(3R,3aR,6S,6aR)-Hexahydrofuro[3,2-b]furan-3,6-diyl bis(4-hydroxybenzoate)

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

April 24, 2002

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

December 29, 2002

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

August 1992

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24, 2000 as this is in line with OECD 404

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(3R,3aR,6S,6aR)-Hexahydrofuro[3,2-b]furan-3,6-diyl bis(4-hydroxybenzoate)

EC Number:

606-059-4

Cas Number:

185756-31-4

Molecular formula:

C20H18O8

IUPAC Name:

(3R,3aR,6S,6aR)-Hexahydrofuro[3,2-b]furan-3,6-diyl bis(4-hydroxybenzoate)

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: Solid, powder / white
- Homogeneity: The test substance was homogeneous by visual inspection.

Specific details on test material used for the study:

- Name of the test substance used in the study report: DKDS - Reinkristallisat
- Purity: 96.8 w/w%
- Batch No.: CP 203-362-04-02
- pH value: 4.5 (10% aqueous preparation)
- Appearance: Solid, powder / white
- Homogeneity: The test substance was homogeneous by visual inspection.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature. The stability under storage conditions was confirmed by reanalysis

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

A1077 INRA (SPF)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: About 5 months
- Weight at study initiation: 3.23 kg - 3.61 kg
- Housing: The animals were single housed in stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordiaet (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 30 - 70% relative humidity
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Remarks:

minimally moistened with a suitable amount of doubly-distilled water to guarantee skin contact immediately before test substance application

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

0.5 g (the test patch was covered with an amount of minimally moistened solid preparation)

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

- Clipping of the fur: At least 24 hours before the beginning of the study clipping of the dorsolateral part of the trunk of the animals.
- Application area: 2.5 x 2.5 cm
- Application site: flank
- Removal test substance: The test substance was removed at the end of the exposure period with Lutrol and Lutrol / water (1 : 1).
- Readings: lmmediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals maximally up to day 14.
- Illumination used for reading: Daylight tubes "Lumilux" (L 58W/860 PLUS EGO 25X1, Osram, Germany)
- Body weight determination: Just before application of the test substance and after the last reading.
- Check for dead or moribund animals: Twice each workday (beginning and end) and once on Saturdays, Sundays and on public holidays.

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

Other effects:

Slight or moderate erythema (grade 1 or 2) was observed in all animals immediately after removal of the patch and persisted in 2 animals up to 1 hour after removal of the patch. No other cutaneous reactions were observed during the study

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met