Cyclooctapentylose

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:

2002

Report date:

2002

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:

Cyclooctapentylose

EC Number:

241-482-4

EC Name:

Cyclooctapentylose

Cas Number:

17465-86-0

Molecular formula:

C48H80O40

IUPAC Name:

cyclooctapentylose

Details on test material:

Designation: .gamma.-cyclodextrin
CAS no.: 17465-86-0
Batch no.: 80P200
Receipt no.: 24323
Date of receipt: February 15th, 2002
Characteristics: white solid powder
Storage conditions: at room temperature, dark, tightly closed
Stability under storage conditions: at +25 °C: <1 year
Expiry date: February, 2003

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

Species / strain: rabbit / Himalayan, an albino rabbit
Breeder: LPT Laboratory of Pharmacology and Toxicology KG; branch Löhndorf; D-24601 Löhndorf/Post Wankendorf
Selection of species: the rabbit is a commonly used non-rodent species for acute skin irritation tests (patch Test)
Sex: female animals
Number of animals: 3
Initial age: approx. 10 months
Initial body weight: 2.4-2.9 kg
Identification of animals: by tattooed number assigned by the Löhndorf breeding station
Duration of study: at least 20 adaptation days, 1 test day and a follow-up period of 72 hours

Diet:
ssniff K-H (ssniff Spezialdiäten GmbH, 0-59494 Soest) served as food. The food was available ad libitum before and after the exposure period.
At regular intervals (at least twice a year), the food is analysed for contaminants. Certificates of analysis of the composition and for contaminants were supplied by the manufacturer.

Drinking Water:
Drinking water was offered ad libitum before and after the exposure period. Samples of the drinking water are examined according to the 'Deutsche Trinkwasserverordnung, Bundesgesetzblatt, Jahrgang 1990' [German Regulations on drinking water, public notice of the law, 1990] by the Wasserbeschaffungsverband Harburg, D-21220 Seevetal twice a year.
In addition, drinking water samples taken at LPT are analysed by LUFA-ITL once a year for means of bacteriological investigations according to the German 'Deutsche Trinkwasserverordnung, Bundesgesetzblatt, Jahrgang 1990, Anlage 4' [German Regulations on drinking water, public notice of the law, 1990, Addendum 4].

Housing:
Before and after the 4-hour exposure period, the animals were kept singly in cages measuring 425 mm x 600 mm x 380 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, D-16352 Schönwalde) at a room temperature of 20°C ± 3°C (maximum range) and relative humidity of 55% ± 15% (maximum range). Deviations from the maximum range caused for example during cleaning procedures are dealt with in SOPs.
During the exposure period, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn. The cages excluded irritation of the skin by excrements and urine.
The rooms were lit (150 lux at approx. 1.5 m room height) and darkened on a 12-hour light/12-hour dark cycle.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

500 mg/6 cm² moistured with water

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

Route of administration: dermal application to the shaved, intact dorsal skin
Selection of route of administration: according to OECD/EC guidelines
Exposure period: 4 hours
Frequency of administration: single administration
Dose level: 500 mg/patch and animal
Approximately 24 hours before the test, the fur was removed by shaving from the dorsal area of the trunk of the animals. Care was taken to avoid abrading the skin. Only animals with healthy intact skin were used. A dose of 500 mg was moistured sufficiently with water, to ensure good contact with the skin and applied to the test site (area: approx. 6 cm2). The test substance was applied to the test site and then covered with a gauze patch.
The patch was held in contact with the skin by means of a semi-occlusive dressing (non-irritating tape) for the duration of the exposure period. The surrounding untreated skin served as a control. Exposure time was four hours. During the exposure the animals were kept in comfortable restrainers.
Protective clothing:
All personnel handling the animals met the requirements for strict cleanliness. All experimental manipulations were performed by the designated personnel wearing a sterile cap, mask, gown and gloves.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

Under the present test conditions three rabbits were exposed for 4 hours to 500 mg .gamma.-cyclodextrin/patch and animal (semi-occlusive condition). An erythema (grade 1) was noted in animal nos. 1 and 3 from 60 minutes up to 24 hours after patch removal. Animal no. 2 showed no substance related changes at the examination time-points 60 minutes, 24, 48 and 72 hours.
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

There were no systemic intolerance reactions.

Executive summary:

Test system: acute skin irritation test (patch test) in rabbits according to EC guideline B.4. and OECD guideline 404

Test substance: .gamma.-cyclodextrin

Under the present test conditions three rabbits were exposed for 4 hours to 500 mg .gamma.-cyclodextrin/patch and animal (semi-occlusive condition). An erythema (grade 1) was noted in animal nos. 1 and 3 from 60 minutes up to 24 hours after patch removal. Animal no. 2 showed no substance related changes at the examination time-points 60 minutes, 24, 48 and 72 hours.

There were no systemic intolerance reactions.

According to the EC-Commission directive 67/548/EEC and its subsequent amendments on the approximation of the laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present test conditions .gamma.-cyclodextrin was non – irritating to skin, hence, no labelling is required.