Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
15. to 28. Sep. 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

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:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Androst-4-ene-3,17-dione
EC Number:
200-554-5
EC Name:
Androst-4-ene-3,17-dione
Cas Number:
63-05-8
Molecular formula:
C19H26O2
IUPAC Name:
androst-4-ene-3,17-dione

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Doses:
250 and 500 mg/kg bw
No. of animals per sex per dose:
3/dose group
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 500 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Compound-related transient clinical signs were apathy and atactic gait. All animals were without compound-related findings from Day 2 onwards.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
For oral administration, androstenedione is classified as harmful (Xn, R22) according to Directive 67/548/EEC criteria as LD50 >200 <2000 mg/kg.
Category 4 according to Regulation 1272/2008/EC criteria as LD 50 >300 <2000 mg/kg after oral administration, and therefore, based on read-across, testosterone is thus classified.
Executive summary:

There are no available acute oral toxicity studies on testosterone. Results of a study conducted with a structurally similar compound (androstendione, ZK5155) are reported and used for read-across.

The single oral administration of ZK 5155 to female rats at doses of 250 and 500 mg/kg caused compound-related transient clinical signs (apathy and atactic gait). All animals were without compound-related findings from Day 2 onwards. No compound-related macroscopic findings were seen. The LD50 after oral administration of ZK 5155 to female rats is above 500 mg/kg