9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21/09/2016 - 19/10/2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione

EC Number:

213-563-4

EC Name:

9β,11β-epoxy-17,21-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione

Cas Number:

981-34-0

Molecular formula:

C22H28O5

IUPAC Name:

17,21-dihydroxy-16-methyl-9,11-epoxypregna-1,4-diene-3,20-dione

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sanzyme Bio-Analytical.Hyderabad. (CPCSEA reg.No.1837/PO/RCBt/s/15/CPCSEA)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-10 weeks
- Weight at study initiation: 155-183 g
- Fasting period before study:
- Housing: housed individually in polycarbonate cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.40 - 23.10°C
- Humidity (%): 47.70 - 67.60%
- Air changes (per hr): more than 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12/ 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

The test item formed a homogenous suspension in corn oil and hence, it was selected as a vehicle. The desired quality of the test item (300 mg and 2000 mg) was added to the mortar and triturated using pestle. The vehicle (corn oil) was added to the mortar slowly and mixed well. The formulation was then transferred to a calibrated measuring cylinder. The stock concentration of 30 mg/ml and 200 mg/ml was achived by making up the volume to 10 ml in the measuring cylinder.
The stability and homogeneity of the test item in the vehicle was not analysed and the same is excluded from the statement of GLP compliance.

Doses:

A total of six rats were administered orally a dose of 300 mg/kg bw.
Another set of six rats were dosed at 2000 mg/ kg bw

No. of animals per sex per dose:

3 female animals per dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once a day during the 14 day observation period, all rats were weighed on days 0, 7 and 14.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at both doses level (300 mg/kg bw and 2000 mg/kg bw).

Clinical signs:

other: At 300 mg/kg bw G1 (step I and II) and 2000 mg/kg bw G2 (step III and IV), all animals of groups were found to be normal throughout study period.

Gross pathology:

No external or internal gross pathological changes were seen in any of the animals of treated at 300 and at 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute oral LD50 of Beta-Methylepoxy was greater than 2000 mg/kg bw. Beta-Methylepoxy is being classified according to the Globally Harmonized System of classification and Labeling of Chemicals (GHS) as Category 5 or Unclassified.