3,20-bis(ethylenedioxy)pregna-5,7-diene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 14 to 28, 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,20-bis(ethylenedioxy)pregna-5,7-diene

EC Number:

243-175-0

EC Name:

3,20-bis(ethylenedioxy)pregna-5,7-diene

Cas Number:

19592-55-3

Molecular formula:

C25H36O4

IUPAC Name:

(1S,3aR,9aR,9bS,11aS)-9a,11a-dimethyl-1-(2-methyl-1,3-dioxolan-2-yl)-1,2,3,3a,6,8,9,9a,9b,10,11,11a-dodecahydrospiro[cyclopenta[a]phenanthrene-7,2'-[1,3]dioxolane]

Test material form:

other: Crystalline powder

Details on test material:

Off-white crystalline powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan/CPB, Zeist, The Netherlands
- Weight at study initiation: 175-200 g- male; 150-175 g-females
- Fasting period before study: About 18 hours
- Housing: 2 to 3 rats per Macrolon cage containing sawdust
- Diet (e.g. ad libitum): a standard laboratory diet RHM-TM, Hope Farms, Woerden
- Water (e.g. ad libitum): tap water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 40-60 %
- Air changes (per hr): 16
- Photoperiod: Artificial light from 7 a.m. till 7 p.m.; Radio-sound 24 hours per day

Administration / exposure

Route of administration:

other: stomach tube

Vehicle:

other: tragacanth mucilage in distilled water

Details on oral exposure:

From the test material suspension samples with a volume of 10 ml/kg were taken, equivalent to 2000 mg/kg, and were administered by stomach tube to five male and five female fasted rats.

Doses:

dose level:2000 mg/kg ( males and females)

No. of animals per sex per dose:

5 females/males per dose

Control animals:

no

Details on study design:

The test procedure used was in accordance with EEC Directive 84-449, Annex V, Part Bl. The animals were individually identified by means of a dye marking system on the fur. From the test material suspension samples with a volume of
10 ml/kg were taken, equivalent to 2000 mg/kg, and were administered by stomach tube to five male and five female fasted rats.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None of the animals died during the observation period.

Clinical signs:

During the 14-day observation period no clinical signs were observed.

Body weight:

Oral administration of proketal had no appreciable effect on body weights and body weight-gains of male rats during the observation period.
In females, relatively low body weight-gains were observed during the second week of the study.

Gross pathology:

At autopsy 14 days after dosing, dark adrenals in one male, slightly enlarged adrenals in three females, slightly swollen livers in two males and in one female, a not completely empty bladder in one male and a slightly swollen uterus in one female rat was seen.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of the test material was > 2000 mg/kg bodyweight.