned in
EEC-Directive 83/467/EEC and published in the Official Journal of the European Communities, L 257, Volume 26, 16 September 1983), .alpha.-cyclodextrin is not irritating or corrosive to skin.

Executive summary:

A sample of .alpha.- cyclodextrin was examined for acute dermal irritating/ corrosive properties in an experiment with three albino rabbits. The test substance, a powder, was moistened with tap water before application to ensure good skin contact and the dermal exposure period was 4 hours under semi-occlusive conditions.

The test substance did not cause signs of skin irritation in any of the three rabbits.

On the basis of the results obtained it is concluded that, under the conditions of this study and according to the EEC-standards (mentioned in EEC-Directive 83/467/EEC and published in the Official Journal of the European Communities, L 257, Volume 26, 16 September 1983), .alpha.-cyclodextrin is not irritating or corrosive to skin.