Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: pre-guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
- Name of test material (as cited in study report): 1alpha-methylandrostane-17beta-ol-3-on

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
physiological saline
Doses:
4000 mg/kg
No. of animals per sex per dose:
5sex
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

The test substance was tolerated without any compound-related clinical or macroscopic pathological findings.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

No acute toxicity studies were conducted with mesterolone acetate. Results of studies conducted with mesterolone (ZK 9226) are regarded as representative as most likely ester-cleavage occurs in vivo after administration.

The single oral administration of an aqueous microcristalline suspension of mesterolone (ZK 9226) to male and female mice was tolerated without any compound-related clinical or macroscopic pathological findings. The acute oral toxicity of ZK 9226 in mice is above 4000 mg/kg body weight.