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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 Mar 2004 to 09 Jul 2004

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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

December 17, 2001

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

September 20, 1996

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

December 202

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

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:

TEST MATERIAL
- Name of the test substance used in the study report: DKDS - Reinkristallisat
- Purity: 96.8 w/w%
- Batch No.: CP 203-362-04-02
- 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:

rat

Strain:

Wistar

Remarks:

HanBrl:WIST(SPF)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd., Wölferstrasse 4, 4414 Füllinsdorf, Switzerland
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Approx 8-12 weeks
- Weight at study initiation: 179 - 191 g
- Fasting before period: Feed was withdrawn from the animals at least 16 hours before administration, but water was available ad libitum.
- Housing: Single housing in stainless steel wire mesh cages, type DK-lll (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiaet (Maus / Ratte Haltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Drinking water: Tap water ad libitum
- Acclimatization: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: Central air-conditioning guaranteed a range of 20 - 24°C
- Humidity: 30 - 70% relative humidity
- Photoperiod: 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Preparation: The test substance preparation was produced for each administration group shortly before administration by stirring with a magnetic stirrer.
- Form of administration: suspension
- Amount of vehicle: 100 mL
- Justification for choice of vehicle: The aqueous formulation corresponds to the physiological medium.
- Concentration used: 20g/100 mL.
- Administration volume: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on the physical and chemical characteristics of the test substance and its composition, no pronounced acute oral toxicity was expected. Therefore, a starting dose of 2,000 mg/kg body weight (limit test) has been chosen in the first step with 3 female animais. As none of those animals died, 2,000 mg/kg body weight were administered to another group of 3 female animais in a second step. Because no mortality occurred either the study fulfilled the criteria for a limit test and was terminated.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Observation period: At least 14 days
- Body weight determination: Individual body weights shortly before administration (day 0), weekly thereafter and at the end of the study.
- Signs and symptoms: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
- Mortality: A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Pathology: Necropsy with gross-pathology examination on the last day of the observation period after killing with CO2.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred

Clinical signs:

other: No clinical signs and findings were observed.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animais examined at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met