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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Sep to Oct 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported 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)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5-Cyano-11 alpha-hydroxy-3,5'-dioxo-4 beta,5',6,7 beta-tetrahydrocyclopenta[4,5,6,7]-5 beta,17 alpha-pregnane-21,17-carbolactone
EC Number:
606-280-6
Cas Number:
192704-54-4
Molecular formula:
C24 H29 N O5
IUPAC Name:
5-Cyano-11 alpha-hydroxy-3,5'-dioxo-4 beta,5',6,7 beta-tetrahydrocyclopenta[4,5,6,7]-5 beta,17 alpha-pregnane-21,17-carbolactone
Details on test material:
- Name of test material (as cited in study report): ZK 233744
- Batch No.: 1366
- Purity: 92.3%

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: physiol. saline + Myrj 53 in bidest.water
Doses:
2000 mg/kg (application volume 10 mL/kg)
No. of animals per sex per dose:
3
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 animal died in the course of the study. No compound-related clinical signs, effects on body weight or abnormalities at necropsy were observed.

Applicant's summary and conclusion

Executive summary:

The single oral administration of the test substance (ZK 233744) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. No compound-related clinical signs or effects on body weight were observed and there were no macroscopic pathological signs.

The acute oral toxicity of Diketon in rats is therefore above 2000 mg/kg body weight.

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