Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A study according to OECD guideline but not GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
no
Test type:
acute toxic class method

Test material

Constituent 1
Reference substance name:
17-alpha-hydroxypregna-4,9(11)-diene-3,20-dione
IUPAC Name:
17-alpha-hydroxypregna-4,9(11)-diene-3,20-dione
Constituent 2
Chemical structure
Reference substance name:
17-hydroxypregna-4,9(11)-diene-3,20-dione
EC Number:
251-868-4
EC Name:
17-hydroxypregna-4,9(11)-diene-3,20-dione
Cas Number:
34184-82-2
Molecular formula:
C21H28O3
IUPAC Name:
(1R,3aS,3bS,9aS,11aS)-1-acetyl-1-hydroxy-9a,11a-dimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,9aH,11H,11aH-cyclopenta[a]phenanthren-7-one
Details on test material:
Test article: Oxediene (raw material)
Batch: 0916860039

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
OFA Sprague Dawley rat, IOPS Caw

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 10 ml/kg in Methylcellulose
Doses:
300 mg/kg. Other doses (50, 2000 mg/kg) are possibly studied depending on the results obtained.
No. of animals per sex per dose:
3 females
Details on study design:
Single administration followed by a 15-day observation period

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study conducted with Oxediene (batch 0916860039), the maximal dose tested was non-lethal (2000 mg/kg). The LD50 > 2000 mg/kg.