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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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