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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
25 Sep to 13 Oct 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-oxopregn-4-ene-21,17α-carbolactone
EC Number:
213-552-4
EC Name:
3-oxopregn-4-ene-21,17α-carbolactone
Cas Number:
976-70-5
Molecular formula:
C22H30O3
IUPAC Name:
(1R,3aS,3bR,9aR,9bS,11aS)-9a,11a-dimethyl-2,3,3a,3b,4,5,7,8,9,9a,9b,10,11,11a-tetradecahydrospiro[cyclopenta[a]phenanthrene-1,2'-oxolane]-5',7-dione
Details on test material:
- Name of test material (as cited in study report): aldona (ZK57564)
- Analytical purity: 95.5% HPLC
- Lot/batch No.: 59035042
- Expiration date of the lot/batch: Aug 2002

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% (m/v) Tylose MH 1000
Doses:
2000 mg/kg
No. of animals per sex per dose:
3/sex
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Transient rough hair coat, apathy, squatting position, decreased body temperature only in females.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 >2000 mg/kg, no classification required
Executive summary:

The single oral administration of aldona (ZK57564) to male and female Wistar rats (3/sex) at the dose of 2000 mg/kg resulted in transient rough hair coat, apathy, squatting position, decreased body temperature only in females. No compound-related macroscopic findings were seen.LD50 >2000 mg/kg

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