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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Jul 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

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
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
7 beta-Hydroxy-3 beta,15 alpha-dipivaloyloxy-5-androsten-17-one
EC Number:
617-708-6
Cas Number:
85390-94-9
Molecular formula:
C29 H44 O6
IUPAC Name:
7 beta-Hydroxy-3 beta,15 alpha-dipivaloyloxy-5-androsten-17-one
Details on test material:
- Name of test material (as cited in study report): ZK 92136
- Batch No.: 21604815

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: physiol. saline + Myrj 53
Doses:
2000 mg/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 compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.

Applicant's summary and conclusion

Executive summary:

The single oral administration of the test substance (ZK 92136) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The acute oral toxicity of Dipivalat in rats is therefore above 2000 mg/kg body weight.

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