2-Hydroxypropyl-β-cyclodextrine ethers

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:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose

IUPAC Name:

.beta.-Cyclodextrin, 2-hydroxypropyl cycloheptaamylose

Constituent 2

Reference substance name:

-

EC Number:

420-920-1

EC Name:

-

Cas Number:

128446-35-5

Molecular formula:

Hill formula: (C42H70-nO35)(C3H7O)n; n(mittel)=5,25

IUPAC Name:

5,10,15,25-tetrakis(hydroxymethyl)-40,44,47,49-tetrakis(2-hydroxypropoxy)-20,30,35-tris[(2-hydroxypropoxy)methyl]-2,4,7,9,12,14,17,19,22,24,27,29,32,34-tetradecaoxaoctacyclo[31.2.2.2³,⁶.2⁸,¹¹.2¹³,¹⁶.2¹⁸,²¹.2²³,²⁶.2²⁸,³¹]nonatetracontane-36,37,38,39,41,42,43,45,46,48-decol

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): hydroxypropyl .beta.-cyclodextrin
- Physical state:solid
- Analytical purity: 100%
- Storage condition of test material: tightly closed containers
- Other: Source: American Maize-Products Company

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mohican Valley Rabbitry, Inc. Loudonville, Ohio
- Age at study initiation: young adult
- Weight at study initiation: 2.203 - 2.415 kilograms
- Housing: housed individually in suspended stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 61-70
- Humidity (%): 40 - 60
- Air changes (per hr): equal to 11 or more
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,5g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 lm of deionized water

Duration of treatment / exposure:

72 hours

Observation period:

Body weights were recorded within 16-30 hours prior to dosing. All rabbits were observed at least once daily during quarantine acclimation and twice daily during the experimental period for mortality and moribundity.

Number of animals:

3 males
3 females

Details on study design:

TEST SITE
- Area of exposure: back
- coverage site: one square inch in size
- Type of wrap if used: hypoallergenic Dermicel tape and elastic Vetrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wiped with disposable paper towels wetted with water
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

no effects

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material, hydroxypropyl .beta.-cyclodextrin, did not produce erythema, edema or other dermal effects in rabbits. The primary irritation index was 0.0. The material was considered to be a nonirritant to the skin of albino rabbits.

Executive summary:

The study equivalent to OECD 404 was conducted to determine the dermal irritation produced by a single application of the test material, hydroxypropyl .beta.-cyclodextrin, in albino rabbits. A dose of 0.5g of the test material was administered to a dorsal skin site on each of six New Zealand White rabbits. The material was maintained at each site over a four-hour exposure period, the sites were wiped with paper towels wetted with water to aid in the removal of any remaining test material. Each of the sites was examined and scored for signs of irritation at 30 to 60 minutes and approx. 24, 48 and 72 hours following the removal of the bandaging and patch.

No erythema, edema or other dermal effects were observed in any of the six rabbits during the study.

The primary irritation index for the test material, hydroxypropyl .beta.-cyclodextrin, was 0.0. The material was considered to be a nonirritant to the skin of albino rabbits.