.alpha.-Cyclodextrin, 2-hydroxypropyl ethers

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002-05-22 until 2002-08-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Good laboratory practice guideline study (OECD).

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Cavasol W6 HP

IUPAC Name:

Cavasol W6 HP

Details on test material:

- Name of test material (as cited in study report): CAVASOL W6 HP
- Physical state: solid powder
- Analytical purity: 95.9% (GC)
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 63B001
- Expiration date of the lot/batch: 2003-02-28
- Stability under test conditions: stable
- Storage condition of test material: in original container, at room temperature, in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan , Horst, The Netherlands
- Weight at study initiation: 1.8 - 1.9 kg
- Age: At least 6 weeks old
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3 °C
- Humidity (%): 30-70 % rel. humidity
- Air changes (per hr): at least 15/h
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: untreated but shaved other side served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g in 0.3 ml water

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: patch held with an non-irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours


SCORING SYSTEM: as stated in Guideline OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal: 1-3

Time point:

other: any

Score:

0

Max. score:

0

Remarks on result:

other: no irritant effects in any animal

Results 2

Irritation parameter:

erythema score

Basis:

animal: 1-3

Time point:

other: any

Score:

0

Max. score:

0

Remarks on result:

other: no irritant effects in any animal

Results 3

Irritation parameter:

edema score

Basis:

animal: 1-3

Time point:

other: any

Score:

0

Max. score:

0

Remarks on result:

other: no irritant effects in any animal

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Substance is not irritating to the skin of rabbits

Executive summary:

The irritation study on three New Zealand White Rabbits with 0.5 g of Cavasol W6 HP dosed semiocclusively with in 0.3 ml of water did not show any seigns of irritating effects within the observation period. No other signs of toxicity were found.