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Registration Dossier
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EC number: 606-059-4 | CAS number: 185756-31-4
Toxicological information
Skin irritation / corrosion
Currently viewing:
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:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- April 24, 2002
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- December 29, 2002
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1992
- 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
- 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.
Constituent 1
- 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
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- 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
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