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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

Constituent 1
Chemical structure
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:
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.
Body weight:
The body weight of all animals treated at 300 mg/kg bw and at 2000 mg/kg bw was recorded and a normal bw gain was noted.
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.