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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Study period:
25. Sep to 12. 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 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute 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 (ZK 57564)
- 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

Type of coverage:
occlusive
Vehicle:
other: 0.5% (m/v) Tylose MH 1000
Duration of exposure:
24 h
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

no clinical signs

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:

Single dermal application of aldona (ZK 57564) to rats (3/sex) for 24 hours did not induce any clinical or pathological signs. LD50 >2000 mg/kg

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